(31 days)
Not Found
No
The summary describes a modification to an existing device involving a change in heparin concentration and source, with no mention of AI or ML technologies.
No.
The device is for in vitro diagnostic use, meaning it is used outside the body to diagnose conditions rather than treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For In Vitro Diagnostic Use."
No
The device description explicitly states it is a modification to an "HMS Plus instrument" and involves "heparinized channels," indicating a hardware component (the instrument and cartridges) is integral to the device's function. The modification is to the heparin used in the cartridges, not to software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in Vitro Diagnostic Use."
- Purpose: The intended use is "For determining in vitro individual responses to heparinization using whole blood on the HMS Plus instrument." This describes a test performed on biological samples (whole blood) outside of the body to provide diagnostic information (individual responses to heparinization).
These points directly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For determining in vitro individual responses to heparinization using whole blood on the HMS Plus instrument. For in Vitro Diagnostic Use.
Product codes (comma separated list FDA assigned to the subject device)
JOX
Device Description
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.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 864.5680 Automated heparin analyzer.
(a)
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.(b)
Classification. Class II (special controls).
0
Image /page/0/Picture/0 description: The image shows the Medtronic logo. On the left side of the logo is a circular graphic with a person in the center. The person is surrounded by other figures in motion. To the right of the graphic is the word "Medtronic" in bold, sans-serif font.
V - 4 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: 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
Page 13 of 109
1
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.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
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
3
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 (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,
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
4
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