The HDR Control set is an in vitro diagnostic device. The primary function is to identify if each pair of heparinized channels of the HDR cartridge has normal or abnormal function by measuring if the clotting time ratios between heparinized and unheparinized channels are within or outside a specified range. HDR control 1 is used to verify that channels 1,2, 5 and 6 of the HDR cartridge are functioning correctly. HDR control 2 is used to verify that channels 3, 4, 5 and 6 of the HDR cartridge are functioning correctly.

The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Heparin Dose Response Controls, based on the K051040 submission.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for the Heparin Dose Response Controls. It describes the device's function and states that "Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device."

However, we can infer the type of acceptance criteria based on the device description:

Acceptance Criteria	Reported Device Performance
Identify if each pair of heparinized channels has normal or abnormal function	Not explicitly stated in quantitative terms; assumed successful through "Validation testing" demonstrating substantial equivalence to predicate.
Clotting time ratios between heparinized and unheparinized channels are within or outside a specified range	Not explicitly stated in quantitative terms; assumed successful through "Validation testing" demonstrating substantial equivalence to predicate.
HDR control 1 verifies channels 1,2, 5 and 6 are functioning correctly	Assumed successful through "Validation testing"
HDR control 2 verifies channels 3, 4, 5 and 6 are functioning correctly	Assumed successful through "Validation testing"
Overall performance verification of HDR cartridges and HMS Plus instrument	Assumed successful through "Validation testing"

Important Note: The K051040 submission for the Heparin Dose Response Control is for a "control set" for an instrument, not a diagnostic device that outputs patient results directly. Therefore, the "performance" here refers to its ability to verify the proper functioning of the main diagnostic system (HDR cartridges and HMS Plus instrument), rather than a diagnostic accuracy metric like sensitivity or specificity for a disease. The typical acceptance criteria for such controls would involve demonstrating that they consistently produce the expected "normal" or "abnormal" results when tested on the system, indicating the system's operational integrity.

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

Test Set Sample Size: Not explicitly stated. The submission mentions "Validation testing," but does not provide a sample size for this testing.
Data Provenance: Not explicitly stated. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable and not provided in the document. As "controls," the ground truth is established by the known properties of the control material itself (i.e., whether it should yield a "normal" or "abnormal" result based on its formulation) when run on a properly functioning system. It does not involve expert interpretation of clinical data or images.

4. Adjudication Method for the Test Set

Not applicable and not provided. Ground truth for control materials doesn't typically involve expert adjudication, as their expected behavior is pre-defined.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size of how much human readers improve with AI vs without AI assistance.

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic control, not an AI-powered diagnostic tool for human interpretation. Therefore, the concept of human readers improving with or without AI assistance does not apply.

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

Yes, in spirit, a "standalone" assessment of the control's performance was done. The device itself is a "control" that produces a result (within or outside a specified range) when run on the HMS Plus instrument. Its performance is evaluated intrinsically through "Validation testing" to ensure it correctly identifies the function of the HDR cartridge channels. There is no "human-in-the-loop" for the control's function itself, only for the subsequent interpretation of the HMS Plus instrument's results when using the control.

7. The Type of Ground Truth Used

The ground truth for this device is based on known chemical/physical properties of the control material and its intended interaction with the HMS Plus instrument and HDR cartridges. The controls are designed to yield specific clotting time ratios that indicate "normal" or "abnormal" function of the system. This is a form of design-based or reference-based ground truth, not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

Not applicable and not provided. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of this 510(k) submission.

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

Not applicable and not provided, as there is no training set for this type of IVD control device.

Summary

{0}------------------------------------------------

K 051040

MAY 2 4 2005

(Optional Format 3-10-98)

510(k) Summary

Date Prepared:	April 20, 2005
Submitter:	Medtronic Perfusion Systems
	7611 Northland Boulevard
	Brooklyn Park, MN 55428
Contact Person:	Bruce Backlund
	Senior Regulatory Affairs Specialist
Phone:	(763)-391-9183
Fax:	(763) 391-9603

Device Name and Classification:

Trade Name:	Heparin Dose Response Control
Common Name:	Analyzer, Heparin, Automated
Classification:	Class II
Predicate Devices:	Heparin Dose Response Controls K043080

{1}------------------------------------------------

Device Description

The HDR controls are single use, non-sterile, point of care, in-vitro diagnostic plasma controls for use with the HMS Plus instrument.

Indication for Use

The Heparin Dose Response (HDR) controls are used to verify the performance of the HDR cartridges and the HMS Plus instrument.

Comparison to Predicate Device

The predicate device 510(k) K043080 was cleared on December 3, 2004.

Summary of Performance Data

Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device.

Conclusion

Medtronic Perfusion Systems has demonstrated that the HDR Controls are substantially equivalent to the predicate devices based upon design, test results, and indications for use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the caduceus, indicating the department's name and country.

MAY 2 4 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Bruce Backlund Senior Regulatory Affairs Specialist Medtronic Perfusion Systems 7611 Northland Drive Brooklyn Park, MN 55428-1008

K051040 Re: Trade/Device Name: Heparin Dose Response Controls Regulation Number: 21 CFR 864.5680 Regulation Name: Automated heparin analyzer Regulatory Class: Class II Product Code: JOX Dated: April 20, 2005 Received: April 25, 2005

Dear Mr. Backlund:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use succe in the exerce , 1976, the enactment date of the Medical Device Amendments, or to conniner of the 114) 2011-01-11 accordance with the provisions of the Federal Food, Drug, de vices that have been that do not require approval of a premarket approval application (PMA). and Cosmeter For (110) and the device, subject to the general controls provisions of the Act. The r ou may, mereleve, mains of the Act include requirements for annual registration, listing of general condolo provisioning 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 your device is enabilitional controls. Existing major regulations affecting your device it may be subject to Sach adde 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 I Trass oc advisod that I Dr Crisean that your device complies with other requirements of the Act that I Dri has made a abientiallations administered by other Federal agencies. You must of any I cacal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with and 110 (21 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), accenses 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) I mis letter will and w you to ough finding of substantial equivalence of your device to a legally premation notification - results in a classification for your device and thus, permits your device to proceed to the market.

{3}------------------------------------------------

Page 2 -

If you desire specific information about the application of labeling requirements to your device, If you destions on the promotion and advertising of your device, please contact the Office of In of questions on the promise Evaluation and Safety at (240) 276-0484. Also, please note the vitto Diagnostic DeMisbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may obtain 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/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, PAD Director Division of Immunology and Hematology 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): KOSS Device Name: Heparin Dose Response Controls

Indications For Use:

The Heparin Dose Response (HDR) controls are used to verify the performance of HDR cartridges and the HMS Plus instrument.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use___________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

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

Josephine Bautista
Division/Sign/Off

Page _1_of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KosTovo

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).