(23 days)
The PowerFlex Extreme PTA balloon catheter is indicated for dilatation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Cordis PowerFlex Extreme PTA balloon catheter is a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in the balloon placement.
The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the POWERFLEXTM EXTREME PTA Catheter. Instead, it details its 510(k) premarket notification and substantial equivalence to a predicate device.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" (e.g., a specific percentage of success, or a defined performance threshold for a particular metric) nor quantitative "reported device performance" are mentioned in the provided text. The document states:
"The safety and effectiveness of the Cordis PowerFlex Extreme PTA Balloon Catheter have been demonstrated via data collect from non-clinical design verification tests and analyses."
This indicates that internal design verification tests were conducted, but their specific criteria and results are not shared in this document.
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding:
- The sample size used for any test set (e.g., number of patients, number of arteries, number of fistulae, or number of devices tested in a clinical setting).
- The data provenance (e.g., country of origin, retrospective or prospective). The document only mentions "non-clinical design verification tests and analyses," implying laboratory or bench testing rather than clinical data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. As no clinical study results or clinical ground truth are discussed, there's no mention of experts establishing ground truth. The "non-clinical design verification tests" would typically rely on engineering specifications and direct measurements rather than expert consensus on clinical findings.
4. Adjudication Method for the Test Set:
Not applicable. Since no clinical test set or subjective interpretations are discussed, there's no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. There is no mention of an MRMC study or any study comparing human readers with and without AI assistance. This device is a physical medical device (balloon catheter), not an AI-powered diagnostic tool.
6. Standalone Performance:
Yes, in a way. The "non-clinical design verification tests and analyses" describe the standalone performance of the device against its design specifications and safety requirements. However, specific metrics are not provided. The performance is assessed based on the device's physical and functional properties (e.g., balloon inflation, pressure resistance, catheter trackability, material biocompatibility), not an algorithm's output.
7. Type of Ground Truth Used:
For the "non-clinical design verification tests and analyses," the 'ground truth' would be engineering specifications, material standards, and validated test methods. For example, balloon burst pressure would be compared against a defined specification, or material biocompatibility against an established standard. It's not clinical pathology, outcomes data, or expert consensus in the typical sense.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
Summary of available information related to performance:
The document primarily focuses on establishing "substantial equivalence" of the POWERFLEX EXTREME PTA Catheter to its predicate device, the Cordis PowerFlex Plus PTA Balloon Catheter. The "performance data" section states:
"The safety and effectiveness of the Cordis PowerFlex Extreme PTA Balloon Catheter have been demonstrated via data collect from non-clinical design verification tests and analyses."
This indicates that the device's performance was evaluated through bench testing and laboratory analyses to ensure it met design specifications and safety requirements, aligning with the performance of its predicate. However, detailed results, specific acceptance criteria (e.g., "burst pressure must be >X psi" or "insertion force must be <Y N"), or the exact methodologies of these non-clinical tests are not disclosed in this summary. The FDA's 510(k) clearance process often relies on this type of non-clinical data for devices where clinical performance is deemed similar to a predicate.
{0}------------------------------------------------
POWERFLEXTM EXTREME PTA Catheter Cordis Corporation, a Johnson & Johnson Company
K99282$
510(k) Premarket Notification
| Appendix C | |
|---|---|
| Summary of Safety and Effectiveness | |
| Submitter: | Cordis Corporation, a Johnson and Johnson Company40 Technology DriveWarren, New Jersey 07059 |
| Telephone: (908) 755-8300Fax: (908) 412-3915 | |
| ContactPerson: | Karen WilkSenior Associate, Regulatory AffairsCordis Corporation, a Johnson and Johnson Company40 Technology DriveWarren, New Jersey 07059 |
| Telephone: (908) 412-7257Fax: (908) 412-3915 | |
| Date Prepared: | August 20, 1999 |
| GeneralProvisions | Trade Name: Cordis PowerFlex ™ Extreme PTA Balloon CatheterCommon Name: Peripheral Transluminal Angioplasty Balloon CatheterClassification Name: CFR 870.1250 Percutaneous Catheter |
| DeviceClassification | Class II. |
| Name ofPredicateDevices | Cordis PowerFlex ™ Plus PTA Balloon Catheter |
| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act. |
{1}------------------------------------------------
.
| Intended Useand DeviceDescription | The PowerFlex Extreme PTA balloon catheter is indicated for dilatation ofstenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renalarteries, and for the treatment of obstructive lesions of native or syntheticarteriovenous dialysis fistulae. |
|---|---|
| The Cordis PowerFlex Extreme PTA balloon catheter is a dual lumen designwith a distal inflatable balloon. Two radiopaque marker bands indicate thedilating section of the balloon and aid in the balloon placement. | |
| Biocompatibility: | All materials used in the PowerFlex Extreme PTA balloon catheter arebiocompatible. |
| PerformanceData: | The safety and effectiveness of the Cordis PowerFlex Extreme PTA BalloonCatheter have been demonstrated via data collect from non-clinical designverification tests and analyses. |
| Summary ofSubstantialEquivalence | The PowerFlex Extreme PTA Balloon Catheter is substantially equivalent tothe previously cleared PowerFlex Plus PTA Balloon Catheters. |
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of a bird or other winged creature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 1999
Ms. Karen Wilk Cordis Corp. 40 Technology Drive Warren, NJ 07059
K992825 Re: Cordis PowerFlex EXTREME Percuataneous Transluminal Angioplasty (PTA) Balloon Catheter Regulatory Class: II (two) Product Code: 74 LIT Dated: August 20, 1999 Received: August 23, 1999
Dear Ms. Wilk:
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 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 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 - Ms. Karen Wilk
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. 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
{4}------------------------------------------------
! ※
Special 510(k) Number:
长992825
Device Name:
Cordis PowerFlex EXTREME Percuataneous Transluminal Angioplasty (PTA) Balloon Catheter
Indication For Use:
The Cordis PowerFlex EXTREME PTA Balloon Catheter is indicated for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries
(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
(Optional Format 1-2-96)
(Division Sign-Off) for Callahan
Division of Cardiovascular and Respiratory Devices
510(k) Number K992825
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).