SurgiCount+ System

K232250

Stryker Instruments · cleared 2024-01-11 · product code PBZ · General Hospital

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The SurgiCount+ [SC+] System Software is a multi-functional software application that is intended to be used as an adjunct in the estimation of blood loss and management of surgical sponges and other surgical substrates. The SaMD product includes the following nonmedical device and Class I consumable and hardware accessories: a mobile device (Apple iPad Pro), RFID-tagged surgical sponges/absorbent items, an RFID reader, a bluetooth-enabled scale, and a stand (or optional wall mount) that houses the hardware accessories and connects the accessory devices to electrical power.”
Algorithmproprietary AI Algorithms trained using machine learning techniques
source quote (p.6)
“The Application then processes the images using proprietary AI Algorithms. The algorithms generate the same output for a given input (are fixed) and have been trained using machine learning techniques to recognize the sponges and to estimate Hb mass and blood loss volume on the imaged substrates.”
Adaptive (vs locked)No
source quote (p.6)
“The algorithms generate the same output for a given input (are fixed)”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“Cybersecurity design planning and testing ensured that the software was architected and designed to minimize cybersecurity threats.”

Validation studies (5)

Bench

sample size not stated

endpoints: accuracy of Hb algorithm in estimating Hb mass; limits of agreement between actual hemoglobin mass and sHbL

Bench

sample size not stated

endpoints: failure rate (sum of false images and failed detection)

Bench

sample size not stated

endpoints: electromagnetic compatibility (EMC) safety and effectiveness

standards: IEC 60601-1-2

Bench

sample size not stated

endpoints: functioned as designed in the presence of Wi-Fi and Bluetooth interferers

standards: ANSI C63.27, AAMI TIR 69

Reader study (MRMC)

n=15 other

endpoints: safety; effectiveness; mitigation of use risks; absence of significant residual or new usability risks

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

0
recalls in product code, 24mo
6
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252282 (decision 2026-03-16) from Stryker Instruments for a matching device line ("SurgiCount+ System") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252282

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Stryker Instruments Div. of Stryker Corporation) — same firm and product code, not necessarily this device · initiated 2020-01-22

    Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in lower than expected results.

    recall event 90464 (openFDA)

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 General Hospital 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/K232250