(199 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML technologies.
Yes
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, which is used to treat obstructive lesions in arteries and fistulae. This procedure involves physically opening up narrowed blood vessels, which is a direct therapeutic intervention.
No
Explanation: The device, a PTA Balloon Catheter, is described for "percutaneous transluminal angioplasty of lesions" and "treat obstructive lesions." This indicates a therapeutic function to treat a condition rather than diagnose one. While it uses "fluoroscopic visualization" for guidance, this is part of the therapeutic procedure, not a diagnostic step performed by the device itself.
No
The device description clearly details a physical catheter with a balloon, radiopaque markers, and specific dimensions, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description and Intended Use: The description clearly states that this is a PTA (Percutaneous Transluminal Angioplasty) Balloon Catheter used for a procedure performed inside the body (in vivo) to treat lesions in arteries and fistulae. It is a therapeutic device, not a diagnostic one that analyzes samples outside the body.
The device is used for a medical procedure, not for testing biological samples.
N/A
Intended Use / Indications for Use
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and is also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
The PTA Balloon Catheter is a double lumen catheter with a balloon near the distal tip. The catheter features a minimally compliant balloon constructed from high density polyethylene material. The balloon is designed to expand to a specified diameter and length at a specific pressure as labeled. The balloon catheter is provided in an overall length of 135cm. The catheter will be made in four balloon diameters of 2.5mm, 3.0mm, 3.5mm and 4.0mm. Balloon lengths will be 1.5cm, 2.0cm, 3.0cm and 4.5cm. The catheter is compatible with 0.014-inch standard PTA wire guides. Two radiopaque marker bands located at the proximal and distal ends of the balloon segment facilitate fluoroscopic visualization of the balloon during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral; native or synthetic arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The balloon catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters: Balloon Minimum Burst Strength Test, Balloon Distensibility Test, Balloon Inflation/Deflation Test, Balloon Fatigue Test, Bond Strength Test, Diameter and Profile Test, Biocompatibility Test. The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a vascular PTA balloon.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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).
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AUG 20 1998
510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
Safety and Effectiveness Information
April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, In 47402 (812) 339-2235 January 30, 1998
Device: Trade Name: Proposed Classification Name: None Catheter, Cardiovascular Balloon Type (79GBR)
Predicate Devices:
The PTA balloon catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as devices for dilation of lesions in peripheral arteries (iliac, renal popliteal, infra popliteal, femoral and ilio femoral).
Device Description
The PTA Balloon Catheter is a double lumen catheter with a balloon near the distal tip. The catheter features a minimally compliant balloon constructed from high density polyethylene material. The balloon is designed to expand to a specified diameter and length at a specific pressure as labeled. The balloon catheter is provided in an overall length of 135cm. The catheter will be made in four balloon diameters of 2.5mm, 3.0mm, 3.5mm and 4.0mm. Balloon lengths will be 1.5cm, 2.0cm, 3.0cm and 4.5cm. The catheter is compatible with 0.014-inch standard PTA wire guides. Two radiopaque marker bands located at the proximal and distal ends of the balloon segment facilitate fluoroscopic visualization of the balloon during use.
Substantial Equivalence
The PTA Balloon Catheter is similar to many devices already in commercial distribution for percutaneous transluminal angioplasty (PTA). The similar indications for use and technological characteristics of the PTA Balloon Catheter as compared to the predicate devices supports a
1
510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
determination of substantial equivalency. Other companies with similar balloon catheters for PTA are Medi-Tech Corporation of Watertown, Massachusetts, United States Catheter and Instrument of C.R. Bard, as well as COOK INCORPORATED.
Test Data
The balloon catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Balloon Minimum Burst Strength Test જુન
- જુન Balloon Distensibility Test
- જુન Balloon Inflation/Deflation Test
- な Balloon Fatigue Test
- ન્દ્ર Bond Strength Test
- 中 Diameter and Profile Test
- નું Biocompatibility Test
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a vascular PTA balloon.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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 three heads, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 20 1998
Ms. April Lavender, RAC Vice President, Regulatory Affairs COOK Inc. 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402
K980390 Re : PTA Balloon Catheter Trade Name: Regulatory Class: II Product Code: LIT Dated: May 21, 1998 Received: May 22, 1998
Dear Ms. Lavender:
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 A substantially equivalent determination assumes compliance with 895. 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 Reqister. Please note: this
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Paqe 2 - Ms. April Lavender
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.
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" (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.D. Director Division of Cardiovascular, Respirator and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
K980390 510(k) Number (if known):
:
PTA Balloon Catheter Device Name:
Indications for Use:
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and is also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use
. Rughi
(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices
510(k) Number_