(89 days)
No
The device description and intended use describe a surgical kit with mechanical components, and there is no mention of AI, ML, image processing, or data analysis.
Yes
The device is intended for bladder neck suspension, which is a medical procedure to treat stress incontinence. This falls under the definition of a therapeutic device as it treats a medical condition.
No
The device description and intended use indicate it is an surgical kit used for bladder neck suspension, which is a therapeutic procedure rather than a diagnostic one. It does not mention any function for detecting, characterizing, or monitoring disease.
No
The device description explicitly lists physical components such as a template assembly, suture retriever, suture cutter, bone anchors, and suture pulling loop, indicating it is a hardware-based medical device kit.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for a surgical procedure (bladder neck suspension) to treat a medical condition (female stress incontinence). This is a therapeutic intervention performed on the patient.
- Device Description: The device components are surgical instruments and implants (bone anchors, sutures) used during the surgical procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for 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.
Product codes
EZL, MBI, HWC, HET
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K963076, K931181, K931182, K932925
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 With
Bone Anchors |
|-------------------------|-------------------------------------------------------------|
| Common/usual name: | Laparotomy Bladder Neck Suspension Kit With
Bone Anchors |
| 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 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