VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION

K971802 · Louisville Laboratories, Inc. · MBI · Jul 30, 1997 · Orthopedic

Device Facts

• Record ID: K971802
• Device Name: VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
• Applicant: Louisville Laboratories, Inc.
• Product Code: MBI · Orthopedic
• Decision Date: Jul 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.

Device Story

Kit includes template assembly, suture retriever, and suture cutter; used for laparoscopic bladder neck suspension. Surgeon operates instruments to position sutures at anatomical sites to correct urethral hypermobility. Output is physical placement of sutures to support bladder neck. Used in surgical setting; assists in treating female stress incontinence.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design similarity and established surgical techniques.

Technological Characteristics

Manual surgical instrument kit consisting of a template assembly, suture retriever, and suture cutter. Components are identical to those cleared in K963076. No energy source, software, or electronic components. Sterilization method not specified.

Indications for Use

Indicated for female patients with stress incontinence due to urethral hypermobility requiring bladder neck suspension procedures.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076)
• Microvasive Percutaneous Bladder Neck Suspension Kit

Reference Devices

• Microvasive Vescia Bladder Neck Suspension Kit

Submission Summary (Full Text)

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K971802

## Louisville Laboratories, Inc Laparoscopic Bladder Neck Suspension Kit

JUL 30 1997

#### Sponsor/Applicant name, address, telephone number, 1.

Louisville Laboratories, Inc. 2400 Crittenden Drive Louisville, Kentucky 40217 [phone] Telephone: [phone] Facsimile:

Contact person:

Michael Campbell

# Date of summary preparation

May 14, 1997

- 2. Device name

| Trade/proprietary name: | Vaginal Suturing Kit for Laparoscopic Bladder Neck |
|-------------------------|----------------------------------------------------|
| | Suspension |
| Common/usual name: | Vaginal Suturing Kit for Laparoscopic Bladder Neck |
| | Suspension |
| Classification name: | Gynecologic Laparoscope and Accessories |
| | Urological Catheter |

### Identification of the predicate or legally marketed device(s) to which equivalence 3. is being claimed

The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is substantially equivalent to several devices on the market such as the Louisville laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076), the Microvasive Percutaneous Bladder Neck Suspension Kit and several surgical techniques that have been performed for over forty years.

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#### 4. Device description

The Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is comprised of a template assembly, suture retriever, and suture cutter. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray.

#### 5. Intended use

The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.

### A statement of how the technological characteristics of the device compare to 6. those of the predicate or legally marketed device(s) cited

The Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension is substantially equivalent to the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray and the Microvasive Vescia Bladder Neck Suspension Kit. The technological characteristics are similar in that they include several kit components for delivering bone anchors and/or sutures for bladder neck suspension. Both the Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension and the predicate devices are similar in design in that they both use a method or a component for positioning the sutures to the appropriate anatomical site. Both the Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension and predicate products are similar in that they use a standard scissors or a suture cutter for cutting the sutures.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES ' ' ' ' ' '

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mary McNamara-Cullinane, RAC ·Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

JUL 30 1997

K971791 Re : Vaginal Suturing Kit for Lapartotomy Bladder Neck Suspension K971802 Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension Requlatory Class: II Product Code: MBI Dated: May 14, 1997 Received: May 15, 1997

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major requlations affecting your devices can be found in the Code of Federal Requiations, Title 21, Farts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action.

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Page 2 - Mary McNamara-Cullinane, RAC

concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 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 devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
to colye

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

Enclosures

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510(k) Number (if known): _1497 | XDス

Device Name: Louisville Laboratories, Inc Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension_

Indications For Use:

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_ --The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparoscopic Bladder Neck The Louisville Laboratories) Ther " Sky procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.

(I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

| | Concurrence of CDRH, Office of Device Evaluation (ODDE) | |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | | Over The-Counter Use |
| | Division of General Restorative Devices K 9-71 PLC Z<br>510(k) Number _ | (Optional Format 1-2-96) |
| | C / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 / 1 | Page V |

Louisville Laboratories, Inc. -5/14/97 Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension - 510(k)

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