(41 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI/ML or related concepts.
Yes
The device is described as a dilatation catheter used to dilate stenoses in arteries and treat obstructive lesions, which are therapeutic interventions.
No
The device is a peripheral dilatation catheter, used for therapeutic purposes (dilating stenoses, treating obstructive lesions, expanding stent graft elements) rather than diagnosing conditions.
No
The device description clearly outlines a physical catheter with a balloon, guidewire lumen, and luer adapter, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use of the Edwards Peripheral Dilatation Catheter clearly indicate it is a device used inside the body (in vivo) to physically dilate blood vessels and treat lesions. It is a catheter with a balloon that is inserted into the peripheral arteries, A-V fistulae, aorta, and iliac arteries.
The device is an interventional medical device used for therapeutic purposes within the patient's body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
The Edwards Peripheral Dilatation Catheter is intended to:
- dilate stenoses in 10 14mm peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- expand endoluminal stent graft elements in the aorta and iliac arteries .
Product codes
DQY
Device Description
The Edwards Peripheral Dilatation Catheter is an over-the-wire-catheter with a flexible distal portion for maneuvering through regions of the peripheral vasculature. A balloon is mounted on the distal end of the catheter and provides the mechanism for dilating the vessel. The shaft of the delivery system is coaxial over the entire length of the catheter. The inner lumen of the coaxial catheter is designed to accommodate a maximum guidewire diameter of 0.035 inches. The outer lumen of the coaxial catheter is used for inflation and deflation of the balloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used for accessing the guidewire lumen while the second port facilitates inflation and deflation of the balloon. The delivery catheter is offered in an 80 cm length. The Edwards Peripheral Dilatation Catheter products are supplied sterile and are "single-use only" devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries, A-V fistulae, aorta and iliac arteries
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
Edwards Lifesciences completed bench testing such as balloon burst strength, balloon compliance, balloon inflation, balloon fatigue, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the Edwards Peripheral Dilatation Catheter performed in a manner substantially equivalent to the predicate devices cited in item 7 above.
Key Metrics
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
ii
OCT - 2 2003
Image /page/0/Picture/2 description: The image shows a logo with the word "Edwards" written in a serif font at the bottom. Above the word, there is a square grid pattern with a large letter "E" superimposed on it. A partial circle is behind the letter "E", adding a design element to the logo.
510(k) Summary
1. Submitter's Name and Address:
Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614
2. Contact:
Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC Phone: (949) 250-2416 Fax: (949) 250-3630 E-mail: kevin_drisko@edwards.com
3. Date Prepared:
August 21, 2003
4. Device Trade Name:
Edwards Peripheral Dilatation Catheter
5. Device Common Name:
Peripheral dilatation catheter
6. Device Classification Name:
Catheter, percutaneous (DQY), Class II
7. Predicate Devices:
Cordis MAXI LD Esophageal Dilator (K023907) Guidant AGILTRAC™ 035 Peripheral Dilatation Catheter (K023320)
1
Image /page/1/Picture/0 description: The image shows a logo with the letter 'E' in a stylized font, set against a textured background that resembles a grid or a pattern of small squares. The letter 'E' is large and prominent, with some circular design elements incorporated into the background. Below the logo, the word 'Edwards' is printed in a serif typeface, with the first letter capitalized.
510(k) Summary (continued)
8. Device Description:
The Edwards Peripheral Dilatation Catheter is an over-the-wire-catheter with a flexible distal portion for maneuvering through regions of the peripheral vasculature. A balloon is mounted on the distal end of the catheter and provides the mechanism for dilating the vessel. The shaft of the delivery system is coaxial over the entire length of the catheter. The inner lumen of the coaxial catheter is designed to accommodate a maximum guidewire diameter of 0.035 inches. The outer lumen of the coaxial catheter is used for inflation and deflation of the balloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used for accessing the guidewire lumen while the second port facilitates inflation and deflation of the balloon. The delivery catheter is offered in an 80 cm length. The Edwards Peripheral Dilatation Catheter products are supplied sterile and are "single-use only" devices.
9. Intended Use:
The Edwards Peripheral Dilatation Catheter is intended to:
- dilate stenoses in 10 14mm peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- expand endoluminal stent graft elements in the aorta and iliac arteries .
10. Technological Characteristics:
Comparisons of the new and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, and packaging are identical or substantially equivalent.
11. Performance Data:
Edwards Lifesciences completed bench testing such as balloon burst strength, balloon compliance, balloon inflation, balloon fatigue, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the Edwards Peripheral Dilatation Catheter performed in a manner substantially equivalent to the predicate devices cited in item 7 above.
12. Conclusion:
Since the Edwards Peripheral Dilatation Catheter has similar intended use, design, materials, performance, safety, effectiveness and labeling, it may be considered substantially equivalent to the predicate devices cited in item 7 above.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Edwards Lifesciences LLC c/o Mr. Kevin Drisko Senior Manager/Regulatory Affairs One Edwards Way Irvine, CA 92614
Re: K032587
Trade Name: Edwards Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 21, 2003 Received: August 22, 2003
Dear Mr. Drisko:
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.
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
3
Page 2 – Mr. Kevin Drisko
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 53) -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 (301) 594-4646. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Kalen TM
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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Image /page/4/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of a grid-like pattern on the left and the text "Edwards Lifesciences" on the right. The text is in a serif font and is black in color.
Page 1 of
510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________
Device Name: Edwards Peripheral Dilatation Catheter
Indications for Use:
The Edwards Peripheral Dilatation Catheter is intended to:
- dilate stenoses in 10 14mm peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- re-expand endoluminal stent graft elements in the aorta and iliac arteries .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Evaluation (CDE)
(Division Sign-Off Division of Cardio
510(k) Number K032587
Prescription Use
(per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Edwards Lifesciences 510(k) Application Edwards Peripheral Dilatation Catheter