HEPARIN ASSAY CONTROLS

K103313 · Medtronic, Inc. · GGN · Dec 1, 2010 · Hematology

Device Facts

• Record ID: K103313
• Device Name: HEPARIN ASSAY CONTROLS
• Applicant: Medtronic, Inc.
• Product Code: GGN · Hematology
• Decision Date: Dec 1, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

To verify the performance of the HMS Plus and Heparin Assay Cartridges. For In Vitro Diagnostic use.

Device Story

Modified Heparin Assay Controls (6 levels) used with HemoTec Hepcon HMS Coagulation System; replaces old USP heparin with revised USP heparin per monograph change; 9% increase in heparin concentration across all 6 levels; device functions as quality control for coagulation monitoring; used in clinical settings by healthcare professionals; modification verified via design control activities and risk analysis to ensure fundamental scientific technology remains unchanged.

Clinical Evidence

No clinical data. Substantial equivalence supported by verification testing confirming performance characteristics remain unchanged following the update to the heparin source material.

Technological Characteristics

Quality control materials for coagulation monitoring; 6 levels of Heparin Assay Controls; modified to incorporate revised USP heparin; 9% concentration increase compared to predicate.

Indications for Use

Indicated for use as quality control materials for the HemoTec Hepcon HMS Coagulation System to monitor heparin levels.

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

• Medtronic Heparin Assay Controls (K894317)
• Medtronic Heparin Assay Controls (K042206)

Submission Summary (Full Text)

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K103313

Image /page/0/Picture/1 description: The image shows the Medtronic logo. The logo consists of a stylized human figure inside a circle with arrows indicating movement, followed by the word "Medtronic" in a bold, sans-serif font. The logo is black and white.

DEC 1 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: | Heparin Assay Controls |
|--------------------|-----------------------------|
| Common Name: | Plasma, Coagulation Control |
| Regulation Number: | 21 CFR 864.5425 |
| Product Code: | GGN |
| Classification: | Class II |

#### Predicate Device

Medtronic Heparin Assay Controls (K894317 and K042206) cleared on September 5, 1989 and October 1, 2004, respectively.

### Comparison to Predicate Device

A comparison of the modified device and the currently marketed Heparin Assay Controls 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 control is to replace old USP heparin with revised USP heparin from the new heparin monograph that became effective October 1, 2009. 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. Applicable tables have also been updated with information on the construction of the modified controls using revised USP heparin.

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

#### Conclusion

The modifications to the Medtronic Heparin Assay Controls described in this submission result in a substantially equivalent device because verification testing indicated that the fundamental scientific technology and the intended use are unchanged.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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 01 2010

Re: k103313

Trade/Device Name: Heparin Assay Controls Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies 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

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Page 2 - Mr. Jeffrey L. Koll

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.

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/ReportalProblem/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

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 10 331 3

Device Name: Heparin Assay Controls

DEC 1 2010

#### Indications for Use:

To verify the performance of the HMS Plus and Heparin Assay 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

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

KID3313 510(k)