HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K051040 · Medtronic Perfusion Systems · JOX · May 24, 2005 · Hematology

Device Facts

• Record ID: K051040
• Device Name: HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
• Applicant: Medtronic Perfusion Systems
• Product Code: JOX · Hematology
• Decision Date: May 24, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5680
• Device Class: Class 2

Intended Use

The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

Device Story

HDR controls are single-use, non-sterile, in-vitro diagnostic plasma controls. Used with HMS Plus instrument to verify performance of HDR cartridges. Controls identify if heparinized channels in HDR cartridge function normally by measuring clotting time ratios between heparinized and unheparinized channels. HDR control 1 verifies channels 1, 2, 5, and 6; HDR control 2 verifies channels 3, 4, 5, and 6. Used at point-of-care to ensure instrument and cartridge accuracy.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements; results demonstrated that predetermined acceptance criteria were met.

Technological Characteristics

Materials: Sheep plasma, hexadimethrine bromide solution. Function: Quality control for coagulation cartridges. Modification: Adjusted clot time ratio pass/fail ranges and increased rehydration time to 5 minutes.

Indications for Use

Indicated for verifying the performance of HDR cartridges and the HMS Plus instrument in a point-of-care setting.

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

• Heparin Dose Response Controls (K043080)

Submission Summary (Full Text)

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K 051040

MAY 2 4 2005

(Optional Format 3-10-98)

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# 510(k) Summary

| Date Prepared: | April 20, 2005 |
|-----------------|--------------------------------------|
| Submitter: | Medtronic Perfusion Systems |
| | 7611 Northland Boulevard |
| | Brooklyn Park, MN 55428 |
| Contact Person: | Bruce Backlund |
| | Senior Regulatory Affairs Specialist |
| Phone: | (763)-391-9183 |
| Fax: | [phone] |

# Device Name and Classification:

:

:

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| Trade Name: | Heparin Dose Response Control |
|--------------------|----------------------------------------|
| Common Name: | Analyzer, Heparin, Automated |
| Classification: | Class II |
| Predicate Devices: | Heparin Dose Response Controls K043080 |

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#### Device Description

The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly.

The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

### Indication for Use

The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

### Comparison to Predicate Device

The predicate device 510(k) K043080 was cleared on December 3, 2004.

### Summary of Performance Data

Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.

#### Conclusion

Medtronic Perfusion Systems has demonstrated that the HDR Controls are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the caduceus, indicating the department's name and country.

MAY 2 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bruce Backlund Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive Brooklyn Park, MN 55428-1008

k051040 Re: Trade/Device Name: Heparin Dose Response Controls Regulation Number: 21 CFR 864.5680 Regulation Name: Automated heparin analyzer Regulatory Class: Class II Product Code: JOX Dated: April 20, 2005 Received: April 25, 2005

Dear Mr. Backlund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use succe in the exerce , 1976, the enactment date of the Medical Device Amendments, or to conniner of the 114) 2011-01-11 accordance with the provisions of the Federal Food, Drug, de vices that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) and the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general condolo provisioning 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 your device is enabilitional controls. Existing major regulations affecting your device it may be subject to Sach adde 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 I Trass oc advisod that I Dr Crisean that your device complies with other requirements of the Act that I Dri has made a abientiallations administered by other Federal agencies. You must of any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with and 110 (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), accenses 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) I mis letter will and w you to ough finding of substantial equivalence of your device to a legally premation notification - 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, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promise Evaluation and Safety at [phone]. Also, please note the vitto Diagnostic DeMisbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain 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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology 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): KOSS Device Name: Heparin Dose Response Controls

Indications For Use:

The Heparin Dose Response (HDR) controls are used to verify the performance of HDR cartridges and the HMS Plus instrument.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use___________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

Josephine Bautista
Division/Sign/Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

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