AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)

K030340 · Cytomedix · JQC · Apr 11, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030340
• Device Name: AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
• Applicant: Cytomedix
• Product Code: JQC · Clinical Chemistry
• Decision Date: Apr 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of autologous platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).

Device Story

AutoloGel Process Centrifuge is a table-top, non-self-decanting, fixed-angle rotor centrifuge. It processes small volumes of whole blood (up to 60 ml) to separate plasma and red blood cells based on liquid density. The device is microprocessor-controlled with preset speed and current-controlled acceleration/braking. It operates at a maximum speed of 7200 RPM, generating approximately 4227 g of force. Used at the point of care, it is intended for the preparation of autologous platelet-rich plasma. The device features lid locking and holding mechanisms for safety. Healthcare providers use the resulting PRP for clinical applications. The device benefits patients by providing a rapid method for autologous PRP preparation.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Table-top centrifuge; fixed-angle rotor; microprocessor-controlled; current-controlled acceleration/braking; max speed 7200 RPM; max force 4227 g; capacity up to 60 ml; lid locking/holding safety features; non-refrigerated; non-self-decanting.

Indications for Use

Indicated for the preparation of autologous platelet-rich plasma (PRP) from a small sample of patient blood (up to 60 ml) at the point of care. Safety and effectiveness for in vivo indications have not been established.

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.

Predicate Devices

• Harvest Technologies, LLC., SmartPrep Centrifugation System (K991430)
• 3i Models 7426 and 7437 CelSep Centrifuge System (K994148)

Submission Summary (Full Text)

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Original 510(k) Notification

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CONFIDENTIAL

## D. 510(K) SUMMARY

KO 30340

APR 11 2003

510K Summary for the AutoloGel Process Centrifuge

| Submitter's Name and Address: | Cytomedix, Inc<br>1523 S. Bowman Road, Suite A<br>Little Rock, AR 72211 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 501-219-2111 |
| Fax Number: | 501-219-2114 |
| Contact Person: | Carelyn P. Fylling<br>Vice President of Professional Services<br>218-547-4142 (o)<br>501-352-1184 (cell)<br>[e-mail] |
| Date Summary Prepared: | January 20, 2003 |
| Device Trade Name: | AutoloGel Process Centrifuge |
| Common Name: | General purpose centrifuge |
| Classification Name: | General purpose laboratory equipment labeled or promoted<br>for a specific medical use<br>(21 CFR 862.2050) - Class I |
| Product Code: | JQC<br>[Centrifuges (Micro, Ultra, Refrigerated) for Clinical Use] |
| Substantial Equivalence: | The proposed device is substantially equivalent to other<br>table-top centrifuges previously cleared by the FDA via the<br>510K Notification process. Two predicative centrifuges have<br>been identified: Harvest Technologies, LLC., SmartPrep<br>Centrifugation System (K991430) and 3i Models 7426 and<br>7437 CelSep Centrifuge System (K994148). |
| Device Description: | The AutoloGel Process Centrifuge consists of a table-top,<br>non self-decanting, rotor spin centrifuge and processing<br>disposables designed to allow for rapid automatic separation<br>of plasma and red blood cells from a small volume of whole<br>blood. The centrifuge spins at a maximum speed of 7200<br>rpms producing a maximum force of approximately 4227 g. |
| Intended Use: | The AutoloGel Process Centrifuge is designed to be used at<br>the patient's point of care for the safe and rapid preparation<br>of autologous platelet-rich plasma (PRP) from a small sample<br>of the patient's blood (up to 60 ml). |

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## Technological Characteristics:

The proposed device has the same technological characteristics and is similar in design and configurations compared with the predicate devices. (See Table A)

| Table A | | | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison of The AutoloGel Process Centrifuge with the Predicative Devices | | | |
| Features | Cytomedix<br>AutoloGel Process<br>Centrifuge<br>(This submission) | Harvest SmartPrep<br>Centrifuge System<br>K991430 | 3i CelSep<br>K994148 |
| Intended Use | To be used at the<br>patient's point-of-care<br>for the safe and rapid<br>preparation of<br>autologous platelet-<br>rich plasma (PRP)<br>from a small sample<br>of the patient's blood<br>(up to 60 ml). | To be used in the<br>clinical laboratory or<br>intraoperatively at<br>point-of-care for the<br>safe and rapid<br>preparation of platelet<br>poor plasma and<br>platelet concentrate<br>from a small sample<br>of blood. The plasma<br>and concentrated<br>platelets produced can<br>be used for diagnostic<br>tests. | For use in the clinical<br>laboratory or<br>intraoperatively at<br>point-of-care for the<br>safe and rapid<br>preparation of platelet<br>poor plasma and<br>platelet concentrate<br>from a small sample<br>(50 - 60 ml of whole<br>blood. The plasma<br>and concentrated<br>platelets produced can<br>be used for diagnostic<br>tests. |
| Principles of<br>Operation | Separation based on<br>density of liquids | Separation based on<br>density of liquids | Separation based on<br>density of liquids |
| Table-Top | Yes | Yes | Yes |
| Refrigerated | No | No | No |
| Swinging Bucket | No, fixed angle rotor | Yes | Yes |
| Automatic Decanting | No | Yes | No |
| Micro-Processor<br>Controlled | Yes | Yes | Yes |
| User Programmable | No, preset by<br>manufacturer | No, preset by<br>manufacturer | Yes |
| Speed Control | Preset | Preset | Selectable |
| Acceleration and<br>Braking | Current-controlled | Current-controlled | Current-controlled |
| Maximum RPM | 7200 RPM | 6000 RPM | 3400 RPM |
| Maximum RCF | 4227 g | 3550 g | 2050 g |
| Tube Capacity | Various sizes,<br>maximum 60 ml | Two Processing<br>Disposables (50 ml<br>/disposable) | 1 Disposable<br>60 ml/disposable |
| Lid Locking, Lid<br>Holding | Yes | Yes | Yes |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Ms. Carelyn P. Fylling Vice President for Professional Services Cytomedix, Inc. 1523 S. Bowman Road - Suite A Little Rock, AR 72211

APR 1 1 2003

Re: k030340 Trade/Device Name: AutoloGel Process Centrifuge 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: JOC Dated: January 31, 2003 Received: January 31, 2003

Dear Ms. Fylling

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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 a 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.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2 - Mr. Lonnie Witham

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

If you desire specific information about the application of other 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"(21 CFR 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,

& Duton

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE B.

Applicant: Cytomedix, Inc. 510(k) Number (if known): K030340 Device Name: AutoloGel Process Centrifuge Indications For Use:

The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jacchini Santini

মুক্

1

Prescription Use (per 21 CFR 801.109)

I Laboratory Devices

510(k) Number K030340

Over-the Counter Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

January 31, 2003 CYTOMEDIX, INC. X AutoloGel Process Centrifuge