(28 days)
No
The description focuses on the physical characteristics and intended use of a balloon catheter, with no mention of AI or ML.
Yes.
The device is intended to dilate stenoses and treat obstructive lesions, which are therapeutic actions.
No
The device is a PTA catheter, which is used for dilating stenoses, indicating a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical medical device (PTA catheter with balloon, lumens, and hub) and its intended use involves a physical intervention (dilating stenoses). There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body to treat obstructive lesions and dilate stenoses in blood vessels. This is an in vivo procedure.
- Device Description: The description details a balloon catheter, which is a medical device used for interventional procedures within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests outside the body on samples taken from a patient. This device is used inside the body for treatment.
N/A
Intended Use / Indications for Use
The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.
The POWERFLEX P3 PTA catheter is intended to dilate 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 OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
74LIT, DOY
Device Description
The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.
The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.
Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature:
Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
native or synthetic arteriovenous dialysis fistulae, iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries
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
The safety and effectiveness of the affected PTA Balloon Catheters have been demonstrated via data collected from non-clinical design verification tests and analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible.
Key Metrics
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
510(k) Premarket Notification
| Attachment 1 | OCT - 2 2003 | ||
|---|---|---|---|
| Summary of Safety and Effectiveness | |||
| Submitter & Contact person: | Cordis Europa, N.V., a Johnson & Johnson Company Oosteinde 8 NL-9300 LJ Roden, The Netherlands | ||
| Harm Hovinga Senior Regulatory Affairs Associate Tel (+31) (5050) 22479 Fax: (+31) (5050)-22456 e-mail: hhovinga@crdnl.jnj.com | |||
| Date Prepared | October 1, 2003 | ||
| Trade Name | Cordis PowerFlex TM Extreme PTA Balloon Catheter Cordis PowerFlex TM P3 PTA Balloon Catheter Cordis OPTA TM PRO PTA Balloon Catheter | ||
| Classification Name & Device Classification | Common Name: Peripheral Transluminal Angioplasty Balloon Catheter. Classification Name: 21 CFR 870.1250: Percutaneous Catheter. Class II; Product Code: #74LIT. |
1
1
| Device
| description | The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence. |
|---|---|
| The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline. | |
| Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: | |
| Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference. | |
| Name of | |
| affected | |
| devices | Cordis PowerFlex™ Extreme PTA Balloon Catheter |
| Cordis PowerFlex™ P3 PTA Balloon Catheter | |
| Cordis OPTA™ PRO PTA Balloon Catheter | |
| Performance | |
| standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards for these devices. |
| Conclusion | The Cordis PowerFlex Extreme, PowerFlex P3 and Opta Pro PTA balloon catheters are substantially equivalent to the predicate devices. |
2
The POWERFLEX EXTREME PTA catheter is intended for the treatment Intended Use 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. The POWERFLEX P3 PTA catheter is intended to dilate 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 OPTA PRO PTA catheter is intended to dilate 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. Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Cordis Corporation c/o Ms. Karen Wilk Manager, Regulatory Affairs 7 Powder Horn Drive Warren, NJ 07059
Re: K032737
Trade/Device Name: Cordis PowerFlex Extreme, PowerFlex P3, and OPTA PRO Percutaneous Transluminal Balloon Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: September 3, 2003 Received: September 4, 2003
Dear Ms. Wilk:
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 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) 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, 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Karen Wilk
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 Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Dna Heuseler for
Brad D. Zuckerman, MD
Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510 (k) Number:
The Cordis POWERFLEX™ EXTREME Percutaneous Transluminal Angioplasty Device Names: (PTA) Catheter, the POWERFLEX™ P3 PTA Catheter and the OPTA™ PRO PTA Catheter
Indications For Use:
The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.
The POWERFLEX P3 PTA catheter is intended to dilate 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 OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
(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)
Division of Cardiovascular, Respiratory and Neurological Devices
| 510(k) Number | K032737 |
|---|---|
| --------------- | --------- |
Special 510 (k) Number: