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

Device Description

The Radius PTCA Guidewire is constructed from a solid stainless steel 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 silicone 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 document (K970466) is a 510(k) Premarket Notification for a medical device, specifically a PTCA Guidewire. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a comparative effectiveness study with human readers or AI.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary. I will fill in the applicable information and indicate where information is not present or not relevant to this type of regulatory document.

Here's the breakdown based on the provided text:

Acceptance Criteria and Study Details for K970466:

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

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Functional/Performance	Tensile Strength (Implicit: Comparable to predicate)	In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
	Torque Strength (Implicit: Comparable to predicate)	In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
	Torqueability (Implicit: Comparable to predicate)	In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
	Tip Flexibility (Implicit: Comparable to predicate)	In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
	Coating Adherence/Integrity (Implicit: Comparable to predicate)	In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.
Biocompatibility	Cytotoxicity (Implicit: Acceptable)	All test results were acceptable.
	Sensitization (Implicit: Acceptable)	All test results were acceptable.
	Intracutaneous Toxicity (Implicit: Acceptable)	All test results were acceptable.
	Acute Systemic Toxicity (Implicit: Acceptable)	All test results were acceptable.
	Material Mediated Pyrogenicity (Implicit: Acceptable)	All test results were acceptable.
	ASTM Hemolysis (Implicit: Acceptable)	All test results were acceptable.
Dimensional	G/W Outer Diameter: .014"	Not explicitly stated as meeting, but these are specifications given for the proposed device, implying it was manufactured to these. The overall conclusion states the device meets "minimum requirements that are considered adequate for its intended use" based on technological characteristics.
	G/W Overall Length: 180cm or 300cm	(See above for dimensional criteria)
	Overall Coil Length: 15cm to 30cm	(See above for dimensional criteria)
	Radiopaque Length: 3cm to 30cm	(See above for dimensional criteria)
	Floppy Tip Length: 2.5cm to 3cm	(See above for dimensional criteria)

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

Sample Size for Test Set: Not specified in the provided document. The performance tests ("in vitro performance tests") and biocompatibility tests were conducted, but the number of units tested is not disclosed.
Data Provenance: The tests were conducted by Radius Medical Technologies, Inc. (Maynard, MA, USA), suggesting the data originated in the USA. The tests are "in vitro," so the data is laboratory-generated, not from human subjects. It would be considered prospective for the device's development but conducted prior to market entry.

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)

Not applicable. This device is a guidewire, and its performance is evaluated through objective physical and chemical tests, not through expert interpretation of images or clinical data. Therefore, "ground truth" in the clinical imaging sense is not relevant here.

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

Not applicable. See point 3. The testing involves measurable parameters (e.g., tensile strength, flexibility, chemical reactions for biocompatibility), not subjective interpretations requiring adjudication.

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. An MRMC study is not relevant for this type of medical device (PTCA Guidewire) as it is not an imaging analysis or diagnostic AI device. This document focuses on the physical and biocompatibility properties of the guidewire itself.

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

Not applicable. This device is a physical medical instrument, not an algorithm or AI system.

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

Not applicable. The "ground truth" for this device's performance is objective measurement against specified engineering requirements and established biocompatibility standards. For substantial equivalence, the performance is compared to the predicate device's established performance, implying the predicate itself served as a benchmark for what constitutes acceptable performance for such a device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

Not applicable. See point 8.

Summary

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K970466

MAY 2 0 1997

瑞| 彩

510(K) SUMMARY

Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Radius Medical Technologies, Inc. is I answited to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Radius Medical Technologies, Inc. chooses to submit a summary of information respecting safety and effectiveness.

GENERAL INFORMATION A.

Submitter's Name:	Radius Medical Technologies, Inc.
Address:	63 Great RoadMaynard, MA 01754
Contact Person:	Maureen A. Finlayson
Date of Preparation:	February 5, 1997
Device Generic Name:	PTCA Guidewire
Device Trade Name:	Radius PTCA Guidewire
Classification Name:	Wire, Guide, Cardiovascular (74DQX)

B. INDICATIONS

DESCRIPTIVE CHARACTERISTICS C.

The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. Table 1 lists the key dimensional characteristics for the proposed device. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

	Specification
G/W Outer Diameter	.014"
G/W Overall Length	180cm or 300cm
Overall Coil Length	15cm to 30cm
Radiopaque Length	3cm to 30cm
Floppy Tip Length	2.5cm to 3cm

14 DJ25181
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COMPARATIVE INFORMATION D.

The Radius PTCA Guidewires are substantially equivalent to the currently marketed ACS High Torque Guidewire family. ACS High Torque Guidewires, marketed by:

Advanced Cardiovascular Systems, Inc. 26531 Ynez Road Temecula, California 92390-1856

E. PERFORMANCE TESTING

The following in vitro performance tests were performed on the Radius PTCA Guidewire:

1. Tensile Strength
1. Torque Strength
1. Torqueability
1. Tip Flexibility
1. Coating Adherence/Integrity

In all cases, the performance of the Radius PTCA Guidewires was comparable to that of the predicate ACS guidewires.

BIOCOMPATIBILITY F.

Biocompatibility testing was conducted on the proposed line of Radius PTCA Guidewires according to General Program Memorandum - #G95-1 issued May 1, 1995 from the ODE. Following is a summary of the tests performed:

1. Cytotoxicity
2 Sensitization
1. Intracutaneous Toxicity
1. Acute systemic toxicity
1. Material Mediated Pyrogenicity
1. ASTM Hemolysis

All test results were acceptable.

CONCLUSION:

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 0 1997

Ms. Maureen A. Finlayson President Radius Medical Technologies, Inc. 63 Great Road Maynard, Massachusetts 01754

K970466 Re : Radius PTCA Guidewire Requlatory Class: II (two) Product Code: LIT Dated: April 23, 1997 Received: April 24, 1997

Dear Ms. Finlayson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions.

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regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ 1 of . 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Radius PTCA Guidewire Device Name:

Indications for Use: -- ------------------------------------------------------------------------------------------------------------------------------------------------------

The Radius PTCA Guidewire is indicated to facilitate the 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, Respiratory,
and Neurological Devices
510(k) Number K970466

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-counter Use

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).