(262 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 software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "balloon catheter" used for "percutaneous transluminal angioplasty of lesions" in arteries and fistulae, explicitly stating its purpose is to "treat obstructive lesions," which are therapeutic actions.
No
The device is a COOK PTA balloon catheter, which is used for percutaneous transluminal angioplasty to treat obstructive lesions. Angioplasty is a therapeutic procedure to open blocked arteries, not a diagnostic one.
No
The device description clearly states it is a "COOK PTA balloon catheter," which is a physical medical device used in angioplasty procedures. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a balloon catheter used for percutaneous transluminal angioplasty. This is a procedure performed inside the body to widen narrowed blood vessels. It does not involve testing samples taken from the body.
The device is an interventional medical device used for a therapeutic procedure, not a diagnostic test performed on samples outside the body.
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 are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
The COOK PTA balloon catheter is an over-the-wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time 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
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
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: Tensile tests, Flow rate tests, Repeated balloon inflation tests, Balloon burst tests, Biocompatibility tests, Animal tests to assess in vivo performance characteristics.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
APR 1 6 1998
510(k) Premarket Notification PTA Balloon Catheter COOK INCORPORATED
0 Safety and Effectiveness Information
Submitted By:
April Lavender, RAC Vice President Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 November 26, 1997
Device:
Trade Name: Proposed Classification Name: None Catheter, Cardiovascular Balloon Type (79GBR)
Predicate Devices:
The COOK PTA balloon catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as devices for transluminal percutaneous angioplasty of vessel lumens which are narrowed or obstructed.
Device Description:
The COOK PTA balloon catheter is an over-the-wire balloon catheter indicated for percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0 French vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality Assurance Program. This device will undergo packaging similar to the devices currently marketed and distributed by COOK INCORPORATED. This device will undergo sterilization similar to the devices currently marketed and distributed. Being similar with respect to indications for use, materials and physical construction to predicate devices, this device meets the requirements for section 510(k) substantial equivalence.
OMPANY
11
1972800
1
CONFIDENT
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
- Tensile tests I
- 트 Flow rate tests
- 그 Repeated balloon inflation tests
- 트 Balloon burst tests
- 포 Biocompatibility tests
- Animal tests to assess in vivo performance characteristics 내
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.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo features a stylized depiction of an eagle or bird with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1998
Ms. April Lavender, RAC Vice President Regulatory Affairs Cook, Inc. 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402
Re: K972800 PTA Balloon Catheter Trade Name: Regulatory Class: II Product Code: LIT Dated: March 3, 1998 Received: March 3, 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 reqistration, 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 Regulations, 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
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Page 2 - Ms. 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 requlations.
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 requlation 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. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Balloon Cathe COOK INCORPORAT
12972800 510(k) Number (if known):
Device Name:
PTA Balloon Catheter
Indications for Use:
For percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and ilio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Ru A Ro
(Division Sign-Off)
stillionn of Cardiovascure 'especatory, no Neurological Devices 510(k) Number.
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Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use ----------------------------------------------------------------------(Per 21 CFR 801.109)