(194 days)
The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the illac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Birgore, Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Signe Dilatation Catheter for post-deployment sten expansion was demonstrated on the bench with the Cordi's Palmaz™ stent *.
All sterts must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.
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 sire 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.
This is a 510(k) premarket notification for a medical device (Bipore Balloon Dilatation Catheter), not an AI/ML device. Therefore, many of the requested categories regarding AI/ML performance, such as sample size for training data, ground truth establishment for training data, number of experts for ground truth, and MRMC studies, are not applicable.
However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate its safety and effectiveness based on the provided text.
Here's the breakdown:
Acceptance Criteria and Device Performance for Bipore Balloon Dilatation Catheter
1. Table of Acceptance Criteria and Reported Device Performance
The document describes in vitro functional tests and biocompatibility tests performed on the device. While specific quantitative acceptance criteria (e.g., "burst pressure must exceed X psi") are not explicitly listed in numerical form, the completion of these tests with acceptable results implies that the device met pre-defined performance standards for each. The document states that "it has been demonstrated that the Bipore Balloon Dilatation Catheter product line extensions are safe and effective for their intended use," which serves as the overall reported performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| In Vitro Functional Tests: | The following tests were performed and implicitly met acceptance criteria: |
| - Balloon Burst Strength | Performed |
| - Balloon Multiple Inflation Durability | Performed |
| - Balloon Compliance (Ability to expand predictably) | Performed |
| - Balloon Inflation/Deflation Time Efficiency | Performed |
| - Rated Burst Pressure within the Stent | Demonstrated on the bench within Cardis Palmaz™ stent. * |
| - Balloon Fatigue within the Stent | Demonstrated on the bench within Cardis Palmaz™ stent. * |
| Biocompatibility Tests: | The following tests were performed on the predicate device (Bipore Balloon Dilatation Catheter; 510(k) K961980) and implicitly met acceptance criteria, extending to the new product line due to the nature of the submission (line extensions): |
| - Systemic Toxicity | Performed |
| - Intracutaneous Toxicity | Performed |
| - Implantation Effects | Performed |
| - Hemolysis (Blood compatibility) | Performed |
| - Cytotoxicity (Cell compatibility) | Performed |
| - Sensitization (Allergic reaction potential) | Performed |
| Overall Safety and Effectiveness | "Safe and effective for their intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the functional and biocompatibility tests.
The provenance of the data is bench testing (in vitro) for functional tests and laboratory testing for biocompatibility, carried out by the manufacturer, Bipore, Inc. There is no indication of human subject data, retrospective or prospective studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML device, and the "ground truth" for its performance is established through standard engineering and laboratory testing protocols rather than expert consensus on images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. This device is not an AI/ML device relying on human interpretation or adjudication for its performance evaluation. Performance is determined by objective physical and chemical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/ML device, and MRMC studies are not relevant to its evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (balloon catheter), not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements and observations from validated in vitro functional tests and standard biocompatibility assessments. For instance, a balloon burst test has a physical burst pressure as its ground truth, not an expert's opinion. Similarly, biocompatibility is assessed against established biological response criteria.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is used for this physical device.
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SUMMARY OF SAFETY AND EFFECTIVENESS BIPORE BALLOON DILATATION CATHETER March 24, 1998 Ref: 510(k) K973563
| Trade Name: | Bipore Balloon Dilatation Catheter |
|---|---|
| Manufacturer: | Bipore, Inc.31 Industrial ParkwayNorthvale, NJ 07647Tel (201)767-1993 Fax (201) 767-0435 |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | Class II, Performance Standards |
| Predicate Devices: | Bipore Balloon Dilatation Catheter510(k) K961980 |
| Description of Device: | The Bipore Balloon Dilatation Catheter is a double lumen ballooncatheter for percutaneous transluminal angioplasty in peripheralvessel. One lumen is for inflation and deflation of the balloon; theother lumen is used to pass the catheter over a guide wire to locatethe balloon at the sire of stenosis. This submission adds two balloonsizes to the existing product line, as follows, and does not affect thesafety or effectiveness of the device. |
| InflatedBalloonDiameter(mm) | BalloonLength(Cm) | CatheterSize(Fr) | UsableLength(cm) |
|---|---|---|---|
| 4 | 4 | 5 | 100 |
| 5 | 4 | 5 | 100 |
| 5 | 10 | 5 | 100 |
| 6 | 10 | 5 | 100 |
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.
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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 within Cardis Palmaz™ stent. *
^Il stents must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.
Rated Burst Pressure within the Stent *Testing included: Balloon Fatigue within the Stent
Safety and Performance:
The following in vitro function tests were performed on the Bipore Balloon Dilatation Catheter product line extensions:
Balloon Burst Balloon Multiple Inflation Balloon Compliance Balloon Inflation/Deflation Time Rated Burst pressure within the Stent Balloon Fatigue within the Stent
The following biocompatibility tests were performed on the Bipore Balloon Dilatation Catheter; 510(k) K961980:
Systemic Toxicity Intracutaneous Toxicity Implantation Hemolysis Cytotoxicity Sensitization
Conclusions:
Based on the indications for use, technological characteristics, and safety and performance tests, it has been demonstrated that the Bipore Balloon Dilatation Catheter product line extensions are safe and effective for their intended use.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle with its wings spread, facing to the left. The eagle is composed of three curved lines that form the body and wings.
Food and Drug Administration 9200 Carporate Boulevard Rockville MD 20850
APR - 1 1998
Mr. Durmus Koch President Bipore, Inc. 31 Industrial Parkway Northvale, NJ 07647
Re : K973563 Trade Name: Bipore Balloon Dilatation Catheter Requlatory Class: II Product Code: LIT Dated: January 6, 1998 January 7, 1998 Received:
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 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 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 regulation (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 under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Koch
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) 594-4618 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callshan
Thomas J. CallaMan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
J
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510(k) Number (if known): _ K973563
Bipore Balloon Dilatation Catheter Device Name:
Indications For Use:
The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the illac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Birgore, Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Signe Dilatation Catheter for post-deployment sten expansion was demonstrated on the bench with the Cordi's Palmaz™ stent *.
All sterts must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.
Testing included:
Rated Burst Pressure within the Stent Balloon Fatigue within the Stent
Tan A. Re
Division Sign-Off) Division of Carc.ovascular, Respiratory, and Neurological D 510(k) Number
/ prescription use only
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).