HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR

K043080 · Medtronic Vascular · JOX · Dec 3, 2004 · Hematology

Device Facts

• Record ID: K043080
• Device Name: HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
• Applicant: Medtronic Vascular
• Product Code: JOX · Hematology
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5680
• Device Class: Class 2

Intended Use

The controls are used to verify the performance of the appropriate cartridge on the HMS Plus instrument

Device Story

HDR Control set consists of single-use, non-sterile, in-vitro diagnostic plasma controls; used at point-of-care with HMS Plus instrument. Controls verify functionality of heparinized channels within HDR cartridges 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. Healthcare providers use these controls to ensure instrument and cartridge performance prior to clinical use, ensuring accurate heparin dose response monitoring for patients.

Clinical Evidence

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

Technological Characteristics

Lyophilized control material (sheep plasma, hexadimethrine bromide). Storage 2-10°C. Rehydration time 3 minutes. Reconstitution stability 1 hour at 15-25°C. Used with HMS Plus instrument and HDR cartridges. Pass/fail criteria based on clot time ratio range.

Indications for Use

Indicated for use as quality control materials to verify the performance of specific cartridges on the HMS Plus coagulation instrument.

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

• HMS Controls (K894317)

Submission Summary (Full Text)

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

K043080

DEC - 3 2004

(Optional Format 3-10-98)

:

# 510(k) Summary

| Date Prepared: | November 04, 2004 |
|-----------------|------------------------------------------------------------------------------------|
| Submitter: | Medtronic Perfusion Systems<br>7611 Northland Boulevard<br>Brooklyn Park, MN 55428 |
| Contact Person: | Bruce Backlund<br>Senior Regulatory Affairs Specialist |
| | Phone: [phone]<br>Fax: [phone] |

# Device Name and Classification:

| Trade Name: | Heparin Dose Response Control |
|--------------------|-------------------------------|
| Common Name: | Analyzer, Heparin, Automated |
| Classification: | Class II |
| Predicate Devices: | HMS Controls K894317 |

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

### 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 Control set is similar in design and use (vial size and reconstitution method) to the existing liquid controls being used in the HMS platform. 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) K894317 was cleared on September 5, 1989. This 510(k) introduced the entire Hepcon® HMS product family, including cartridges and controls.

The HDR cartridge marketed under K042070 (previously K894317, see table for chronology), Instructions for Use is included in Appendix A.

#### 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.

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

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 features a stylized depiction of an eagle's head and three horizontal lines above it, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bruce Backlund Senior Regulatory Affairs Specialist Medtronic Cardiac Surgery 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: k043080 Trade/Device Name: Heparin Dose Response Control Regulation Number: 21 CFR § 864.5680 Regulation Name: Automated Heparin Analyzer Regulatory Class: II Product Code: JOX, GGC Dated: November 4, 2004 Received: November 8, 2004

Dear Mr. Backlund:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nove 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.

DFC - 3 2004

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 Eederal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r four ove actived 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 or uny I edetal statuated and states and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice OFF Part 887), as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in keting 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.

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

Page 2

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 of questions on all proxie 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 I ou may obtain other general messantional 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

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

### Indications for Use

510(k) Number (if known): K04308080 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

Page _1_ of _1__

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safe

510(k) K043080