(15 days)
Not Found
No
The summary describes a physical medical device (balloon catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter, used for therapeutic dilation of arteries.
No
The device is a balloon dilatation catheter used for Percutaneous Transluminal Angioplasty, which is a therapeutic procedure to widen arteries, not diagnose conditions.
No
The device description clearly states it is a physical balloon catheter with hardware components (catheter, balloon, marker bands).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for Percutaneous Transluminal Angioplasty (PTA) of specific arteries. This is a therapeutic procedure performed directly on the patient's body to widen narrowed blood vessels.
- Device Description: The device is a balloon catheter, which is a physical tool used to perform the angioplasty procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic intervention.
N/A
Intended Use / Indications for Use
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters Line Extension 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.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters Line Extension, 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, as labeled.
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.
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 the substantial equivalence of the subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension, 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 additional in vitro tests were performed:
- Dimensional Testing
- Distensibility Testing
- Fatigue Testing
- Inflation Time
- Deflation Time
- Balloon Burst Strength
- Balloon Burst Mode
- Balloon to Shaft Tensile
- Reinsertion
- Catheter Shaft Leaks
- Sheath Compatibility
- Trackability
The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension is 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
K12 1856
Ultraverse® 014 and 018 PTA Balloon Dilatation Catheter Line Extension
510(k) Summary 21 CFR 807.92
JUL 1 1 2012
Page 11 of
ﺪ
As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the information upon which substantial equivalence determination is based as follows:
1. Submitter Information:
Applicant: Bard Peripheral Vascular, Inc.
1625 West Third Street
Tempe, Arizona 85281
Phone: 480-379-2841
Fax: 480-449-2546
Contact: Erin Fox, Regulatory Affairs Specialist II
Date: June 25, 2012
2. 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® 014 and 018 PTA Balloon Dilatation Catheters |
|---|---|
| Cleared 510(K) Number: | K093965 |
| Date of Cleared 510(K): | 03/17/10 |
4. Summary of Change:
The modifications from the predicate device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters, to the subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension, were to add balloon and catheter lengths.
1
- Device Description:
The subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters Line Extension, 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, as labeled.
6. Indications for Use of Device:
The Ultraverse® 014 & 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 & 018 PTA Balloon Dilatation Catheter Line Extension, are substantially equivalent to those of the predicate device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters, in terms of intended use, indications for use, materials, fundamental scientific technology, target population, operating principle, packaging, sterility assurance level and method of sterilization.
8. Performance Data:
To demonstrate the substantial equivalence of the subject device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension, 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 additional in vitro tests were performed:
- Dimensional Testing .
- Distensibility Testing �
- . Fatigue Testing
- Inflation Time �
- Deflation Time .
2
- Balloon Burst Strength .
- Balloon Burst Mode .
- . Balloon to Shaft Tensile
- Reinsertion .
- . Catheter Shaft Leaks
- Sheath Compatibility .
- . Trackability
The results from these tests demonstrate that the technological characteristics and performance criteria of the subject Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension is 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.
Kla 1856 ... Page 13 of 3
9. Conclusions:
The Ultraverse® 014 & 018 PTA Balloon Dilatation Catheter Line Extension 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 & 018 PTA Balloon Dilatation Catheter Line Exentsion are substantially equivalent to the legally marketed predicate device, the Ultraverse® 014 & 018 PTA Balloon Dilatation Catheters.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bard Peripheral Vascular c/o Ms. Erin Fox 1625 West 3rd St. Tempe, AZ 85281-1740
JUL 1 1 2012
Re: K121856
Trade/Device Name: Ultraverse PTA catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: LIT Dated: June 25, 2012 Received: June 26, 2012
Dear Mr. Fox:
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
Page 2 -- Ms. Eric Fox
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 yours,
M.S. Gillham
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters Line Extension
The Ultraverse® 014 and 018 PTA Balloon Dilatation Catheters Line Extension 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 X CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part21 (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)
CMAZAHLLLL
ardiovascular Devices 510(k) Number