(33 days)
The ViperSphere PTA balloon dilatation catheter is intended to dilate stenoses in peripheral arteries including the iliac, femoral, popliteal, and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Vipersphere™ PTA balloon catheter is a standard percutaneous transluminal angioplasty balloon catheter intended for use in the peripheral vessels. The Vipersphere™ PTA balloon catheter is provided in an over-the-wire configuration with a standard y-adapter on the proximal and a hydrophilic coating balloon on the distal end. The multiple balloon sizes are available with diameter of 2.0mm to 5.0mm and lengths of 10cm, 15cm and 20cm.
This document describes a 510(k) submission for the Vipersphere™ PTA Balloon Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the context of AI/ML or diagnostic devices.
Therefore, the requested information elements related to AI/ML or diagnostic studies (acceptance criteria, device performance, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable to this type of regulatory submission.
The document primarily focuses on:
- Device Description: The Vipersphere™ PTA balloon catheter is a standard percutaneous transluminal angioplasty balloon catheter for peripheral vessels, available in over-the-wire configuration with various sizes.
- Intended Use/Indications for Use: To dilate stenoses in peripheral arteries (iliac, femoral, popliteal, infra-popliteal) and treat obstructive lesions in native or synthetic arteriovenous dialysis fistulae.
- Substantial Equivalence: The submission claims substantial equivalence to several predicate PTA balloon catheters, listed with their 510(k) numbers.
- Supporting Evidence: "Laboratory test data were provided to support the safety and effectiveness of the Vipersphere PTA balloon catheter." (No specifics on these tests or acceptance criteria are given in the provided text).
- Regulatory Decision: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
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1683139
2. 510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.651 Campus DriveSt. Paul, MN 55112 | NOV 2 5 2008 | |
|---|---|---|---|
| Contact: | David BrookeSr. Regulatory Manager | ||
| Phone: | (651) 259-1630 | ||
| Fax: | (651) 259-1696 | ||
| Summary Date: | November 14, 2008 | ||
| Trade Name: | Vipersphere™ PTA Balloon Catheter | ||
| Common Name: | Peripheral Angioplasty Balloon Catheter | ||
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250; Product Code: LIT) | ||
| Predicate Device: | 510(k) Number:Manufacturer:Trade Name: | K993913Infinity Extrusion & EngineeringTRUE PTA Balloon Catheter | |
| 510(k) Number:Manufacturer:Trade Name: | K053116Boston ScientificSterling PTA Balloon Catheter | ||
| 510(k) Number:Manufacturer:Trade Name: | K971010Cordis CorporationSavvy PTA Balloon Catheter | ||
| 510(k) Number:Manufacturer:Trade Name: | K052791ev3Amphirion PTA Balloon Catheter |
Description of Device 2.1
The Vipersphere™ PTA balloon catheter is a standard percutaneous transluminal angioplasty balloon catheter intended for use in the peripheral vessels.
The Vipersphere™ PTA balloon catheter is provided in an over-the-wire configuration with a standard y-adapter on the proximal and a hydrophilic coating balloon on the distal end. The multiple balloon sizes are available with diameter of 2.0mm to 5.0mm and lengths of 10cm, 15cm and 20cm.
2.2 Intended Use
The ViperSphere PTA balloon dilatation catheter is intended to dilate stenoses in peripheral arteries including the iliac, femoral, popliteal, and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
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2.3 Conclusions
The Vipersphere™ PTA balloon catheter is substantially equivalent to the predicate devices. Laboratory test data were provided to support the safety and effectiveness of the Vipersphere PTA balloon catheter.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 5 2008
Cardiovascular Systems, Inc. c/o Mr. Mark Job Reviewer Regulatory Technology Scrvices LLC 1394 25" Street NW Buffalo, MN 55313
Re: K083139
Vipersphere™ PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: November 17, 2008 Received: November 18, 2008
Dear Mr. Job:
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 ffor 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.
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Page 2 - Mr. Mark Job
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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Rcporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Dma R. balmer
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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1. Indications for Use Statement
510(k) Number:
Device Name: Vipersphere™ PTA Balloon Catheter
Indications for Use:
The ViperSphere PTA balloon dilatation catheter is intended to dilate stenoses in peripheral arteries including the iliac, femoral, popliteal, and infra-popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duma R. Velmer
(Division Sign-Off) (Division of Cardiovascular Devices
510(k) Number_koriza
CSI, Inc. November 14, 2008 CSI response to FDA questions K083139 Vipersphere PTA Balloon Catheter (Confidential Information) Confidential
§ 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).