(160 days)
K894317/A3
Not Found
No
The summary describes a microprocessor-based clot timing system with automated handling, but 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 an in vitro diagnostic device used for evaluating blood clotting times and heparin levels, not for directly treating a patient or condition.
Yes
The device performs "in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times," which are tests used to assess a patient's condition or diagnose a medical issue.
No
The device description explicitly states it is an "instrument" and a "multichannel clot timing system with automated syringe handling," indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device "performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times." The term "in vitro" is a key indicator of an IVD, meaning the tests are performed outside of the living body, typically on samples like blood.
- Device Description: The description mentions it's a "clot timing system with automated syringe handling for pipetting blood into single use cartridges." This further supports the idea that it's used for testing blood samples.
- Predicate Device: The predicate device listed is "K894317/A3; HMS Plus". Looking up this K number would likely confirm its classification as an IVD.
Therefore, based on the provided information, the HMS Plus instrument is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.
Product codes (comma separated list FDA assigned to the subject device)
JOX
Device Description
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges.
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.
HMS Plus (K894317/A3)
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. The logo consists of a circular graphic on the left and the word "Medtronic" in bold, sans-serif font on the right. The graphic depicts a person in motion, possibly representing movement or activity.
510(k) Summary
Date Prepared May 5, 2010 Submitter Medtronic, Inc. OCT 1 3 2010 Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 Contact Person Jeffrey L. Koll Regulatory Affairs Specialist Phone: (763) 514-9842 (763) 367-8360 Fax:
Email: jeffrey.l.koll@medtronic.com
Device Name and Classification
Trade Name: Common Name: Regulation Number: Product Code: Classification:
Hemostasis Management System Plus (HMS Plus) Automated Heparin Analyzer 21 CFR 864.5680 JOX Class II
Predicate Device
HMS Plus (K894317/A3)
Comparison to Predicate Device
. A comparison of the modified device and the currently marketed HMS Plus show the following similarities:
- . Same intended use.
- Same operating principle. .
- Same technological characteristics. ●
- Same performance claims. ●
Alleviating Pain · Restoring Health · Extending Life
Page 11 of 231
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Description of Device Modification
Software
- Change dispense volume used during quality control test from 240 uL to 220 uL . when instrument is in IU setting.
Intended Use
The intended use is unchanged.
Labeling
The labeling is unchanged by this device modification.
- Appendix A contains the current IFU. .
- . Appendix B contains the current labels.
Conclusion
The modifications to the HMS Plus 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right, and its wings are curved upwards. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Medtronic, Inc. c/o Mr. Jeffrey Koll Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
Re: K101271
Trade/Device Name: Hemostasis Management System Plus Regulation Number: 21 CFR 864.5680 Regulation Name: Analyzer, Heparin, Automated Regulatory Class: Class II Product Code: JOX Dated: October 6, 2010 Received: October 7, 2010
OCT 1 3 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 notification. The FDA finding of substantial equivalence of your device to a legally marketed
3
Page 2 -- Mr. Jeffrey Koll
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,
ia m. Chan
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): 《《ΟΙΖΖΥ
OCT 1 3 2010
Device Name: Hemostasis Management System Plus (HMS Plus)
Indications for Use:
The HMS Plus instrument is a microprocessor based, multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges. It performs in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.
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)
and the same of the same of the same of the same of the same of the same of
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K/0127/