(67 days)
Not Found
Not Found
No
The device description focuses on the mechanical components of a balloon catheter and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is described as "AGILTRAC™ .035 Peripheral Dilatation Catheter" and its "Intended Use / Indications for Use" section indicates it is used to "dilate stenoses in peripheral arteries," "treat obstructive lesions of native or synthetic A-V fistulae," and "secure the attachment systems in the iliac arteries," which are all therapeutic interventions.
No
Explanation: This device is a dilatation catheter used to treat stenoses and obstructive lesions by physically dilating them, not for diagnostic purposes. Its function is interventional/therapeutic.
No
The device description clearly outlines a physical catheter with a balloon, guidewire lumen, and other hardware components. It is not solely software.
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 device used in vivo (within the body) for therapeutic procedures (dilating arteries, treating lesions, securing systems, expanding prostheses). IVDs are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter with a balloon designed for insertion into blood vessels and inflation within the body. This is consistent with an interventional medical device, not an IVD.
- Anatomical Site: The specified anatomical sites (peripheral arteries, iliac arteries, A-V fistulae) are all within the human body, where the device is intended to be used.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or functions associated with in vitro diagnostics.
Therefore, the AGILTRAC™ .035 Peripheral Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AGILTRAC™ .035 Peripheral Dilatation Catheter is intended:
- . To secure attachment systems in the iliac arteries and/or
- To expand vascular prosthesis limbs. .
The AGILTRAC™ .035 Periheral Dilatation Catheter is intended to:
-
dilate stenoses in peripheral arteries
-
treat obstructive lesions of native or synthetic A-V fistulae
-
secure the attachment systems in the iliac arteries, and
-
to expand vascular prosthesis limbs
Product codes
DQY, LIT
Device Description
The AGILTRAC™ .035 Peripheral Dilatation Catheter is an over the wire catheter with an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft is a dual lumen design. The smaller lumen provides for inflation of the balloon with contrast medium and the larger lumen permits use of a 0.035" quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the dual lumen tubing and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a surace film over the dual lumen tubing.
The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac arteries, peripheral arteries, A-V 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 AGILTRAC™ .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
KO23320
DEC 1 0 2002
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant Corporation
Endovascular Solutions |
|-----------------------------|-----------------------------------------------|
| Submitter's Address: | 1525 O'Brien Drive
Menlo Park, CA 94025 |
| Telephone:
Fax: | (650) 470-6372
(650) 617-5024 |
| Contact Person: | Michelle Grossman |
| Date Prepared: | October 2, 2002 |
| Device Trade Name: | AGILTRAC™.035 Peripheral Dilatation Catheter |
| Device Common Name: | Balloon Catheter |
| Device Classification Name: | LIT |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The AGILTRAC™ .035 Peripheral Dilatation Catheter is available with balloon diameters of 4.0-10.0 mm, with lengths of 20. 40 and 60 mm, 12.0 and 14.0 mm balloon diameters with lengths of 20 and 40 mm, 4.0-8.0 mm balloon diameters with a length of 80mm and 4.0-7.0 mm balloon diameters with a length of 100mm. The catheter lengths are 55 cm, 80 cm and 135 cm. The AGILTRAC™ .035 Peripheral Dilatation Catheter is substantially equivalent to Guidant's Ancure® Iliac Balloon Catheter consisting of balloon diameters of 9.5 - 14.5 in 1 mm increments, balloon lengths of 30 mm with system. The AGILTRAC™ .035 Peripheral Dilatation Catheter is substantially equivalent to the legally marketed comparison device with respect to design, materials, method of delivery and intended use.
1
Device Description:
The AGILTRAC™ .035 Peripheral Dilatation Catheter is an over the wire catheter with an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft is a dual lumen design. The smaller lumen provides for inflation of the balloon with contrast medium and the larger lumen permits use of a 0.035" quide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the dual lumen tubing and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a suface film over the dual lumen tubing.
The balloon, which has two (2) radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of known diameter and length at specific pressures.
The proximal end of the catheter has a sidearm adaptor that provides access to the inflation lumen and guidewire lumen. It is designed with a luer-lock fitting for connection with an inflation device.
Indications for Use:
The AGILTRAC™ .035 Peripheral Dilatation Catheter is intended:
- . To secure attachment systems in the iliac arteries and/or
- To expand vascular prosthesis limbs. .
Technological Characteristics:
Comparisons of the subiect and predicate device show that technological characteristics such as materials, biocompatibility, mode of operation, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate device, Ancure® Iliac Balloon Catheter.
Performance Data:
The safety and effectiveness of the AGILTRAC™ .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized design featuring an eagle's head and three horizontal bars.
ood and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
DEC 10 2002
Guidant Corporation c/o Ms. Michelle Grossman 1525 O'Brien Drive Menlo Park, CA 94025
Re: K023320
Guidant Aqiltrac .035 Peripheral Dilatation Catheter Regulation Number: 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY and LIT Dated: October 2, 2002 Received: October 4, 2002
Dear Ms. Grossman:
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 or any Federal statutes and regulations administered by other Federal agencies. You must
3
Page 2 - Ms. Michelle Grossman
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 (301) 594-4646. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1
. 510(k) Number (if known): K023320
Device Name: Guidant Agiltrac .035 Peripheral Dilatation Catheter
Indications For Use: The AGILTRAC™ .035 Periheral Dilatation Catheter is intended to:
-
dilate stenoses in peripheral arteries
-
treat obstructive lesions of native or synthetic A-V fistulae
-
secure the attachment systems in the iliac arteries, and
-
to expand vascular prosthesis limbs
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Cardiovascular & Recipient Form
(k) Number K023320
(Optional Format 3-10-98)