GENESISCS COMPONENT CONCENTRATING SYSTEM

K070666 · Perfusion Partners & Assoc., Inc. · JQC · Jun 20, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070666
• Device Name: GENESISCS COMPONENT CONCENTRATING SYSTEM
• Applicant: Perfusion Partners & Assoc., Inc.
• Product Code: JQC · Clinical Chemistry
• Decision Date: Jun 20, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow.

Device Story

GenesisCS Component Concentrating System processes blood or bone marrow samples to isolate plasma, platelet concentrate, or cell concentrate. Used in clinical laboratories or intraoperatively at point-of-care; operated by clinicians. Device facilitates rapid preparation of autologous concentrates. Output is concentrated cellular/plasma product for clinical use. Benefit includes efficient, rapid preparation of biological components for therapeutic applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System for blood/bone marrow component concentration. Mechanical separation principle. Standalone device. No software or electronic components described.

Indications for Use

Indicated for clinical laboratory or intraoperative point-of-care preparation of platelet poor plasma, platelet concentrate from blood, and cell concentrate from bone marrow.

Regulatory Classification

Identification

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Nancy Lord, MD, Esquire Perfusion Partners & Associates, Inc. 1970 North Leslie Road, Number 220 Pahrump, Nevada 89060

JUN 2 0 2007

Re: k070666

Trade/Device Name: GenesisCS Component Concentrating System Regulation Number: 21 CFR 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: Class I Product Code: JQC Dated: November 26, 2006 Received: March 12, 2007

Dear Dr. Lord:

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.

The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:

The safety and effectiveness of this device for in vivo indications for use has not been established.

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Nancy Lord, MD, Esquire

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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,

Robert G. Becker

Robert L. Becker, Jr., MD, PhD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE STATEMENT (As required by 21 CFR 801.109)

The GenesisCS Component Concentrating System is intended to be used in a clinical laboratory or intraoperatively at the point of care for the safe and rapid preparation of plasma and platelet concentrate from a small sample of blood and for a preparation of a cell concentrate from bone marrow. The safety and effectiveness of this device for in vivo indications for use has not been established.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

Over-the-Counter Use:

Auschine Bautista

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K070666

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