The Modified Radius Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Modified Radius Cougar Wires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an 014 guidewire.

Device Description

The Modified Radius Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Modified Radius Cougar Wire. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria in the typical sense of AI/software performance.

Therefore, many of the requested points regarding AI device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission. This is a submission for a physical medical device (guidewire) and its performance is evaluated through in vitro (bench) testing, not through analysis of images or other data by an AI algorithm.

Here's an interpretation of the requested information based on the provided text, acknowledging the differences in context:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide explicit numerical "acceptance criteria" in the format of a typical acceptance test specification (e.g., "Accuracy > 90%"). Instead, it lists performance tests that were conducted to demonstrate that the modified device "meets the minimum requirements that are considered adequate for its intended use" and is "substantially equivalent" to predicate devices. The "reported device performance" is essentially that the device passed these tests.

Performance Test	Acceptance Criterion (Implicit)	Reported Device Performance
Tensile Strength	Meets established standards for PTCA guidewires to ensure structural integrity and prevent breakage during use.	Performed/Passed
Accelerated Age Testing	Maintains structural integrity and functional performance after simulated aging, indicative of a reasonable shelf-life.	Performed/Passed
Coating Adherence/Integrity	Coating remains intact and functional, reducing friction and ensuring proper device delivery.	Performed/Passed
Biocompatibility	Meets established standards for biological safety, demonstrating non-toxicity and non-reactivity with human tissues.	Performed/Passed

Note: The specific quantitative results or detailed pass/fail criteria for these in vitro tests are not provided in this summary. The 510(k) process relies on demonstrating that these tests were "performed" and the device was found to be "substantially equivalent" rather than publishing raw results in the summary.

2. Sample size used for the test set and the data provenance:

Sample Size for the Test Set: Not specified in the provided summary. This would typically involve a certain number of guidewire samples for each in vitro test.
Data Provenance: Not applicable in the context of data used for AI. For a physical device, the "provenance" of test results comes from the manufacturer's internal testing facilities.
Retrospective or Prospective: Not applicable as these tests are laboratory (in vitro) evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for these physical performance tests is determined by specific laboratory measurement techniques and engineering standards, not by expert interpretation of data.

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

Not applicable. This concept pertains to resolving discrepancies in expert labeling or review for AI datasets.

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. This is a submission for a physical guidewire, not an AI software device. An MRMC study is completely irrelevant here.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for these performance tests is defined by established engineering and material science standards (e.g., ISO standards for tensile strength, biocompatibility standards). For example, a guidewire's tensile strength must meet a certain threshold as measured by a calibrated tensile testing machine.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for physical device performance testing in this context. The "training" in manufacturing comes from process validation and quality control, not machine learning.

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

Not applicable.

Summary

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OCT 17 2003

Attachment 6 510(k) Summary of Safety and Effectiveness September 15, 2003

GENERAL INFORMATION A.

Submitter's Name:	Radius Medical Technologies, Inc.
Address:	15 Craig RoadActon, MA 01720
Contact Person:	Maureen A. Finlayson
Device Generic Name:	PTCA Guidewire
Device Trade Name:	Radius Cougar Wire
Classification Name:	Wire, Guide, Cardiovascular (74DOX)

B. INDICATIONS

ட் DESCRIPTIVE CHARACTERISTICS

COMPARATIVE INFORMATION D.

The Modified Radius Cougar Wire is substantially equivalent to the currently marketed Radius PTCA Guidewire (K970466) and the Radius Cougar Wire (K011287).

PERFORMANCE TESTING E.

The following in vitro performance tests were performed on the Modified Radius Cougar Wire: 1. Tensile Strength

1. Accelerated Age Testing
1. Coating Adherence/Integrity
1. Biocompatability

CONCLUSION:

Based on the indications for use, technological characteristics, and safety and performance testing, the proposed modifications to the Radius Cougar Wire meets the minimum requirements that are considered adequate for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community or interconnectedness.

OCT 17 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Radius Medical Technologies, Inc. c/o Ms. Debbie Iampietro 7 Tiffany Trail Hopkinton, MA 01748

Re: K032899

Trade Name: Radius Cougar Wire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DQX Dated: September 15, 2003 Received: September 18, 2003

Dear Ms. Iampietro:

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. Ilsting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 – Ms. Debbie Iampietro

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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. 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,

Mefan Mup
Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: Radius Cougar Wire

Indications For Use:

Radius Cougar Wire is intended for placement of balloon dilatation catheters during PTCA and/or PTA.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K032899
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.