MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300

K021902 · Medtronic Vascular · JQC · Aug 12, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021902
• Device Name: MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
• Applicant: Medtronic Vascular
• Product Code: JQC · Clinical Chemistry
• Decision Date: Aug 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2050
• Device Class: Class 1

Intended Use

The Magellan™ Autologous Platelet Separator 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 (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.

Device Story

Magellan Autologous Platelet Separator System; microprocessor-controlled table-top centrifuge; processes small blood samples to separate plasma and platelets. Operates at max 3800 RPM (approx. 1300g). Used in clinical labs or intraoperatively at point-of-care; operated by healthcare professionals. Produces platelet-poor plasma and platelet-rich plasma for diagnostic testing. Benefits include safe, rapid autologous blood component preparation.

Clinical Evidence

Performance data supporting safety and effectiveness included in 510(k) notification; comparative performance testing conducted against predicate device.

Technological Characteristics

Microprocessor-controlled table-top centrifuge; max speed 3800 RPM; max g-force ~1300g; utilizes processing disposables for blood separation.

Indications for Use

Indicated for preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) 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.

Predicate Devices

• SmartPREPTM Centrifuge System (K991430)

Submission Summary (Full Text)

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AUG 1 2 2002

K021902

# Appendix II

## 510(k) Summary Magellan™ Autologous Platelet Separator System (as required by 21 CFR 807.92)

### Submitter Information A.

| Submitter's Name: | Medtronic Perfusion Systems |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 7611 Northland Drive N<br>Minneapolis, Minnesota 55428-1088 U.S.A. |
| Telephone Number: | 763.391.9000 |
| Contact Person: | Lucy Tan |
| Date Submission Prepared: | June 07, 2002 |
| B. Device Information | |
| Device Trade Name: | Magellan™ Autologous Platelet Separator System |
| Common or usual 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) |
| Predicate Device: | SmartPREPTM Centrifuge System<br>Harvest Technologies Corp.<br>K991430 - 05/28/1999 |
| Device Description: | Magellan Autologous Platelet Separator system<br>consists of a microprocessor controlled table-top<br>centrifuge and processing disposables designed to<br>allow for safe and rapid automatic separation of<br>plasma and platelets. The centrifuge spins at a<br>maximum speed of 3800 rpms at the maximum g-<br>force of approximately 1300g. |
| Indications for Use: | The Magellan Autologous Platelet Separator<br>System is designed to be used in the clinical<br>laboratory or intraoperatively at point of care for the<br>safe and rapid preparation of platelet poor plasma<br>and platelet concentrate (platelet rich plasma) from<br>a small sample of blood. |

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### C. Comparison of Required Technological Characteristics

The technological characteristics of the Magellan Platelet Separator system are substantially equivalent to the noted predicate device.

### D. Performance Data

Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification.

#### D. Conclusion

Magellan Autologous Platelet Separator System is substantially equivalent to the noted predicate device based on the similarities of technological characteristics, the identical indications for use and the results of performance comparative testing.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is a stylized image of three abstract human figures, possibly representing a family or community, with their heads overlapping and facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# AUG 1 2 2002

Ms. Lucy Tan Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N. Minneapolis, Minnesota 55428-1088

Re: k021902

> Trade/Device Name: Magellan™ Autologous Platelet Separator System Regulation Number: 21 CFR § 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: II Product Code: FMF, JQC Dated: June 7, 2002 Received: June 10, 2002

Dear Ms. Tan:

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.

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.

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.

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### 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 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,

Steven Sutman

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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# Appendix III Indications for Use Statement

| -------------------------------------------------------------------- | | The Comments of Children<br>CHECK CHE COLLECT COLLECTION CONTRACT COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARDER COLLECTION CONTRACT CARACT CARACT CARACT CARACT CARACT |
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| 510(k) Number (if known): | K021902 |
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Device Name:

Indications for Use:

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The Magellan™ Autologous Platelet Separator 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 (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K021902 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR Over-The-Counter Use<br>(Optional Format 1-2-96) |
|------------------------------------------|-----------------------------------------------------|
| ✓ | |