SUTURE FIXATION DEVICE; MESH FIXATION DEVICE

K021834 · Mle, Inc. · GAW · Aug 28, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021834
• Device Name: SUTURE FIXATION DEVICE; MESH FIXATION DEVICE
• Applicant: Mle, Inc.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Aug 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Device Story

System comprises surgical stainless steel retention anchor, attached polypropylene suture, and delivery device. Used by surgeons in clinical settings for soft tissue fixation during procedures like pubourethral or bladder neck support. Delivery device facilitates placement of implant into soft tissue. Provides mechanical fixation for suspending sutures or surgical mesh to treat female stress urinary incontinence. Benefits patient by providing secure support for bladder neck/urethra, addressing anatomical causes of incontinence.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

System includes surgical stainless steel retention anchor, polypropylene suture, and delivery device. Class II device (procode GAW).

Indications for Use

Indicated for female patients requiring soft tissue fixation of suspending sutures or surgical mesh, specifically for pubourethral or bladder neck support to treat stress urinary incontinence caused by urethral hypermobility or intrinsic sphincter deficiency.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Suture retention device (21CFR 878.4930)
• Soft tissue Fastener (21CFR 878.5010, procode GAW MBI)

Submission Summary (Full Text)

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# AUG 2 8 2002

510(k) Premarket Notification: Sulure/ Mesh Fixation System K021384: Response I to FDA Email 8/21/02

## III. Summary of Safety and Effectiveness

0 2 1 8 34

### 510(k) Summary for Suture Fixation System

A. Sponsor

MLE, Inc. 52 Commercial Wharf #1 Boston, MA 02110

#### B. Device Name

Suture/ Mesh Fixation System

### C. Predicate Device(s)

21CFR 878.4930 Class I, KGS Suture retention device Devices Classified per 21CFR 878.5010 as Class II, procode GAW MBI, Soft tissue Fastener

#### D. Device Description

The system includes a surgical stainless stcel retention anchor with attached polypropylene suture, and a delivery device for placement of the implant. The system may be supplied with legally marketed surgical mesh marketed for use in treating female stress urinary incontinence.

### 1) Intended Use

For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

#### 2) Technological Characteristics and Substantial Equivalence

The proposed device is substantially equivalent to the predicate devices currently marketed for use for fixation of soft tissuc in terms of intended use and functional characteristics tested.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads in profile, facing to the right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 8 2002

MLE, Inc. c/o Ms. Christine E. Nichols RCS Regulatory Consulting Services 10 Greenlawn Avenue S. Grafton, Massachusetts 01560

Re: K021834

Trade/Device Name: Suture Fixation Device and Mesh Fixation Device Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: May 29, 2002 Received: June 4, 2002

Dear Ms. Nichols:

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.

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR. 1000-1050.

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## Page 2 - Ms. Christine E. Nichols

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Hypt. Ruckls

M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification: Suture/ Mesh Fixation System K021384: Response I to FDA Email 8/21/02

#### IV. Indications for Use Statement

510(k) Number (if Known);

K0218

Device Name: Suture/Mesh Fixation System

Indications For Use:

For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

(PLEASE DO NOT WRITF BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use √ OR Over-The-Counter Use
(Optional Format 1-2-96)

Stupten Rhodes

. ...

Division of General, Restorative and Neurological Devices

1021834 510(k) Number.