The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.

Device Description

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is a dual 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

Here's an analysis of the provided information regarding the Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter:

The provided text does not contain detailed acceptance criteria or a comprehensive study report that demonstrates the device meets specific performance standards. Instead, it is a 510(k) summary focusing on substantial equivalence to predicate devices.

Here's what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific functional, analytical, or clinical performance metrics (e.g., burst pressure, inflation/deflation times, lesion re-stenosis rates, success rates)	Not explicitly stated within the provided text. The document states: "Bench testing shows that the modified catheter is substantially equivalent to the predicate Ultraverse Catheter." This implies performance is comparable to the predicate, but specific criteria and results are not detailed.

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

Test Set Sample Size: Not specified.
Data Provenance: Not specified. (The document mentions "Bench testing," which implies laboratory testing, but details on the data origin, whether it involved human or animal subjects, or geographical location are absent.)
Retrospective/Prospective: Not specified.

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

Number of Experts: Not applicable. This type of device (balloon dilatation catheter) would not typically involve "experts" establishing a ground truth in the same way a diagnostic imaging AI would. Performance would be assessed through objective engineering and mechanical tests (bench testing).
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Performance is assessed through objective bench testing, not through expert review needing adjudication.

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

Was an MRMC study done? No. This type of study is primarily relevant for diagnostic imaging devices or software where human interpretation plays a role. A balloon dilatation catheter's effectiveness is evaluated through physical performance and clinical outcomes, not through reader performance.
Effect Size of Human Reader Improvement with AI vs. without AI Assistance: Not applicable. There is no AI component mentioned in this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Not applicable. This device is a physical medical instrument, not an algorithm. Its performance is inherent to its design and manufacture, tested through bench and potentially clinical performance, not an algorithm's standalone performance.

7. Type of Ground Truth Used

Type of Ground Truth: For bench testing, the "ground truth" would be established by engineering specifications and validated testing methodologies (e.g., maximum burst pressure specified by design, inflation time, guidewire compatibility, lumen patency, etc.). These are objective physical parameters. Pathology or outcomes data may be relevant in clinical trials but are not referenced here for this premarket notification's performance data.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physical catheter, not a machine learning model, so there is no "training set."

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

How Ground Truth for Training Set Was Established: Not applicable.

Summary of Device Performance and Study Information provided:

The core of the performance data for the Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter, as described in the 510(k) summary, relies on bench testing. The crucial statement is: "The design, materials and manufacturing process for the predicate and the modified device are the same. Bench testing shows that the modified catheter is substantially equivalent to the predicate Ultraverse Catheter." This indicates that the device's performance was compared to a previously cleared predicate device through laboratory (bench) tests, and it was found to be comparable. However, the specific test parameters, acceptance criteria, or quantitative results of these bench tests are not provided in this summary. The FDA's clearance (K012913) is based on this assertion of substantial equivalence.

Summary

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K012913

Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E Covington, GA 30014

SEP 2 8 2001

510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

A.. Submitter Information:

C.R. Bard, Inc., Peripheral Technologies Division Submitter's Name: Submitter's Address: 13183 Harland Drive, Covington, GA 30014 Carol Vierling Contact Person: Contact Person's Telephone Number: (770) 385-2347 Contact Person's FAX Number: (770) 385-2340 Date of Preparation: August 30, 2001

Device Name: B.

Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter

C. Predicate Devices:

Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Bard® Opti-Plast™ PTA Catheter Boston Scientific Symmetry™ Balloon Dilatation Catheter

D. Device Description:

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is a dual 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.

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E. Intended Use:

Technological Characteristics Summary: F.

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter has a 3.5 Fr shaft and is available in lengths of 100 and 120 cm. Various balloon diameters and lengths are available.

G. Performance Data:

The design, materials and manufacturing process for the predicate and the modified device are the same. Bench testing shows that the modified catheter is substantially equivalent to the predicate Ultraverse Catheter.

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Image /page/2/Picture/2 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures.

SEP 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

C.R. Bard, Inc. c/o Ms. Carol Vierling 13183 Harland Dr, NE Covington, GA 30014

Re: K012913

Trade Name: Bard Ultraverse Small Vessel PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 30, 2001 Received: August 30, 2001

Dear Ms. Vierling:

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.

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Page 2 - Ms. Carol Vierling

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

signature

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 5

Indications for Use Statement

Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Device Name

The Bard® Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter Indications is recommended for use in Percutaneous Transluminal Angioplasty of the for Use renal, tibial, popliteal, femoral and peroneal vessels. This catheter is not for use in coronary arteries.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K012913

V Prescription Use (Per 21 CFR 801.109

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).