The Bipore Balloon Dilation Catheter is intended to be used for multations for out. The Bipos Daily of the iliac, femoral and renal arteries, and for perculariedus thanslaminar angloplace, or the autologous or synthetic arteriovenous dialysis fistulae.

Device Description

The Bipore Inc. Balloon Dilation Catheter is an over-the-wire double lumen balloon catheter designed for percutaneous transluminal angioplasty (PTA) in peripheral arteries, including iliac, femoral, and renal arteries. The catheter consists of a 5 French nylon-based shaft with two lumens. One lumen is for inflation and deflation of the balloon. The other lumen accepts a guidewire for manipulation of the catheter to the site stenosis. Guidewires up to 0.035" diameter may be used. There is a bifurcated proximal juncture that provides access to each lumen. A non-compliant dilation balloon of nylon (11) is at the distal end of the catheter. When inflated, the balloon exerts a controlled radial pressure. Located under the proximal and distal ends of the balloon are radiopaque markers, which provide a reference point for locating the balloon within the vessel. A Teflon™ sleeve is placed over the deflated balloon prior to shipping. This sleeve is designed to protect the balloon in storage and is removed prior to use.

AI/ML Overview

The acceptance criteria and the methods used to demonstrate that the Bipore Balloon Dilation Catheter (with nylon balloon) meets these criteria are described below.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document outlines several acceptance criteria and implies the device met these criteria for 510(k) clearance, as denoted by the statement: "The proposed device modification meets Bipore, Inc. original device specification." and the fact that the 510(k) was cleared. However, specific numerical performance results for EACH criterion are not explicitly detailed in the provided text. The document primarily focuses on the acceptance criteria thresholds that the new nylon balloon must meet. Based on the clearance, we can infer that the device did meet these criteria.

Acceptance Criteria	Reported Device Performance (Inferred from 510(k) Clearance)
1. Burst Pressure (Single Inflation)	Achieved (device does not burst below specified pressures: 15 Atm for 3-8mm, 12 Atm for 10mm, 10 Atm for 12mm balloons).
2. Burst Pressure (Multiple Inflations - Fatigue)	Achieved (device does not burst below specified pressures after 40 pressurization cycles).
3. Balloon Compliance (Diameter Expansion)	Achieved (balloon expanded to within +14%/-1% of nominal rated size at specified pressures).
4. Inflation/Deflation Time	Achieved (inflated to specified size within 60 seconds, completely deflated within 60 seconds).
5. Tensile Strength (Catheter Shaft Connection)	Achieved (withstood pull force greater than 5 lbs for one minute without leakage/separation).
6. Burst Pressure (Within Stent Simulator)	Achieved (device does not burst below specified pressures: 15 Atm for 3-8mm, 12 Atm for 10mm, 10 Atm for 12mm balloons when placed in a stent simulator).
7. Shelf Life (Simulated 3-Year Period)	Achieved (aged units met original specifications after accelerated aging).

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

The document states: "The sample size must be sufficiently large enough to yield data that is 95% confident that 99.9% of the balloons will not fail at or below specification." This is a statistical requirement for the sample size, typically indicating a substantial number of units were tested to achieve this confidence level (e.g., for a 95% confidence and 99.9% reliability, a zero-failure test would require at least 299 units). However, the exact numerical sample size used for each test is not explicitly stated.

Data Provenance: The nature of the tests (material properties, mechanical performance, accelerated aging) indicates that the data was generated through prospective bench testing and in-vitro studies conducted by the manufacturer, Bipore, Inc., in a controlled laboratory environment. The country of origin for the data is not explicitly stated, but given the company's location (Northvale, NJ, USA), it's highly likely the studies were conducted in the USA.

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

This information is not applicable to this submission. The "ground truth" for the performance characteristics of this medical device (a balloon dilation catheter) is established through objective, quantifiable engineering and materials testing (e.g., measuring burst pressure, diameter, inflation time). It does not involve subjective human interpretation of images or clinical data that would require expert consensus.

4. Adjudication Method for the Test Set

This is not applicable to this submission. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in subjective expert assessments, typically for clinical endpoints or image interpretation. The tests described here are objective, quantitative engineering tests with clear pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-powered diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Bipore Balloon Dilation Catheter is a physical medical device, and its performance is assessed via engineering and material tests, not through human interpretation of cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. This is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device modification is based on objective and quantifiable engineering specifications and material properties. This includes measurements of:

Burst pressure (maximum pressure before rupture)
Dimensional accuracy (balloon diameter at specific pressures)
Time-based performance (inflation/deflation time)
Mechanical strength (tensile strength)
Fatigue resistance (performance after multiple cycles)
Stability over time (shelf life after accelerated aging)

These are measured directly from the physical device under controlled conditions.

8. The Sample Size for the Training Set

This question is not applicable. This submission details a modification to a physical medical device. There is no "training set" in the context of machine learning algorithms. The material (Nylon 11) itself is characterized, and the manufacturing process is validated, but there isn't a "training set" of data in the AI sense.

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

This question is not applicable for the reasons outlined in point 8. The "ground truth" for the design and manufacturing process of the catheter's components is established through established engineering principles, material science, and quality control procedures to ensure components meet their intended specifications.

Summary

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K04/293

Abbreviated 510(k): Device modification Bipore, Inc. Balloon Dilation Catheter

510(k) Summary

Submitted by:

Keith Paluch Consultant Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647

Proposed Device:

Bipore Balloon Dilation Catheter

Product Classification:

C.F.R. 880.5025 Product code: LIT Class II

FDA registration number:

2248069

Predicate Devices:

510(k)	Name	Manufacturer
--------	------	--------------

Bipore, Inc. Balloon Dilation Catheter K961980

Device Description:

A non-compliant dilation balloon of nylon (11) is at the distal end of the catheter. When inflated, the balloon exerts a controlled radial pressure.

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Located under the proximal and distal ends of the balloon are radiopaque markers, which provide a reference point for locating the balloon within the vessel.

A Teflon™ sleeve is placed over the deflated balloon prior to shipping. This sleeve is designed to protect the balloon in storage and is removed prior to use.

Information on proposed change to the device:

The currently cleared device uses a polyethylene terephthalate (PET) balloon. The rated pressure for 3mm through 8mm balloons is 12 atmospheres. (Atm.) The rated pressure for the 10mm balloon is 10 atmospheres. (Atm.) And, the rated pressure for the 12mm balloon is 8 atmospheres. (Atm.) The change from PET to Nylon balloon construction material improves the burst resistance of the device. Because of the improved properties of the Nylon polymer rated burst pressures increase to 15 atmospheres for 3mm through 8mm balloons, 12 atmospheres for the 10mm balloon and 10 atmospheres for the 12mm balloon size.

The material is nylon 11 manufactured by ELF Atochem designated Besvo A. This material is known to be commonly used in the manufacture of similar type medical devices.

All materials and assembly processes except for the balloon are identical to the original 510(k) submission. Newly performed FMEA identified seven items that were evaluated to access the suitability of material change to nylon.

1. Balloon pressure to yield (burst test).
1. Balloon multiple inflations (to access the element of fatigue)
1. Balloon compliance (ability of the balloon to expand to a predetermined diameter at a specified pressure).
1. Balloon inflation and deflation time.
1. Tensile strength at the catheter shaft connection.
1. Balloon pressure to burst when placed within stent (expansion)
1. Shelf life at simulated three-year period.

Bipore Inc Abbreviated 510(k) submission Device modification K961980 K973563 and K983650

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Acceptance Criteria:

All tests conducted on radiation-sterilized units exposed to a minimum of 40 kilo gray dosage representative of worst-case exposure. Tests performed at 37°C, water bath immersed to simulate actual use conditions.

The device must not yield (burst) at pressures of less than 15 1. atmospheres for 3mm, 3.5mm, 4mm, 5mm, and 6mm 7mm and 8mm balloons. The 10mm balloon must withstand 12 atmospheres. The 12mm balloon size must withstand 10 atmospheres. The sample size must be sufficiently large enough to yield data that is 95% confident that 99.9% of the balloons will not fail at or below specification.
The device must not yield (burst) at pressures of less than 15 2. atmospheres for 3mm, 3.5mm, 4mm, 5mm, and 6mm 7mm and 8mm balloons. The 10mm balloon must withstand 12 atmospheres. The 12mm balloon size must withstand 10 atmospheres. All sizes must withstand at least 40 individual pressurization cycles. This test accesses the element of fatigue. The sample size must be sufficiently large enough to yield data that is 95% confident that 99.9% of the balloons will not fail at or below specification.
The Balloon must expand to a predetermined diameter at a pressurization 3. range of between 4 and 15 atmospheres for 3.5mm through 8mm sized balloons and 4 to 10 atmospheres for the 10mm and 12mm balloon. The test result must be no less than 1% under the nominal rated size and no greater than 14% at the highest pressurization (+14%/-1%).
The Balloon must be capable of inflating to the specified size within 60 4. seconds after setup and air purge. The Balloon must be capable of completely deflating within 60 seconds of the initiation of test.
The Balloon must withstand a straight-line pull force of greater than 5 ട്. pounds for one minute. No leakage or separation of the junction or joint is permitted.
A non-compliant hollow tube is used to simulate stent expansion. Each 6. French sized balloon is placed inside of the stent simulator and pressurized until burst. The test results must be as follows: The device must not yield (burst) at pressures of less than 15 atmospheres for 3mm, 3.5mm, 4mm, 5mm, and 6mm 7mm and 8mm balloons. The 10mm balloon must withstand 12 atmospheres. The 12mm balloon size must withstand 10 atmospheres.

Bipore Inc Abbreviated 510(k) submission Device modification K961980 K973563 and K983650

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Shelf life at simulated three-year period was performed by elevated 7. Oncil fire at officiation and time. Test units were placed in an incubator at 51°C for a temperature and time. Tool anion of the 3-year period is based upon "Shelf Life Extension of Medical Devices dated April 1991 (DSMA of FDA). Aged units must meet original specification.

Comparison to predicate device:

Similarities:

Proposed and predicate devices have the same indications for use.

The proposed device modification meets Bipore, Inc. original device specification.

The modified device is fully reverse compatible with the originally cleared device.

Proposed modification and predicate devices are sterile and nonpyrogenic.

Burst ratings are within the range of competitors advertised claims.

Differences:

Modified device have a greater burst pressure rating than the original device.

Bipore Inc Abbreviated 510(k) submission Device modification K961980 K973563 and K983650

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Image /page/4/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with three horizontal bars extending from the eagle's body. The seal is black and white and appears to be a logo or emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 9 2004

Bipore, Inc. c/o Mr. Keith Paluch Consultant for Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647

Re: K041293

Bipore Balloon Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT Dated: May 11, 2004 Received: May 14, 2004

Dear Mr Paluch:

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 for associated in the 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 – Mr. Keith Paluch

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of actived a determination that your device complies with other requirements of the Act that I Dr head statutes and regulations administered by other Federal agencies. You must or any I court 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 OF N Fart 607), adoling (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. product ratuall allow you to begin marketing your device as described in your Section 510(k) I mb lotter witification. The FDA finding of substantial equivalence of your device to a legally prematicated predicated on " 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 If you attire of Compliance at (301) 594-4648. 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 other Economic 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,

Bram D. Zuckerman, M.D.

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): K041293

Device Name: Bipore Balloon Dilation Catheter

Indications For Use: The Bipore Balloon Dilation Catheter is intended to be used for multations for out. The Bipos Daily of the iliac, femoral and renal arteries, and for perculariedus thanslaminar angloplace, or the autologous or synthetic arteriovenous dialysis fistulae.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 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
510(k) Number	K041293

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).