K Number
K083657
Device Name
CONQUEST PTA BALLOON DILATATION CATHETER
Manufacturer
Date Cleared
2008-12-24

(14 days)

Product Code
Regulation Number
870.1250
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Conquest™ PTA Balloon Dilatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.
Device Description
The Conquest™ PTA Balloon Dilatation Catheter is composed of a coaxial lumen catheter. One lumen accommodates a guidewire for catheter tracking and the second provides a channel for balloon inflation/deflation. 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 platinum iridium marker bands that indicate the working length of the balloon and aid in placement.
More Information

Not Found

No
The description focuses on the mechanical components and intended use of a balloon catheter, with no mention of AI/ML technologies or data processing.

Yes
The device is used for Percutaneous Transluminal Angioplasty (PTA) to treat obstructive lesions, which is a therapeutic intervention aimed at restoring blood flow or treating blockages.

No

The device is a balloon dilatation catheter used for therapeutic angioplasty and post-dilatation of stent grafts, which are treatment procedures, not diagnostic ones.

No

The device description clearly outlines a physical catheter with lumens, a balloon, and marker bands, indicating it is a hardware medical device, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The Conquest™ PTA Balloon Dilatation Catheter is a medical device used directly within the body (in vivo) for mechanical procedures (angioplasty and dilatation) on blood vessels and fistulae. It is a physical tool used to open narrowed or blocked vessels.
  • Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing performed outside the body.

Therefore, the Conquest™ PTA Balloon Dilatation Catheter is an in vivo medical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Conquest™ PTA Balloon Dilatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Product codes (comma separated list FDA assigned to the subject device)

DQY

Device Description

The Conquest™ PTA Balloon Dilatation Catheter is composed of a coaxial lumen catheter. One lumen accommodates a guidewire for catheter tracking and the second provides a channel for balloon inflation/deflation.

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 platinum iridium 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

femoral, iliac, and renal 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)

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.

Conquest™ PTA Balloon Dilatation Catheter (K014212), Dorado™ PTA Balloon Dilatation Catheter (K072283), Edwards Peripheral Dilatation Catheter (K052149)

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

Conquest™ PTA Balloon Dilatation Catheter

DEC 2 4 2008

510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part

(1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial

equivalence determination is based is as follows:

Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe, Arizona 85281 |

-------------------------------------------------------------------------------------------

Phone: 480-303-2524

Fax: 480-449-2546

  • Genevieve Balutowski, Associate Project Manager, Regulatory Contact: Affairs
  • Date November 13, 2008

Subject Device Name:

| Device Trade Name: | Conquest™ PTA Balloon Dilatation
Catheter |
|-----------------------|--------------------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250,
Product Code DQY) |
| Classification: | Class II |

Classification Panel: Cardiovascular

Predicate Devices:

  • Conquest™ PTA Balloon Dilatation Catheter (K014212; cleared January . 17, 2002)
  • Dorado™ PTA Balloon Dilatation Catheter (K072283; cleared September . 19, 2007)
  • Edwards Peripheral Dilatation Catheter (K052149; cleared September 2, . 2005)

Image /page/0/Picture/24 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 overall design is simple and straightforward, focusing on the legibility of the word.

1

Device Description:

The Conquest™ PTA Balloon Dilatation Catheter is composed of a coaxial lumen catheter. One lumen accommodates a guidewire for catheter tracking and the second provides a channel for balloon inflation/deflation.

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 platinum iridium marker bands that indicate the working length of the balloon and aid in placement.

Indications for Use of Device:

The Conquest™ PTA Balloon Difatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Comparison of Indications for Use to Predicate Devices:

The indication for use statement for the Conquest™ PTA Balloon Dilatation Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices, the Conquest™ PTA Balloon Dilatation Catheter, the Dorado™ PTA Balloon Dilatation Catheter and the Edwards Peripheral Dilatation Catheter. Therefore, the subject device, the Conquest™ PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate devices.

Technological Comparison to Predicate Devices:

The Conquest™ 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) .
  • Same fundamental scientific technology (all predicates) .
  • . Same operating principle (all predicates)

Image /page/1/Picture/19 description: The image shows the word "BARD" in a bold, outlined font. The letters are capitalized and evenly spaced. The font style appears to be a blocky, sans-serif typeface, giving the word a strong and distinct visual presence.

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  • Same packaging materials and configuration (Conquest™ PTA Balloon . Dilatation Catheter)
  • Same sterility assurance level and method of sterilization (Conquest™ . PTA Balloon Dilatation Catheter and Dorado™ PTA Balloon Dilatation Catheter)

Conclusions:

The subject device, the Conquest™ 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 Conquest™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Conquest™ PTA Balloon Dilatation Catheter, the Dorado™ PTA Balloon Dilatation Catheter, and the Edwards Peripheral Dilatation Catheter.

Image /page/2/Picture/9 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style is simple and geometric, with straight lines and sharp angles. The overall impression is clean and modern.

3

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2008

Bard Peripheral Vascular, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Mecting, PA 19462

Re: K083657

Conquest PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Perculaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 9, 2008 Received: December 10, 2008

Dear Mr. Mosenkis:

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 cither 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.

4

Page 2 - Mr. Robert Mosenkis

Please be advised that HDA'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 Biometrics' (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/cdrl/industry/support/index.html.

Sincerely vours.

ellmll

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: Conquest™ PTA Balloon Dilatation Catheter

Indications for Use: The Conquest™ PTA Balloon Dilatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in 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)

comell

n of Cardiovascular Devices K083657 510(k) Number

Image /page/5/Picture/15 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 aligned horizontally. The image is simple and clear, with a focus on the word itself.