SMARTPREP CENTRIFUGE SYSTEM

K991430 · Harvest Technologies, LLC · JQC · May 28, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991430
• Device Name: SMARTPREP CENTRIFUGE SYSTEM
• Applicant: Harvest Technologies, LLC
• Product Code: JQC · Clinical Chemistry
• Decision Date: May 28, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

The Harvest SmartPReP Centrifuge System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.

Device Story

SmartPReP Centrifuge System is a table-top, swinging bucket centrifuge; utilizes processing disposables for rapid automatic separation of plasma and platelets from blood samples. Operates via density-based liquid separation; microprocessor-controlled; features preset speed/acceleration/braking. Used in clinical laboratories or intraoperatively at point-of-care; operated by clinicians. Device provides automated decanting; includes lid locking, lid holding, and imbalance detection for safety. Output is platelet poor plasma and platelet concentrate for diagnostic use; facilitates rapid preparation compared to manual methods.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Table-top, swinging bucket centrifuge; metal housing and rotor with anti-torsion construction. Microprocessor-controlled; preset speed control (max 6000 RPM, 3550g). Features automatic decanting, lid locking/holding, and imbalance detection. Connectivity not specified. Sterilization not specified.

Indications for Use

Indicated for the preparation of platelet poor plasma and platelet concentrate from small blood samples for diagnostic testing in clinical laboratory or intraoperative point-of-care settings.

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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K991430

MAY 2 8 1999

## 510(k) Summary for the Harvest Technologies SmartPReP Centrifuge System

| Submitter's Name and Address: | Harvest Technologies Corp.<br>77 Accord Park Drive, D-7 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 781-982-1900 |
| Telefax Number: | 781-982-7288 |
| Contact Person: | Richard Lariviere, Operations Manager |
| Date Summary Prepared: | April 22, 1999 |
| Device Trade Name: | SmartPRePTM Centrifuge System |
| Common name: | General Purpose Centrifuge for Clinical Use |
| Classification Name: | General purpose laboratory equipment labeled or<br>promoted for a specific medical use (21 CFR<br>862.2050) |
| Substantial Equivalence: | The proposed device is substantially equivalent<br>to other table-top centrifuges previously cleared<br>by the FDA via the 510(k) Notification process |
| Device Description: | SmartPReP Centrifuge System: Includes a<br>table-top, self-decanting, swinging bucket<br>centrifuge and processing disposable designed to<br>allow for rapid automatic separation of plasma<br>and platelets. The centrifuge spins at a<br>maximum speed of 6000 rpms at a maximum<br>force of approximately 3550g. |
| Intended Use: | The Harvest SmartPReP Centrifuge System is<br>designed to be used in the clinical laboratory or<br>intraoperatively at point-of-care for the safe and<br>rapid preparation of platelet poor plasma and<br>platelet concentrate from a small sample of<br>blood. |
| Technological Characteristics: | The proposed device has the same technological<br>characteristics and is similar in design and<br>configurations compared with the predicate<br>device (See Table 6-1). |

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# TABLE 6-1
COMPARISON OF THE HARVEST SMARTPReP AND PREDICATE CENTRIFUGES

| Features | SmartPReP<br>(This Submission) | Predicate Centrifuge |
|----------------------------|----------------------------------------------------|----------------------------------------------------|
| Principle of Operation | Separation based on density of liquids | Separation based on density of liquids |
| Table-Top | Yes | Yes |
| Refrigerated | No | No |
| Swinging Bucket | Yes | Yes |
| Automatic Decanting | Yes | No |
| Micro-processor Controlled | Yes | Yes |
| User Programmable | No, program set by manufacturer | Yes |
| Speed Control | Preset | Selectable |
| Acceleration and Braking | Current-controlled | Current-controlled |
| Maximum RPM | 6000 RPM | 4000 RPM |
| Maximum RCF | 3550 g | 3077 g |
| Tube Capacity | Two Processing Disposables<br>(50 mL/disposable) | Variety of sizes and volumes<br>up to 250mL |
| Lid Locking, Lid Holding | Yes | Yes |
| Imbalance Detector | Yes | Yes |
| Construction | Anti-torsion construction, metal housing and rotor | Anti-torsion construction, metal housing and rotor |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAY 28 1999

Richard Lariviere Operations Manager HARVEST TECHNOLOGIES CORPORATION 77 Accord Park Drive, D-7 Norwell, MA 02061

Re: K991430 Trade Name: SmartPREP Centrifuge System Requlatory Class: I Product Code: JQC April 23, 1999 Dated: Received: April 26, 1999

Dear Mr. Lariviere:

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 The general controls provisions of the provisions of the Act. 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 Regulations, 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug 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. this response to your premarket notification Please note: 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 regulations.

Image /page/2/Picture/8 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 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,

Steven Putman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT

Page 1 of 1

510(k) Number (if known):

Harvest Technologies SmartPRePTM Centrifuge System Device Name:

The Harvest SmartPReP™ CENTRIFUGE SYSTEM is designed to be Indications for Use: used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small sample of blood.

> The plasma and concentrated platelets produced can be used for diagnostic tests.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Jiter E. Malin

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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