(68 days)
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due to urethral hypermobility.
The Laparoscopic Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. 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 suture placement system that is offered in the kit is the Laurus Medical Disposable Suture Placement System.
I am sorry, but the provided text primarily consists of a 510(k) summary for the "Louisville Laboratories, Inc. Laparoscopic Suspension Kit." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study that proves the device meets acceptance criteria through performance data.
Therefore, the document does not contain the information necessary to fill out a table of acceptance criteria and reported device performance or answer the specific questions about study design, sample sizes, expert ground truth, adjudication, or MRMC comparative effectiveness. The text highlights:
- Intended use: Bladder neck suspension for female stress incontinence due to urethral hypermobility.
- Device description: Comprised of a template assembly, suture retriever, suture cutter, and suture placement system.
- Technological characteristics comparison: States similarity in components and method of positioning sutures to predicate devices.
- Predicate devices: Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray (K963076) and Laurus Medical Suturing System (K932553).
The 510(k) process typically relies on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, often by showing similar technological characteristics and intended use, rather than requiring extensive clinical trials with specific acceptance criteria and performance metrics for the new device as would be seen in a PMA or De Novo submission.
{0}------------------------------------------------
र971797
103
JUL 2 2 1997
APPENDIX D
510(k) Summary
:
Louisville Laboratories, Inc. Laparoscopic Suspension Kit - 510(k)
:
.
5/14/97
{1}------------------------------------------------
Sponsor/Applicant name, address, telephone number, 1.
Louisville Laboratories, Inc. 2400 Crittenden Drive 40217 Louisville, Kentucky (502) 634-5900 Telephone: (502) 634-5959 Facsimile:
Contact person:
Michael Campbell
Date of summary preparation
May 14, 1997
-
- Device name
Laparoscopic Bladder Neck Suspension Kit Trade/proprietary name: Laparoscopic Bladder Neck Suspension Kit Common/usual name: Classification name: Gynecologic Laparoscope and Accessories Urological Catheter
- Device name
Identification of the predicate or legally marketed device(s) to which equivalence 3. is being claimed
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit 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.
243
{2}------------------------------------------------
Device description 4.
Bladder Neck Suspension Kit is comprised of a template The Laparoscopic assembly, suture retriever, and suture cutter and suture placement system. 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 suture placement system that is offered in the kit is the Laurus Medical Disposable Suture Placement System.
5. Intended use
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit 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 Laparoscopic Bladder Neck Suspension Kit 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 Laparoscopic Bladder Neck Suspension Kit 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 Laparoscopic Bladder Neck Suspension Kit and predicate products are similar in that they use a standard scissors or a suture cutter for cutting the sutures.
Louisville Laboratories, Inc. Laparoscopic Suspension Kit - 510(k)
5/14/97
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 1997
Louisville Laboratories, Inc. % Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K971797
Laparotomy Bladder Neck Suspension Kit Dated: May 14, 1997 Received: May 15, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET 21 CFR §876.5130/Product code: 78 EZL
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Preniarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device 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 Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, 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
Image /page/3/Picture/11 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
{4}------------------------------------------------
Page 2 - Ms. Mary McNamara-Cullinane, RAC
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,
Robert N. Sattungi/
Image /page/4/Picture/4 description: The image contains a handwritten symbol or character. It appears to be a cursive letter or a stylized mark, possibly resembling a lowercase 'sa' or a similar combination of curves and lines. The character is dark against a white background, suggesting it was written with ink or a dark marker.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
510(k) Number (if known): __
Device Name: Louisville Laboratories, Inc Laparoscopic Bladder Neck Suspension Kit
Indications For Use:
・・
The Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit is indicated for urethropexy procedures for bladder neck suspension to correct female stress incontinence due ....... to urethral hypermobility.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use مما (Per 21 CFR 801.109)
OR
Rohr R. Sattino. I
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number 1971797
(Optional Format 1-2-96)
Louisville Laboratories, Inc. Laparoscopic Bladder Neck Suspension Kit - 510(k)
5/14/97
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.