PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM

K022167 · Pall Corp. · CAC · Mar 7, 2003 · Anesthesiology

Device Facts

• Record ID: K022167
• Device Name: PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM
• Applicant: Pall Corp.
• Product Code: CAC · Anesthesiology
• Decision Date: Mar 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5830
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DONOR, HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery. They are indicated for the post-operative collection of blood from an orthopedic surgery patient's wounds and body cavities, filtration of that blood, and reinfusion of the same patient. Thus, the DONOR has the same intended use and general indications as its predicate devices. In addition, The DONOR significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.

Device Story

System collects, filters, and reinfuses post-operative blood for orthopedic surgery patients. Device utilizes pre-evacuated vacuum technology to draw blood from surgical sites. Integrated filtration mechanism reduces lipids, leukocytes, and C3a levels prior to reinfusion. Used in clinical settings; operated by healthcare professionals. Benefits patient by providing autologous blood transfusion, reducing need for donor blood, and minimizing potential adverse reactions through reduction of inflammatory/lipid components.

Clinical Evidence

Bench testing only. Device tested for compliance with ANSI/AAMI/AT-6 (1991). Bench data substantiates claims for reduction of lipids, leukocytes, and C3a.

Technological Characteristics

Pre-evacuated autotransfusion system. Filtration mechanism for lipid, leukocyte, and C3a reduction. Complies with ANSI/AAMI/AT-6 (1991) standards. Mechanical operation via vacuum-assisted collection.

Indications for Use

Indicated for post-operative collection, filtration, and autologous reinfusion of blood from wounds and body cavities in orthopedic surgery patients.

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
• Gish Biomedical, Inc.'s Orthofusor Wound Drainage/Autotransfusion System
• Richards' Solocotrans
• Stryker Surgical's CBC-ConstaVac

Submission Summary (Full Text)

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### Attachment 7

### 510(k) SUMMARY

## PALL's DONOR® Pre-evacuated Post-Operative Autologous Blood Transfusion System

### Submitter's Name, Address, Telephone Number, Contact Personand Date Prepared

Pall Medical 2200 Northern Boulevard East Hills, NY 11548 Phone: [phone] Fax:

Contact Person: Leonard S. Berman. Ph.D.

Date Prepared: June 28,2002]

#### Name of Device

Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System

### Common or Usual Name: Autotransfusor

Classification Name: Autotransfusion Apparatus

Predicate Devices:

- Zimmer Hemovac ●
- Gish Biomedical, Inc.'s Orthofusor Wound Drainage/Autotransfusion System ●
- Richards' Solocotrans .
- Stryker Surgical's CBC-ConstaVac® ●

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## Intended Use / Indications for Use

The DONOR. HemoVac, Orthofusor, Solocotrans, and ConstaVac are intended to be use to collect, filter, and reinfuse blood lost by the patient due to surgery. They are indicated for the post-operative collection of blood from an orthopedic surgery patient's wounds and body cavities, filtration of that blood, and reinfusion of the same patient. Thus, the DONOR has the same intended use and general indications as its predicate devices.

In addition, The DONOR significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it. The 510(k) notice includes bench data that substantiates each of these claims.

# Performance Data

The Donor was tested in accordance with ANSVAAMI/AT-6 (1991) and found to comply with that standard. Bench data substantiates the DONOR's leukocyte, lipid, and C3a reduction claims.

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MAR 0 7 2003

Pall Corporation c/o Leonard S. Berman, Ph.D. Director of Scientific Affairs 2200 Northern Boulevard East Hills, NY 11548

Re: K022167

Trade Name: Pall Donor® Pre-evacuated Post-Operative Autologous Blood Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: December 15, 2002 Received: December 17, 2002

Dear Dr. Berman:

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. Iisting 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.

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Page 2 - Leonard S. Berman, Ph.D.

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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

M.A.B. D. Zakeri, M.D.

Bram D. Zuckerman. M.D. Director Division of Cardiovascualr Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 8

Indications for Use Statement

510(k) Number (if known):

Medical

Device Name: Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System

Indications for Use: Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System is indicated for the post-operative collection of blood from an orthopedic surgerv patient's wounds and body cavities, filtration of that blood, and reinfusion of the blood into the same patient. Pall Donor ® Pre-evacuated Post-Operative Autologous Blood Reinfusion System significantly reduces lipids, leucocytes, and C3a from the blood before reinfusing it.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**510(k) Number** K022167

Prescription Use
(Per 21 C.F.R. 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)