(221 days)
Not Found
No
The summary describes a mechanical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties and mechanical performance.
Yes.
Explanation: The device is intended to dilate stenoses and treat obstructive lesions in various arteries, which directly impacts and improves the health of the patient, thus qualifying it as a therapeutic device.
No
The device is a Percutaneous Transluminal Angioplasty (PTA) catheter, which is used for dilating stenoses and treating obstructive lesions. Its intended use is therapeutic, not diagnostic.
No
The device description clearly states it is a "Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon," indicating it is a physical hardware device.
Based on the provided information, 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 physically dilate blood vessels and treat lesions. This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a catheter with an inflatable balloon, designed for insertion into arteries. This is consistent with a therapeutic device used in a medical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, ilio-femoral, popliteal and renal arteries; native or synthetic arteriovenous dialysis fistulae; peripheral vasculature
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 Powerflex™ Pro PTA Catheter and the substantial equivalence to the predicate devices have been demonstrated via data collected in non-clinical design verification and validation tests and analyses as well as the post-market surveillance data analyses of the predicate devices. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are similar to the predicate devices and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.
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.
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
K112797 page 1 of 3
MAY -- 4 2012
Cordis®
a Johnson-Johnson company
510(k) Summary
| Submitter: | Cordis Corporation, a Johnson & Johnson company
430 Route 22 East
Bridgewater, NJ 08807 |
| ------------ | ----------------------------------------------------------------------------------------------- |
|---|
Contact Person: Donna Marshall Manager, Regulatory Affairs Ph: (908) 541-4781 Fax: (908) 541-4559 e-mail: dmarsha2@its.jnj.com
May 3, 2012 Date Prepared:
Device Trade Name: Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter
Device Common Name: Peripheral Transluminal Angioplasty Balloon Catheter
- Class: ll
Classification Name: Percutaneous Catheter (21 CFR 870.1250)
LIT Product Code:
Predicate Devices:
| Device | Company | Product
Code | 510(k)
Number | Predicate for:
(if multiple predicates) |
|------------------------------------------------------------------|-----------------------------------|-----------------|------------------|--------------------------------------------------------|
| Powerflex™ Extreme
Powerflex™ P3 & OPTA™ PRO
PTA Catheters | Cordis
Corporation | LIT | K032737 | Design, Materials,
Construction,
Characteristics |
| Aviator Plus PTA Balloon
Dilatation Catheter | Cordis
Corporation | LIT | K071189 | Intended Use |
| Savvy Long and Sleek PTA
Catheters | Clearstream
Technologies, Ltd. | LIT | K072947 | Dimensions - longer lengths
(120 x 220 mm) |
1
Traditional 510(k) Cordis Powerflex™ Pro PTA Catheter
Device Description:
The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035" guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.
Indications for Use:
The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Summary of Performance Testing:
The safety and effectiveness of the Powerflex™ Pro PTA Catheter and the substantial equivalence to the predicate devices have been demonstrated via data collected in non-clinical design verification and validation tests and analyses as well as the post-market surveillance data analyses of the predicate devices. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are similar to the predicate devices and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.
2
K112797 page 3 of 3
Traditional 510(k) Cordis Powerflex™ Pro PTA Catheter
The following in-vitro performance tests were completed for the Powerflex™ Pro PTA Catheter:
Marker Band Spacing Balloon Diameter (Nominal, RBP) System Burst (Inflation Lumen) System Burst (Guide wire Lumen) Hub to Shaft Pull Strength CSI Insertion Kink Diameter Catheter Shaft Inflation/Deflation Time Multiple Inflation (System Fatigue) Torque Testing Particle Free Hemolysis
Balloon Working Length Balloon Burst Marker Band Placement Proximal Pull Strength Tip to Balloon/Inner Body Pull Strength CSI Withdrawal Force Guide Wire Compatibility Useable Catheter Length Rated Burst Pressure PreConditioning Tensile Testing Cytotoxicity Physicochemical Aqueous Extraction
Summary of Substantial Equivalence.Comparison:
Comparison of the new and the following predicate devices: Cordis Corp. Opta Pro/Powerflex™ P3 PTA Catheter and ClearStream Technologies, Savyy Long (dimensions only) PTA Catheter show that technological characteristics such as materials, components, biocompatibility, performance properties, dimensions (size range), method of delivery, fundamental technology (operating principle), packaging configuration and packaging materials, labeling, manufacturing and sterilization processes featured with the Powerflex Pro PTA Catheter are substantially equivalent to those featured with the currently marketed Cordis Opta Pro/Powerflex P3 PTA Catheter and ClearStream Technologies, Savvy Long (dimensions) PTA Catheter. The intended use of the new and the above predicate devices are identical with the exception of the additional indication for post dilatation of balloon-expandable and self expanding stents in the peripheral vasculature of the subject device; Cordis Corp., Aviator Plus PTA Catheter is the predicate in regards to the post dilatation indication.
Conclusion:
Based on the intended use, technological characteristics, safety and performance testing, the Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Cordis Powerflex™ P3 and Opta™ Pro Percutaneous Transluminal Angioplasty Catheters (K032737), Aviator Plus PTA Balloon Dilatation Catheter (K071189) and ClearStream Savvy Long PTA Catheter (K072947).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is simple and monochromatic.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
MAY - 4 2012
Cordis Corp. % Donna Marshall 430 Route 22 East Bridgewater, NJ 08807
Re: K112797
Trade/Device Name: Powerflex Pro PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 9, 2012 Received: April 10, 2012
Dear Ms. Marshall:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
4
Page 2 - Ms. Donna Marshall
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
M.L. Hieber
Cuckerman, M. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Traditional 510(k) Cordis Powerflex™ Pro PTA Catheter
Indications for Use Statement
510(k) Number (if known):
Device Name:
Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter
Indications for Use:
The Powerflex™ 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. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Prescription Use × (Per 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
M. S. Helleben
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K