HEMOVAC BLOOD REINFUSION SYSTEM

K041525 · Zimmer, Inc. · CAC · Oct 14, 2004 · Anesthesiology

Device Facts

• Record ID: K041525
• Device Name: HEMOVAC BLOOD REINFUSION SYSTEM
• Applicant: Zimmer, Inc.
• Product Code: CAC · Anesthesiology
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HEMOVAC® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.

Device Story

The Hemovac® Blood Reinfusion System is a sterile, single-patient-use, closed, disposable system for post-operative autologous blood management. The system utilizes a Hemovac® evacuator to create suction, drawing blood from the surgical site through a wound drain and blood lines into an 800ml collection reservoir. The reservoir features a pre-filter and a fat retention valve designed to separate fats from the collected blood. Anticoagulant may be added via an injection port. Collected blood is transferred to a reinfusion bag via gravity feed. The reinfusion bag is then spiked with a standard patient administration set (containing a 20-40 micron filter, not supplied) for gravity reinfusion to the patient. The system can be converted to straight drainage for disposal after reinfusion is no longer required. The device is operated by clinical staff in a post-operative setting to facilitate autotransfusion, potentially reducing the need for homologous blood products.

Clinical Evidence

No clinical data was required or provided for this device. Substantial equivalence is supported by non-clinical bench testing, including compliance with ANSI/AAMI AT6-1991 (Autologous Transfusion Devices) and ISO 10993-1:1997 (Biological evaluation) and ISO 10993-4:2002 (Hemocompatibility).

Technological Characteristics

Closed, disposable autotransfusion system. Components include wound drain, trocars, blood lines, 800ml collection reservoir with pre-filter and fat retention valve, Hemovac® evacuator, and reinfusion bag. Operates via mechanical suction and gravity feed. Materials evaluated per ISO 10993-1 and ISO 10993-4. No electronic or software components; purely mechanical fluid management system.

Indications for Use

Indicated for post-operative collection, filtration, and reinfusion of autologous blood in patients undergoing procedures where such therapy is deemed appropriate by a physician.

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

• Zimmer Hemovac® Autotransfusion System (K920273)
• CBC II Constavac™ Autotransfusion System (K952224)
• Suretrans™ Autotransfusion System (K913247 or 914119)

Submission Summary (Full Text)

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## Summary of Safety and Effectiveness

| Submitter: | Zimmer Orthopaedic Surgical Products<br>200 West Ohio Avenue<br>P.O. Box 10<br>Dover, Ohio 44622 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy J. Dickey<br>Regulatory Compliance Manager<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | June 4, 2004 |
| Trade Name: | HEMOVAC® BLOOD REINFUSION SYSTEM |
| Common Name: | Autotransfusion System |
| Classification Name<br>and Reference: | Apparatus, Autotransfusion<br>21 CFR § 868.5830 |
| Predicate Devices: | Zimmer Hemovac® Autotransfusion System,<br>manufactured by Zimmer Orthopaedic Surgical<br>Products, K920273, cleared January 28, 1993 |
| | CBC II Constavac™ Autotransfusion System,<br>manufactured by Stryker®, K952224, cleared<br>November 17, 1995 |
| | Suretrans™ Autotransfusion System, manufactured<br>by Davol®, K913247 or 914119, cleared February<br>25, 1993 or December 3, 1992 |
| Device Description: | The HEMOVAC® Blood Reinfusion System is a<br>sterile, single patient use, closed, disposable system<br>intended for post operative collection, filtration, and<br>reinfusion of autologous blood. |
| | The system consists of a wound drain and trocars,<br>blood lines, graduated 800ml blood collection<br>reservoir (contains pre-filter, air filter, fat retention<br>valve), Hemovac® evacuator, anticoagulant port,<br>transfer tube, and blood reinfusion bag. |

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The wound is drained utilizing suction created by activating the Hemovac® evacuator. Blood passes through the drain, blood line tubing, and into the collection reservoir (pre-filter located inside of collection reservoir).

Anticoagulant may be added through the injection port located in the blood line. Anticoagulant therapy is administered at the discretion of the physician.

To reinfuse the collected blood back to the patient. the blood is transferred from the collection reservoir to the reinfusion bag via gravity feed. A fat retention valve (located inside of the collection reservoir) is designed to retain the top portion of the collected blood which may contain fats. The blood bag is spiked with a standard patient administration set that contains a 20-40 micron filter (not supplied with the system), and the blood bag is gravity reinfused to the patient per hospital/AABB guidelines.

The process is repeated for additional collection/reinfusions. After collection for reinfusion is no longer desired, the system can be converted to straight drainage for disposal only. The Hemovac® evacuator is removed from the collection reservoir and reconnected to the blood line assembly. An accessory infection control bag (not supplied with the system) may be used to empty the contents of the evacuator. This is used for disposal only.

Indications for Use: The Hemovac® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.

Comparison to Predicate Device:

The Hemovac® Blood Reinfusion system is substantially equivalent to the legally marketed

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autotransfusion systems, specifically the Stryker® CBC II Constavac™, Davol® Suretrans™, and the Zimmer Hemovac® Autotransfusion in that the devices are similar in design, materials, and indications for use.

## Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

This device has been tested and does meet the applicable sections of the American National Standard for Autologous Transfusion Devices, ANSI/AAMI AT6-1991, as well as ANSI/AAMI/ ISO 10993-1:1997, "Biological evaluation of Medical Devices." Hemocompatibility was conducted in accordance with AAMI/ANSI/ ISO 10993-4:2002.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

OCT 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer Orthopaedic Surgical Products c/o Ms. Cindy J. Dickey Regulatory Compliance Manager 200 West Ohio Avenue P.O. Box 10 Dover, OH 44622

Re: K041525

> Trade/Device Name: Hemovac® Blood Reinfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: II Product Code: CAC Dated: June 4, 2004 Received: September 22, 2004

Dear Ms. Dickey:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 – Ms. Cindy J. Dickey

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only to begin marketing your device as described in your Section 510(k) rins letter with anon yourse FDA finding of substantial equivalence of your device to a legally prematic. In a classification of 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 regulation (21 CFR Part 801), please 11 you dome office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Dmna R. boihner

- J Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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## Indications for Use

510(k) Number (if known): KO4 | 5 25

Device Name:

Hemovac® Blood Reinfusion System

Indications for Use:

The HEMOVAC® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.

Prescription Use _X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donna R. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

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510(k) Number K041525