The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

Device Description

The Heparin Dose Response (HDR) cartridge is an in vitro diagnostic test. The HDR cartridge uses fresh whole blood for determining in vitro individual responses to heparinization based on a target activated clotting time (ACT). The cartridge is for use in the HMS or HMS Plus (Hemostasis Management System) instruments.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Heparin Dose Response (HDR) Cartridge. This document is a summary of the notification and a letter from the FDA.

Here's an analysis of the acceptance criteria and the study as requested, based solely on the provided text.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states that "Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not mention the use of experts to establish ground truth for a test set. This device is an in vitro diagnostic test for determining responses to heparinization, suggesting that the "ground truth" would likely be derived from laboratory measurements or established clinical reference methods, not expert consensus on image interpretation or similar.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for a test set, as it does not rely on expert interpretation for its validation.

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

No such study (MRMC or AI-assisted performance) is mentioned. This device is an in vitro diagnostic tool, not an AI-assisted diagnostic imaging device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to a standalone performance of the device itself (the HDR cartridge and HMS/HMS Plus instruments). The summary states: "Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device." This implies standalone performance testing was conducted for these specific characteristics. However, detailed results or specific methodology for these tests are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For an in vitro diagnostic test determining individual responses to heparinization, the "ground truth" would typically refer to:

Reference laboratory methods: Established and validated laboratory techniques for measuring heparin response or activated clotting time, which the device's measurements are compared against.
Clinical outcomes (potentially secondary): While not explicitly stated as "ground truth" for direct performance evaluation, the ultimate clinical utility would tie into patient outcomes related to heparinization.
The document refers to "accuracy," implying a comparison to a known or reference value, but does not specify the exact nature of this reference or "ground truth."

8. The sample size for the training set

The document does not mention a training set. This is a 510(k) for an in vitro diagnostic device, not an AI-based system that typically uses training and test sets in the same manner. Its validation focuses on functional performance like stability, accuracy, and precision against a predicate device.

9. How the ground truth for the training set was established

Not applicable, as no training set is mentioned or relevant to the reported validation approach.

Summary

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K042070

OCl 1 - 2004

510(k) Summary

Date Prepared: August 19, 2004

Submitter:

Medtronic Perfusion Systems 7611 Northland Boulevard Brooklyn Park, MN 55428

Contact Person: Dawn M. Stenstrom Principal Regulatory Affairs Specialist Phone: (763) 391-9604 Fax: (763) 391-9603

Device Name and Classification:

Trade Name:	Heparin Dose Response Cartridge
Common Name:	Analyzer, Heparin, Automated
Classification:	Class II
Predicate Devices:	Hepcon® HMS Coagulation System and its AssociatedCartridges and Controls
	K894317

Device Description

Indication for Use

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

Comparison to Predicate Device

The predicate device is the currently marketed HDR cartridge. The currently marketed HDR cartridge has the same indications for use and is the same in all aspects to the modified cartridge with exception of the source of heparin.

Summary of Performance Data

Functional testing such as stability, accuracy and precision were used to establish the performance characteristic of the modifications of this device from the previously marketed device.

Conclusion

Medtronic has demonstrated that the HDR cartridge is substantially equivalent to the predicate device based upon design, test results, and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized design featuring three abstract shapes that resemble human figures or waves, stacked on top of each other.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 1 - 2004

Ms. Dawn M. Stenstrom Principal Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive N Minneapolis, MN 55428-1088

Re: K042070

Trade/Device Name: Heparin Dose Response Cartridge Regulation Number: 21 CFR § 864.5680 Regulation Name: Automated Heparin Analyzer Regulatory Class: II Product Code: JOX Dated: September 16, 2004 Received: September 17, 2004

Dear Ms. Stenstrom:

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 either class II (Special Controls) or class III (PMA), 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); 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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

Robert L. Becker, Jr., M.D., Ph. 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): K042070

Device Name:

Heparin Dose Response Cartridge

Indications for Use:

The heparin dose response cartridge is intended for determining in vitro individual responses to heparinization using whole blood on the HMS or HMS Plus instruments.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Djagnostic Devices (OIVD)

Josephine Bautista
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042070

Page 1 of 1_

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).