(16 days)
The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheter with a distal balloon and utilizes a rapid exchange design and accepts a 0.014" guide wire. The catheter tip is tapered to facilitate crossing of tight lesions. The proximal hub is used as a balloon inflation port. Two radiopaque marker bands within the balloon indicate the dilating section of the balloon and aid in balloon placement.
The provided text describes a Special 510(k) submission for a device modification, the Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter. This type of submission relies on the concept of "substantial equivalence" to a predicate device, rather than explicit acceptance criteria with numerical performance targets from a clinical study.
Therefore, many of the requested data points (like sample size for test sets, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission because clinical performance studies with specific acceptance criteria are generally not required for device modifications that can demonstrate substantial equivalence through non-clinical design verification and validation testing.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the traditional sense. The 510(k) summary states: "The safety and effectiveness of the subject Cordis AVIATOR PLUS PTA Balloon Catheter has been demonstrated via data collected from non-clinical design verification and design validation tests and analyses."
This indicates that the device met internal design specifications and engineering performance criteria (e.g., burst pressure, durability, trackability, crossing profile, guidewire compatibility) through bench testing and potentially animal studies, which are not detailed in this public summary. These non-clinical tests would have their own acceptance criteria, but they are not the type of clinical performance criteria usually associated with AI/diagnostic devices.
The "reported device performance" is essentially that it passed these non-clinical tests and is "substantially equivalent" to its predicate device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No clinical "test set" in the context of human data or diagnostic imaging was used for this 510(k) submission. The evaluation was based on non-clinical design verification and validation tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth in the context of clinical endpoints or diagnostic accuracy is not relevant for this non-clinical submission. Engineering and quality control experts would have assessed the device against its specifications.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for a balloon dilatation catheter's 510(k) submission, especially one based on device modification and non-clinical data. This type of study would be for AI-powered diagnostic devices comparing human performance with and without AI assistance.
6. If a Standalone Performance Study Was Done
Not applicable. Standalone (algorithm-only) performance is relevant for AI algorithms. This is a physical medical device (balloon catheter), and its performance is evaluated through non-clinical engineering tests.
7. The Type of Ground Truth Used
For the purpose of this 510(k) submission, the "ground truth" was established by engineering design specifications and performance standards. The device performs as intended according to its design and manufacturing criteria, which are sufficient to demonstrate substantial equivalence to the predicate device.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of machine learning or AI for this physical device submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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K071189 p. I of 2
Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter
| Attachment 5: | 510(k) Summary | MAY 16 2007 |
|---|---|---|
| --------------- | ---------------- | ------------- |
| Submitter & Contact person: | Harm HovingaSenior Regulatory Affairs AssociateCordis Europa, N.V.Oosteinde 89301 LJ RodenNetherlands |
|---|---|
| Date Prepared | April 26, 2007 |
| Trade Name | Cordis AVIATOR PLUS Percutaneous Transluminal Angioplasty BalloonDilatation Catheter |
Classification Name and Device Classification
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
|---|---|
| Classification: | Class II |
| FDA Classification Panel: | Cardiovascular |
| Product Code: | LIT |
| Predicate Device(s) | The predicate device in this submission is the Cordis AMIIA PTA BalloonDilatation Catheter (510(k) #K063563 & #K050645), which was determinedsubstantial equivalent on March 7, 2007 and April 1, 2005 respectively. |
|---|---|
| Device description | The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheterwith a distal balloon and utilizes a rapid exchange design and accepts a0.014" guide wire. The catheter tip is tapered to facilitate crossing of tightlesions. The proximal hub is used as a balloon inflation port. Two radiopaquemarker bands within the balloon indicate the dilating section of the balloonand aid in balloon placement. |
: 上一篇:
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Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter
| Intended Use | The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is intendedfor Percutaneous Transluminal Angioplasty in the peripheral vasculature,including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, andcarotid arteries and for the treatment of obstructive lesions of native orsynthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheralvasculature. |
|---|---|
| Safety andPerformanceData | The safety and effectiveness of the subject Cordis AVIATOR PLUS PTABalloon Catheter has been demonstrated via data collected from non-clinicaldesign verification and design validation tests and analyses. |
| SubstantialEquivalenceConclusion | In summary, the subject Cordis AVIATOR PLUS PTA Catheter issubstantial equivalent to the predecessor / predicate Cordis AMIIA PTABalloon Dilatation Catheter. |
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 16 2007
Cordis Europa, N.V. c/o Mr. Harn Hovinga Senior Regulatory Affairs Associate Oosteinde 8 9301 LJ Roden, Netherlands
Re: K071189
Trade/Device Name: Aviator Plus PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: April 26, 2007 Received: April 30, 2007
Dear Mr. Hovinga:
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.
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Page 2 – Mr. Harn Hovinga
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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dmna R. Lochner
Image /page/3/Picture/5 description: The image shows a stylized signature. The signature appears to be a combination of curved lines and a straight line. The curved lines form a shape that resembles the letters 'S' and 'V' stacked on top of each other. A straight line is drawn below the curved lines, possibly underlining the signature.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter
Attachment 3
Intended Use Statement
Page 1 of 1
510(k) Number (if known): K071189
Device Name:
Cordis AVIATOR PLUS Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter
Indications for Use Statement
The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.
Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
suma R. Vochner
(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices
510(k) Number K071189
§ 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).