(41 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a balloon catheter, with no mention of AI or ML.
Yes
The device is intended to treat medical conditions by dilating stenoses and re-expanding elements within the body, which are direct therapeutic actions.
No
The device is a dilatation catheter intended for therapeutic purposes such as dilating stenoses and re-expanding stent graft elements, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like a catheter, balloon, guidewire ports, and radiopaque markers, indicating it is a hardware 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 dilate blood vessels and treat lesions. This is an in vivo procedure.
- Device Description: The description details a physical catheter with a balloon designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the defining characteristic of an IVD. The device does not perform tests or provide diagnostic information based on biological samples.
Therefore, the Rival® PTA Dilatation Catheter is a therapeutic medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Rival® PTA Dilatation Catheters are intended to dilate stenoses in the peripheral arteries, treat obstructive lesions of native or synthetic A-V fistulae, and/or re-expand endoluminal stent graft elements in the aorta and iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQY, LIT
Device Description
The Rival® PTA Dilatation Catheter is a 0.035" guidewire compatible balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The hub of the catheter includes inflation and guidewire ports with female luer locks. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries, A-V fistulae, aorta, iliac arteries, peripheral vasculature
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)
To demonstrate substantial equivalence of the subject device, the Rival PTA Dilatation Catheter to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed:
- Puncture Resistance .
- Robustness .
The results from these tests demonstrate that the technological characteristics and performance criteria of the Rival® PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use.
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.
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
APR 1 9 2012
Rival® PTA Dilatation Catheter 510(k) Summary 21 CFR 807.92
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:
Submitter Information:
| Applicant: | Bard Peripheral Vascular, Inc |
|---|---|
| 1625 West 30 Street | |
| Tempe, Arizona 85281 |
- Phone: 480-303-2662
- Fax: 480-449-2546
- Contact: Candace Wade, Regulatory Affairs Specialist
- September 1, 2011 Date
Subject Device Name: Device Trade Name:
Rival® PTA Dilatation Catheter
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250,
Product Code DQY and LIT) |
|-----------------------|----------------------------------------------------------------------|
| Classification: | Class II |
Classification Panel: Cardiovascular
Predicate Devices:
- . Edwards Peripheral Dilation Catheter (K052149; cleared September 2, 2005)
- Dorado® PTA Dilatation Catheter (K072283; cleared September 19, 2007) .
ﺎﺭﺓ،، ﻓﺈﻧ
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Device Description:
The Rival® PTA Dilatation Catheter is a 0.035" guidewire compatible balloon catheter consisting of an over the wire catheter with a balloon fixed at the distal tip. The noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The hub of the catheter includes inflation and guidewire ports with female luer locks. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. A stylet is placed into the tip of the catheter to aid in rewrap/refolding of the balloon.
| Attribute | Rival PTA Dilatation Catheter
Product Offering |
|--------------------------------------------------------------------------------|----------------------------------------------------|
| Balloon Diameter
(mm) | 3, 4, 5, 6, 7, 8, 9, 10 |
| Balloon Length
(cm) | 2, 4, 6, 8, 10, 15 |
| Catheter Shaft
Lengths (cm) | 80, 120, 135 |
| Introducer Sheath
Compatibility
(compatible
balloon
diameters, mm) | 5F: (3, 4, 5, 6)
6F: (6, 7, 8, 9)
7F: (10) |
Indications for Use of Device:
The Rival® PTA Dilatation Catheters are intended to dilate stenoses in the peripheral arteries, treat obstructive lesions of native or synthetic A-V fistulae, and/or re-expand endoluminal stent graft elements in the aorta and iliac arteries. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature.
Image /page/1/Picture/8 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are evenly spaced and aligned horizontally. The overall impression is clean and modern.
2
Comparison of Indications for Use to Predicate Devices:
The indication for use statement for the Rival® PTA Dilatation Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices, the Edwards Peripheral Dilation Catheter and the Dorado® PTA Dilatation Catheter. Therefore, the subject device, the Rival® PTA Dilatation Catheter, is substantially equivalent to the predicate devices.
Technological Comparison to Predicate Devices:
The Rival® PTA Dilatation Catheter has the following similarities to the predicate devices:
- . Similar intended use (combination of both predicates)
- . Similar indications for use (combination of both predicates)
- . Same target population (both predicates)
- . Same fundamental scientific technology (both predicates)
- . Same operating principle (both predicates)
- . Same packaging materials and configuration (Dorado® PTA Dilatation Catheter)
- . Same sterility assurance level and method of sterilization (both predicates)
Performance Data:
To demonstrate substantial equivalence of the subject device, the Rival PTA Dilatation Catheter to the predicate devices, the technological characteristics and performance criterion were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed:
- Puncture Resistance .
- Robustness .
The results from these tests demonstrate that the technological characteristics and performance criteria of the Rival® PTA Dilatation Catheter are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the similar intended use.
Image /page/2/Picture/19 description: The image shows the word "BARID" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The font style is simple and easy to read.
3
Conclusions:
The subject device, the Rival® PTA Dilatation Catheter, met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Rival® PTA Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Edwards Peripheral Dilation Catheter and the Dorado® PTA Dilatation Catheter,
Image /page/3/Picture/5 description: The image shows the word "BARD" in a bold, outlined font. The letters are large and evenly spaced, filling the frame. The outline gives the word a three-dimensional effect, making it stand out against the background.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 9 2012
Bard Peripheral Vascular, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313 .
Re: K120722
Trade/Device Name: Rival PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (Two) Product Code: LIT, DQY Dated: March 8, 2012 Received: March 9, 2012
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 (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
5
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours,
M. G. Milliken
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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aditional 510(k) ival® PTA Dilatation Catheter
Indications for Use
510(k) Number (if known): K120722
Device Name: Rival® PTA Dilatation Catheter
Indications for Use: The Rival® PTA Dilatation Catheters are intended to dilate stenoses in the peripheral arteries, treat obstructive lesions of native or synthetic A-V fistulae, and/or re-expand endoluminal stent graft elements in the aorta and iliac arteries. This device is also recommended for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.
Prescription Use_ X (Part21 CFR 801, Subpart D) AND/OR
Over-The-Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.A. Hillen
(Division Sian-Off) Division of Cardiovascular Devices
510(k) Number K120722
Image /page/6/Picture/16 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a blocky appearance. The overall design is simple and eye-catching.
Bard Peripheral Vascular, Inc.