BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

K982241 · Duxbury Scientific, Inc. · CAC · Nov 30, 1998 · Anesthesiology

Device Facts

• Record ID: K982241
• Device Name: BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
• Applicant: Duxbury Scientific, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Nov 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.

Device Story

The Betatrans Intraoperative Autotransfusion System collects intraoperative drainage blood; processes/filters blood for reinfusion to the patient. Used in surgical settings; operated by trained clinical staff. System reduces reliance on homologous blood transfusions, mitigating risks of infectious agents like Hepatitis or HIV. Device functions as a mechanical collection and reinfusion circuit.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical autotransfusion system; consists of collection and reinfusion components. Operates via standard intraoperative blood salvage principles. No software or electronic components described.

Indications for Use

Indicated for patients undergoing surgery requiring intraoperative blood collection and reinfusion to reduce or eliminate the need for homologous blood transfusion.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 30 1998

Mr. Robert M. Engler Director of Operations Duxbury Scientific, Inc. 80 Seabury Point Road Duxbury, MA 02332

K982241 Re : Betatrans Intraoperative I and II Autotransfusion Systems Regulatory Class: II (Two) Product Code: CAC September 19, 1998 Dated: Received: September 24, 1998

Dear Mr. Engler:

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 Requlations, 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 requlations.

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## Page 2 - Mr. Robert M. Engler

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding acberibed in your ivalence 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,

Sincerely yours,

Thomas J. Callahan

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

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## INDICATIONS FOR USE OPTIONAL FORMAT

510(k) Number (if known): __ K 982241

Device Name: BETATRANS INTRAOPERATIVE AUTOTRANSFUSION SYSTEM

Indications For Use:

The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.

Bete L. Lamperle
(Division Sign-Off)

Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_K 98 224 /

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use (Per 21 CFR 801.109)

Over The Counter Use_________________

(Optional Format 1-2-96 Reproduced)