The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.

Device Description

The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial, dual lumen design with a inflatable balloon on the distal end and compatible with 0.035" guidewires. Two radiopaque markers indicate the dilating portion of the balloon and aid in balloon placement. The device is available with balloon diameters of 7.0 - 10.0 mm, balloon lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm.

AI/ML Overview

The provided text describes the 510(k) summary for the Admiral™.035 Dilatation Catheter, a Peripheral Transluminal Angioplasty (PTA) Catheter. The document outlines performance testing conducted to demonstrate its safety and effectiveness, and for comparison to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Material Composition	To be constructed of similar materials to the predicate device.	Constructed of similar materials to the predicate device and other currently marketed PTA Catheters.
Dimensions (Diameter & Length)	To be available in similar diameters and lengths to the predicate device.	Available in similar diameters and lengths as the predicate device.
Design	To have a similar design to the predicate device.	Has a similar design as the predicate device (Over-the-Wire, Coaxial, dual lumen design with an inflatable balloon on the distal end and compatible with 0.035" guidewires; two radiopaque markers).
Indications for Use	To have the same indications for use as the predicate device.	Has the same indications as the predicate device.
Biocompatibility	Must pass all biocompatibility testing.	The Admiral™.035 Dilatation Catheter has passed all Biocompatibility testing.
Balloon Minimum Burst Strength	(Not explicitly stated, but assumed to meet industry standards for safety and efficacy).	Performance testing was conducted, including Balloon Minimum Burst Strength, to demonstrate Safety and Effectiveness.
Compliance	(Not explicitly stated, but assumed to meet industry standards for safety and efficacy).	Performance testing was conducted, including Compliance, to demonstrate Safety and Effectiveness.
Fatigue	(Not explicitly stated, but assumed to meet industry standards for safety and efficacy).	Performance testing was conducted, including Fatigue, to demonstrate Safety and Effectiveness.
Inflation/Deflation performance	(Not explicitly stated, but assumed to meet industry standards for safety and efficacy).	Performance testing was conducted, including Inflation/Deflation performance, to demonstrate Safety and Effectiveness.
Bond Strengths	(Not explicitly stated, but assumed to meet industry standards for safety and efficacy).	Performance testing was conducted, including Bond Strengths, to demonstrate Safety and Effectiveness.
Coating Integrity	(Not explicitly stated, but assumed to meet industry standards for safety and efficacy).	Performance testing was conducted, including Coating Integrity, to demonstrate Safety and Effectiveness.
Overall Safety and Effectiveness	To demonstrate safety and effectiveness.	Bench and Biocompatibility testing has demonstrated the safety and effectiveness of the device.
Substantial Equivalence	To achieve substantial equivalence to the predicate device.	The Admiral™.035 Dilatation Catheter is substantially equivalent to the predicate device and other currently marketed PTA Catheters.

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

The provided text does not specify sample sizes for specific performance tests (e.g., how many catheters were tested for burst strength, fatigue, etc.). It only states that "Performance testing was conducted." The data provenance is also not detailed regarding geographical origin or whether the tests were retrospective or prospective, though bench testing implies a controlled, prospective lab environment. However, the study is a bench study, meaning it was conducted in a laboratory setting using physical specimens of the device, not on human or animal subjects.

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

This information is not applicable to this type of device submission. This is a medical device, and the evaluation is based on engineering and materials performance, not on interpretation of medical images or patient data by human experts for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as there are no human interpretations or judgments to adjudicate in the described bench testing.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is a physical medical device (catheter), not an AI diagnostic or assistive technology for human readers.

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

No, this is not an algorithm or AI technology. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established through:

Engineering specifications and standards: The device's physical properties are measured against established engineering requirements and industry norms for catheters.
Predicate device characteristics: The predicate device serves as a benchmark for comparison in terms of materials, design, dimensions, and intended use.
Biocompatibility standards: International and national standards for biological safety of medical devices are used as the ground truth for biocompatibility testing.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI or machine learning device requiring a training set.

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

This information is not applicable as this is not an AI or machine learning device requiring a training set.

Summary

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APR - 3 2003

K 030062 p 1/1

510(k) Summary - Admiral™.035 Dilatation Catheter

Submitter	Avantec Vascular Corporation1049 Kiel CourtSunnyvale, CA 04089
Date Prepared	January 6, 2003
Contact Person	James M. ShyPhone: (408) 743-3125FAX: (408) 548-0088e-mail: jshy@avantecvascular.com
Device Trade Name	Admiral™.035 Dilatation Catheter
Device Common Name	Peripheral Transluminal Angioplasty (PTA) Catheter
Classification Name	21 CFR 870.1250 Percutaneous Catheter
Device Classification	Regulatory Class: Class II (two)Product Code: 74 LIT
Predicate Device	Boston Scientific Medi-Tech®MARSHAL™ Balloon Dilatation Catheter
Performance Standards	Not promulgated for PTA Catheters.
Intended Use	The Admiral™ .035 Dilatation Catheter is indicated for percutaneoustransluminal angioplasty of the femoral, renal, iliac, popliteal,peroneal and profunda arteries and native or synthetic arteriovenousdialysis fistulae. It is not intended for use in the coronary vasculatureor the neurovasculature.
Device Description	The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial,dual lumen design with a inflatable balloon on the distal end andcompatible with 0.035" guidewires. Two radiopaque markers indicatethe dilating portion of the balloon and aid in balloon placement. Thedevice is available with balloon diameters of 7.0 - 10.0 mm, balloonlengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm.
Biocompatibility	The Admiral™ .035 Dilatation Catheter has passed allBiocompatibility testing.
Performance Data	Performance testing was conducted to demonstrate Safety andEffectiveness and for comparison to the predicate device.Testing included: Balloon Minimum Burst Strength, Compliance,Fatigue, and Inflation/Deflation performance, Bond Strengths andCoating Integrity.
Summary	The Admiral™ .035 Dilatation Catheter is constructed of similarmaterials, is available in similar diameters and lengths, has a similardesign and the same indications as the Predicate Device and othercurrently marketed PTA Catheters. Bench and Biocompatibilitytesting has demonstrated the safety and effectiveness of the device.
Conclusion	The Admiral™ .035 Dilatation Catheter is substantially equivalent tothe predicate device and other currently marketed PTA Catheters.

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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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with a triple helix-like design representing the interconnectedness of health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

Avantec Vascular Corporation c/o Mr. James M. Shy 1049 Kiel Court Sunnyvale, CA 04089

Re: K030062

Trade Name: Admiral™ .035 Dilatation Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: LIT Dated: January 6, 2003 Received: January 7, 2003

Dear Mr. Shy:

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 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 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

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Page 2 -- Mr. James M. Shy

(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 vours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

Device Name: Admiral™ .035 Dilatation Catheter

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The- Counter

(Optional Format 1-1-96)

(Division Sign-Off)
Divas... of Cardiovascula.
510(k) Number 4030062

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).