(36 days)
The AGILTRAC™ .018 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.
The AGILTRAC™ .018 Peripheral Dilatation Catheter is a two-lumen catheter with a balloon near the distal tip. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated, and the injection of contrast and/or medication through the distal tip.
The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
The provided text describes a 510(k) premarket notification for a medical device, the AGILTRAC™ .018 Peripheral Dilatation Catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a new, AI-powered diagnostic device.
Therefore, many of the requested categories in your prompt are not applicable to this document as it does not describe an AI medical device or a study involving such a device.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no explicit table of acceptance criteria or reported device performance in the context of an AI device. The document focuses on demonstrating substantial equivalence to an existing predicate device based on technological characteristics and performance data from in vitro bench tests and analyses.
2. Sample size used for the test set and the data provenance:
Not applicable. This is not an AI device. The "test set" would refer to the in vitro bench tests, but no sample sizes or data provenance (country, retrospective/prospective) are specified for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI device, and the ground truth for in vitro bench tests would be established through engineering specifications and measurement standards, not expert consensus.
4. Adjudication method for the test set:
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the in vitro bench tests, the "ground truth" would be the established engineering specifications and measurement standards for balloon dilatation catheters.
8. The sample size for the training set:
Not applicable. This is not an AI device, so there is no training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available: Performance Data
The document states:
"The safety and effectiveness of the AGILTRAC™ .018 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses."
This indicates that the "study" demonstrating performance was a series of in vitro bench tests. The ultimate "acceptance criteria" were met by showing that the new device's performance in these in vitro tests was substantially equivalent to the predicate device, the OTW VIATRACTM 18 Peripheral Dilatation Catheter, across various technological characteristics (materials, biocompatibility, mode of operation, performance properties, sterilization, and packaging). No specific numerical thresholds or detailed results of these in vitro tests are provided in this summary.
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K02016
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FEB 2 2 2002
510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Guidant CorporationEndovascular Solutions |
|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95052 |
| Telephone:Fax: | (408) 845-1419(408) 845-3743 |
| Contact Person: | Curtis Truesdale |
| Date Prepared: | January 16 , 2002 |
| Device Trade Name: | AGILTRACTM .018 Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: LIT |
Device Classification: Class II
Summary of Substantial Equivalence:
The AGILTRAC™ .018 Peripheral Dilatation Catheter consisting of balloon diameters of 4.0-10.0 mm and 12.0 mm, balloon lengths of 20, 30, 40 and 60 mm with a system lengths of 80 cm and 135 cm is substantially equivalent to Guidant's OTW VIATRACTM 18 Peripheral Dilatation Catheter consisting of balloon diameters of 6.0-10.0, balloon lengths of 20, 30, and 40 mm with system lengths of 75cm and 135 cm. The AGILTRACTM .018 Peripheral Dilatation Catheter is substantially equivalent to the legally marketed comparison device with respect to design, materials, method of delivery and intended use.
Device Description:
The AGILTRAC™ .018 Peripheral Dilatation Catheter is a two-lumen catheter with a balloon near the distal tip. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated, and the injection of contrast and/or medication through the distal tip.
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The balloon has radiopaque marker(s) to aid in positioning the balloon in the stenosis, and is designed to provide an expandable segment of known diameter and length at a specific pressure.
Indications for Use:
The AGILTRACTM .018 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 OTW VIATRACTM 18 Peripheral Dilatation Catheter.
Performance Data:
The safety and effectiveness of the AGILTRACTM .018 Peripheral Dilatation Catheter has been demonstrated through data collected from in vitro bench tests and analyses.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Mr. Curtis D. Truesdale Regulatory Affairs Associate Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054-2807
Re: K020161
Trade Name: AGILTRAC™ .018 Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter. Regulatory Class: II (two) Product Code: DQY Dated: February 14, 2002 Received: February 15, 2002
Dear Mr. Truesdale:
We have reviewed your Section 510(k) premarket notification of intent to market the device w o no reviewed your becermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass surfed in also encreated of the Medical Device Amendments, or to devices that provisions 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 therefore, manies are as novel 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 forth in the quality
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Page 2 - Mr. Curtis D. Truesdale
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) This letter will and in yours of substantial equivalence of your device to a legally promated nodicate 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 and 11 you deeline bpoints art 809.10 for in vitro diagnostic devices), please contact the Office of additionally 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,
Dahtill
Drew D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
K02016
Device Name: _AGILTRAC™ .018 Peripheral Dilatation Catheter
Indications for Use:
The AGILTRAC™ .018 Peripheral Dilatation Catheter is indicated for dilation of
er and the may and see and secured willing formeral, nonlitest, infra poplited The AGLITRAC™ .018 Penpheral Lilia, femoral, ilio-femoral, popliteal, infra popliteal,
stenoses in the peripheral arteries (ilia, femoral, popliteal, infra popliteal, stenoses in the periplieral arteries (that, tomoral, me see 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 K020161
§ 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).