(194 days)
Not Found
No
The summary describes a standard balloon dilatation catheter and its intended use, with no mention of AI or ML capabilities. The performance studies are focused on physical properties and biocompatibility, not algorithmic performance.
Yes
The device is used for percutaneous transluminal angioplasty and post-deployed stent expansion, which are medical treatments aimed at improving patient health.
No
The device is a balloon dilatation catheter used for percutaneous transluminal angioplasty, which is a therapeutic intervention to treat obstructive lesions, not to diagnose them.
No
The device description clearly describes a physical balloon catheter with lumens for inflation and a guidewire, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a procedure performed within the body (percutaneous transluminal angioplasty) to treat blockages in blood vessels and dialysis fistulae. This is an in vivo procedure.
- Device Description: The device is a balloon catheter designed to be inserted into blood vessels. This is a medical device used for treatment, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical (balloon inflation for dilation).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 within Cardis Palmaz™ stent. *
^Il stents must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, and renal arteries, arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Parkway | |
| Northvale, NJ 07647 | |
| Tel (201)767-1993 Fax (201) 767-0435 | |
| Device Generic Name: | Balloon Dilatation Catheter |
| Classification: | Class II, Performance Standards |
| Predicate Devices: | Bipore Balloon Dilatation Catheter |
| 510(k) K961980 | |
| Description of Device: | 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. |
| Inflated
Balloon
Diameter
(mm) | Balloon
Length
(Cm) | Catheter
Size
(Fr) | Usable
Length
(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.
1
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.
2
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.
3
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)