(10 days)
Not Found
No
The summary describes a standard balloon catheter and does not mention any AI or ML components or functionalities.
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which is a therapeutic intervention.
No
The device is a therapeutic balloon dilatation catheter used for angioplasty, not for diagnosing medical conditions.
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, the Bard® AtlasTM PTA Balloon Dilatation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "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 to treat a physical condition.
- Device Description: The description details a catheter with a balloon for mechanical dilation, which is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Bard® AtlasTM PTA Balloon Dilatation Catheter is a therapeutic device used for a medical procedure.
N/A
Intended Use / Indications for Use
The Bard® AtlasTM 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.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Bard® 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, 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)
Not Found
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
SUMMARY OF SAFETY AND EFFECTIVENESS
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:
- A. Submitter Information:
| | Applicant: | Bard Peripheral Vascular, Inc.
1625 West 3rd Street
Tempe, Arizona 85280 |
|----|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: | 480-303-2752 |
| | Fax: | 480-449-2546 |
| | Contact: | Aymee R. Berry, Associate Manager, Regulatory Affairs |
| B. | Device Name: | Bard® AtlasTM PTA Balloon Dilatation Catheter |
| | Common or
Usual Name: | Catheter, Percutaneous |
| | Classification: | Class II |
| C. | Predicate
Device Name(s): | Bard® ConquestTM PTA Balloon Dilatation Catheter
(K014212, cleared 01/17/02)
BardTM Opti-Plast® CenturionTM 5.5F PTA Catheter |
(K973013, cleared 06/19/98)
D. Device Description:
The Bard® 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.
-
ய் Statement of Intended Use:
The Bard® 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. -
F. Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the Bard® Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the abovereferenced predicates in terms of composition, design, intended use, and performance attributes.
1
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 3 2004
C.R. Bard, Inc. c/o Ms. Aymee R. Berry Associate Manager, Regulatory Affairs Bard Peripheral Vascular 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740
Re: K040243
Bard Atlas PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: February 2, 2004 Received: February 3, 2004
Dear Ms. Berry:
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 cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Trug, 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 max publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Aymee R. Berry
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, permitte vour 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 (301) 594-4648. 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/dsma/dsmamain.html
Sincercly vours,
Duna R. Vochner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K040243 |
|---|---|
| Device Name: | BardTM AtlasTM PTA Balloon Dilatation Catheter |
| Indications For Use: | The Bard® AtlasTM 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. |
V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DUNCAN R. VACHER
(Division Sign-Off) Division of Cardiovascular Devices
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