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.

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.

AI/ML Overview

This 510(k) summary (K101271) describes a modification to the Medtronic Hemostasis Management System Plus (HMS Plus), an automated heparin analyzer. The modification involves a software change related to the dispense volume used during quality control tests.

Therefore, the study supporting this submission is not a typical clinical performance study demonstrating diagnostic accuracy, but rather a verification and validation study to ensure the modified software continues to meet its pre-established performance criteria. Since the document states "Same performance claims," the acceptance criteria and performance are implicitly based on ensuring the device functions as intended after the software change and maintains the performance established for the prior version (K894317/A3).

Based on the provided information, I can deduce the following:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Software Functionality	Dispense volume during QC tests successfully changed from 240 uL to 220 uL when in IU setting.	The modification was approved, implying successful implementation and testing of the software change.	This is the core change indicated in the submission. Performance would refer to the accurate and consistent dispensing of 220 uL during QC tests.
Intended Use	Device continues to meet its original intended use as an automated heparin analyzer for in vitro heparin sensitivity evaluations, heparin assays, and activated clotting times.	The intended use is explicitly stated as "unchanged."	This indicates that the software modification did not alter the fundamental purpose or application of the device.
Operating Principle	Device maintains the same operating principle.	Explicitly stated as "Same operating principle."	Confirms no fundamental change in how the device functions.
Technological Characteristics	Device maintains its same technological characteristics.	Explicitly stated as "Same technological characteristics."	Confirms no fundamental change in the underlying technology.
Performance Claims	Device continues to meet its original performance claims.	Explicitly stated as "Same performance claims."	This is a crucial point, suggesting that the modified device's accuracy, precision, and reliability remain consistent with the predicate device. Specific quantitative performance claims (e.g., accuracy, precision, linearity) are not detailed in this summary but would have been part of the original device's approval (K894317/A3) and would need to be re-verified or confirmed as unaffected by the software change.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in terms of patient samples or data. Given that this is a software modification involving a change in dispense volume for a quality control test, the test set would primarily involve:

Internal validation/verification test runs: This would involve a sufficient number of QC tests to demonstrate the accurate and consistent dispensing of the new 220 uL volume and ensure the overall system functionality remains within specifications.
Data provenance: The data would likely be prospective from internal testing conducted at Medtronic. Given the nature of the device (heparin analyzer), the testing would occur in controlled laboratory settings. Country of origin is likely USA (Minneapolis, MN is where Medtronic Perfusion Systems is located).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

For a software modification that changes a dispense volume in a QC test, the "ground truth" would be established by:

Engineering specifications and measurement standards: The new dispense volume (220 uL) is a precise engineering parameter. The ground truth is the accurate measurement of this volume using calibrated instruments.
Quality Control (QC) protocols: The ground truth for the device's overall performance after the change would be its ability to pass established QC criteria using reference materials.

Therefore, it's unlikely a panel of external "experts" (like radiologists) was used to establish ground truth in the traditional sense. Instead, qualified engineers, metrologists, and quality control personnel at Medtronic, with expertise in instrument calibration, fluid dynamics, and medical device testing, would have been responsible for verifying the change and confirming that the device met its specifications. Their qualifications would include relevant degrees in engineering, science, or related fields, and experience in medical device development and quality assurance.

4. Adjudication Method for the Test Set

Adjudication, in the context of expert review, is not applicable here. The "adjudication" for this type of submission would be:

Verification and validation testing: Did the device perform as expected according to predetermined test protocols and specifications?
Compliance with internal quality procedures: Was the change implemented and tested according to Medtronic's quality management system?
Regulatory review: The FDA's review and approval of the 510(k) submission serves as the ultimate "adjudication" that the device is substantially equivalent and safe/effective for its intended use after the modification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to assess the diagnostic performance of imaging devices or algorithms that require human interpretation, often evaluating the impact of AI on human reader performance. This submission is for a software modification to an automated heparin analyzer, where human interpretation of results in a diagnostic setting is not the primary focus of the change.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The device itself is an automated analyzer, meaning it operates in a standalone manner to generate results. The "study" (i.e., verification and validation testing) would inherently involve evaluating the algorithm's performance in generating results based on the new dispense volume, without direct human intervention in the result generation process. So, in essence, the evaluation of the software change was a "standalone" assessment of its functionality and impact on the automated process. There's no "human-in-the-loop" aspect to the core function of an automated analyzer's measurements.

7. The Type of Ground Truth Used

The ground truth used would be based on:

Engineering specifications and metrology: For the dispense volume change, the ground truth is the precisely measured volume using validated and calibrated metrology instruments.
Reference materials and calibrated controls: For overall device performance, the ground truth would be established using reference materials (e.g., known heparin concentrations) and calibrated quality control solutions. The device's results would be compared against these known values.
Predicate device performance data: Since the performance claims are stated as "same," the original performance data for the predicate HMS Plus (K894317/A3) serves as a benchmark for the expected performance (ground truth) of the modified device.

8. The Sample Size for the Training Set

There is no mention of a training set in this document. This is not an AI/ML device in the sense of predictive modeling that requires a separate training set. The software modification is a deterministic change to a dispense volume rather than an algorithm trained on data.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this type of software change, this question is not applicable.

Summary

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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

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K161271

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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.

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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

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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

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Indications for Use

510(k) Number (if known): 《《ΟΙΖΖΥ

OCT 1 3 2010

Device Name: Hemostasis Management System Plus (HMS Plus)

Indications for 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)

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/

Regulation Number and Section

§ 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).