(68 days)
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
The Laparotomy 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 is the Laurus Medical Disposable Suture Placement System.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit.
Unfortunately, the provided document does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the requested table and the subsequent points about sample sizing, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document as they are not present.
The document primarily covers:
- Sponsor/Applicant information
- Device name
- Identification of predicate devices
- Device description
- Intended use
- Comparison of technological characteristics to predicate devices
- FDA's letter of clearance based on substantial equivalence.
Key takeaway: This 510(k) focuses on regulatory clearance via substantial equivalence, not on a detailed performance study with defined acceptance criteria.
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JUL 222 1997
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K971801
142
510(k) Summary Louisville Laboratories, Inc Laparotomy Bladder Neck Suspension Kit
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
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- Device name
| Trade/proprietary name: | Laparotomy Bladder Neck Suspension Kit |
|---|---|
| Common/usual name: | Laparotomy Bladder Neck Suspension Kit |
| Classification name: | Manual Surgical Instruments |
| Urological Catheter |
- Identification of the predicate or legally marketed device(s) to which equivalence 3. is being claimed
The Louisville Laboratories, Inc. Laparotomy 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.
5/14/97
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Device description 4.
The Laparotomy 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 is the Laurus Medical Disposable Suture Placement System.
Intended use న్.
The Louisville Laboratories, Inc. Laparotomy 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 Laparotomy 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 Laparotomy 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 Laparotomy 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. Bladder Neck Suspension Kit - 510(k)
5/14/97
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Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUI 22 1997
Re: K971801
Louisville Laboratories, Inc. Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
th Attleboro; Massachusetts 02760
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 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket 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 QS 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), picase contact the Office of Compilance 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" (2 i CFR 807.97). Other general
Laparotomy Bladder Neck Suspension Kit Dated: May 14, 1997 Received: May 15, 1997 Regulatory class: II 21 CFR §876.5130/Product code: 78 EZL and KNY
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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".
ﺮ ﮐ
Sincerely yours,
Roker R. Sattingl
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
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510(k) Number (if known): _
Device Name: Louisville Laboratories, Inc Laparotomy Bladder Neck Suspension, Kit
Indications For Use:
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is indicated for I The Louisville Laboration (100 and 11 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)
OR Over-The-Counter Use Prescription Use u (Per 21 CFR 801.109) Does- 2 1 at (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_K971801 (Optional Format 1-2-96) Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit - 510(k)
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5/14/97
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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 § 876.9.