CARA System

K252500

Cara Medical, Ltd. · cleared 2026-02-20 · product code OWB · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“The CARA System is a medical device comprising two integrated functions. The CARA System device components include the CARA Metis Simulator and the CARA Atlas Navigator. Both components provide diagnostic imaging software and hardware functions... The Cara Metis Simulator is a Software as a Medical Device (SaMD). The software utilizes AI/ML algorithms to provide OCR detection, automated segmentation of anatomical structures, and detection of catheters.”
AlgorithmAI/ML algorithms, including deep learning models, are used for OCR detection, automated segmentation of anatomical structures (heart chambers, aorta), conduction system modeling, and detection of catheters.
source quote (p.7)
“The CARA System utilizes AI/ML algorithms to provide OCR (Optical Character Recognition), automated segmentations and device tracking: ... Segmentations - the system utilizes deep learning models to automatically generate anatomical segmentations of the heart chambers and aorta. ... The subject device utilizes AI/ML-based algorithms for CT-based cardiac anatomical segmentation, conduction system modeling, OCR-based metadata extraction, and fluoroscopic device detection to assist in overlay initialization and refinement.”
Adaptive (vs locked)No
source quote (p.15)
“Algorithms were trained using retrospective, multi-site clinical datasets. Data augmentation techniques (e.g., rotation, scaling, and noise injection) were applied to support generalizability. Training and test datasets were independent.”
PCCPNo
Cybersecurity addressedYes
source quote (p.15)
“cybersecurity controls were validated against NIST SP 800-53 and FDA guidance to confirm the air-gapped architecture.”

Validation studies (6)

Bench

sample size not stated

endpoints: CT-to-fluoroscopy registration accuracy; system latency; image fidelity

standards: IEC 62304, NIST SP 800-53, IEC 60601-1, IEC 60601-1-2

Standalone

n=61 images

endpoints: Error rate

Standalone

n=50 scans

endpoints: Dice Similarity Coefficient; Average Surface Distance

Standalone

n=480 images

endpoints: Dice Similarity Coefficient

Standalone

n=2,139 images

endpoints: Median distal tip

Retrospective clinical

n=403 patients

endpoints: association between the CARA-visualized Conduction System Axis (CSA) and post-procedural outcomes; pacing effectiveness relative to the CARA-visualized Left Bundle Branch (LBBP)

Reported performance (4 observations)

diceas written: “Cardiac Chambers Segmentation - Dice Similarity Coefficient”stated without value
source quote (p.15)
“DSC ≥ 0.85”
diceas written: “Aortic Segmentation - Dice Similarity Coefficient”0.962
source quote (p.15)
“Mean DSC = 0.962”
accuracyas written: “CT-to-fluoroscopy registration accuracy - Mean registration error”2
source quote (p.15)
“The system achieved a mean registration error of ≤ 2.0 mm and a maximum error of ≤ 3.0 mm, meeting predefined thresholds within clinically acceptable limits for fluoroscopic overlay systems.”
time_to_resultas written: “System latency”stated without valueCI ≤ 133 ms (95% upper bound)
source quote (p.15)
“The system demonstrated latency of ≤ 133 ms (95% upper bound), supporting real-time synchronization during intra-procedural guidance.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

100
recalls in product code, 24mo
10937
MAUDE reports in code, 12mo
+44%
vs code's own 3-yr baseline
7
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2026-05-20): "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99079

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19): "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99041

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-29): "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98244

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98096

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98108

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-08): "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor," Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98071

  • …and 1 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252500