3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM

K994148 · Implant Innovations, Inc. · JQC · Feb 1, 2000 · Clinical Chemistry

Device Facts

• Record ID: K994148
• Device Name: 3I MODEL(S)7426 AND 7427 CELSEP CENTRIFUGE SYSTEM
• Applicant: Implant Innovations, Inc.
• Product Code: JQC · Clinical Chemistry
• Decision Date: Feb 1, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

The 3i "CelSep" centrifuge System is designed for use 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.

Device Story

CelSep Centrifuge System is a table-top, swinging bucket centrifuge; processes small volumes (50-60ml) of whole blood using single-use disposables. Principle of operation: density-based separation via centrifugation (max 3400 RPM, 2050g). Used in clinical labs or intraoperatively at point-of-care by clinicians. Device features microprocessor-controlled speed and acceleration/braking. Output is platelet-poor plasma and platelet concentrate for diagnostic testing. Benefits include rapid, self-contained, and safe blood component preparation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Table-top, swinging bucket centrifuge. Anti-rotational metal housing and rotor. Microprocessor-controlled. Max speed 3400 RPM; max force 2050g. Current-controlled acceleration/braking. User-programmable speed. Single-use disposable processing system. Non-refrigerated.

Indications for Use

Indicated for use in clinical laboratories or intraoperatively at point-of-care for the preparation of platelet-poor plasma and platelet concentrate from small (50-60ml) whole blood samples for diagnostic testing.

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)

{0}------------------------------------------------

.

K994148

# 510(k) SUMMARY 3i CelSep Centrifuge System

| Submitter's name and address: | Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410 | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Telephone: | [phone] | |
| Contact Person: | William G. Conety | |
| Date Summary prepared: | 1999 November 02 | |
| Device proprietary/trade name: | "CelSep" 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 to<br>other table-top centrifuges previously cleared by the<br>FDA via the 510(k) Notification process. | |
| Device Description: | "CelSep" Centrifuge System consists of a table-top,<br>non self-decanting, swinging bucket centrifuge and<br>single-use processing disposable, designed to permit<br>rapid and completely self-contained and safe<br>separation of plasma and platelets from a small<br>volume of whole blood. The centrifuge spins at a<br>maximum speed of 3400 rpms at a maximum force<br>of approximately 2050g. | |
| Intended Use: | The 3i "CelSep" centrifuge System is designed for<br>use in the clinical laboratory or intraoperatively at<br>point-of-care for the safe and rapid preparation of<br>platelet poor plasma and platelet concentrate from a<br>small sample of blood. | |
| Technological Characteristics: | "CelSep" centrifuge has the same technological<br>characteristics and is similar in design and<br>configuration compared with the predicate device<br>(See Table 15c) | |
| Principle of operation | Separation based on density<br>processing speed and equipment | Separation based on density<br>processing speed and equipment |
| Table-Top Design | Yes | Yes |
| Refrigerated | No | No |
| Swinging Bucket | Yes | Yes |
| Automatic Decanting | No (1) | Yes |
| Micro-Processor Controlled | Yes | Yes |
| User Programmable | Yes | No |
| Speed Control | Selectable | Preset |
| Acceleration/breaking | Current-controlled | Current-controlled |
| Maximum RPM | 3400 RPM | 6000g |
| Maximum RCF | 2050 RPM | 3550g |
| Processing capacity | 1 disposable<br>60ml/disposable | 2 disposables<br>50ml/disposable |
| Lid Locking/Holding | Yes | Yes |
| Imbalance Detector | No (2) | Yes |
| Construction | Anti-rotational, metal<br>housing and rotor | Anti-rotational, metal<br>housing and rotor |

{1}------------------------------------------------

## Table 15a

## COMPARISON OF 3i "CelSep" AND PREDICATE CENTRIFUGE

#### Features

## 3i "CelSep"

### Predicate Centrifuge

- (1) The "CelSep" centrifuge is not automatic decanting by design. The processing disposable is completely self-contained and is manually, pneumatically decanting.
- (2) No imbalance detection feature is required by "CelSep" due in part to the lower speeds required for processing.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

{2}------------------------------------------------

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 stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

#### 1 2000 FEB

Mr. William G. Conety Regulatory Affairs Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K994148

> Trade Name: 3i "CelSep" Centrifuge System Regulatory Class: I Product Code: JQC Dated: December 1, 1999 Received: December 8, 1999

Dear Mr. Conety:

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 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 (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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification 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.

{3}------------------------------------------------

Page 2

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" (21CFR 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 Butman

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

{4}------------------------------------------------

510(k) Number: K 994/48

Page 1 of 1

3i "CelSep" Centrifuge System Device Name:

# INDICATIONS FOR USE:

The 3i "CelSep" Centrifuge System, is designed for use in the clinical laboratory or intraoperatively at point-of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60ml) of whole blood.

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

#### DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rita E. Madini

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994148

Prescription Use: √
(Per 21 CFR 801.109)

OR

Over the counter use: ________________________________________________________________________________________________________________________________________________________