(21 days)
Not Found
No
The summary describes a modification to a control solution for a heparin assay, specifically replacing an old heparin source with a new one. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as "For In Vitro Diagnostic use" and is intended to "verify the performance of the HMS Plus and Heparin Assay Cartridges," which are diagnostic rather than therapeutic purposes.
No
The device is described as a control used to "verify the performance of the HMS Plus and Heparin Assay Cartridges". This indicates it is a quality control material used to assess the accuracy of diagnostic devices, rather than a diagnostic device itself. The "For In Vitro Diagnostic use" statement refers to the intended use of the products it verifies, not the control itself as directly diagnostic of a patient's condition.
No
The device description clearly states it is a "control" and involves replacing a physical component (USP heparin) in a cartridge, indicating it is a physical in vitro diagnostic device, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic use."
This is the primary indicator that the device is intended to be used outside of the body to examine specimens (like blood or other bodily fluids) to provide information for the diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
To verify the performance of the HMS Plus and Heparin Assay Cartridges.
For In Vitro Diagnostic use.
Product codes
GGN
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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. |
| 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 | |
| Fax: (763) 367-8360 | |
| Email: jeffrey.l.koll@medtronic.com |
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
1
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.
2
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
3
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 (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/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 (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
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
4
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)