RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250

K982712 · Genzyme Surgical Product (Genzyme Biosurgery) · CAC · Dec 18, 1998 · Anesthesiology

Device Facts

• Record ID: K982712
• Device Name: RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
• Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
• Product Code: CAC · Anesthesiology
• Decision Date: Dec 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame; used for blood evacuation and reinfusion of shed mediastinal and pleural drainage. Operates in conjunction with Pleur-evac Continuous Reinfusion Autotransfusion Systems. User expands bag via actuator handle to facilitate blood transfer. Used in clinical settings by healthcare professionals to manage autotransfusion, potentially benefiting patients by enabling reinfusion of shed blood.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Flexible vinyl bag with rigid frame; manual actuator handle for expansion; mechanical operation; non-powered.

Indications for Use

Indicated for patients requiring shed mediastinal and pleural drainage and autotransfusion. Used in conjunction with Pleur-evac Continuous Reinfusion Autotransfusion Systems.

Regulatory Classification

Identification

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

Predicate Devices

• Genzyme Surgical Products Pleur-evac Autotransfusion Blood Recovery Bag
• Atrium Medical Corporation ATS Blood Bag

Submission Summary (Full Text)

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DEC 18 1998

# K982712 510(K) SUMMARY

# 1. SUBMITTER:

Genzyme Surgical Products 600 Airport Road Fall River, MA 02720 Telephone: [phone]

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:

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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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.

Mark Kramer

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

510(k) Number K182712

Prescriptions use

TC *_*_