The CLOTtrac® HTC Control is an in vitro diagnostic device. This control is intended to TIC CEO Fudos TF C Collier CT instrument and the Heparinase (HR HTC) cartridges. The cartridge is for use in the ACT (Automated Coagulation Timer) instrument.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CLOTtrac® HTC Control, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) Summary for the CLOTtrac® HTC Control, is a pre-market notification to establish substantial equivalence to a predicate device. It does not explicitly state numerical "acceptance criteria" in the format of a table with specific thresholds. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device.

The "reported device performance" is also not presented with specific quantitative metrics. The document states:
"Validation testing was used to establish the performance characteristic of the modifications of this device from the previously marketed device."

This implies that the device performed equivalently to the predicate device during the validation testing. Without the actual test results or the criteria for "performance characteristic," a specific table of acceptance criteria and reported device performance cannot be generated from the given text.

Detailed Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The exact nature of the "validation testing" (e.g., in-house, multi-center, clinical trial) is not detailed.
- Retrospective or Prospective: Not specified.
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)
- Not applicable/Not specified. This device is an in vitro diagnostic control for an instrument, not a device that requires expert interpretation for "ground truth" in the same way an imaging or diagnostic AI would. The "ground truth" for a control device would be its known chemical properties and its ability to produce expected results on the instrument.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be disagreement in assessment. This is a quality control device.
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 MRMC study was done. This is not an AI-assisted diagnostic device, but a control for an Automated Coagulation Timer.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the typical sense. The device itself (CLOTtrac® HTC Control) is a "control" material used to verify the performance of an instrument (ACT instrument) and its cartridges. It does not perform an algorithm standalone; rather, it is used by the instrument, and its performance is assessed by how well the instrument produces expected results when tested with the control.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a control material, the "ground truth" would be its precisely manufactured, known concentration or activity levels. The device (control) itself is the standard against which the instrument's performance is measured. The study aimed to demonstrate that the modified control maintains the performance characteristics of the previously marketed control (which implicitly had a known 'truth').
The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established
- Not applicable for the same reason as above.

Summary

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K042175

OCT 1 8 2004

510(k) Summary

Date Prepared:	September 28, 2004
Submitter:	Medtronic Perfusion Systems7611 Northland BoulevardBrooklyn Park, MN 55428
Contact Person:	Dawn M. StenstromPrincipal Regulatory Affairs SpecialistPhone: (763) 391-9604Fax: (763) 391-9603
Device Name and Classification:
Trade Name:	CLOTtrac® HTC Control
Common Name:	Activated Whole Blood Clotting Time
Classification:	Class II
Predicate Devices:	Heparinase HR ACT ControlK902081

Device Description:

Indication for Use

This product is intended to verify the performance of the ACT instrument and the Heparinase (HR HTC) cartridges

Comparison to Predicate Device

The predicate device, Heparinase HR ACT control is currently marketed. The THE Preac® HTC Control has the same indications for use and is the same in all aspects to the modified control with exception of the source of heparin.

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 has demonstrated that the CLOTtrac® HTC Control is substantially equivalent to the predicate device based upon design, test results, and indications for use.

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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

OCT 1 8 2004

K042175 Re:

Trade/Device Name: CLOTtrac® HTC Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: II Product Code: GGN, JBP Dated: September 28, 2004 Received: September 29, 2004

Dear Ms. Stenstrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your because a sees per is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to togens and ment date of the Medical Device Amendments, or to commerce pror to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have been recensement asse approval of a premarket approval application (PMA). and Cosmetor For (10) that do never, subject to the general controls provisions of the Act. The r ou may, merelore, manel and act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 a0070) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations aff may be subject to suel additions (CFR), Parts 800 to 895. In addition, FDA be found in Thre 21, Ocouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase be activised that I Drivision that your device complies with other requirements of the Act that I Dr Has made a aond regulations administered by other Federal agencies. You must of any I cacal statutes and regairements, including, but not limited to: registration and listing (21 compry with an the Free 22 CFR Parts 801 and 809); and good manufacturing practice CITY art 607), laooning (21 OF Ready systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quartly advice as described in your Section 510(k) premarket whil anow you to begin marketing your intial equivalence of your device to a legally marketed nunfication. THE I Driving of the intention for your device and thus, permits your device to proceed to the market.

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If you desire specific information about the application of labeling requirements to your device, If you desire specific information about the appears device, please contact the Office of In
or questions on the promotion and advertising of your device, please contact the of questions on the promotion and acrestions 2019 594-3084. Also, please note the Vitto Diagnostic Device Lyanaaton and Baroy at (3 co verset on the moder the Ast from the fegulation entitled, "Misoranting of responsibilities under the Act from the take the tall from the You may of all other general informational 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):

K042175

Device Name:

CLOTtrac® HTC Control

Indications for Use:

To verify the performance of the ACT instrument and the Heparinase (HR HTC) cartridges

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

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

Josephine Brutaka

Division Sigh-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042175

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Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.