(29 days)
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, or image processing.
Yes
The device is clearly indicated for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, which is a therapeutic intervention.
No
The device is a therapeutic angioplasty catheter used to treat obstructive lesions in arteries and fistulae, not to diagnose a condition. Its function is to dilate, which is a treatment, not a diagnostic measurement.
No
The device description clearly states it is a physical catheter with a balloon and lumens, indicating it is a hardware device, not software-only.
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 procedure performed within the body (Percutaneous Transluminal Angioplasty) to treat obstructive lesions in blood vessels and fistulae. This is an in vivo procedure.
- Device Description: The description details a catheter with a balloon designed for insertion into the vasculature. This is a medical device used for treatment within the body.
- 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 screening.
IVD devices are used to perform tests outside the body on samples taken from the body. This device is used inside the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Vaccess TM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Product codes
LIT, DQY
Device Description
The Vaccess™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion of the guidewire and the second provides a channel for balloon inflation/deflation. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, iliac, and renal arteries; native or synthetic 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)
The Vaccess™ PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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200g
Vaccess™ PTA Balloon Dilatation Catheter
510(k) Summary
21 CFR 807.92
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 P.O. Box 1740 Tempe, Arizona 85280 480-303-2752 Phone: Fax: 480-449-2546
Jennifer Logvin, Regulatory Affairs Associate Contact:
2. Subject Device:
| Device Trade Name: | Vaccess™ PTA Balloon Dilatation Catheter |
|---|---|
| Common or Usual Name: | Catheter, Angioplasty, Peripheral, Transluminal |
| Catheter, Percutaneous | |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
3. Predicate Device:
| Device Trade Name: | Conquest™ PTA Balloon Dilatation Catheter |
|---|---|
| Cleared 510(K) Number: | K014212 |
| Date of Cleared 510(K): | 01/17/02 |
Image /page/0/Picture/17 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, and the interior of the letters is white. The letters are evenly spaced and appear to be of the same size. The overall impression is one of simplicity and clarity.
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K073472 Page 2 of 2
4. Summary of Change:
The modifications from the predicate device, the Conquest™ PTA Balloon Dilatation Catheter, to the subject device, the Vaccess™ PTA Balloon Dilatation Catheter, were to the balloon design, catheter design, and performance characteristics.
5. Device Description:
The Vaccess™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion of the guidewire and the second provides a channel for balloon inflation/deflation. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
6. Indications for Use of Device:
The Vaccess™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
7. Technological Comparison to Predicate Device:
The technological characteristics of the subject device, the Vaccess™ PTA Balloon Dilatation Catheter, are substantially equivalent to those of the predicate device, the Conquest™ PTA Balloon Dilatation Catheter, in terms of intended use, indications for use, fundamental scientific technology, target population, operating principle, packaging configuration, sterility assurance level and method of sterilization.
8. Conclusions:
The Vaccess™ PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Vaccess™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device, the Conquest™ PTA Balloon Dilatation Catheter.
Image /page/1/Picture/15 description: The image shows the word "BARD" 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 modern.
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Public Health Service
Image /page/2/Picture/2 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" around the perimeter. Inside the circle is a stylized symbol resembling three human profiles facing right, with flowing lines beneath them.
JAN -- 9 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bard Peripheral Vascular, Inc. c/o Ms. Jennifer Logvin Regulatory Affairs Associate 1625 West Third Street P.O. Box 1740 Tempe, Arizona 85280
Re: K073472
Trade/Device Name: Vaccess PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT/DQY Dated: December 10, 2007 Received: December 11, 2007
Dear Ms. Logvin:
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.
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 – Ms. Jennifer Logvin
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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (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 yours.
Duna R. Vuhner
A 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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Indications for Use
| 510(k) Number (if known): | K073472 |
|---|---|
| Device Name: | Vaccess TM PTA Balloon Dilatation Catheter |
| Indications for Use: | The Vaccess TM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is 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)
Dwina P. Jones
(Division Sic, - Off) Division or Cardiovascular Devices
510(k) Number_Ko 73472
Bard Peripheral Vascular, Inc.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
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