Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.

Device Description

The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheter is designed to be used in conjunction with a 0.035" diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labeled diameter and length at a 10 atmosphere Operating Pressure. The Rated Burst Pressure of the device ranges from 17-20 atmospheres, depending on balloon diameter (see attached table).

AI/ML Overview

The provided text describes a medical device, the Opti-Plast® Centurion 5.5F PTA Catheter, and its performance testing for substantial equivalence to predicate devices, rather than a study using AI or digital health technology. Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document.

However, I can extract information related to the device's technical specifications and the bench testing performed.

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

The document does not explicitly state "acceptance criteria" for each performance test. Instead, it presents a comparison of technological characteristics between the proposed device and two predicate devices. The "reported device performance" are the characteristics of the proposed device itself, and the implicit acceptance criterion for the premarket notification (510(k)) is that these characteristics demonstrate substantial equivalence to legally marketed predicate devices, and that there are no new safety or effectiveness issues.

Feature	Acceptance Criteria (Implied: Substantial Equivalence to Predicate Devices & No New Safety/Effectiveness Issues)	Reported Device Performance (Opti-Plast® Centurion 5.5F PTA Catheter)
Indicated Use	Similar to predicate devices, expanding on specific applications.	PTA of femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for coronary arteries.
Material/Construction	Similar to predicate devices, ensuring safety and performance.
- Balloon Material	Nylon (matching one predicate)	Nylon
- Catheter Shaft, Tip, Collar, Extensions Material	Nylon Co-polymer	Nylon Co-polymer
- Coating on Shaft	Glissando (new, but no new safety/effectiveness issues)	Glissando
- Radiopaque Shaft	Yes	Yes
- Marker Bands	Yes, with clear visibility	Yes, Gold
Dimensions	Comparable to predicate devices.
- Inflated Balloon Diameters	4 mm - 10 mm	4 mm - 10 mm
- Inflated Balloon Length	2 cm - 4 cm (shorter than one predicate, but within typical ranges)	2 cm - 4 cm
- Catheter Shaft Diameter	5.5 French	5.5 French
- Shaft Length	50 cm - 140 cm (wider range than one predicate, comparable to another)	50 cm - 140 cm
- Tip Length	3 mm (shorter than predicate)	3 mm
- Guidewire Capability	0.035 inch diameter	0.035 inch diameter
Performance Characteristics	Demonstrated functionality and safety.
- Recommended Operating Pressure	10 atmospheres (higher than one predicate)	10 atmospheres
- Rated Burst Pressure	17 atmospheres - 20 atmospheres (higher than predicates)	17 atmospheres - 20 atmospheres
- Shaft configuration	Double lumen	Double lumen

Performance Data (Bench Testing):
The document states: "The test results indicate that the Opti-Plast Centurion 5.5F PTA Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication."

Bench testing was conducted for the following characteristics:

Balloon burst strength
Balloon distensibility
Balloon inflation/deflation time
Balloon fatigue
Joints and material strength
Catheter balloon profile
Introducer sheath compatibility
Catheter flow rate and maximum injection pressure
Deflatability and trackability
Tip torque performance
Puncture resistance ("toughness")
Balloon scratch resistance
Balloon fatigue (cycling to rated burst pressure) within a stent
Balloon burst within a stent

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

Not applicable. The document describes bench testing of a physical medical device, not a study involving a test set of data (e.g., medical images, patient records). No human or animal data were used. The tests were performed in a laboratory setting. No country of origin for the data is specified, but the applicant is a US company.

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)

Not applicable. This is a physical device testing, not a study requiring expert ground truth for interpretation of results.

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

Not applicable. This is a physical device testing, not a study requiring adjudication of interpretations.

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

Not applicable. This document pertains to a physical medical device (catheter) and no AI or human-in-the-loop performance studies were conducted or are relevant.

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

Not applicable. This document pertains to a physical medical device (catheter); there is no algorithm involved.

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

Not applicable. For bench testing of physical characteristics, the "ground truth" generally refers to physical measurements and engineering specifications, not expert consensus or medical outcomes. For example, balloon burst strength is measured against a specified pressure.

8. The sample size for the training set

Not applicable. There is no training set as this is a physical medical device, not an AI/algorithm-based product.

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

Not applicable. There is no training set for this type of device.

Summary

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<973013

C. R. Bard, Inc. 8195 Industrial Blvd. Covington, GA 30209

JUN 1 9 1998

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

C. R. Bard, Inc., Radiology Division Submitter Information: A. 13183 Harland Dr. Covington, GA 30014

Contact Person:	Donna J. Wilson
Contact Person's Address:	8195 Industrial Blvd.Covington, GA 30014
Contact Person's Telephone:	770-784-6135
Contact Person's FAX:	770-784-6419
Date of Preparation:	June 17, 1998
B. Device Name:	Opti-Plast® Centurion 5.5F PTA Catheter
C. Predicate Device:	Opti-Plast® 5.5F PTA Catheter (#K933483)
Predicate Device forIndications for Use:	Medi-Tech® Blue-Max™ Balloon DilatationCatheter (#K934191)

D. Device Description:

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E. Indications for Use:

F. Technological Characteristics Summary:

Summarized in the attached table.

G. Performance Data:

Bench testing was conducted for the following characteristics: balloon burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joints and material strength, catheter balloon profile, introducer sheath compatibility, catheter flow rate and maximum injection pressure, deflatability and trackability, tip torque performance, puncture resistance ("toughness"), balloon scratch resistance, balloon fatigue (cycling to rated burst pressure) within a stent and balloon burst within a stent. The test results indicate that the Opti-Plast Centurion 5.5F PTA Catheter is substantially equivalent to the stated predicate device, that there are no new safety or effectiveness issues, and that the device can be utilized for its stated indication.

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Technological Characteristics Summary

Features	Proposed Vas-Cath Opti-Plast®Centurion 5.5F PTA Catheter	Vas-Cath Opti-Plast® 5.5F PTACatheter (K933483)	Medi-tech® Blue-Max™ BalloonDilatation Catheter (K934191)
Indicated Use	PTA of the femoral, iliac and renalarteries, post-deployment dilatationof peripheral vascular stents and forthe treatment of obstructive lesions of nativeor synthetic arteriovenous dialysis fistulae.	PTA of vessels of the peripheralvascular system	PTA of the Iliac, Femoral and Renal Arteriesand for the treatment of obstructive lesions ofnative or synthetic arteriovenous dialysis fistulae
Balloon Material	Nylon	Nylon	Poly-5TM
Inflated Balloon Diameters	4 mm - 10 mm	4 mm - 10 mm	4 mm - 10 mm
Inflated Balloon Length	2 cm - 4 cm	2 cm - 10 cm	2 cm - 10 cm
Recommended OperatingPressure	10 atmospheres	6 atmospheres - 8 atmospheres	NA
Rated Burst Pressure	17 atmospheres - 20 atmospheres	8 atmospheres - 12 atmospheres	17 atmospheres
Material for catheter shaft,tip, collar, and extensions	Nylon Co-polymer	Nylon Co-polymer	NA
Coating on shaft	Glissando	None	Medi-Glide
Radiopaque shaft	Yes	Yes	NA
Catheter Shaft Diameter	5.5 French	5.5 French	5.8 French
Shaft Length	50 cm - 140 cm	50 cm - 120 cm	40 cm - 120 cm
Shaft configuration	Double lumen	Double lumen	Double lumen
Marker Bands	Yes, Gold	Yes, Tantalum	Yes, material NA
Tip Length	3 mm	5 mm	5 mm
Guidewire Capability	0.035 inch diameter	0.035 inch diameter	0.035 inch diameter

NA - Not available from promotional literature

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Image /page/3/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 three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 1998

Ms. Donna J. Wilson Director, Requlatory Affairs C.R. Bard, Inc. 8195 Industrial Boulevard Covington, GA 30209

Re: K973013 Opti-Plast® Centurion 5.5F PTA Catheter Requlatory Class: II (two) Product Code: 74 LIT Dated: March 20, 1998 March 23, 1998 Received:

Dear Ms. Wilson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Donna J. Wilson

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices 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: Bard® Opti-Plast® Centurion 5.5 F PTA 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)

V Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use_

(Optional Format 1-2-96)

i
Division Sign Off

(Division Sign-Off) Division of Cardiovascular, Resphalory, and Neurological Devices x 974013 510(k) Number -----

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).