Atlas® PTA Balloon Dilatation Catheters are indicated for use in Percutaneous Transluminal Angioplasty (PTA) of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Device Description

The Atlas® PTA Balloon Dilatation Catheter is a high performance balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The over the wire catheter is compatible with 0.035" guidewires and is available in 75 and 120 cm working lengths. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen.

Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.

AI/ML Overview

The provided text describes a 510(k) submission for the Atlas® PTA Balloon Dilatation Catheter, focusing on its substantial equivalence to predicate devices. The document explicitly states that the submission is for a "modified indications for use statement" and outlines performance data used to demonstrate equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not provide a table of specific numerical acceptance criteria. Instead, it states:

Acceptance Criteria Category	Reported Device Performance
Overall Equivalence	"The subject device, the Atlas® PTA Balloon Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation activities for the modified indications for use statement, as specified by applicable standards, guidance, test protocols and/or customer inputs."
Technological Characteristics and Performance Criterion	"The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Atlas® PTA Balloon Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use."
Specific In Vitro Tests	The device's performance was evaluated through: - Puncture Resistance - Robustness - Balloon Removal (The specific results for these tests are not provided, only that they were performed and supported comparability/equivalence.)

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

The document describes in vitro tests ("Puncture Resistance," "Robustness," "Balloon Removal") for performance data. It does not mention clinical trials or studies with human subjects that would have a "test set" in the context of diagnostic accuracy or effectiveness on patients. Therefore, information about sample size for a test set (in a clinical sense) or data provenance (country, retrospective/prospective) is not applicable here as this is an engineering performance evaluation, not a clinical study.

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)

This information is not applicable. Since the performance data is based on in vitro engineering tests, there is no mention of human experts being used to establish ground truth in the way it would be for a diagnostic tool or clinical assessment.

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

This information is not applicable. As the performance data is based on in vitro engineering tests, there is no mention of an adjudication process typically used in clinical studies involving interpretation by multiple readers.

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

This information is not applicable. The document does not describe an MRMC study or any study involving human readers or AI assistance. This is a medical device (balloon catheter) and its clearance is based on performance equivalence, not AI-assisted interpretation.

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

This information is not applicable. The device is a physical medical instrument (balloon catheter), not a software algorithm or AI.

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

For the in vitro tests, the "ground truth" would be established by the physical and mechanical properties and measurements against defined specifications and industry standards for balloon catheters. The document lists "applicable standards, quidance, test protocols and/or customer inputs" as the basis for acceptance criteria, which implies objective measurement against known benchmarks rather than subjective expert consensus or clinical outcomes data.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" in the context of device development for this type of medical instrument. The performance evaluation is based on engineering tests, not machine learning model training.

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

This information is not applicable for the same reasons as point 8.

Summary

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Atlas® PTA Balloon Dilatation Catheter

510(k) Summary 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 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1625 West 3rd StreetTempe, Arizona 85281
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Phone: 480-379-2848

480-449-2546 Fax:

Megan Brown, Regulatory Affairs Associate Contact:

Date March 12, 2012

Subject Device Name:

Device Trade Name:	Atlas® PTA Balloon Dilatation Catheter
Common or Usual Name:	Percutaneous Catheter (21 CFR 870.1250,Product Code DQY and LIT)
Classification:	Class II
Classification Panel:	Cardiovascular

Predicate Devices:

Atlas® PTA Balloon Dilatation Catheter (K052236; cleared August 23, ● 2005)
Vaccess® PTA Dilatation Catheter (K111850; cleared July 13, 2011) .

Image /page/0/Picture/18 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 readable.

Bard Peripheral Vascular, Inc.

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Device Description:

Attribute	Atlas PTA Balloon DilatationCatheter Product Offering
Balloon Diameter (mm)	12, 14, 16, 18, 20, 22, 24, 26
Balloon Length (cm)	2, 4, 6
Catheter Shaft Lengths (cm)	75, 120
Introducer SheathCompatibility(compatible balloon sizes,mm x cm)	7F: (12x 2,4,6; 14x 2,4)8F: (14x 6; 16x 2,4,6; 18x 2,4)9F: (18x 6; 20x 2,4)10F: (22x 2,4; 24x 2,4)12F: (26x 2,4)

Indications for Use of Device:

Bard Peripheral Vascular, Inc.

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Comparison of Indications for Use to Predicate Devices:

The modified indications for use statement for the Atlas® PTA Balloon Dilatation Catheter does not raise any new issues of safety and effectiveness when compared to the predicate devices, the Atlas® PTA Balloon Dilatation Catheter and the Vacces® PTA Dilatation Catheter, as demonstrated through the risk analysis process. As such, the subject device, the Atlas® PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate devices, the Atlas® PTA Balloon Dilatation Catheter and the Vacces® PTA Dilatation Catheter.

Technological Comparison to Predicate Devices:

The Atlas® PTA Balloon Dilatation Catheter has the following similarities to the predicate devices:

. Same intended use (both predicates)
. Similar indications for use (combination of both predicates)
Same target population (both predicates)
. Same fundamental scientific technology (both predicates)
. Same operating principle (both predicates)
. Same packaging materials and configuration (Atlas® PTA Balloon Dilatation Catheter)
. Same sterility assurance level and method of sterilization (both predicates)

Performance Data:

To demonstrate the substantial equivalence of the subject device, the Atlas® PTA Balloon Dilatation Catheter, to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on nonclinical testing of medical devices and internal Risk Assessment procedures, the following additional in vitro tests were performed:

. Puncture Resistance
Robustness .
. Balloon Removal

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The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Atlas® PTA Balloon Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

Conclusions:

The subject device, the Atlas® PTA Balloon Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation activities for the modified indications for use statement, as specified by applicable standards, quidance, test protocols and/or customer inputs. The Atlas® PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Atlas® PTA Balloon Dilatation Catheter and the Vaccess® PTA Dilatation Catheter.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

APRE 1 9r 2012

Bard Peripheral Vascular, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K120971

Trade/Device Name: Atlas PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DOY Dated: March 30, 2012 Received: April 2, 2012

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Mr. Mark Job

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.A. Killelea

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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Indications for Use

510(k) Number (if known): K12097 |

Device Name: Atlas® PTA Balloon Dilatation Catheter

Indications for Use: Atlas® PTA Balloon Dilatation Catheters are indicated for use in Percutaneous Transluminal Angioplasty (PTA) of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Prescription Use_X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

zgkille

(Division Sign-Division of Cardiovascular Devices

510(k) Number

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Bard Peripheral Vascular, Inc.

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).