PTFE FELTS AND PLEDGETS

K041716 · Boston Scientific Corp · DXZ · Jul 22, 2004 · Cardiovascular

Device Facts

• Record ID: K041716
• Device Name: PTFE FELTS AND PLEDGETS
• Applicant: Boston Scientific Corp
• Product Code: DXZ · Cardiovascular
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3470
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Felts: Indicated for Ventricular aneurysmectomy; tissue prosthesis, and suture buttressing. Pledgets: Indicated for Tissue, prosthesis, and suture buttressing.

Device Story

PTFE Felts and Pledgets are surgical implants manufactured from 100% polytetrafluoroethylene (PTFE) fibers. The device is used by surgeons in clinical settings to reinforce tissue, support prosthetic implants, or buttress sutures during cardiovascular procedures, including ventricular aneurysmectomy. The felt is supplied in bulk and cut into squares, while pledgets are provided in various shapes (oval, round, square, rectangular). By providing a stable, biocompatible material at the suture site, the device reduces the risk of suture pull-through and promotes secure tissue or prosthetic closure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: 100% polytetrafluoroethylene (PTFE) fibers. Form factor: Felts (1.245mm thickness) and Pledgets (0.99mm or 1.245mm thickness). Manufacturing: Heat set and scoured. Non-electronic, mechanical implant.

Indications for Use

Indicated for patients requiring ventricular aneurysmectomy, tissue repair, prosthetic attachment, or suture buttressing.

Regulatory Classification

Identification

An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

Predicate Devices

• PTFE Felts and Pledgets (Preamendment devices)

Submission Summary (Full Text)

{0}------------------------------------------------

JUL 2 2 2004

## 510(k) Summary
per 21 CFR §807.92

| Submitter's Name<br>and Address | Boston Scientific Corporation (BSC)<br>Two Scimed Place<br>Maple Grove, MN 55311 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Name: Maureen Montbriand<br>Title: Regulatory Affairs Specialist<br>Telephone: [phone]<br>Facsimile: 763-494-2981<br>e-mail: [e-mail] |
| Date Prepared | June 23, 2004 |
| Proprietary<br>Name(s) | PTFE Felts and Pledgets |
| Common Name | Intracardiac patch or pledget made of polytetrafluoroethylene |
| Product Code | DXZ |
| Classification of<br>Device | Class II, 21 CFR Part 870.3470 |
| Predicate Device | PTFE Felts and Pledgets (Preamendment devices) |
| Device<br>Description | The PTFE Felts and Pledgets are manufactured from 100%<br>polytetraflouroethylene fibers. The felt is purchased from an<br>outside supplier in bulk, which is then heat set, scoured and cut<br>into squares, offering two sizes, or punched into oval, round,<br>square or rectangular pledgets. The Felts have a nominal<br>thickness of 1.245mm (0.049"). The Pledgets have a nominal<br>thickness of either 0.99mm (0.039") or 1.245mm (0.049")<br>depending upon size. |
| Intended Use of<br>Device | Felts:<br>Indicated for Ventricular aneurysmectomy; tissue prosthesis,<br>and suture buttressing. |
| | Pledgets: Indicated for Tissue, prosthesis, and suture<br>buttressing. |
| Summary of<br>Substantial<br>Equivalance | The PTFE Felts and Pledgets have been tested. All data<br>gathered has demonstrated that the device is Substantially<br>Equivalent to the predicate device. No new issues of safety and<br>efficacy have been raised. |

{1}------------------------------------------------

Public Health Service

Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 2 2004

Boston Scientific Corporation c/o Ms. Maureen Montbriand Regulatory Affairs Specialist Two Scimed Place B220 Maple Grove, MN 55311-1566

Re: K041716 PTFE Felts and Pledgets Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget Regulatory Class: Class II Product Code: DXZ Dated: June 23, 2004 Received: June 24, 2004

Dear Ms. Montbriand:

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.

{2}------------------------------------------------

Page 2 - Ms. Maureen Montbriand

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Dina R. Vahner

Image /page/2/Picture/5 description: The image shows a signature. The signature is illegible, but it appears to be written in cursive. The signature is black and is on a white background. The signature is likely from a document or other official paper.

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<br>(if known) | Preamendment device |
|-----------------------------|---------------------------------------------------------------------------------------------------|
| Device Name | PTFE Felts and Pledgets |
| Indications<br>For Use | Felts:<br>Indicated for Ventricular aneurysmectomy; tissue<br>prosthesis, and suture buttressing. |
| | Pledgets:<br>Indicated for Tissue, prosthesis, and<br>suture buttressing. |

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)

Duna R. Wehner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K041716

Page 1 of __1__1__