HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20

K042070 · Medtronic Vascular · JOX · Oct 1, 2004 · Hematology

Device Facts

• Record ID: K042070
• Device Name: HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
• Applicant: Medtronic Vascular
• Product Code: JOX · Hematology
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5680
• Device Class: Class 2

Intended Use

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

Device Story

The Hepcon Hemostasis Management System (HMS) Heparin Dose Response (HDR) Cartridge is an in vitro diagnostic device used for hemostasis management. The device modification involves replacing USP bovine heparin with USP porcine heparin due to the commercial unavailability of bovine heparin. The system operates by measuring heparin dose response to guide clinical anticoagulation management. The device is used in clinical settings by healthcare professionals. The modification was verified through precision and stability testing, including comparisons between bovine and porcine HDR cartridges and HR-ACT cartridges on the HMS Plus system. The modification does not alter the fundamental scientific technology or the intended use of the device.

Clinical Evidence

No clinical data; performance established via bench testing including stability, accuracy, and precision studies.

Technological Characteristics

In vitro diagnostic cartridge for use with HMS/HMS Plus instruments. Measures whole blood coagulation response to heparin. Modification involves heparin source. No specific materials or software algorithm details provided.

Indications for Use

Indicated for determining in vitro individual responses to heparinization using whole blood in patients requiring heparin therapy, for use with HMS or HMS Plus instruments.

Regulatory Classification

Identification

An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

Special Controls

*Classification.* Class II (special controls).

Predicate Devices

• Hepcon® HMS Coagulation System and its Associated Cartridges and Controls (K894317)

Submission Summary (Full Text)

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K042070

OCl 1 - 2004

510(k) Summary

Date Prepared: August 19, 2004

Submitter:

Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428

Contact Person: Dawn M. Stenstrom Principal Regulatory Affairs Specialist Phone: [phone] Fax: [phone]

## Device Name and Classification:

| Trade Name: | Heparin Dose Response Cartridge |
|--------------------|------------------------------------------------------------------------------|
| Common Name: | Analyzer, Heparin, Automated |
| Classification: | Class II |
| Predicate Devices: | Hepcon® HMS Coagulation System and its Associated<br>Cartridges and Controls |
| | K894317 |

#### Device Description

The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.

#### Indication for Use

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

## Comparison to Predicate Device

The predicate device is the currently marketed HDR cartridge. The currently marketed HDR cartridge has the same indications for use and is the same in all aspects to the modified cartridge with exception of the source of heparin.

## Summary of Performance Data

Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device.

#### Conclusion

Medtronic has demonstrated that the HDR cartridge is substantially equivalent to the predicate device based upon design, test results, and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 - 2004

Ms. Dawn M. Stenstrom Principal Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: k042070

> Trade/Device Name: Heparin Dose Response Cartridge Regulation Number: 21 CFR § 864.5680 Regulation Name: Automated Heparin Analyzer Regulatory Class: II Product Code: JOX Dated: September 16, 2004 Received: September 17, 2004

#### Dear Ms. Stenstrom:

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 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.

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.

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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 L. Becker, Jr.

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

Enclosure

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# Indications for Use

510(k) Number (if known): K042070

Device Name:

## Heparin Dose Response Cartridge

Indications for Use:

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Djagnostic Devices (OIVD)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042070

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