(120 days)
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.
The RX VIATRACTM 14 Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel which provides support and flexibility to the shaft and is attached at the proximal end.
The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of know diameter and length at specific pressures.
The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is available in 75 cm and 135 cm catheter lengths and with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm.
The provided text describes the 510(k) summary for the RX VIATRACTM 14 Peripheral Dilatation Catheter. The study conducted to demonstrate the device meets acceptance criteria is a bench testing study, not a clinical study involving human or AI performance. Therefore, many of the requested elements are not applicable in this context.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Bench testing was performed to demonstrate that the [device] met the acceptance criteria and performed similar to the predicate Cordis Jupiter™ and OPTA 5™ PTA Catheters." It further concludes, "The results from the bench tests showed that the new RX VIATRAC™ 14 Peripheral Dilatation Catheter met acceptance criteria and performed in a manner equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5™ PTA Catheters."
However, the specific acceptance criteria (e.g., burst pressure thresholds, flexibility, trackability, etc.) for each test and the precise numerical results from the RX VIATRAC™ 14 are not detailed in this 510(k) summary. The summary only provides a high-level statement of compliance.
Example Table (Conceptual, as specific details are missing):
| Test Performed | Acceptance Criteria (Illustrative) | Reported Device Performance (Summary Statement) |
|---|---|---|
| Not specified | To be equivalent or superior to predicate devices | Met acceptance criteria and performed in a manner equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5™ PTA Catheters |
| Not specified | No new safety or effectiveness issues raised | No new safety or effectiveness issues were raised during the testing program. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. Bench testing typically involves multiple samples of the manufactured device.
- Data provenance: Not applicable in the context of clinical data. This refers to laboratory bench test data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth in this context refers to the defined engineering specifications or performance characteristics of the device being tested on a bench. The "ground truth" for bench testing is established by engineering design specifications and industry standards for similar devices.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically for clinical studies with expert reviewers. Bench testing results are objectively measured against predefined criteria.
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
No. This is a bench testing study for a physical medical device (catheter), not an AI algorithm. Therefore, MRMC studies and AI-assisted human performance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical medical device, not a standalone AI algorithm.
7. The type of ground truth used
For bench testing, the "ground truth" is defined by engineering specifications, design requirements, and industry standards for device performance (e.g., burst pressure, tensile strength, flexibility, lubricity, deliverability, etc.). The comparator is also the performance of the predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI study, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI study, so there is no "training set" or corresponding ground truth establishment process in that context.
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DEC 30 1998
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, seemingly handwritten. The sequence starts with the letter 'K', followed by the number '9830', and ends with the letters 'JJ'. The characters are written in a dark color, possibly black or dark blue, against a light background.
510(k) SUMMARY
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
| 1. Submitter's Name: | Guidant CorporationAdvanced Cardiovascular Systems, Inc. |
|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95054 |
| Telephone: | 408-235-3995 |
| Fax: | 408-235-3743 |
| Contact Person: | Susan Silavin, Ph.D. |
| Date Prepared: | August 28, 1998 |
| 2. Device Trade Name: | RX VIATRAC TM 14 Peripheral Dilatation Catheter |
| Device Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Device Classification Name: | LIT |
| 3. Predicate Devices: | Cordis Jupiter TM PTA Catheter (K970299)Cordis OPTA 5 TM PTA Catheter (K972825) |
-
- Device Description:
The RX VIATRACTM 14 Peripheral Dilatation Catheter is a rapid exchange catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal shaft has a tapered stainless steel mandrel which provides support and flexibility to the shaft and is attached at the proximal end.
- Device Description:
The balloon, which has 2 radiopaque markers to aid in positioning the balloon in the stenosis, is designed to provide an expandable segment of know diameter and length at specific pressures.
The proximal end of the catheter has a single arm adaptor that provides access to the inflation lumen. It is designed with a luer-lock fitting for connection with an inflation device.
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The RX VIATRAC™ 14 Peripheral Dilatation Catheter is available in 75 cm and 135 cm catheter lengths and with balloon diameters of 4.0, 4.5, 5.0, 5.5, 6.0, 6.5 and 7.0 mm.
-
- Intended Use:
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.
- Intended Use:
-
- Technological Characteristics:
Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties (see below), sterilization, and packaging are identical or substantially equivalent to the currently marketed predicate devices.
- Technological Characteristics:
-
- Performance Data:
Bench testing was performed to demonstrate that the met the acceptance criteria and performed similar to the predicate Cordis Jupiter™ and OPTA 5™ PTA Catheters. The following tests were performed:
- Performance Data:
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The results from the bench tests showed that the new RX VIATRAC™ 14 Peripheral Dilatation Catheter met acceptance criteria and performed in a manner equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5™ PTA Catheters. No new safety or effectiveness issues were raised during the testing program.
-
- Conclusions:
Since the new RX VIATRAC™ 14 Peripheral Dilatation Catheter has the same intended use, similar design and technological characteristics, equivalent performance properties, identical sterilization and packaging, and no new safety or effectiveness issues, the RX VIATRAC™ 14 Peripheral Dilatation Catheter may be considered substantially equivalent to the predicate Cordis Jupiter™ and Cordis OPTA 5TM PTA Catheters.
- Conclusions:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three birds in flight, arranged in a row.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 30 1998
Sudan Silavin, Ph.D. Senior Regulatory Affairs Coordinator Guidant Corporation 3200 Lakeside Drive P.O. Box 58167 Santa Clara, CA 95054
Re : K983055
Trade Name: RX VIATRAC™ 14 Peripheral Dilatation Catheter Regulatory Class: II Product Code: LIT Dated: November 20, 1998 November 23, 1998 Received:
Dear Dr. Silavin:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to
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Page 2 - Dr. Susan Silavin
your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory And Neurological 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):
Device Name: RX VIATRAC™ 14 Peripheral Dilatation Catheter
Indications for Use:
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.
Tara A. Ry
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K983055
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | -- |
OR
| Over-The-Counter | |
|---|---|
| ------------------ | -- |
(Optional Format 1-1-96)
§ 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).