(6 days)
Not Found
No
The summary describes a mechanical device (balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which is a therapeutic procedure.
No
Explanation: The device description and intended use clearly state that it is a Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter, used for treatment (dilatation of arteries/fistulae), not for diagnosis.
No
The device description clearly describes a physical catheter with a balloon, lumens, and radiopaque markers, 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 states "Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae." This describes a procedure performed within the body (in vivo) to treat a physical condition.
- Device Description: The description details a catheter with a balloon designed for inflation within blood vessels. This is a therapeutic device used for mechanical intervention, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac 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
DQY
Device Description
The Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. 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
iliac 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
The Atlas™ PTA Balloon 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.
Key Metrics
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).
0
AUG 2 3 2005
Atlas™ PTA Balloon Dilatation Catheter 510(k) Summary of Safety and Effectiveness 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 safety and effectiveness information upon which substantial equivalence determination is based as follows:
-
- Submitter Information:
- Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280 480-303-2524 Phone: 480-449-2546 Fax:
Genevieve Balutowski, Regulatory Affairs Specialist Contact:
2. Subject Device Name:
- Atlas™ PTA Balloon Device Trade Name: Dilatation Catheter Common or Usual Name: Percutaneous catheter Class II Classification:
- Cardiovascular Classification Panel:
Predicate Device: 3.
Atlas™ PTA Balloon Dilatation Catheter (K040243, cleared 02/13/04)
Image /page/0/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and modern appearance. The overall design is simple yet impactful, making the word easily recognizable.
1
Summary of Change: 4.
The design modification to the Atlas™ PTA Balloon Dilatation Catheter as represented in this submission is additional balloon sizes. All other aspects of the subject device remain the same as the predicate device.
Device Description: 5.
The Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
Intended Use of Device: ર.
The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.
Technological Comparison to Predicate Device: 7.
The technological characteristics of Atlas™ PTA Balloon Dilatation Catheter are substantially equivalent to those of the predicate device, the Atlas™ PTA Balloon Dilatation Catheter, in terms of intended use, indication for use, application, user population, basic design, performance, and sterilization method.
Conclusions: 8.
The Atlas™ PTA Balloon 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 Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device, the Atlas™ PTA Balloon Dilatation Catheter.
Image /page/1/Picture/14 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a hollow appearance. The font is uniform in size and spacing, creating a balanced and legible design.
2
Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff entwined with snakes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2005
Bard Peripheral Vascular, Inc. c/o Ms. Genevieve Balutowski 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740
Re: K052236
Bard® Atlas™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 16, 2005 Received: August 17, 2005
Dear Ms. Balutowski:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications felerenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regard chances of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices that have been receasined in asset approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app allu Cosmetic Act (11ct) market the device, subject to the general controls provisions of the Act. The I ou may, utcrefore, market the act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (500 above) this Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
3
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
suma R. Vochines
er R. Vocus
Center for Devices and Radiological Health
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation
Enclosure
4
Indications for Use
510(k) Number (if known): Kos 223 &
Device Name: Atlas™ PTA Balloon Dilatation Catheter
Indications for Use: The Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac 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)
. DIAMS & Concertify Conce of Device Evaluation (ODE)
Concession Concerner Comment
்பாங்கா Sigm-Off) ്വേടിന് വ് Cardiovascular Devices
Page 1 of 1
Number K052236
Bard Peripheral Vascular, Inc
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
BARD