(23 days)
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.
The modification to the current control is to replace old USP heparin with revised USP heparin. The source of the heparin remains porcine.
The provided text does not contain detailed information about specific acceptance criteria for a device's performance, nor does it describe a study with performance data against such criteria.
The document is a 510(k) summary for a device modification (CLOTtrac® Heparinase Test Cartridge (HTC) Coagulation Control). It states that the modification is to replace old USP heparin with revised USP heparin, and that the device still has the "Same intended use," "Same operating principle," "Same technological characteristics," and "Same performance claims" as the predicate device (K042175).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication method, MRMC study details, standalone performance, or training set information.
The document's conclusion simply states that the modified device is "substantially equivalent" to the predicate device because the fundamental scientific technology and intended use are unchanged. This suggests that extensive new performance studies to establish new acceptance criteria were likely not conducted or required for this type of 510(k) submission, as substantial equivalence to a previously cleared device implies that the new device meets the performance characteristics demonstrated by the predicate.
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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: (763) 514-9842 (763) 367-8360 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.
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, symbolizing strength and freedom. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle, indicating the organization's name and location.
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
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.(b)
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.