(84 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 a Pertaineous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter, used to treat narrowed arteries, which is a therapeutic intervention.
No
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter, used for therapeutic dilation of arteries, not for diagnosing conditions.
No
The device description clearly outlines a physical medical device (catheter with a balloon) and the performance studies focus on physical characteristics and mechanical testing, not software validation.
Based on the provided information, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) of specific arteries (renal, tibial, popliteal, femoral, and peroneal). This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a physical catheter with a balloon designed to be inserted into blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis on bodily specimens.
The device is a therapeutic medical device used for a surgical procedure, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DOY
Device Description
The subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are small vessel balloon catheters consisting of an over the wire catheter with a balloon fixed at the distal tip. The semi-compliant, low profile balloon has two radiopaque marker bands to delineate the working length of the balloon and aid in balloon placement. The coaxial, over the wire catheter is compatible with 0.014" and 0.018" guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
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 Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters to the predicate device, 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:
- Catheter Length.
- Guidewire Inner Lumen Diameter.
- Shaft Outer Diameter.
- Balloon Outer Diameter at Operating Pressure ●
- Balloon Length.
- Marker Band Spacing/Alignment.
- . Tip Length
- . Tip Taper
- Guidewire Compatibility.
- Distensibility.
- Balloon Fatigue.
- . Balloon Inflation and Deflation
- Balloon Burst Strength.
- Balloon to Catheter Shaft Bond Strength.
- Joint Strength of Hub to Shaft.
- Hub Torsion Testing.
- Hub Stress Testing.
- Simulated Use: Introducer Sheath Compatibility.
- Catheter Shaft Leaks.
- Catheter Elongation.
- Crossing Profile.
- Simulated Use: Trackability 4
- Marker Band Visibility.
- . Compatibility with Standard Luer Locks
- Rewrapping with Stylet ●
- . Package Integrity
- . Dye Penetration of Packaging
- . Pouch Seal Strength
The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same 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
Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters
510(k) Summary
MAR 1 7 2010
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 summary of the information upon which substantial equivalence determination is based as follows:
- Submitter Information:
Applicant: Bard Peripheral Vascular, Inc.
1625 West Third Street
Tempe, Arizona 85281
Phone: 480-303-2662
Fax: 480-449-2546
Contact: Candace Wade, Regulatory Affairs Associate
Date: December 22, 2009
- Subject Device:
| Device Trade Name: | Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters |
|---|---|
| Common or Usual Name: | Catheter, Angioplasty, Peripheral, Transluminal/ |
| Catheter, Percutaneous | |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
3. Predicate Device:
| Device Trade Name: | Ultraverse® Small Vessel PTA Balloon Dilatation Catheter |
|---|---|
| Cleared 510(K) Number: | K012913 |
| Date of Cleared 510(K): | 09/28/01 |
4. Summary of Change:
The modifications from the predicate device, the Ultraverse® Small Vessel PTA Balloon Dilatation Catheter, to the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters, were to the balloon design, catheter design, and performance characteristics.
1
5. Device Description:
The subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are small vessel balloon catheters consisting of an over the wire catheter with a balloon fixed at the distal tip. The semi-compliant, low profile balloon has two radiopaque marker bands to delineate the working length of the balloon and aid in balloon placement. The coaxial, over the wire catheter is compatible with 0.014" and 0.018" guidewires.
14093969
6. Indications for Use of Device:
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters, are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
7. Technological Comparison to Predicate Device:
The technological characteristics of the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters, are substantially equivalent to those of the predicate device, the Ultraverse Small Vessel PTA Balloon Dilatation Catheter, in terms of intended use, indications for use, fundamental scientific technology, target population, operating principle, sterility assurance level and method of sterilization.
8. Performance Testing Summary:
To demonstrate substantial equivalence of the subject device, the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters to the predicate device, 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:
- Catheter Length .
- Guidewire Inner Lumen Diameter .
- Shaft Outer Diameter .
- Balloon Outer Diameter at Operating Pressure ●
- Balloon Length .
- Marker Band Spacing/Alignment .
- . Tip Length
- . Tip Taper
- Guidewire Compatibility .
2
- Distensibility .
- Balloon Fatigue .
- . Balloon Inflation and Deflation
- Balloon Burst Strength .
- Balloon to Catheter Shaft Bond Strength .
- Joint Strength of Hub to Shaft .
- Hub Torsion Testing .
- Hub Stress Testing .
- Simulated Use: Introducer Sheath Compatibility .
- Catheter Shaft Leaks .
- Catheter Elongation .
- Crossing Profile .
- Simulated Use: Trackability 4
- Marker Band Visibility .
- . Compatibility with Standard Luer Locks
- Rewrapping with Stylet ●
- . Package Integrity
- . Dye Penetration of Packaging
- . Pouch Seal Strength
The results from these tests demonstrate that the technological characteristics and performance criteria of the Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are comparable to the predicate device and that it can perform in a manner equivalent to devices currently on the market for the same intended use.
9. Conclusions:
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are substantially equivalent to the legally marketed predicate device, the Ultraverse® Small Vessel PTA Balloon Dilatation Catheter.
3
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, with its arms outstretched. The logo is simple and uses a monochromatic color scheme.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MAR ] 7 2010
Bard Peripheral Vascular, Inc. c/o Candace Wade Regulatory Affairs Associate 1625 West Third Street Tempe, AZ 85281
Re: K093965
Trade/Device Name: Ultraverse 014 and 018 PTA Balloon Dilatation Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: LIT, DOY Dated: February 5, 2010 Received: February 12, 2010
Dear Ms. Wade:
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.
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
4
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/ResourcesforYou/Industry/default.htm.
https://www.fda.gov/MedicalDevices/ResourcesforYouIndustry/default.htm
Sincerely yours,
er R. V. Mmer
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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Page 73
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
KO93965
Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the renal, tibial, popiteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries.
Prescription Use × (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)
Rma R. V. Lines
(Division Sign-Off) (Division Sign Silvascular Devices
510(k) Number K 093965
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
BARD