(23 days)
Not Found
Not Found
No
The summary describes a physical medical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is indicated for dilating stenoses and treating obstructive lesions, which are therapeutic interventions.
No
The device is a balloon catheter used for dilatation of stenoses, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states it is a "dual lumen design with a distal inflatable balloon" and includes "radiopaque marker bands," indicating it is a physical hardware 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 used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description and intended use of the PowerFlex Extreme PTA balloon catheter clearly indicate it is a device used within the body for a therapeutic procedure (dilating stenoses in arteries and treating obstructive lesions). It is a physical tool used to directly interact with anatomical structures.
The information provided describes a device used for interventional procedures, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
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 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.
Product codes (comma separated list FDA assigned to the subject device)
74 LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries; 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Cordis PowerFlex Plus PTA Balloon Catheter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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 Company |
| 40 Technology Drive | |
| Warren, New Jersey 07059 | |
| Telephone: (908) 755-8300 | |
| Fax: (908) 412-3915 | |
| Contact | |
| Person: | Karen Wilk |
| Senior Associate, Regulatory Affairs | |
| Cordis Corporation, a Johnson and Johnson Company | |
| 40 Technology Drive | |
| Warren, New Jersey 07059 | |
| Telephone: (908) 412-7257 | |
| Fax: (908) 412-3915 | |
| Date Prepared: | August 20, 1999 |
| General | |
| Provisions | Trade Name: Cordis PowerFlex ™ Extreme PTA Balloon Catheter |
| Common Name: Peripheral Transluminal Angioplasty Balloon Catheter | |
| Classification Name: CFR 870.1250 Percutaneous Catheter | |
| Device | |
| Classification | Class II. |
| Name of | |
| Predicate | |
| Devices | Cordis PowerFlex ™ Plus PTA Balloon Catheter |
| Performance | |
| Standards | Performance standards have not been established by the FDA under section |
| 514 of the Food, Drug and Cosmetic Act. |
1
.
| Intended Use
and Device
Description | 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. |
| Biocompatibility: | All materials used in the PowerFlex Extreme PTA balloon catheter are
biocompatible. |
| Performance
Data: | 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. |
| Summary of
Substantial
Equivalence | The PowerFlex Extreme PTA Balloon Catheter is substantially equivalent to
the 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