(5 days)
The Boston Scientific Talon Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Talon Balloon Dilatation Catheter is an over-the-wire catheter offered in a two lumen catheter shaft design. One lumen is used to pass the catheter over a guidewire. The device is designed to be placed over guidewires which have outer diameters of 0.018" or smaller. The second lumen communicates with the balloon and is used to inflate and deflate the balloon during the procedure. The guidewire lumen and the balloon lumen terminate at the proximal end of the catheter by means of a bifurcated hub with luer lock fittings. The device is offered in two lengths of 90 cm and 135 cm. The shaft tapers proximally from 4.0 Fr to a distal 3.4 Fr.
A non-compliant balloon is bonded to the distal tip of the catheter, which inflates to a known diameter and length at a specific pressure. The balloon is offered in diameters of 4.0 mm, 5.0 mm, 6.0 mm, and 7.0 mm and is available in lengths of 15 mm, 20 mm and 40 mm. The balloon is designed to exhibit controlled compliance, high rated burst pressure, and safe failure modes (longitudinal tearing).
Two radiopaque markerbands are located under the effective dilatation area of the balloon, one at the proximal transition area and the other at the distal transition area. These markerbands enable accurate positioning of the balloon in the stenosis.
Proximally the balloon lumen ends in a female luer fitting for attachment of a manometer and inflation device.
Each catheter is shipped with a wing-folding tool in place over the balloon. It is designed to protect the balloon and to hold it tightly during shipping and prior to use.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for a training set.
The document is a 510(k) summary for the Boston Scientific Talon Balloon Dilatation Catheter, which primarily focuses on establishing substantial equivalence to a predicate device (K000798). The summary states that the materials and design are equivalent and the only change is the addition of a warning to the Directions for Use. It describes the device, its intended use, and confirms its classification and regulatory status.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study.
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K060 960
510(k) Summary
per 21 CFR §807.92
| Submitter's Nameand Address | Boston Scientific CorporationTwo Scimed PlaceMaple Grove, MN 55311 |
|---|---|
| Contact Name andInformation | Sara L. CoonSenior Specialist, Regulatory AffairsPhone: 763-494-1500Fax: 763-494-2981 |
| Date Prepared | April 6, 2006 |
| ProprietaryName(s) | Boston Scientific Talon Balloon Dilatation Catheter |
| Common Name | Balloon Dilatation Catheter |
| Product Code | LIT |
| Classification ofDevice | Class II, 21 CFR Part 870.1250 |
| Predicate Device | Talon BalloonDilatation CatheterK000798June 8, 2000 |
| DeviceDescription | The Talon Balloon Dilatation Catheter is an over-the-wirecatheter offered in a two lumen catheter shaft design. Onelumen is used to pass the catheter over a guidewire. Thedevice is designed to be placed over guidewires which haveouter diameters of 0.018" or smaller. The second lumencommunicates with the balloon and is used to inflate anddeflate the balloon during the procedure. The guidewirelumen and the balloon lumen terminate at the proximal endof the catheter by means of a bifurcated hub with luer lockfittings. The device is offered in two lengths of 90 cm and135 cm. The shaft tapers proximally from 4.0 Fr to a distal3.4 Fr.A non-compliant balloon is bonded to the distal tip of thecatheter, which inflates to a known diameter and length at aspecific pressure. The balloon is offered in diameters of 4.0mm, 5.0 mm, 6.0 mm, and 7.0 mm and is available inlengths of 15 mm, 20 mm and 40 mm. The balloon isdesigned to exhibit controlled compliance, high rated burstpressure, and safe failure modes (longitudinal tearing). |
| Device Description, continued | Two radiopaque markerbands are located under the effective dilatation area of the balloon, one at the proximal transition area and the other at the distal transition area.These markerbands enable accurate positioning of the balloon in the stenosis.Proximally the balloon lumen ends in a female luer fitting for attachment of a manometer and inflation device.Each catheter is shipped with a wing-folding tool in place over the balloon. It is designed to protect the balloon and to hold it tightly during shipping and prior to use. |
| Intended Use of Device | The Boston Scientific Talon Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. |
| Comparison of Technological Characteristics | The materials and design of the Talon balloon dilatation catheter are equivalent to the predicate Talon Balloon dilatation catheter. |
| Support of Substantial Equivalence | Boston Scientific Corporation considers the proposed Talon Balloon Dilatation Catheter to be substantially equivalent to the existing Talon Balloon Dilatation Catheter (K000798 cleared June 8, 2000). This assessment is based upon identical device materials and design characteristics and the only change being initiated is to add a single warning to the Directions for Use. |
| Conclusion | Based on the indications for use and the technological characteristics, the Talon Balloon Dilatation Catheter has been shown to be equivalent in intended use and is considered to be substantially equivalent to the Talon Balloon Dilatation Catheter (K000798; cleared June 8, 2000) |
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (USA). The logo features a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 2 2006
Boston Scientific Corporation c/o Ms. Angela Byland Manager, Regulatory Affairs Two Scimed Place Maple Grove, MN 55311-1566
Re: K060960
Talon Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II Product Code: LIT Dated: April 6, 2006 Received: April 7, 2006
Dear Ms. Byland:
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. Angela Byland
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 or any 1 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) I mo lotes notification. The FDA finding of substantial equivalence of your device to a legally premaince nedicate 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 other general 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
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 Statement
510(k) Number:
Boston Scientific Talon Balloon Dilatation Catheter Device Name:
Indications for Use:
The Boston Scientific Talon Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) of the iliac, femoral, ilio-femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Prescription Use _ X (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)
(Division Sign-Off) . . . on of Cardiovascular Devices
510(k) Number K060966
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§ 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).