(89 days)
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone Anchors is intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
The Laparotomy Bladder Neck Suspension Kit With Bone Anchors is comprised of a template assembly, suture retriever, suture cutter, bone anchors 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 text is a 510(k) summary for a medical device (Laparotomy Bladder Neck Suspension Kit With Bone Anchors). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria and performance metrics in the way a clinical trial for a new drug or a novel high-risk device might.
Therefore, many of the requested details about acceptance criteria, study design, expert qualifications, adjudication methods, and sample sizes for training/test sets are not present in this document. The FDA 510(k) process for this type of device typically relies on a comparison of technological characteristics to existing devices and performance testing that demonstrates safety and effectiveness without necessarily involving large-scale clinical outcome studies in the same way.
Here's what can be extracted based on the provided text, with clear indications where information is not available:
Acceptance Criteria and Device Performance
1. Table of acceptance criteria and the reported device performance:
This document does not contain a table of explicit acceptance criteria with numerical performance targets for the device itself. The 510(k) summary asserts substantial equivalence to predicate devices based on technological characteristics and intended use. Performance data is not detailed in a quantitative manner here.
General Statement on Equivalence (as the primary "acceptance"):
| Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| Intended Use | To be for bladder neck suspension for female stress incontinence due to urethral hypermobility, similar to predicates. | The device's intended use matches that of the predicate devices: "bladder neck suspension for female stress incontinence due to urethral hypermobility." |
| Technological Characteristics | Similar design, components, and method of action to predicate devices for delivering bone anchors and positioning sutures. | The device is described as "similar in design" and using "a method or a component for positioning the sutures to the appropriate anatomical site," and for cutting sutures. |
| Safety and Effectiveness | To be as safe and effective as the legally marketed predicate devices. | Assumed to meet this based on substantial equivalence to predicates like K963076 and the Microvasive kits (K931181, K931182, K932925). |
Study Details (or lack thereof)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of evaluating performance metrics against ground truth. The submission is based on demonstrating substantial equivalence to pre-existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. This information is relevant for studies that establish ground truth (e.g., image-based diagnostic AI models). This 510(k) summary does not detail such a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable/Not provided. As there is no described test set or ground truth establishment process involving experts, adjudication methods are not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable/Not provided. This type of study (MRMC for AI assistance) is not mentioned in the 510(k) submission. The device is a surgical kit, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. The device is a surgical kit for use by a surgeon, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable/Not provided. No explicit "ground truth" (in the sense of a definitive diagnostic or outcome label) is discussed in relation to a study for this device within the given text. Substantial equivalence relies on comparing the device's characteristics and intended use to approved predicate devices.
8. The sample size for the training set:
Not applicable/Not provided. There is no mention of a "training set" as would be used for machine learning models.
9. How the ground truth for the training set was established:
Not applicable/Not provided. As there is no training set, this information is not relevant or available.
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510(k) Summary Louisville Laboratories, Inc Laparotomy Bladder Neck Suspension Kit With Bone Anchors
Sponsor/Applicant name, address, telephone number, 1.
Louisville Laboratories, Inc. 2400 Crittenden Drive Louisville, Kentucky 40217 (502) 634-5900 Telephone: Facsimile: (502) 634-5959
Contact person:
Michael Campbell
Date of summary preparation
May 14, 1997
- Device name 2.
| Trade/proprietary name: | Laparotomy Bladder Neck Suspension Kit WithBone Anchors |
|---|---|
| Common/usual name: | Laparotomy Bladder Neck Suspension Kit WithBone Anchors |
| Classification name: | Manual Surgical InstrumentsUrological 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 With Bone Anchors is substantially equivalent to several devices on the market such as the Louisville laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray
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(K963076), the Microvasive Percutaneous Bladder Neck Suspension Kit, (K931181, K931182, K932925) and several surgical techniques that have been performed for over forty years.
Device description 4.
The Laparotomy Bladder Neck Suspension Kit With Bone Anchors is comprised of a template assembly, suture retriever, suture cutter, bone anchors 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.
న. Intended use
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone Anchors 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 Laparotomy Bladder Neck Suspension Kit With Bone Anchors is substantially equivalent to the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray and the Microvasive Percutaneous Bladder Neck Suspension Kit. The technological characteristics are similar in that they include several kit components for delivering bone anchors for bladder neck suspension. Both the Laparotomy Bladder Neck Suspension Kit With Bone Anchors 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 With Bone Anchors and predicate products are similar in that they use a standard scissors or a suture cutter for cutting the sutures.
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Image /page/2/Picture/0 description: The image shows the logo for Louisville Laboratories. The logo consists of a black and white checkered cross-like symbol on the left, followed by the text "Louisville" on the top line and "Laboratories" on the bottom line. The text is in a serif font and is black in color.
Premarket Notification Truthful and Accurate Statement for Laparotomy Bladder Neck Suspension Kit with Bone Anchors
I certify that, in my capacity as Regulatory Affairs Specialist of Louisville Laboratories, I believe to the best of my knowledge, that all data and information submitted in this premarket notification for the Laparotomy Bladder Neck Suspension Kit with Bone Anchors are truthful and accurate and that no material fact has been omitted.
Signature
4/28/97
Date
David Phelps, Regulatory Affairs Specialist Typed Name and Title
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Image /page/3/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white.
Mary McNamara-Cullinane, RAC Staff Consultant AUG 1 2 1997 Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
K971796 Re : Laparotomy Bladder Neck Suspension Kit with Bone Anchors Requlatory Class: II Product Codes: EZL, MBI, HWC, HET Dated: May 14, 1996 Received: May 15, 1997
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. 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to
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Page 2 - Mary McNamara-Cullinane, RAC
comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.
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 our labeling requlation (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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Cellia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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_
Indications For Use:
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit With Bone I he Louisville Laboutered, fire: 25px crocedures 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
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Division Sign-Off)
Division of General Restorative Devices K971726.
510(k) Number (Optional Format 1.2-96)
Louisville Laboratories, Inc. 5/14/97 Laparotomy Bladder Neck Suspension Kit With Bone Anchors - 510(k) Page v
§ 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.