The Atlas Gold PTA 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 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 Gold PTA Dilatation Catheter is 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" guidewire and is available in 80 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

Here's a breakdown of the acceptance criteria and study information for the Atlas Gold PTA Dilatation Catheter, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the device "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 provide a specific table detailing the acceptance criteria values for each test alongside the performance results. Instead, it lists the types of tests performed.

Therefore, a table cannot be constructed with specific numerical acceptance criteria and performance data. The reported device performance is broadly stated as follows:

Acceptance Criteria Category	Reported Device Performance
In Vitro Tests	"The results from these tests demonstrate that the technological characteristics and performance criteria of the Atlas Gold PTA Dilatation Catheter is comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the similar intended use."
Dimensional Verification	Met criteria (implied by overall statement)
Media Interaction	Met criteria (implied by overall statement)
Equipment Interface	Met criteria (implied by overall statement)
Sheath Compatibility	Met criteria (implied by overall statement)
Rated Burst Pressure	Met criteria (implied by overall statement)
Balloon Burst Mode	Met criteria (implied by overall statement)
Catheter Shaft Leaks	Met criteria (implied by overall statement)
Catheter Shaft Burst	Met criteria (implied by overall statement)
Fatigue	Met criteria (implied by overall statement)
Balloon Nominal Pressure	Met criteria (implied by overall statement)
Balloon Distensibility	Met criteria (implied by overall statement)
Inflation Time	Met criteria (implied by overall statement)
Deflation Time	Met criteria (implied by overall statement)
Balloon to Shaft Tensile	Met criteria (implied by overall statement)
Catheter Shaft Elongation	Met criteria (implied by overall statement)
Hub to Shaft Tensile	Met criteria (implied by overall statement)
Tip Tensile	Met criteria (implied by overall statement)
Tip Morphology	Met criteria (implied by overall statement)
Trackability	Met criteria (implied by overall statement)
Tip Visibility	Met criteria (implied by overall statement)
Catheter Shaft Visibility	Met criteria (implied by overall statement)
Marker Band Visibility	Met criteria (implied by overall statement)
Marker Band Alignment	Met criteria (implied by overall statement)
Balloon Burst Strength in Stent/Stent Graft	Met criteria (implied by overall statement)
Fatigue in Stent/Stent Graft	Met criteria (implied by overall statement)
Balloon Removal from Stent/Stent Graft	Met criteria (implied by overall statement)
Visual Inspection of Packaging	Met criteria (implied by overall statement)
Dye Penetration	Met criteria (implied by overall statement)
Pouch Tensile Strength	Met criteria (implied by overall statement)
Biocompatibility Tests	"The results from these tests demonstrate that the subject device...is comparable to the predicate device and that it is considered safe and biocompatible for its intended use."
Cytotoxicity	Met criteria (implied by overall statement)
Sensitization	Met criteria (implied by overall statement)
Intracutaneous Reactivity	Met criteria (implied by overall statement)
Acute Systemic Toxicity	Met criteria (implied by overall statement)
Hemocompatibility	Met criteria (implied by overall statement)
Material Mediated Pyrogenicity	Met criteria (implied by overall statement)

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

The document does not specify a distinct "test set" in the context of clinical data for algorithmic performance. The tests described are in vitro (laboratory) tests on the device itself and biocompatibility tests. The document does not provide sample sizes for these tests, nor does it mention country of origin or whether the data is retrospective or prospective, as these are typically considerations for clinical studies involving patient data, not mechanical or biocompatibility testing.

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

This information is not applicable. The evaluations were based on engineering specifications and laboratory testing protocols, not expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable. There's no mention of an adjudication process as would be used for subjective assessments or expert reviews of clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device's submission.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not conducted or mentioned. The device is a physical medical instrument (catheter), not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for the performance evaluation relies on established engineering specifications, test protocols, and recognized standards (e.g., ISO 10993-1:2009 for biocompatibility). For mechanical and performance tests, the ground truth is often defined by the design requirements and the physical properties expected of the device.

8. Sample Size for the Training Set:

This information is not applicable. There is no software algorithm or AI that requires a training set for this device. The evaluation is based on direct device testing.

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

This information is not applicable, as there is no training set mentioned for this device.

Summary

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K122984

Page 168

Atlas Gold PTA Dilatation Catheter 510(k) Summary 21 CFR 807.92

OCT 2 2012

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
Phone:	480-303-2752
Fax:	480-449-2546
Contact:	Jennifer Logvin, Senior Regulatory Affairs Specialist
Date:	July 20, 2012

Subject Device Name:

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

Predicate Device:

Atlas® PTA Balloon Dilatation Catheter (K120971, cleared April 19, 2012) .
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Device Description:

Attribute	Atlas Gold PTA Dilatation CatheterProduct Offering
Balloon Diameter (mm)	12, 14, 16, 18, 20, 22, 24, 26
Balloon Length (cm)	2, 4, 6
Catheter Shaft Lengths (cm)	80, 120
Introducer Sheath CompatibilityCompatible Balloon Diameters and Lengths (mm x cm)	7F: 12 2,4,6
	14 2,4
	8F: 14 6
	16 2,4,6
	18 2,4
	9F: 18 620 2,4
	10F: 22 2,424 2,412F: 26 2,4

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Indications for Use of Device:

Comparison of Indications for Use to Predicate Device:

The indication for use statement for the Atlas Gold PTA Dilatation Catheter is identical to that of the predicate device, the Atlas PTA Balloon Dilatation Catheter.

Technological Comparison to Predicate Device:

The Atlas Gold PTA Dilatation Catheter has the following similarities to the predicate device:

. Same intended use
. Same indications for use
. Same target population
Same fundamental scientific technology .
. Same operating principle
. Similar packaging materials and configuration
. Same sterility assurance level and method of sterilization

Performance Data:

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

. Dimensional Verification
- o Tip Length
- Balloon Outer Diameter O
- Balloon Working Length O

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Catheter Shaft Outer Diameter o
Catheter Shaft Inner Diameter o
o Catheter Shaft Length
Media Interaction .
. Equipment Interface
. Sheath Compatibility
Rated Burst Pressure .
Balloon Burst Mode ●
Catheter Shaft Leaks .
Catheter Shaft Burst .
. Fatigue
. Balloon Nominal Pressure
Balloon Distensibility .
. Inflation Time
Deflation Time .
Balloon to Shaft Tensile .
Catheter Shaft Elongation .
. Hub to Shaft Tensile
. Tip Tensile
Tip Morphology .
Trackability (Flexibility and Kink) .
Tip Visibility .
Catheter Shaft Visibility .
Marker Band Visibility .
Marker Band Alignment .
Balloon Burst Strength in a Stent/Stent Graft .
Fatigue in a Stent/Stent Graft .
Balloon Removal from a Stent/Stent Graft .
t Visual Inspection of Packaging
Dye Penetration .
Pouch Tensile Strength .

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

Biocompatibility:

To demonstrate substantial equivalence of the subject device, the Atlas Gold PTA Dilatation Catheter to the predicate device, the following biocompatibility testing was performed in accordance ISO 10993-1:2009, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process," and "Blue Book Memorandum - G95-1 Use of International Standard ISO 10993: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing."

. Cytotoxicity
Sensitization .
Intracutaneous Reactivity .
Acute Systemic Toxicity .
Hemocompatibility .
- Hemolysis, In Vivo Thrombogenicity, Complement Activation .
. Material Mediated Pyrogenicity

The results from these tests demonstrate that the subject device, the Atlas Gold PTA Dilatation Catheter, is comparable to the predicate device and that it is considered safe and biocompatible for its intended use.

Conclusions:

The subject device, the Atlas Gold PTA 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 Gold PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate device. the Atlas PTA Balloon Dilatation Catheter.

Image /page/4/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The overall design is simple and straightforward, focusing on the legibility of the word.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The caduceus is positioned to the right of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

OCT 22 2012

Bard Peripheral Vascular, Inc. C/O Mr. Mark Job Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K122984

Trade/Device Name: Atlas GOLD PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: September 25, 2012 Received: September 26, 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, listing 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.

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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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/CDRH/CDRHOffices/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.

Sincerety yours,

Bram 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):

Device Name: Atlas Gold PTA Dilatation Catheter

Indications for Use: The Atlas Gold PTA 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 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 (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off
Division of Cardiovascular Devices
K Number	K122984

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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).