(34 days)
Not Found
No
The document describes a physical medical device (a balloon catheter) and its intended use and construction. There is no mention of software, algorithms, or data processing that would indicate the presence of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions in arteries and dialysis fistulae, and for post-dilatation of stents, all of which are therapeutic procedures.
No
The device is a therapeutic device used for angioplasty and post-dilatation of stents, not for diagnosing conditions.
No
The device description clearly states it is a "multi-lumen catheter with 5 or 5.8 French shaft outer diameter" and a "composite balloon is mounted onto the distal tip of the catheter," indicating it is a physical medical device, not software only.
Based on the provided information, the Dorado™ PTA Balloon Dilatation Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Dorado™ PTA Balloon Dilatation Catheter is a medical device used within the body (in vivo) for a therapeutic procedure (angioplasty). It is used to physically dilate blood vessels and treat obstructive lesions.
The description clearly outlines its use in procedures performed directly on the patient's arteries and fistulae, not on samples taken from the patient.
N/A
Intended Use / Indications for Use
The Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for postdilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
DQY, LIT
Device Description
The subject device, the Dorado™ PTA Balloon Dilatation Catheter, is composed of a multi-lumen catheter with 5 or 5.8 French shaft outer diameter, depending on balloon size. A composite balloon is mounted onto the distal tip of the catheter. During use, the balloon position in the vessel is identified by two radiopaque marker bands that indicate the working length of the balloon and aid in placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries; arteriovenous dialysis fistulae; peripheral vasculature
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 Dorado™ 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 (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.
K014212, K012913, K053116, K060572
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
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:
| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
P.O. Box 1740
Tempe, Arizona 85280 |
|------------|------------------------------------------------------------------------------------------------|
| Phone: | 480-303-2524 |
| Fax: | 480-449-2546 |
| Contact: | Genevieve Balutowski, Senior Regulatory Affairs Specialist |
| Date | July 18, 2007 |
Subject Device Name:
| Device Trade Name: | Dorado™ PTA Balloon Dilatation Catheter |
|---|---|
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250, |
| Product Code DQY& LIT) | |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |
Predicate Devices:
- . Conquest™ PTA Balloon Dilatation Catheter (K014212, cleared January 17, 2002), manufactured by Bard Peripheral Vascular, Inc.
- Ultraverse® Small Vessel PTA Balloon Dilatation Catheter (K012913, . cleared September 28, 2001), manufactured by Bard Peripheral Vascular, Inc.
Image /page/0/Picture/12 description: The image shows the word "BARD" in a bold, outlined font. The letters are blocky and geometric, giving the word a strong and distinct appearance. The outline emphasizes the shape of each letter, making the word stand out.
SEP 1 9 2007
1
- Sterling™ Over-The-Wire PTA Balloon Dilatation Catheter (K053116, . cleared December 16, 2005), manufactured by Boston Scientific Corporation.
- PolarCath™ Peripheral Dilatation System (K060572, cleared March 15, . 2006), manufactured by Boston Scientific Corporation.
Device Description:
The subject device, the Dorado™ PTA Balloon Dilatation Catheter, is composed of a multi-lumen catheter with 5 or 5.8 French shaft outer diameter, depending on balloon size. A composite balloon is mounted onto the distal tip of the catheter. During use, the balloon position in the vessel is identified by two radiopaque marker bands that indicate the working length of the balloon and aid in placement.
Intended Use of Device:
Dilatation of stenosis in the peripheral vascular, for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and post-deployed stent expansion of self-expanding and balloon expandable peripheral vascular stents.
Indications for Use of Device:
The Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in the coronary arteries.
Comparison of Indications for Use to Predicate Devices:
The Indications for Use of the Dorado™ PTA Balloon Dilatation Catheter is a combination of the Indications for Use of the predicate devices. Therefore, while the indications statement of the subject and predicate devices are different, the differences do not affect the safety and effectiveness of the device when used as labeled as all the indications of the subject device are cleared for similar legally marketed devices.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
Image /page/1/Picture/14 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font is simple and geometric, with straight lines and sharp angles. The image is in black and white.
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Technological Comparison to Predicate Devices:
The Dorado™ PTA Balloon Dilatation Catheter has the following similarities to the predicate devices:
- Similar intended use (all predicates) .
- Similar indications for use (all predicates) .
- Same target population (all predicates) .
- Similar fundamental scientific technology (all predicates) .
- t Similar operating principle (all predicates)
- . Similar packaging materials (Conquest™ PTA Balloon Dilatation Catheter and Ultraverse® Small Vessel PTA Balloon Dilatation Catheter)
- Same sterility assurance level and method of sterilization (Conquest™ . PTA Balloon Dilatation Catheter and Ultraverse® Small Vessel PTA Balloon Dilatation Catheter)
Conclusions:
The Dorado™ 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 Dorado™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Conquest™ PTA Balloon Dilatation Catheter, the Bard Ultraverse® Small Vessel Balloon Dilatation Catheter, the Sterling™ Over-The-Wire PTA Balloon Dilatation Catheter, and the PolarCath™ Peripheral Dilatation System.
Bard Peripheral Vascular, Inc.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.
Image /page/2/Picture/16 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 font style is consistent throughout the word, creating a unified and recognizable logo or brand name.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a stylized body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2007
Bard Peripheral Vascular, Inc. c/o Mr. Genevieve Balutowski Senior Regulatory Affairs Specialist 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740
Re: K072283
Dorado™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, LIT Dated: September 5, 2007 Received: September 6, 2007
Dear Mr. Balutowski:
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 - Mr. Genevieve Balutowski
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,
R. Vuhner
ABram 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): Ko72283
Device Name: Dorado™ PTA Balloon Dilatation Catheter
Indications for Use: The Dorado™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for postdilatation of balloon expandable and self-expanding stents in the peripheral vasculature. This catheter is not for use in the coronary arteries.
Prescription Use X (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)
Dumua R. Vachmes
Division Sign-C Olvision of Cardiovascular Devices
510(k) Number K07228
Page 1 of 1
Bard Peripheral Vascular, Inc.
TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.