(16 days)
No
The document describes a standard balloon catheter for angioplasty and does not mention any AI or ML components or functionalities.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in various arteries and for post-dilatation of stents, which are therapeutic medical procedures.
No
The device description and intended use clearly state that it is a dilatation catheter used for Percutaneous Transluminal Angioplasty (PTA) and post-dilatation of stents, which are therapeutic procedures, not diagnostic ones. It is used to open up obstructed vessels, not to diagnose conditions.
No
The device description clearly describes a physical catheter with a balloon, guide wire, and radiopaque markers, indicating it is a 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 procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat blockages in blood vessels. IVDs are used to examine specimens outside the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter with a balloon designed for mechanical dilation within blood vessels. This is a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is a therapeutic medical device used for angioplasty, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LIT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries; arteriovenous dialysis fistulae
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 subject Cordis AVIATOR PLUS PTA Balloon Catheter has been demonstrated via data collected from non-clinical design verification and design validation tests and analyses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Hovinga
Senior Regulatory Affairs Associate
Cordis Europa, N.V.
Oosteinde 8
9301 LJ Roden
Netherlands |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 26, 2007 |
| Trade Name | Cordis AVIATOR PLUS Percutaneous Transluminal Angioplasty Balloon
Dilatation 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 Balloon
Dilatation Catheter (510(k) #K063563 & #K050645), which was determined
substantial equivalent on March 7, 2007 and April 1, 2005 respectively. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | 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. |
: 上一篇:
1
Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter
| Intended Use | The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is intended
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. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and
Performance
Data | 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. |
| Substantial
Equivalence
Conclusion | In summary, the subject Cordis AVIATOR PLUS PTA Catheter is
substantial equivalent to the predecessor / predicate Cordis AMIIA PTA
Balloon Dilatation Catheter. |
:
:
2
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.
3
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
4
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