(28 days)
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Not Found
No
The summary describes a physical medical device (a balloon catheter) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or data sets, which are typically associated with AI/ML technologies in medical devices.
Yes
The device is a Percutaneous Transluminal Angioplasty (PTA) balloon catheter, which is used to treat obstructive lesions in arteries, clearly indicating a therapeutic purpose.
No
The device description clearly states it is a "COOK PTA balloon catheter" intended for "percutaneous transluminal angioplasty," which is a therapeutic procedure to open narrowed arteries, not a diagnostic one.
No
The device description clearly describes a physical balloon catheter made of vinyl tubing, which is a hardware component. The performance studies also focus on physical properties and in vivo performance, not software validation.
No, 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, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Description: The provided description clearly states that this is a PTA balloon catheter used for percutaneous transluminal angioplasty. This is a procedure performed inside the body (in vivo) to widen narrowed or blocked blood vessels.
- Intended Use: The intended use is to treat lesions in peripheral arteries and dialysis fistulae, which are anatomical structures within the body.
The device is a therapeutic medical device used for a surgical procedure, not a diagnostic device used for testing biological samples.
N/A
Intended Use / Indications for Use
For percutaneous transluminal angioplasty of lesions in peripheral arteries i or porcellinoode transmit infrapopliteal, femoral and ilio femoral and are interating may ronal populaudive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
74 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 ilias, renal, popliteal, infrapopliteal, femoral and illio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0(6.0) French vinyl tubing compatible with an 0.035-inch guidewire. It will be supplied sterile, intended for one-time use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
peripheral arteries including ilias, renal, popliteal, infrapopliteal, femoral and illio femoral; native or synthetic arteriovenous dialysis fistulae
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The balloon catheter was subjected to the following tests to assure reliable design and The balloon cannoter was sabled testing parameters. These tests were comprised of:
- l Tensile tests
- Flow rate tests
- Repeated balloon inflation tests
- Balloon burst tests
- Biocompatibility tests
- Animal tests to assess in vivo performance characteristics
The results of these tests provide reasonable assurance that the device has been tested to assure conformance to the requirements for its use as a vascular PTA balloon.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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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
JUN 2 9 1998
Special 510(k) Premarket Notification PTA Balloon Catheter, D.C.#K981906 COOK INCORPORATED
Safety and Effectiveness Information 0
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 June 25, 1998
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 ilias, renal, popliteal, infrapopliteal, femoral and illio femoral and are also intended to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 5.0(6.0) 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.
1
Test Data
The balloon catheter was subjected to the following tests to assure reliable design and The balloon cannoter was sabled testing parameters. These tests were comprised of:
- l Tensile tests
- Flow rate tests 트
- Repeated balloon inflation tests E
- Balloon burst tests 트
- I Biocompatibility tests
- Animal tests to assess in vivo performance characteristics I
The results of these tests provide reasonable assurance that the device has been I we readler of ested 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 U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of a bird or eagle with three human profiles incorporated into its design, creating a symbolic representation of health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 9 1998
Ms. April Lavender Cook, Inc. 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402
K981906 Re: PTA Balloon Catheter Requlatory Class: II (two) Product Code: 74 LIT Dated: May 29, 1998 Received: June 1, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 Failure to comply with the GMP regulation may result in assumptions. 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 - Ms. April Lavender
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) 594-4648. 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. Callahan
Thomas J. Ca llahan, 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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Special 510(k) Premarket Notification PTA Balloon Catheter, D.C.#K972800 COOK INCORPORATED
×981906 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
PTA Balloon Catheter
Indications for Use:
For percutaneous transluminal angioplasty of lesions in peripheral arteries i or porcellinoode transmit infrapopliteal, femoral and ilio femoral and are interating may ronal populaudive lesions of native or synthetic arteriovenous dialysis fistulae.
Taia f R
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 1981906 510(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)