(27 days)
Not Found
No
The description focuses on hardware and software updates to existing components and operating systems, with no mention of AI or ML algorithms for data analysis or decision-making.
No
The device performs in vitro diagnostic tests (heparin sensitivity, heparin assays, and activated clotting times) rather than providing direct treatment to a patient.
Yes
The "Intended Use / Indications for Use" section states that the device performs "in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times," which are tests used to diagnose or monitor medical conditions.
No
The device description explicitly details hardware components, modifications, and replacements, indicating it is a physical instrument with integrated software, not a software-only device.
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" means "in glass" or "in the lab," referring to tests performed outside of a living organism.
- Device Description: The description reinforces this by stating it's a "multichannel clot timing system with automated syringe handling for pipetting blood into single use cartridges." This describes a laboratory instrument used to analyze biological samples (blood) outside the body.
These points clearly indicate that the device is designed to perform diagnostic tests on samples taken from the body, which is the definition of 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
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. Hardware modifications addressed in this submission are a direct response to the obsolescing of several major hardware components including the Print Circuit Board, the ADU Controller and the Printer. The HMS software has also been modified to run on Windows CE 5.0. The Display Adapter Hantronix PCBA and Power Interconnect PCBA have been incorporated into the Interface PCBA to reduce interconnects and have a more reliable device. The Common Processing Platform has been used to replace the Freescale HC11. A new Printer has been selected that will work with the new Off the Shelf Computer PCBA. The voltage of the printer has been reduced from 24 V to 7V. The Operators Manual and Device labels have been updated to reference the IEC 61010-1: 2001, 2nd Edition standard.
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
A complete system verification and software verification of all requirements have been performed. A complete ADU software verification of all requirements has been performed.
Key Metrics
Not Found
Predicate Device(s)
HMS Plus (K101271)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 three figures in different positions. To the right of the graphic is the word "Medtronic" in a bold, sans-serif font.
JUN - 8 2011
510(k) Summary
Date Prepared
Submitter
June 8, 2011
Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009
Contact Person
Amra Racic Regulatory Affairs Specialist Phone: (763) 514-9838 Fax: (763) 367-8360 Email: amra.racic@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 (K101271 - Cleared October 13, 2010)
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.
1
Description of Device Modification and the Reasons for Implementation
ADS - Hantronix HMS Plus PCBA
Hardware modifications addressed in this submission are a direct response to the obsolescing of several major hardware components including the Print Circuit Board, the ADU Controller and the Printer. The HMS software has also been modified to run on Windows CE 5.0: A complete system verification and software verification of all requirements have been performed. The Display Adapter Hantronix PCBA and Power Interconnect PCBA have been incorporated into the Interface PCBA to reduce interconnects and have a more reliable device.
HMS Plus ADU Controller PCBA
. The Common Processing Platform has been used to replace the Freescale HC11. A complete ADU software verification of all requirements has been performed.
HMS Plus Printer
A new Printer has been selected that will work with the new Off the Shelf Computer PCBA. The voltage of the printer has been reduced from 24 V to 7V.
HMS Plus Labeling
The Operators Manual and Device labels have been updated to reference the IEC 61010-1: 2001, 2nd Edition standard.
Intended 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.
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Medtronic, Inc. c/o Amra Racic Senior Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112
JUN 0 8 2011
Re: K111339
Trade/Device Name: Hemostasis Management System Plus (HMS Plus) Regulation Number: 21 CFR 864.5680 Regulation Name: Automated Heparin Analyzer Regulatory Class: Class II Product Code: JOX Date: May 11, 2011 Received: May 13, 2011
Dear Ms. Racic:
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 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
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Page 2 - Ms.Racic
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,
Maria 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
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Indications for Use
510(k) Number (if known): K 11/339
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 × (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
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K111339