(124 days)
The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.
The Bipore Balloon Dilatation catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guide wire to locate the balloon at the site of stenosis. This submission adds two balloon sizes to the existing product line, as follows, and does not affect the safety or effectiveness of the device.
The document provided is a 510(k) premarket notification for a medical device, the Bipore Balloon Dilatation Catheter. It outlines the device's description, indications for use, and confirms substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results typically found in reports specifically designed to prove a device meets acceptance criteria for efficacy or performance in a clinical setting.
The "Testing included" section only mentions "Rated Burst pressure within the stent" and "Balloon Fatigue within the stent." These are likely engineering or bench tests for device integrity and durability, not clinical performance metrics.
Therefore, many of the requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the input:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Rated Burst pressure within the stent | Not specified in the provided document |
| Balloon Fatigue within the stent | Not specified in the provided document |
Explanation: The document only lists "Rated Burst pressure within the stent" and "Balloon Fatigue within the stent" under "Testing included." It does not provide the specific acceptance criteria (e.g., minimum burst pressure, number of cycles for fatigue) nor the actual performance results (e.g., "device achieved X burst pressure," "device endured Y fatigue cycles"). These details would typically be found in an engineering report or a full test report, which is not part of this 510(k) summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Cannot be determined from the provided document.
Explanation: The document refers to "bench" testing, implying laboratory-based engineering tests rather than clinical trials with patient data. As such, concepts like "test set," "data provenance," "country of origin," "retrospective," or "prospective" do not apply in the usual clinical sense. The sample size for the devices tested on the bench (e.g., number of catheters subjected to burst pressure or fatigue tests) is not mentioned.
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 / Cannot be determined from the provided document.
Explanation: This question pertains to studies involving human interpretation or assessment, often in diagnostic imaging or clinical outcomes. The mentioned "bench" testing does not involve human experts establishing ground truth in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Cannot be determined from the provided document.
Explanation: Adjudication methods are used in studies where multiple human readers or evaluators independently assess data, and a process is needed to resolve discrepancies. This is not relevant to the "bench" testing described.
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
No MRMC comparative effectiveness study was mentioned or performed.
Explanation: The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
Explanation: The device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense for the described tests.
Explanation: For the "Rated Burst pressure" and "Balloon Fatigue" tests, the "ground truth" would be engineering specifications and physical properties measured against those specifications (e.g., a pressure gauge reading, a cycle counter). This isn't "expert consensus," "pathology," or "outcomes data" as typically used in medical device performance evaluation for clinical effectiveness.
8. The sample size for the training set
Not applicable (no training set mentioned).
Explanation: This question relates to machine learning models, which are not involved in the description of this physical medical device's testing.
9. How the ground truth for the training set was established
Not applicable (no training set mentioned).
Explanation: This question also relates to machine learning models, which are not involved.
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K983650
Summary of Safety and Effectiveness Bipore Balloon Dilatation Catheter
| Trade Name: | Bipore Balloon Dilatation Catheter | |
|---|---|---|
| Manufacturer: | Bipore, Inc.31 Industrial ParkwayNorthvale, New Jersey 07647Tel 201-767-1993 FAX 201-767-0435 | |
| Device Generic Name: | Balloon Dilatation Catheter | |
| Classification: | Class II, Performance Standards | |
| Predicate Devices: | Bipore Balloon Dilatation Catheter | |
| Description of Device: | The Bipore Balloon Dilatation catheter is a double lumen balloon catheterfor percutaneous transluminal angioplasty in peripheral vessel. One lumen is forinflation and deflation of the balloon; the other lumen is used topass the catheter over a guide wire to locate the balloon at the site of stenosis.This submission adds two balloon sizes to the existing product line, as follows,and does not affect the safety or effectiveness of the device. | |
| Indications for Use: | The Bipore Balloon Dilatation Catheter is recommended for percutaneoustransluminal angioplasty of the iliac, femoral, and renal arteries, and for thetreatment of obstructive lesions of autologous or synthetic arteriovenous dialysisfistulae. | |
| The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployedstent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench within CordisPalmaz™ stent. | ||
| *Testing included: | Rated Burst pressure within the stentBalloon Fatigue within the stent |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 1999
Mr. Durmus Koch President Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647
K983650 Re: Trade Name: Bipore Balloon Dilatation Catheter Requlatory Class: II Product Code: LIT Dated: January 28, 1999 Received: January 29, 1999
Dear Mr. Koch:
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 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). 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in 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
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Page 2 - Mr. Durmus Koch
under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph Director Division of Cardiovascular, Respiratory and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page 1 of 1
510(k) Number (if known):
Device Name:
Indications For Use:
The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.
Rated Burst Pressure within the stent *Testing included: Balloon Fatigue within the stent
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Callahon
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number
§ 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).