MedWorks Urinary Incontinence Surgical Devices are indicated for use in urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility.

Device Description

The devices described in this 510(k) are surgical procedure kits intended for use in urethropexy procedures, and include components such as suture placement templates, bone anchors, bone drills, syringes, suture retrievers and suture cutters.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MedWorks Urinary Incontinence Surgical Devices:

Based on the provided text, the device is not a software/AI device and therefore the questions regarding AI-specific studies, ground truth establishment for AI, sample sizes for AI training/test sets, and expert involvement for AI adjudication are not applicable.

The document describes a device modification for surgical kits. The focus is on demonstrating substantial equivalence to predicate devices and adherence to regulatory standards for medical devices, rather than establishing performance through clinical efficacy studies with specific acceptance criteria in the manner one would for a diagnostic or AI-powered device.

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC, as typically seen in AI device submissions, is not present here. Instead, the "acceptance criteria" are implied by compliance with regulatory requirements and demonstration of substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with 21 CFR 820.30 Design Control requirements	"MedWorks has provided certification of compliance to 21 CFR 820.30 Design Control requirements."
Description of internal Risk Analysis procedure	"A description of the internal Risk Analysis procedure."
Validation testing (Pull testing, Bond integrity testing, Simulated use performance testing)	"Validation testing including pull testing, bond integrity testing and simulated use performance testing is included in Design Validation and Verification planning." (It states the testing is included in planning, implying it was performed as part of design control, but doesn't provide specific results or acceptance criteria for these tests.)
Substantial equivalence to predicate devices (K971791, K971796, K971797, K963076, K971801, K971802)	"Based on the indications for use, technological characteristics, and comparison to predicate devices, the MedWorks Urinary Incontinence Surgical Devices have been shown to be safe and effective for its intended use." (The FDA's letter concurs with this finding of substantial equivalence.)
Indications for Use (Urethropexy surgical procedures for bladder neck suspension to correct female stress urinary incontinence due to urethral hypermobility)	The FDA's letter states: "we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Study Details (Not Applicable for AI/Software Performance)

Since this is a filing for a physical surgical device modification, the following questions are not applicable in the context of an AI/software performance study:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of AI performance for this device. The validation mentioned ("pull testing, bond integrity testing, simulated use performance testing") would have its own sample sizes, but these are not for AI performance assessment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI-assisted device for human interpretation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this submission is for a traditional medical device (surgical kits) undergoing a modification, and the "study" demonstrating its acceptability revolves around regulatory compliance, quality system adherence, and benchmarking against predicate devices rather than clinical efficacy studies or AI performance metrics.

Summary

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MedWorks Corp. Special 510(k) Premarket Notification: Device Modification

July 24, 1998 Urinary Incontinence Surgical

AUG 20 1998

510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, MedWorks Corp. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." MedWorks chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

Trade Name:	MedWorks Urinary Incontinence Surgical Devices
Sponsor:	MedWorks Corp.
	2400 Crittenden Drive
	Louisville, KY 40217
	Resistration #1530618
Device Generic Name:	Urinary incontinence surgical devices
Classification:	According to Section 513 of the Federal Food, Drug, and
	Cosmetic Act, the device classification is Class II.
Predicate Devices:	K971791 - Urethropexy Suture Placement Kit
	K971796 - Mini-Laparotomy MMK Kit
	K971797 - Laparoscopic Burch Set
	K963076 - Laparoscopic MMK Kit
	K971801 - Mini-Laparotomy Burch Set
	K971802 - Urethropexy Suture Placement Set
Manufactured by:
	MedWorks Corp.
	2400 Crittenden Drive
	Louisville, KY 40217

Product Description: The devices described in this 510(k) are surgical procedure kits intended for use in urethropexy procedures, and include components such as suture placement templates, bone anchors, bone drills, syringes, suture retrievers and suture cutters.

Indications for Use:

Safety and Performance:

This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), MedWorks has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and a description of the internal Risk Analysis procedure. Validation testing including pull testing, bond integrity testing and simulated use performance testing is included in Design Validation and Verification planning.

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MedWorks Corp. Special 510(k) Premarket Notification: Device Modification

July 24, 1998 Urinary Incontinence Surgical Devices

Conclusion:

ﭘﺎ

Based on the indications for use, technological characteristics, and comparison to predicate devices, the MedWorks Urinary Incontinence Surgical Devices have been shown to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1998

Medworks Corporation c/o Ms. Pamela Papineau Delphi Medical Device Consulting 50 Brewster Street Pawtucket, Rhode Island 02860

Re: K982626

Modified Foley Catheter for Medworks Urinary Incontinence Surgical Device Kits: Urethropexy Suture Placement Kit, Mini-Laparotomy Kit, Laparoscopic Burch Kit, Laparoscopic MMK Kit, and Mini-Laparotomy Burch Kit Dated: July 24, 1998 Received: July 28, 1998 Regulatory Class: II 21 CFR 876.5130/Procodes: 78 EZL

Dear Ms. Papineau:

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 legally marketed predicate 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 OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In

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Page 2 - Ms. Pamela Papineau

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.

FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used in the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:

The labeling, packaging and method of sterilization of the suture cannot be changed 1. without prior notification, review and clearance by FDA.
1. The supplier of the sutures used in your device cannot be changed without prior notification, review and clearance by FDA.

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), 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 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/dsma/dsmamain.html".

Sincerely yours,

Robert R. Sather/

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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Page

510(k) Number (if known):

Device Name: MedWorks Urinary Incontinence Surgical Devices: Urethropexy Suture Placement Kit, Mini-Laparotomy MMK Kit, Laparoscopic Burch Kit, Laparoscopic MMK Kit, Mini-Laparotomy Burch Kit

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R Sather/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K982626

Prescription Use (Per 21 CFR 801.109)

Over-the -Counter Use _

Regulation Number and Section

§ 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.