The Stryker ConstaVac Blood Conservation System II (CBCII) is an autologous blood recovery system intended for the post-operative collection and filtration of blood from a surgical wound in order to transfuse the whole blood back to the patient.

The Stryker ConstaVac Blood Conservation System II (CBCII) Disposal Blood Bag is used with the previously cleared CBC II System to provide a disposal Blood Bag is used with the CBCII reservoir in the CBCII reservoir.

Device Description

The Stryker CBCII System is a single patient use, sterile, disposable, autotransfusion apparatus. The system consists of a wound drain and evacuator tube, an 800cc blood collection reservoir, a means for providing a vacuum in which to drain the blood from the wound site, a means for transferring the blood to a reinfusion bag and a reinfusion The blood disposal bag provides a means for the user to dispose of wound baq. drainage collection once reinfusion has been discontinued.

AI/ML Overview

No specific acceptance criteria or a study proving the device meets them are provided in the input text. The document is primarily a 510(k) clearance letter for the Stryker ConstaVac Blood Conservation System II, establishing its "substantial equivalence" to predicate devices.

From the text, we can glean the following information about the device and its regulatory clearance:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness	Substantially equivalent to existing marketed products. No new safety and efficacy concerns raised.
Applicable Standards	Meets applicable sections of American National Standard for Auto Transfusion Devices, ANSI/AAMI AT6-1981.
Biocompatibility	Meets biocompatibility guidelines set forth in the Tripartite Guidance.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. The provided text does not describe a clinical study with a "test set" in the context of device performance metrics or a comparison to ground truth. The clearance is based on substantial equivalence to predicate devices, supported by adherence to standards and biocompatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not Applicable. As no specific "test set" and associated ground truth establishment are described, this information is not provided.

4. Adjudication Method for the Test Set:

Not Applicable. As no specific "test set" and associated ground truth establishment are described, this information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No MRMC comparative effectiveness study is mentioned. The clearance is based on substantial equivalence and adherence to standards, not a direct comparison of human reader performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not Applicable. This device is a physical medical apparatus (Autotransfusion Apparatus), not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used:

Not Applicable / Implied Equivalence: The concept of "ground truth" as it applies to diagnostic or prognostic AI models is not directly relevant here. The "ground truth" for the clearance of this autotransfusion device is an assessment of its equivalence to already legally marketed devices in terms of intended use, power modality, and safety risks, along with compliance with established industry standards (ANSI/AAMI AT6-1981) and biocompatibility guidelines.

8. The Sample Size for the Training Set:

Not Applicable. This device is a physical medical apparatus, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. As per point 8, there is no "training set" for this type of device.

Summary

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Stryker® K90714

4100 East Milham Avenue Kalamazoo, MI 49001-6197 (616) 323-7700 (800) 253-3210

DEC 1 6 1997

Device Name:

Classification Name:	Autotransfusion Apparatus: 21 CFR 868.5830,Class II
Common/Usual Name:	Postoperative Autotransfusion Device
Proprietary Name:	Stryker ConstaVac Blood Conservation System I(CBCII)
Device Sponsor:	Stryker CorporationInstruments Division4100 E. Milham AvenueKalamazoo, MI 49001Registration No: 1811755

Regulatory Class:

Summary of Safety and Effectiveness:

Class II

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This reinfusion device has been tested and does meet the applicable sections of the American National Standard for Auto Transfusion Devices, ANSI/AAMI AT6-1981 as well as the biocompatibility guidelines set forth in the Tripartite Guidance.

The CBCII System is equivalent to existing marketed products by companies such as Baxter V. Mueller. Power modality, intended use, and safety risks are all substantially equivalent. The CBCII Blood Disposal Bag is equivalent to existing marketed products by companies such as Zimmer. Intended use and safety risks are substantially equivalent.

The Stryker CBC II System, including the blood disposal bag, does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Therefore, the Stryker CBC II System is substantially equivalent to these existing devices.

Tammy Founds

Tammy Loui Assoc. Manager, Regulatory Affairs Stryker Instruments

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, positioned to the right of a circular emblem. The emblem contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circle's perimeter.

Public Health Service

Rockville MD 20857

Mr. Rodney Parker Microbologist and Supervisor of Regulatory Affairs Stryker Instruments 4100 East Milham Avenue Kalamazoo, MI 49001

DEC I 6 1997

Re: K970714 Stryker Constavac Blood Conservation System II Requlatory Class: II (Two) Product Code: CAC October 15, 1997 Dated: Received: October 22, 1997

Dear Mr. Parker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Rodney Parker

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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868 · 5830 CAC II -Autorbransfosion eratus

Page_l

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ k 97074

Device Name: CBCII Blood Disposal Bag_

Indications For Use:

The Stryker ConstaVac Blood Conservation System II (CBCII) Disposal Blood Bag is used with the previously cleared CBC II System to provide a disposal Blood Bag is used with
in the CBCII reservoir in the CBCII reservoir.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The- Counter Use _

(Optional Format 1-2-96)

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).