(25 days)
Not Found
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 or ML.
Yes
The device is intended "to dilate stenoses" and "for the treatment of obstructive lesions," which are therapeutic actions.
No
The device is a peripheral dilatation catheter used to treat stenoses by dilating them, which is a therapeutic function, not a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, guidewire lumen, and other hardware components, indicating it is not a software-only 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 device used within the body to physically dilate blood vessels. This is an interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a catheter with a balloon designed for insertion into arteries and fistulae. This is consistent with an interventional device, not a device for analyzing biological 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.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is used directly on the patient's anatomy for therapeutic purposes.
N/A
Intended Use / Indications for Use
The AGILTRACTM . 035 Peripheral Dilatation Catheter is intended:
- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and
- . For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
DQY
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" guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the catheter shaft and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a surface film over the catheter shaft.
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
peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and obstructive lesions of native or synthetic 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 AGILTRACTM .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)
AGILTRACTM . 018 Peripheral Dilatation Catheter
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
SEP 1 3 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: | (650) 617-5218 |
| Fax: | (650) 617-5024 |
| Contact Person: | Nadine Sakakini |
| Date Prepared: | August 16, 2002 |
| Device Trade Name: | AGILTRACTM .035 Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: | DQY |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The AGILTRACTM .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 AGILTRACTM .035 Peripheral Dilatation Catheter is substantially equivalent to Guidant's AGILTRACTM . 018 Peripheral Dilatation Catheter consisting of balloon diameters of 4.0-12.0mm, balloon lengths of 20, 30, 40 and 60 mm with system lengths of 80cm and 135 cm. The AGILTRACTM .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" guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The distal 20 cm of the catheter shaft and the entire length of the balloon are coated with Microglide®, a silicone based material used to reduce friction by providing a surface film over the catheter shaft.
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 AGILTRACTM . 035 Peripheral Dilatation Catheter is intended:
- To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries); and
- . For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Technological Characteristics:
Comparisons of the subject 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, the AGILTRACTM . 018 Peripheral Dilatation Catheter.
Performance Data:
The safety and effectiveness of the AGILTRACTM .035 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 3 2002
Guidant Corporation c/o Ms. Nadine Sakakini Regulatory Affairs Associate 1525 O'Brian Drive Menlo Park, CA 94025
K022738 Re:
Trade Name: AGILTRACTM .035 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 16, 2002 Received: August 19, 2002
Dear Ms. Sakakini:
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 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
3
Page 2 -- Ms. Nadine Sakakini
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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
K. Deen Telle
am D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 |
|---|---|
Device Name: AGILTRACTM .035 Peripheral Dilatation Catheter
Indications for Use:
The AGILTRACTM .035 Peripheral Dilatation Catheter is indicated for the dilatation of stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Division of Cardiovascular & Respiratory Devices
510(k) Number