The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing.

The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.

Device Description

The UroMed Needle Grasper is a single use, manual surgical instrument for use during endoscopic/laparoscopic surgical procedures. The Needle Grasper will be used through an endoscopic/laparoscopic operating channel or under open surgical procedures. The instrument will be used to place and pass suture in bladder neck suspension procedures (urethropexy).

The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.

AI/ML Overview

The provided 510(k) summary for the UroMed® Needle Grasper does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study particulars. The document focuses on demonstrating substantial equivalence to predicate devices based on design and material standards, rather than presenting a performance study with specific acceptance criteria that would typically be found in direct performance assessment.

Here's a breakdown of what can and cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics are provided in the document. The submission relies on "Summary of Standards Achieved" for materials and biocompatibility to establish equivalence.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document does not describe a performance test set or clinical study to assess device performance in the way implied by this question.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set adjudication method is described.

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. This device is a manual surgical instrument and does not involve AI or human "readers" in the context of diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual surgical instrument and does not involve an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth for performance evaluation is described. The "ground truth" for the submission is the regulatory acceptance of predicate devices and adherence to material standards.

8. The sample size for the training set

Not applicable. The document does not describe a training set for an algorithm or a performance study.

9. How the ground truth for the training set was established

Not applicable. The document does not describe a training set or its ground truth establishment.

Summary of available information regarding compliance/study:

The 510(k) submission for the UroMed® Needle Grasper primarily demonstrates substantial equivalence through adherence to recognized standards and comparison to legally marketed predicate devices.

Study Type: This is not a performance study with "acceptance criteria" in the sense of effectiveness or diagnostic accuracy. It's a regulatory submission demonstrating substantial equivalence primarily through design comparison and material compliance evaluations.
Compliance to Standards: The device's "performance" is implicitly demonstrated through its construction from materials that meet established standards for surgical instruments and biocompatibility:
- ASTM F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments.
- USP Class VI Biocompatibility.
Equivalence to Predicate Devices: The core of the justification is that the UroMed Needle Grasper is "substantially equivalent to legally marketed devices" (Cook Endoscopic Grasping Forceps, Laurus Medical Suture Placement System) in terms of its intended use, indications for use, and basic function. The text states: "Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness."

In conclusion, the 510(k) summary provided does not contain the information requested for a detailed performance study with specific acceptance criteria and ground truth establishment, as it focuses on demonstrating substantial equivalence through design, materials, and intended use alignment with existing predicate devices and adherence to specific material standards.

Summary

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K974137

JAN 3 0 1998

510(k) Summary of Safety and Effectiveness UroMed® Needle Grasper

Company Name

UroMed Corporation 64 A Street Needham, MA 02194

Official Contact

Frederick Tobia Director, Clinical and Regulatory Affairs

Device Name

Proprietary Name:	UroMed® Needle Grasper
Common Name:	Endoscope/Laparoscope and Accessories - Needle Driver
Classification Name(s):	21 CFR § 876.1500 Endoscope and Accessories21 CFR § 876.4730 Manual Surgical Instruments

Predicate Devices used for Substantial Equivalence

Cook Endoscopic Grasping Forceps Laurus Medical Suture Placement System

K924196 K933698

K932533

Intended Use

The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing.

Indications for Use

UroMed® Needle Holder - 510(k) 10/31/97

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Description

The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.

Summary of Standards Achieved

ASTM F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments.

USP Class VI Biocompatibility.

Summary

In summary, the UroMed Needle Grasper is substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.

UroMed® Needle Holder - 510(k) 10/31/97

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Tobia · Director, Clinical and Regulatory Affairs UroMed Corporation 64 A Street Needham, Massachusetts 02194

Re: K974137 UroMed® Needle Grasper Trade Name: Regulatory Class: II Product Code: KOG Dated: October 31, 1997 Received: November 3, 1997

Dear Mr. Tobia: . .

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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 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.

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Page 2 - Mr. Frederick Tobia

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) 594-4595. 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/dsmamain.html".

Sincerely yours,

Celia 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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K974137

510(k) Premarket Notification UroMed® Needle Grasper

510(k) Number (if known): K97

Device Name: UroMed® Needle Grasper

Indication for Use: The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Over-The-Counter Use

Acosta

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number

K974137
35

UroMed® Needle Holder - 510(k) 10/31/97

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.