The Candidate Devices are intended for irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic procedures, (e.g. laparoscopic cholecystectomy, appendectomy and herniorrhaphy). They are not intended for use in hysteroscopy or for contraceptive coagulation of the Fallopian tube.
The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.

Device Description

The Candidate Devices consist of a stainless steel cannula and connector used to communicate electrosurgical, suction, and irrigation capabilities to the operative site during laparoscopic surgical procedures.

AI/ML Overview

I am sorry, but the provided text does not contain detailed information about acceptance criteria for a device's performance or a specific study proving it meets those criteria. The document is a 510(k) summary for ModulapTM, which is a regulatory submission for premarket notification of a medical device to the FDA.

Here's what the document does provide:

Device Name: ModulapTM (Reusable Unipolar Electrosurgical Probes and Reusable Unipolar Electrosurgical Inserts)
Intended Use: Irrigation, evacuation of body fluids, and electrosurgical cutting/coagulation during general laparoscopic procedures.
Technological Characteristics Summary: The device consists of a stainless steel cannula and connector for electrosurgical, suction, and irrigation capabilities.
Predicate Device: Nezhat-Dorsey Reusable Electrosurgical Attachments and Nezhat-Dorsey Reusable Electrosurgical Unipolar Inserts.
Regulatory Outcome: The FDA found the device "substantially equivalent" to predicate devices marketed before May 28, 1976. This means it met the regulatory requirements for market clearance based on its similarities to already approved devices, rather than requiring extensive new clinical trials to prove efficacy from scratch.

The document does not include the following information, which would be necessary to answer your request:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Information about a standalone performance study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

For devices approved via the 510(k) pathway by demonstrating substantial equivalence, extensive de novo clinical studies with detailed performance metrics and ground truth establishment are often not required to the same extent as for novel devices or those undergoing PMA (Premarket Approval). The focus is primarily on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Summary

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K983623

DEC 1 8 1998

VIII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's Name A.

Address 1.

ATC Technologies, Inc. 80 Cummings Park Woburn, Massachusetts 01801

Phone Number 2.

(781) 939-0725

3. Contact Person

Paul C. Kierce, President

Summary Preparation Date 4.

August 3, 1998

B. Device Name

Trade/Proprietary Name 1.
ModulapTM

2. Common/Usual Name

Reusable Unipolar Electrosurgical Probes and Reusable Unipolar Electrosurgical Inserts

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Classification Name 3.

General and Plastic Surgery Electrosurgical Cutting and Coaqulation Device and Accessories

Predicate Device(s) C.

Nezhat-Dorsey Reusable Electrosurgical Attachments and Nezhat-Dorsey Reusable Electrosurgical Unipolar Inserts

Device Description D.

Function 1.

When used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, suction source, electrosurgical generator and and suction/irrigation trumpet valve, the Candidate Devices provide irrigation, suction and electrosurgical cutting and coagulation capabilities to the operative site during general laparoscopic surgical procedures.

Scientific Basis 2.

Provides electrosurgical cutting and coagulation to the surgical site during general laparoscopic surgical procedures by communicating the high-frequency electric current generated by a legally-marketed electrosurgical generator to the operative site.

Significant Physical/Performance Characteristics . 3.

Design a)

Non-sterile, reusable.

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Materials b)

Information regarding the materials from which the Candidate Device is constructed is proprietary.

c) Physical Properties

Not applicable.

Intended Use Statement E.

1. Disease/Conditions

Patient Population 2.

The Candidate Devices are intended for use in patient populations eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.

Technological Characteristics Summary F.

TMTrademark of ATC Technologies, Inc.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 8 1998

ATC Technologies, Inc. C/O Ms. Marian Harding Cochran, Esquire 1034 Lincoln Street Hollywood, Florida 33019

Re: K983623 Trade Name: Modulap™M Regulatory Class: II Product Code: GCJ Dated: October 10, 1998 Received: October 15, 1998

Dear Ms. Cochran:

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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.

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Page 2 - Ms. Marian Harding Cochran, Esquire

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 regulation (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,

t colla

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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INDICATIONS FOR USE STATEMENT IX.

510(k) Number (if known):	Not yet assigned. K983623
Device Name:

Indications for Use:

The Candidate Devices are indicated for use in patients eligible for monopolar electrosurgical treatment via general laparoscopic surgical procedures.

TMTrademark of ATC Technologies, Inc.

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

. .

Prescription Use_XX
(Per 21 CFR 801.109)

Over-The-Counter Use
----------------------	--

(Division Sign-Off) (Optional Format 1-2-96)

Division of General Restorative Devices

510(k) Number	29 K983623
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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.