(76 days)
The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparobomy Bladder Neck Suspension is indicated for urethropexy procedures for bladder neck suspension to correct incontinence due to urethral hypermobility.
The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, suture cutter and suture pulling loop. 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.
The provided document K971791 is a 510(k) Pre-Market Notification for a medical device submitted to the FDA in 1997. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data with specific acceptance criteria and performance metrics typically seen for novel devices.
Therefore, the document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what the document does provide:
- Acceptance Criteria and Study Data: The 510(k) pathway for medical device regulation in 1997 (and largely today) focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate). This typically involves comparing device design, materials, intended use, and technological characteristics. It does not generally require de novo clinical trials with predefined acceptance criteria and performance metrics like sensitivity, specificity, or outcomes data, unless there's a significant difference in technology or intended use that raises new questions of safety and effectiveness.
Instead, the document provides the following relevant information for a 510(k) submission:
-
Identification of the Predicate Devices:
-
Statement of Substantial Equivalence: The document states that the Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension is substantially equivalent to the aforementioned predicate devices. The basis for this claim is similarity in:
- Intended use (bladder neck suspension for female stress incontinence due to urethral hypermobility).
- Technological characteristics: Both the subject device and predicates include kit components for delivering bone anchors and/or sutures for bladder neck suspension, use a method or component for positioning sutures, and use a standard scissors or suture cutter for cutting sutures.
-
FDA Determination: The FDA reviewed the 510(k) notification and determined that the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This determination allows the sponsor to market the device.
In summary, because this is a 510(k) pre-market notification from 1997, it relies on demonstrating substantial equivalence to existing devices rather than presenting novel clinical study data with specific acceptance criteria.
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JUL 30 1997
510(k) Summary Louisville Laboratories, Inc Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension
Sponsor/Applicant name, address, telephone number, 1.
Louisville Laboratories, Inc. 2400 Crittenden Drive Louisville, Kentucky 40217 (502) 634-5900 Telephone: (502) 634-5959 Facsimile:
Contact person:
Michael Campbell
Date of summary preparation
May 14, 1997
-
- Device name
| Trade/proprietary name: | Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension |
|---|---|
| Common/usual name: | Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension |
| Classification name: | Manual Surgical Instruments Urological Catheter |
3. Identification of the predicate or legally marketed device(s) to which equivalence is being claimed
The Louisville Laboratories, Inc. Vaginal Suturing Kit For Laparotomy 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 Laurus Medical Suturing System (K932553) and several surgical techniques that have been performed for over forty years.
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4. Device description
The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, suture cutter and suture pulling loop. 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.
న్. Intended use
The Louisville Laboratories, Inc. Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension is all 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 Laparotomy Bladder Neck Suspension is substantially equivalent to the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray and the Laurus Medical Disposable Suture Placement System. 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 Laparotomy Bladder Neck Suspension and 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 Laparotomy 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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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
Re : K971791 Vaginal Suturing Kit for Lapartotomy Bladder Neck Suspension K971802 Vaginal Suturing Kit for Laparoscopic Bladder Neck Suspension Regulatory 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 (Special Controls) or class III (Premarket Approval), they II may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code_of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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.
Image /page/2/Picture/9 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like design with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
to colly
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): K971791
Device Name: Louisville Laboratories. Inc Vaginal Suturing Kit For Laparotomy Bladder Neck Suspension
Indications For Use:
The Louisville Laboratories, Inc. Vaginal Suturing Kit for Laparobomy Bladder Neck The Louisville Laboratores, Inc. Vaguiar Durania - Love and Suspension to correct
Suspension is indicated for urethropexy procedures for bladder neck suspension to correct
. Cuspension - is incontinence due to urethral hypermobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K971791
Over-The-Counter Use
(Optional Format 1-2-96)
Louisville Laboratories, Inc. 5/14/97 Dullsville Laboratories, Inc.
Vaginal Suturing Kit for Laparotomy Bladder Neck Suspension - 510(k) Page v
12
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
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.(b)
Classification. Class II.