HEPARIN DOSE RESPONSE CARTRIDGE

K102953 · Medtronic, Inc. · JOX · Nov 4, 2010 · Hematology

Device Facts

• Record ID: K102953
• Device Name: HEPARIN DOSE RESPONSE CARTRIDGE
• Applicant: Medtronic, Inc.
• Product Code: JOX · Hematology
• Decision Date: Nov 4, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5680
• Device Class: Class 2

Intended Use

The Heparin Dose Response (HDR) Cartridge is intended for use with the Hepcon HMS system to measure the heparin dose response of a patient's blood. It is intended for use in a clinical setting by trained healthcare professionals.

Device Story

The Heparin Dose Response (HDR) Cartridge is an in vitro diagnostic consumable used with the HMS Plus instrument. It processes whole blood samples to measure individual patient responses to heparin. The device modification involves a 13.6% increase in porcine-derived USP heparin concentration within the cartridge channels. The cartridge functions as part of an automated heparin analyzer system, typically used in clinical settings to guide anticoagulation management. Healthcare providers use the resulting data to assess heparin sensitivity, which informs clinical decisions regarding heparin dosing during procedures requiring anticoagulation. The device provides quantitative output to assist in patient-specific heparin therapy.

Clinical Evidence

Bench testing only. Verification testing was conducted to confirm performance of the modified cartridges containing revised USP heparin concentrations. Data from this testing was used to update applicable tables in the Instructions for Use.

Technological Characteristics

Single-use cartridge for Hepcon HMS system. Contains heparinized channels (1-4) with revised USP heparin concentrations (2.84 units/mL and 1.7 units/mL). Fundamental sensing technology unchanged from predicate.

Indications for Use

Indicated for patients requiring heparin anticoagulation monitoring during procedures where heparin is administered. No specific age or gender contraindications provided.

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 (HDR) Cartridge (k042070)

Submission Summary (Full Text)

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V - 4 2010

## 510(k) Summary

| Date Prepared | October 1, 2010 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establish Registration Number: 2184009 |
| Contact Person | Jeffrey L. Koll<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |

## Device Name and Classification

Trade Name: Common Name: Regulation Number: Product Code: Classification:

Heparin Dose Response (HDR) Cartridge Automated Heparin Analyzer 21 CFR 864.5680 JOX Class II

## Predicate Device

Heparin Dose Response (HDR) Cartridge (K042070) cleared on October 1, 2004.

#### Comparison to Predicate Device

A comparison of the modified device and the currently marketed Heparin Dose Response (HDR) Cartridge shows the following similarities:

- Same intended use.
- Same operating principle. .
- Same technological characteristics. .
- Same performance claims. ●

Alleviating Pain · Restoring Health · Extending Life

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## Description of Device Modification

Heparin

- The modification to the current device is to replace old USP heparin with revised . USP heparin. The heparin concentrations have been increased by 13.6% for heparinized channels (ch 1 & 2 and ch 3 &4). The source of the heparin remains porcine.
### Intended Use

The intended use is unchanged.

## Labeling

The current labels and IFU are being updated to reflect the revised USP heparin concentrations in heparinized channels (ch. I & 2 and ch.3 & 4). The current IFU also includes updates for style, grammar and readability. Applicable tables have also been updated with data generated from the verification testing with modified cartridges using revised USP heparin.

- . Appendix A contains the current IFU.
- Appendix B contains the draft IFU. ●
- Appendix C contains the current and draft labels .

#### Conclusion

The modifications to the Heparin Dose Response (HDR) Cartridge described in this submission result in a substantially equivalent device because the fundamental scientific technology and the intended use are unchanged.

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Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Medtronic, Inc. Medtronic Perfusion Systems c/o Mr. Jeffrey Koll Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112

NOV 0 4 2010

Re: k102953

Trade/Device Name: Heparin Dose Response (HDR) Cartridge Regulation Number: 21 CFR 864.5680 Regulation Name: Automated heparin analyzer Regulatory Class: Class II Product Code: JOX Dated: October 28, 2010 Received: November 1, 2010

Dear Mr. Koll:

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 class II (Special Controls), 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 Feceral 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

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Page 2 – Mr. Jeffrey Koll

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 Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/industry/support/index.html.

Sincerely yours,

m. Chen

Maria M. Chan. Ph.D 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

KID2953 510(k) Number (if known):

Device Name: Heparin Dose Response Cartridge

NOV 0 4 2010

Indications for Use:

.

For determining in vitro individual responses to heparinization using whole blood on the HMS Plus instrument.

For in Vitro Diagnostic Use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K102953