(90 days)
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.
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.
Opta5 and Powerflex PTA Balloon Catheters are similar in design, construction and indications for use compared to commercially available PTA catheters.
This document is a 510(k) premarket notification for the "Opta5™ and PowerFlex™ PTA Balloon Catheters." The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed. Therefore, the "acceptance criteria" and "study" described in the provided text are not in the context of device performance metrics or a clinical study proving superiority/non-inferiority, but rather are focused on demonstrating substantial equivalence to existing devices.
Here's a breakdown of the requested information based on the provided text, recognizing its context as a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In a 510(k) submission, "acceptance criteria" generally refers to the characteristics and performance attributes that need to be comparable to predicate devices to establish substantial equivalence. "Reported device performance" would then be the results demonstrating that comparability.
| Acceptance Criteria (from text, implied for substantial equivalence) | Reported Device Performance (from text, as claimed) |
|---|---|
| Common Name and Proprietary Name: Clear identification. | Common Name: Peripheral Transluminal Angioplasty Balloon CatheterProprietary Name: Opta5 PTA Balloon Catheter, Powerflex PTA Balloon Catheter |
| Classification: Adherence to regulatory classification. | Class: II |
| Intended Use: Similar indications for use. | Indications for Use: 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. Certain sizes also indicated for deployment of Palmaz and Palmaz-Schatz balloon expandable stents for the biliary system. |
| Material/Design/Construction similarity to predicates. | "Opta5 and Powerflex PTA Balloon Catheters are similar in design, construction and indications for use compared to commercially available PTA catheters." |
| Biocompatibility: Device materials must be biocompatible. | "All appropriate biocompatibility tests were successfully performed on Cordis' Opta5 and Powerflex PTA Balloon Catheters." |
| Performance Standards: No specific FDA performance standards apply. | "Performance Standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." |
The "study" that proves the device meets "acceptance criteria" in this context is the demonstration of substantial equivalence to the listed predicate devices. This is established by comparing the new device's design, materials, manufacturing processes, performance data (including biocompatibility), and intended use to those of the predicate devices. The document explicitly states: "Opta5 and Powerflex PTA Balloon Catheters are substantially equivalent to the predicate devices."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided text does not specify a sample size for a test set or data provenance for any performance study that would resemble a clinical trial or algorithm validation. The reference to "biocompatibility tests" implies in-vitro and/or in-vivo (animal) testing, but no details on sample size, design, or provenance are given. For a 510(k), extensive clinical trials are often not required if substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or present in the provided 510(k) document. Establishing "ground truth" by experts is typically done for diagnostic accuracy studies, especially with AI algorithms. This submission is for a medical device (balloon catheter) that is not a diagnostic AI, and therefore, such expert-driven ground truth establishment wouldn't be part of its typical regulatory submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or present in the provided 510(k) document for the same reasons as (3).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable or present in the provided 510(k) document. MRMC studies are specific to evaluating diagnostic performance, often for imaging devices or AI tools assisting human readers. The Opta5 and Powerflex PTA Balloon Catheters are interventional devices, not diagnostic or AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or present in the provided 510(k) document. The device in question is a physical medical device (balloon catheter), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for diagnostic or AI validation studies does not directly apply in this 510(k) submission for a balloon catheter. The truth for this submission is whether the device is safe and effective when used as intended, and this is primarily established by demonstrating substantial equivalence to predicate devices, supported by:
- Biocompatibility testing results: (implied 'ground truth' of material safety)
- Engineering and design specifications: (implied 'ground truth' of functional performance)
- Comparison to predicate device characteristics: showing similar features and intended use.
8. The sample size for the training set
This information is not applicable or present in the provided 510(k) document. "Training set" refers to data used to train machine learning models, which is irrelevant for this physical medical device submission.
9. How the ground truth for the training set was established
This information is not applicable or present in the provided 510(k) document for the same reasons as (8).
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OCT - Total
| General Provisions | Common Name: Peripheral Transluminal Angioplasty Balloon CatheterProprietary Name: Opta5 PTA Balloon CatheterPowerflex PTA Balloon Catheter |
|---|---|
| Name of Predicate Devices | 1. Cordis Opta5 PTA Balloon Catheter2. Cordis Powerflex PTA Balloon Catheter3. Medi-tech Ultra-thin Diamond Balloon Dilatation Catheter4. 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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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).
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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
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Indications for Use
| 510(k) Number | To be Assigned |
|---|---|
| Device Name | Cordis Opta5 PTA Balloon CatheterCordis 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 thetreatment of obstructive lesions of native or synthetic arteriovenous dialysisfistulae.Powerflex PTA Balloon Catheters are indicated for dilatation of stenoses iniliac, femoral, popliteal and renal arteries.In addition, certain sizes of Opta5 and Powerflex catheters are also indicatedfor deployment of Palmaz and Palmaz-Schatz Balloon Expandable Stents forthe 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 |
§ 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.