The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.

Device Description

The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.

AI/ML Overview

The provided text is a 510(k) summary for the "Rapid Transfer Blood Bag," a medical device. This document focuses on the regulatory submission process and the intended use of the device, rather than detailed performance studies or specific acceptance criteria with reported data.

Therefore, the document does not contain the information requested to comprehensively fill out the table regarding acceptance criteria and study details.

Here's a breakdown of what can be extracted and why other sections cannot be completed:

1. A table of acceptance criteria and the reported device performance

Cannot be filled. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., blood transfer rate, efficiency, mechanical strength, sterility, biocompatibility data from specific tests). It's a regulatory submission summarizing the device and its intended use, rather than a detailed study report.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be filled. The document does not describe any specific testing, test set sample sizes, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This question pertains to studies involving expert review for ground truth establishment, typically for diagnostic or image-based devices. The Rapid Transfer Blood Bag is a device for fluid transfer, and its evaluation would not typically involve expert consensus on "ground truth" in this manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI/diagnostic software, so MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. See point 3.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

In summary, the provided document is a regulatory affairs submission (510(k) summary and FDA letter) focused on demonstrating substantial equivalence to predicate devices, rather than a detailed technical study report containing performance data and acceptance criteria.

Summary

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DEC 18 1998

K982712 510(K) SUMMARY

1. SUBMITTER:

Genzyme Surgical Products 600 Airport Road Fall River, MA 02720 Telephone: 508-677-6600

Contact: Stephen M. Page, Director of Regulatory Affairs Date Prepared: July 31, 1998

2. DEVICE:

Genzyme Surgical Products Rapid Transfer Blood Bag Classification Name: Autotransfusion Apparatus Trade Name: Rapid Transfer Blood Bag

3. PREDICATE DEVICE:

Genzyme Surgical Products Pleur-evac Autotransfusion Blood a. Recovery Bag
b Atrium Medical Corporation ATS Blood Bag

4. DEVICE DESCRIPTION:

The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.

5. INTENDED USE:

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol, which is a staff with a serpent entwined around it, representing medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

Mr. Stephen M. Page Genzyme Surgical Products Corp. 600 Airport Road Fall River, MA 02720-4740

K982712 Re: Rapid Transfer Blood Bag Regulatory Class: II (two) Product Code: 73 CAC Dated: November 19, 1998 November 23, 1998 Received:

Dear Mr. Page:

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 legally marketed predicate 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, Drug, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 Failure to comply with the GMP regulation may result in assumptions. In addition, FDA may publish further announcements regulatory action. 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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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/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Allelson

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

Enclosure

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INDICATIONS FOR USE Rapid Transfer Blood Bag

Mark Kramer

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

510(k) Number K182712

Prescriptions use

TC __

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).