(30 days)
The Opta LP and Powerflex Plus PTA Balloon Catheters are 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 LP and Powerflex Plus PTA Balloon Catheters have a dual lumen design with distal inflatable balloon. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. All balloons distend to sizes above the nominal size at pressures greater than the nominal pressure. The balloon inflation lumen is used to inflate and deflate the balloon. The nominal balloon size is printed on the hub. The guidewire lumen is used to track the catheter over a prepositioned guidewire or to inject contrast medium and/or saline. The maximum injection pressure is 150 psi. The compatible guidewire size, catheter shaft French size and catheter length are printed on the hub. The radiopaque marker bands indicate the stated nominal length of the balloon
This submission, K981407, pertains to the Cordis Opta LP and Powerflex Plus PTA Balloon Catheters. The provided documents focus on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these specific documents.
Here's an analysis of what information can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided documents do not contain a table of acceptance criteria or reported device performance in relation to specific quantitative metrics. The submission focuses on demonstrating substantial equivalence to predicate devices, implying that the performance is expected to be similar to legally marketed devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given documents. The submission is a 510(k) premarket notification that relies on demonstrating equivalence rather than presenting a de novo clinical study with a specific test set.
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 provided as no specific test set requiring expert ground truth is described in the context of this 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as no specific test set requiring adjudication is described.
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
An MRMC comparative effectiveness study is not mentioned or implied in these documents. This submission is for medical devices (balloon catheters), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as 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)
This information is not provided as there is no mention of a specific study requiring ground truth establishment for a diagnostic or AI performance evaluation. The "ground truth" for a device like this would typically relate to its physical and mechanical properties, and its ability to perform its intended function (e.g., dilate stenoses), which would be assessed through bench testing and potentially pre-clinical or limited clinical use, not typically through ground truth similar to diagnostic imaging.
8. The sample size for the training set
This information is not provided and is not applicable as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
This information is not provided and is not applicable as this is not an AI/algorithm-based device.
Summary of Information from the Provided Documents:
The core of this submission (K981407) is to demonstrate substantial equivalence of the Cordis Opta LP and Powerflex Plus PTA Balloon Catheters to predicate devices that have already received 510(k) concurrence.
Predicate Devices Referenced:
- Cordis Opta LP PTA Balloon Catheter
- Cordis Powerflex Plus PTA Balloon Catheter
- Cordis Opta5 PTA Balloon Catheter
- Cordis Powerflex PTA Balloon Catheter
Basis of Substantial Equivalence:
The submission states that the new devices are similar in their:
- basic design
- construction
- indications for use
- performance characteristics
This indicates that the "study" demonstrating this is a comparison to the established performance and safety profiles of the predicate devices, rather than a de novo clinical trial with specific acceptance criteria and detailed performance metrics presented here. The FDA's review and concurrence mean that they have accepted this argument of substantial equivalence.
{0}------------------------------------------------
Attachment 4
_ ------ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
1.2.
| MAY 20 1998 | Summary of Safety and Effectiveness |
|---|---|
| GeneralProvisions | Trade Name: Opta LP PTA Balloon CatheterPowerflex Plus PTA Balloon Catheter |
| Common/Classification Name: Peripheral Transluminal Angioplasty BalloonCatheter | |
| Name ofPredicateDevices | Cordis Opta LP PTA Balloon CatheterCordis Powerflex Plus PTA Balloon CatheterCordis Opta5 PTA Balloon CatheterCordis Powerflex PTA Balloon Catheter |
| Classification | Class II. |
| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act. |
| Intended Useand DeviceDescription | The Opta LP and Powerflex Plus PTA Balloon Catheters are intended todilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal andrenal arteries and, for the treatment of obstructive lesions of native orsynthetic arteriovenous dialysis fistulae. |
| The Opta LP and Powerflex Plus PTA Balloon Catheters have a dual lumendesign with distal inflatable balloon. Two radiopaque marker bands indicatethe dilating section of the balloon and aid in balloon placement. | |
| All balloons distend to sizes above the nominal size at pressures greater thanthe nominal pressure. | |
| The balloon inflation lumen is used to inflate and deflate the balloon. Thenominal balloon size is printed on the hub. | |
| The guidewire lumen is used to track the catheter over a prepositionedguidewire or to inject contrast medium and/or saline. The maximum injectionpressure is 150 psi. The compatible guidewire size, catheter shaft French sizeand catheter length are printed on the hub. The radiopaque marker bandsindicate the stated nominal length of the balloon |
ar and o
{1}------------------------------------------------
Summary of Substantial Equivalence
The Opta LP and Powerflex Plus PTA Balloon Catheters described in this submission are similar in their basic design, construction, indications for use and performance characteristics to Opta LP, Powerflex Plus, Opta5 and Powerflex PTA catheters which previously received 510(k) concurrence.
000000
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 20 1998
Mirjam Barboza, M.D. Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K981407 Trade Name: Cordis Opta LP PTA Balloon Catheter and Cordis Powerflex Plus PTA Balloon Catheter Regulatory Class: II Product Code: LIT Dated: April 17, 1998 Received: April 20, 1998
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 indications for use stated in the enclosure) to leqally 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 Requlations, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
{3}------------------------------------------------
Page 2 - Dr. Barboza
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.
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) 594-4692. 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"(21CFR 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. Callahan
Thomas J. Callaha Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
in and the same
{4}------------------------------------------------
Indications for Use Statement
| 510(k) Number(if known) | |
|---|---|
| Device Name | Cordis Powerflex Plus PTA Balloon Catheter |
| Indications forUse | The Powerflex Plus PTA Balloon Catheter is indicated to dilate stenoses iniliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries, and fortreatment of obstructive lesions of native or synthetic arteriovenous dialysisfistulae. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Turt. A. Q
(Division Sign-Off) Division of Cardiovascular, P and Neurological Devices 18/45/ 510(k) Number
Prescription Use _ (Per 21 CFR 801.109)
. --
OR
Over-The-Counter Use_
§ 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).