CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL

K103314 · Medtronic, Inc. · GGN · Dec 3, 2010 · Hematology

Device Facts

• Record ID: K103314
• Device Name: CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
• Applicant: Medtronic, Inc.
• Product Code: GGN · Hematology
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is used to verify the performance of the ACT instrument and the Heparinase (HR-HTC) cartridges. For In Vitro Diagnostic Use.

Device Story

The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is an in vitro diagnostic device used to verify the performance of ACT instruments and Heparinase (HR-HTC) cartridges. The device contains porcine-derived USP heparin. It is used by healthcare professionals in clinical settings to ensure the accuracy and reliability of coagulation testing equipment. The device does not perform automated analysis itself but serves as a quality control standard to validate the operational integrity of the associated testing system, thereby supporting clinical decision-making regarding patient anticoagulation status.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

In vitro diagnostic control containing porcine-derived USP heparin. The device functions as a quality control standard for ACT instruments and Heparinase cartridges. No software or complex electronic sensing components are described; the device is a chemical control reagent.

Indications for Use

Indicated for use as an in vitro diagnostic control to verify the performance of the ACT instrument and Heparinase (HR-HTC) cartridges.

Regulatory Classification

Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control (K042175)

Submission Summary (Full Text)

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K103314

Image /page/0/Picture/1 description: The image shows the Medtronic logo. The logo consists of a circular graphic on the left and the word "Medtronic" on the right. The graphic shows three figures in motion inside of a circle. The word "Medtronic" is in a bold, sans-serif font.

#### DEC2 2010

# 510(k) Summary

Date Prepared

October 1, 2010

Submitter

Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009

Contact Person

Jeffrey L. Koll Senior Regulatory Affairs Specialist Phone: [phone] [phone] Fax: Email: jeffrey.l.koll(@medtronic.com

# Device Name and Classification .

Trade Name: CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control Common Name: Activated Whole Blood Clotting Time Regulation Number: 21 CFR 864.7140 Product Code: JBP Classification: Class II

# Predicate Device

CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control (K042175) cleared on October 18, 2004.

# Comparison to Predicate Device

A comparison of the modified device and the currently marketed CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control show the following similarities:

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

Alleviating Pain · Restoring Health · Extending Life

CLOTtrac Heparinase Test Cartridge (HTC) Coagulation Control Special 510k

Medtronic, Inc. CONFIDENTIAL

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# Description of Device Modification

### Heparin

- The modification to the current control is to replace old USP heparin with revised . USP heparin. The source of the heparin remains porcine.
### Intended Use

The intended use is unchanged.

# Labeling

The current labels are unchanged by this device modification. The current Instructions for Use (IFU) has been updated for style, grammar and readability.

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

# Conclusion

The modifications to the CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control described in this submission result in a substantially equivalent device because the fundamental scientific technology and the intended use are unchanged.

Medtronic, Inc. CONFIDENTIAL

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is likely part of a document or presentation from the U.S. Department of Health and Human Services.

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

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

DEC 0 2 2010

Re: k103314

Trade/Device Name: CLOTtrac®Heparinase Test Cartridge (HTC) Coagulation Control Regulation Number: 21 CFR 864.7140 Regulation Name: Activated whole blood clotting time tests Regulatory Class: Class II Product Code: GGN Dated: October 1, 2010 Received: November 10, 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 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); 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 L. 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,

Reena Philip

1192

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

510(k) Number (if known): . K / 0 33 / 4

K/03314

Device Name: CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control

### Indications for Use:

The CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control is used to verify the performance of the ACT instrument and the Heparinase (HR-HTC) cartridges.

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) K103314