(33 days)
Not Found
No
The description details a standard balloon catheter and does not mention any AI/ML components or functionalities.
Yes
The device is used to treat stenoses and obstructive lesions, which aligns with the definition of a therapeutic device.
No
The device is a therapeutic balloon dilatation catheter designed to dilate stenoses in arteries and fistulae, not to diagnose medical conditions.
No
The device description clearly describes a physical balloon catheter, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ViperSphere PTA balloon dilatation catheter is a medical device used within the body to physically dilate narrowed arteries and fistulae. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a procedure performed on the patient's circulatory system, not the analysis of a biological sample.
The information provided about the device's description, intended use, and performance studies all point to it being an interventional medical device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, and infra-popliteal arteries, 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)
Laboratory test data were provided to support the safety and effectiveness of the Vipersphere PTA balloon catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K993913, K053116, K971010, K052791
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
1683139
2. 510(k) Summary
| Company Name: | Cardiovascular Systems, Inc.
651 Campus Drive
St. Paul, MN 55112 | | NOV 2 5 2008 |
|----------------------|------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------|
| Contact: | David Brooke
Sr. 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: | K993913
Infinity Extrusion & Engineering
TRUE PTA Balloon Catheter | |
| | 510(k) Number:
Manufacturer:
Trade Name: | K053116
Boston Scientific
Sterling PTA Balloon Catheter | |
| | 510(k) Number:
Manufacturer:
Trade Name: | K971010
Cordis Corporation
Savvy PTA Balloon Catheter | |
| | 510(k) Number:
Manufacturer:
Trade Name: | K052791
ev3
Amphirion 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.
1
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.
2
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.
3
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
4
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