(90 days)
Not Found
Not Found
No
The document describes a physical medical device (balloon catheters) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for dilatation of stenoses and treatment of obstructive lesions, which are therapeutic interventions.
No
The device is a balloon catheter used for dilatation of stenoses and deployment of stents, which are therapeutic interventions rather than diagnostic procedures.
No
The device description clearly indicates that the device is a physical balloon catheter, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Device Description: The provided text describes a PTA Balloon Catheter. This is a device used within the body (in vivo) to physically dilate narrowed blood vessels or deploy stents.
- Intended Use: The intended uses listed are all procedures performed within the body to treat conditions affecting arteries and fistulae.
The device is a therapeutic device used in interventional procedures, not a diagnostic device used to analyze samples outside the body.
N/A
Intended Use / Indications for Use
Opta5 and Powerflex PTA Balloon Catheters are 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.
In addition, certain sizes of Opta5 and Powerflex catheters are also indicated for deployment of Palmaz and Palmaz-Schatz balloon expandable Stents for the biliary system.
Product codes
78 FGE
Device Description
Opta5 and Powerflex PTA Balloon Catheters are similar in design, construction and indications for use compared to commercially available PTA catheters.
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, biliary system, arteriovenous dialysis fistulae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All appropriate biocompatibility tests were successfully performed on Cordis' Opta5 and Powerflex PTA Balloon Catheters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Cordis Opta5 PTA Balloon Catheter, Cordis Powerflex PTA Balloon Catheter, Medi-tech Ultra-thin Diamond Balloon Dilatation Catheter, Cordis Palmaz and Palmaz-Schatz Balloon Expandable Stents
Reference Device(s)
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).
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§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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长972825
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OCT - Total
| General Provisions | Common Name: Peripheral Transluminal Angioplasty Balloon Catheter
Proprietary Name: Opta5 PTA Balloon Catheter
Powerflex PTA Balloon Catheter |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Predicate Devices | 1. Cordis Opta5 PTA Balloon Catheter
2. Cordis Powerflex PTA Balloon Catheter
3. Medi-tech Ultra-thin Diamond Balloon Dilatation Catheter
4. Cordis Palmaz and Palmaz-Schatz Balloon Expandable Stents |
| Classification | Class II |
| Performance Standards | Performance Standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act. |
| Intended Use and Device Description | Opta5 and Powerflex PTA Balloon Catheters are 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.
In addition, certain sizes of Opta5 and Powerflex catheters are also indicated for deployment of Palmaz and Palmaz-Schatz balloon expandable Stents for the biliary system. |
| Bio-compatibility | All appropriate biocompatibility tests were successfully performed on Cordis' Opta5 and Powerflex PTA Balloon Catheters. |
| Summary of Substantial Equivalence | Opta5 and Powerflex PTA Balloon Catheters are substantially equivalent to the predicate devices. Opta5 and Powerflex PTA Balloon Catheters are similar in design, construction and indications for use compared to commercially available PTA catheters. |
Summary of Safety and Effectiveness
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Continued on next page
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Summary of Safety and Effectiveness (Continued)
A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA stated "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits" 42 Fed. Reg. 42, 50 et seq. (1977).
1412825
PLOZZ
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract appearance. The seal is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mirjam Barboza, M.D. Manager, Regulatory and Clinical Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K972825
Opta5™ and PowerFlex™ PTA Balloon Catheters Dated: July 8, 1997 Received: July 9, 1997 Regulatory class: II 21 CFR §876.5010/Product code: 78 FGE
Dear Dr. Barboza:
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 intenstated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (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 requirement, 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. 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 Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours.
William Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
| 510(k) Number | To be Assigned |
|---|---|
| Device Name | Cordis Opta5 PTA Balloon Catheter |
| Cordis Powerflex PTA Balloon Catheter | |
| Indications for Use | Opta5 PTA Balloon Catheters are 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. |
Powerflex PTA Balloon Catheters are indicated for dilatation of stenoses in
iliac, femoral, popliteal and renal arteries.
In addition, certain sizes of Opta5 and Powerflex catheters are also indicated
for deployment of Palmaz and Palmaz-Schatz Balloon Expandable Stents for
the biliary system. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE AS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ | OR | Over - The Counter Use |
|---|---|---|---|
| (Division Sign-Off) | |||
| Division of Reproductive, Abdominal, ENT, | |||
| and Radiological Devices | |||
| 510(k) Number: 16972825 |