(27 days)
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.
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. 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. The Common Processing Platform has been used to replace the Freescale HC11. A complete ADU software verification of all requirements has been performed. 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.
The provided text describes a 510(k) premarket notification for the Hemostasis Management System Plus (HMS Plus). This submission focuses on hardware and software modifications to an already cleared device (HMS Plus, K101271). As such, the document primarily aims to demonstrate substantial equivalence to the predicate device rather than presenting a novel study to establish performance acceptance criteria.
The information requested regarding acceptance criteria and a study proving the device meets them is not present in the provided text in the typical format of a new clinical or performance study. The text explicitly states: "A complete system verification and software verification of all requirements have been performed." This suggests that the device's performance was verified against its existing, established requirements (those of the predicate device).
However, based on the provided text, I can infer and extract some relevant points:
1. A table of acceptance criteria and the reported device performance:
The document explicitly states:
- "Same intended use."
- "Same operating principle."
- "Same technological characteristics."
- "Same performance claims."
This strongly implies that the acceptance criteria for the modified device are identical to those of the predicate HMS Plus (K101271). The "reported device performance" is implicitly stated to be equivalent to the predicate device due to these similarities and the conducted verifications.
| Acceptance Criterion | Reported Device Performance (Implied) |
|---|---|
| Intended Use | Same as predicate HMS Plus |
| Operating Principle | Same as predicate HMS Plus |
| Technological Characteristics | Same as predicate HMS Plus |
| Performance Claims | Same as predicate HMS Plus |
2. Sample size used for the test set and the data provenance:
The document mentions "A complete system verification and software verification of all requirements have been performed." However, it does not specify the sample size, the type of test set (e.g., patient samples, simulated data), or the data provenance (e.g., country of origin, retrospective or prospective) for these verifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. The document refers to "system verification and software verification," which typically involves testing against specifications and defined outcomes, rather than expert-established ground truth in the context of diagnostic interpretation.
4. Adjudication method for the test set:
This information is not provided in the text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This type of study is not applicable to the information provided. The device is an "Automated Heparin Analyzer," which is a laboratory instrument, not an AI-powered diagnostic imaging system requiring human reader interaction for interpretation. The modifications described are hardware and software updates to an existing instrument, not the introduction of AI for human assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device (HMS Plus) is an "Automated Heparin Analyzer." Its operation, as described, is inherently "standalone" in performing the assays and providing results. The submission focuses on verifying that the modified hardware and software components maintain the original standalone performance. The text states: "A complete system verification and software verification of all requirements have been performed." This implies that the standalone performance requirements of the predicate device were met by the modified device.
7. The type of ground truth used:
Given that the device performs "in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times," the "ground truth" for its performance would typically be established by established laboratory methods, reference standards, and control materials with known values, against which the device's measurements are validated. The document explicitly mentions "system verification and software verification of all requirements," implying verification against predefined performance standards and expected analytical results for these assays.
8. The sample size for the training set:
The document does not describe a "training set" in the context of machine learning, as this submission is about hardware/software modifications to an existing, cleared medical device for "Automated Heparin Analyzer." While software was modified to run on Windows CE 5.0, the type of "training" typically associated with AI models is not discussed.
9. How the ground truth for the training set was established:
As no "training set" for an AI model is described, this information is not applicable.
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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.
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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.
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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
§ 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).