The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Device Description

The Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

AI/ML Overview

This 510(k) summary for the Atlas™ PTA Balloon Dilatation Catheter (K052236) does not contain the specific acceptance criteria or a detailed study description to prove the device meets said criteria.

Here's an explanation of what is available and what is missing, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not provided	Not provided
(Specific performance metrics, e.g., bursting pressure, catheter flexibility, marker band visibility, etc., are not detailed.)	(None specifically reported in this summary.)

Explanation: The summary explicitly states: "The Atlas™ PTA Balloon Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not list what those specific acceptance criteria were or present the data from tests that demonstrate the device met them.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

Explanation: This 510(k) refers to "design verification and validation" but does not detail the specific test sets, their sizes, or the nature of experiments conducted (e.g., in vitro, in vivo, clinical trials).

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

Number of Experts: Not applicable/Not provided.
Qualifications of Experts: Not applicable/Not provided.

Explanation: No information is given about expert involvement in establishing ground truth for any test data, as no specific test data or ground truth methodology is discussed.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/Not provided.

Explanation: Since no detailed test set or ground truth establishment is described, neither is an adjudication method.

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:

MRMC Study: No.
Effect Size: Not applicable.

Explanation: This is a 510(k) for a medical device (balloon catheter), not an AI-powered diagnostic tool. MRMC studies and AI assistance metrics are not relevant to this device type.

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

Standalone Study: No.

Explanation: This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

Type of Ground Truth: Not applicable/Not provided.

Explanation: As no specific data or evaluation of diagnostic accuracy is discussed, the concept of "ground truth" as typically used for AI or diagnostic imaging devices is not relevant here. The "ground truth" for a physical device might relate to engineering specifications and performance, but these are not detailed.

8. The Sample Size for the Training Set:

Sample Size: Not applicable/Not provided.

Explanation: This is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

Ground Truth Establishment: Not applicable/Not provided.

Explanation: As above, this is not an AI/ML device, so no training set and its ground truth establishment are relevant.

Summary of what the document does provide:

Device Name: Atlas™ PTA Balloon Dilatation Catheter
Submitter: Bard Peripheral Vascular, Inc.
Predicate Device: Atlas™ PTA Balloon Dilatation Catheter (K040243)
Change: Additional balloon sizes.
Intended Use: Percutaneous Transluminal Angioplasty (PTA) of the iliac arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for coronary arteries.
Conclusion: The device met all predetermined acceptance criteria for design verification and validation, establishing substantial equivalence to the predicate device.

To get the specific acceptance criteria and detailed study data, one would typically need to refer to the full design verification and validation documentation which is referenced but not included in this 510(k) summary.

Summary

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AUG 2 3 2005

Atlas™ PTA Balloon Dilatation Catheter 510(k) Summary of Safety and Effectiveness 21 CFR 807.92.

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:

1. Submitter Information:
Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280 480-303-2524 Phone: 480-449-2546 Fax:

Genevieve Balutowski, Regulatory Affairs Specialist Contact:

2. Subject Device Name:

Atlas™ PTA Balloon Device Trade Name: Dilatation Catheter Common or Usual Name: Percutaneous catheter Class II Classification:
Cardiovascular Classification Panel:

Predicate Device: 3.

Atlas™ PTA Balloon Dilatation Catheter (K040243, cleared 02/13/04)

Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The overall design is simple yet impactful, making the word easily recognizable.

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Summary of Change: 4.

The design modification to the Atlas™ PTA Balloon Dilatation Catheter as represented in this submission is additional balloon sizes. All other aspects of the subject device remain the same as the predicate device.

Device Description: 5.

Intended Use of Device: ર.

Technological Comparison to Predicate Device: 7.

The technological characteristics of Atlas™ PTA Balloon Dilatation Catheter are substantially equivalent to those of the predicate device, the Atlas™ PTA Balloon Dilatation Catheter, in terms of intended use, indication for use, application, user population, basic design, performance, and sterilization method.

Conclusions: 8.

The Atlas™ PTA Balloon Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device, the Atlas™ PTA Balloon Dilatation Catheter.

Image /page/1/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The font is uniform in size and spacing, creating a balanced and legible design.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2005

Bard Peripheral Vascular, Inc. c/o Ms. Genevieve Balutowski 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K052236

Bard® Atlas™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 16, 2005 Received: August 17, 2005

Dear Ms. Balutowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications felerenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regard chances of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices that have been receasined in asset approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app allu Cosmetic Act (11ct) market the device, subject to the general controls provisions of the Act. The I ou may, utcrefore, market the act include requirements for annual registration, listing of general controls provisions of wactice, 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 (500 above) this Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

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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 (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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

suma R. Vochines

er R. Vocus

Center for Devices and Radiological Health

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Enclosure

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Indications for Use

510(k) Number (if known): Kos 223 &

Device Name: Atlas™ PTA Balloon Dilatation Catheter

Indications for Use: The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

Prescription Use × (Part21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

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

. DIAMS & Concertify Conce of Device Evaluation (ODE)
Concession Concerner Comment

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Number K052236

Bard Peripheral Vascular, Inc

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

BARD

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).