(25 days)
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance™ 18LP PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 4.0 French nylon tubing compatible with a 0.018-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided document is a 510(k) Premarket Notification for a medical device, specifically the Advance™ 18LP PTA Balloon Catheter. This type of document is for demonstrating substantial equivalence to a predicate device, not typically for reporting on studies comparing AI performance to human performance or establishing a new clinical effectiveness claim for a novel technology.
Therefore, the requested information regarding AI-specific studies (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) is not applicable to this document. This submission focuses on the physical and material performance of a medical device.
Here's the information that can be extracted or inferred from the provided text, primarily related to the physical device's performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests performed on the Advance™ 18LP PTA Dilatation Catheter to assure reliable design and performance. While the specific acceptance criteria (e.g., "burst pressure must be X psi") and the numerical results (e.g., "burst pressure was Y psi") are not explicitly detailed, the document states that these tests were conducted and the device "conforms to the requirements for its use."
| Test Name | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Tensile test | Device maintains structural integrity under specified tension. | Results provide reasonable assurance of reliable design and performance. |
| Balloon inflation/deflation test | Balloon inflates and deflates as intended. | Results provide reasonable assurance of reliable design and performance. |
| Balloon burst test | Balloon withstands specified pressure without bursting prematurely. | Results provide reasonable assurance of reliable design and performance. |
| Balloon compliance test | Balloon expands to its intended diameter at specified pressures. | Results provide reasonable assurance of reliable design and performance. |
| Balloon fatigue test | Balloon withstands repeated inflation/deflation cycles without failure. | Results provide reasonable assurance of reliable design and performance. |
| Balloon profile test | Balloon maintains low profile for ease of insertion. | Results provide reasonable assurance of reliable design and performance. |
| Bond strengths test | Components (e.g., balloon to shaft) have adequate bond strength. | Results provide reasonable assurance of reliable design and performance. |
| Shelf life test | Device maintains performance characteristics over its shelf life. | Results provide reasonable assurance of reliable design and performance. |
| Sterility test | Device remains sterile. | Results provide reasonable assurance of reliable design and performance. |
| Sheath compatibility test | Device is compatible with target introducer sheaths. | Results provide reasonable assurance of reliable design and performance. |
| Biocompatibility test | Device materials are safe for human contact. | Results provide reasonable assurance of reliable design and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for each of the physical tests listed (e.g., how many balloons were burst tested). It also does not mention any human-involved "test set" in the context of clinical or AI performance. The data provenance is Cook Incorporated's internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. The "ground truth" for these physical tests would be objective measurements and adherence to engineering specifications, not expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
Not Applicable. No adjudication method is relevant for these physical engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This document describes the substantial equivalence of a physical medical device (a catheter) and its engineering performance, not a software device involving AI or human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by engineering specifications, material science principles, and regulatory standards for medical device safety and efficacy. For example, the ground truth for the burst test is the scientifically determined pressure at which the balloon should rupture.
8. The Sample Size for the Training Set
Not Applicable. This is not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
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K073378 9. 1 of 2 25
Special 510(K) Premarket Notification PTA Balloon Catheter Cook Incorporated
510(k) Summary
Submitted By:
Nathan Simon, M.S. Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 November 30, 2007
DEC 3 8 2007
Device:
| Trade Name: | Advance™ 18LP PTA Dilatation Catheter |
|---|---|
| Proposed Classification: | Catheter, Angioplasty, Peripheral, Translumina(74 DQY) |
Indications for Use:
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Predicate Devices:
The Advance™ 18LP PTA Dilatation 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 Advance™ 18LP PTA Dilatation Catheter is an over-the wire balloon catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device will be made with 4.0 French nylon tubing compatible with a 0.018-inch guidewire. It will be supplied sterile, intended for one-time use.
Substantial Equivalence:
Cook currently markets the PTA Balloon Catheter which is considered substantially equivalent to the Advance™ 18LP PTA Dilatation Catheter. The similar indications for use and technological characteristics of the Advance™ 18LP PTA Dilatation Catheter as compared to the predicate device support a determination of substantial equivalency.
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Special 510(K) Premarket Notification PTA Balloon Catheter Cook Incorporated
Test Data:
The Advance™ 18LP PTA Dilatation Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Tensile test 1.
- Balloon inflation/deflation test 2.
- Balloon burst test 3.
- Balloon compliance test 4.
-
- Balloon fatigue test
- Balloon profile test 6.
-
- Bond strengths test
-
- Shelf life test
-
- Sterility test
- Sheath compatibility test 10.
- Biocompatibility test 11.
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 PTA dilatation balloon catheter.
. 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around it. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
DEC 2 8 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Incorporated c/o Nathan Simon Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402-0489
Re: K073378
Trade/Device Name: Advance™ 18LP PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: November 30, 2007 Received: December 3, 2007
Dear Mr. Simon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the includine 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 In microadic
in the 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) that do not require approval of a premarket approval application (PMA). 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbrandi, n3 and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations aftecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, TDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Nathan Simon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Blymmerman fr
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(K) Premarket Notification PTA Balloon Catheter Cook Incorporated
| 510(k) Number (if known): | K073378CONCULTION |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Device Name: Advance™ 18LP PTA Balloon Catheter
Indications for Use:
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
R. Hummer
District Clerk, Rio
Division Simn Off Division of Cardiovascular Devices 510(k) Number
§ 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).