This device intends to provide pinpoint suction and irrigation to the surgical site during laparoscopic procedures. It is to be used in conjunction with a legally-marketed irrigation pump, irrigant bag or bottle, legally-marketed suction source, and a laparoscopic probe.

For USE INDICATED DEVICE THIS FOR PATIENTS ELIGIBLE VIA GENERAL LAPAROSCOPIC TREATMENT SURGICAL PROCEDURES

Device Description

This device consists of the following parts already connected to each other:

Main Body to control suction and irrigation. A pool suction tip may be connected to the body
10 ft Twin tubing to allow for suction and irrigation. The blue color tube allows for irrigation and the clean color tube allows for suction.
A "Y" connector connects the blue tube to two branch tubes (clear color, 12" each). Each branch ends with spike with guard, allowing connection to saline bags. Also, each branch includes a clamp intended to avoid back-flow to the disconnected branch. Clamps may not be used if both branches are simultaneously connected.
An adapter at the end of the other clear color tube allows connection to a suction machine.

AI/ML Overview

The provided K994256 submission is for a Suction Irrigation Trumpet Valve Set, which is a Class II medical device. This type of submission relies on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than testing against specific performance acceptance criteria in the way a novel diagnostic algorithm might.

Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to diagnostic AI devices with quantifiable performance metrics (like sensitivity, specificity, AUC) is not directly applicable here. Instead, the "acceptance criteria" for a 510(k) submission like this revolve around demonstrating that the new device is as safe and effective as its predicate.

Here's how to interpret the request in the context of this device:

1. Table of "Acceptance Criteria" and Reported Device Performance

For this device, the "acceptance criteria" are the characteristics of the predicate device (Trump-It II and Magnum 250), and the "reported device performance" is the claim of equivalence for each of those characteristics.

Characteristic ("Acceptance Criteria" from Predicate)	Reported Device Performance (Claim for New Device)
Indications for use	Equivalent
Target population	Equivalent
Design	Equivalent
Materials	Equivalent
Performance	Equivalent
Sterility	Similar
Biocompatibility	Equivalent
Mechanical safety	Equivalent
Chemical safety	Equivalent
Anatomical sites	Equivalent
Human factors	Equivalent
Energy used and/or delivered	Equivalent
Compatibility with environment and other devices	Equivalent
Where used	Equivalent
Standards met	Equivalent
Electrical safety	Equivalent (not applicable)
Thermal safety	Equivalent (not applicable)
Radiation safety	Equivalent (not applicable)

2. Sample size used for the test set and the data provenance

Not applicable. This submission doesn't involve a "test set" or data provenance in the context of evaluating a diagnostic algorithm. It's about demonstrating equivalence to a predicate device. The assessment is based on comparing design, materials, intended use, etc., rather than performance on a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "test set" requiring expert ground truth for this type of device submission. The "ground truth" or standard for comparison is the established safety and effectiveness of the predicate device, which is based on its prior regulatory clearance and market history.

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

Not applicable. There is no "test set" and therefore no adjudication method required.

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 surgical instrument (suction irrigation set), not an AI diagnostic tool that assists human readers. Therefore, MRMC studies and AI effect sizes are irrelevant.

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

Not applicable. This device is a manual surgical tool, not an algorithm.

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

The "ground truth" for this 510(k) submission is the established safety and effectiveness profile of the predicate devices (Trump-It II and Magnum 250), as determined by their prior FDA clearance. The new device demonstrates "equivalence" by showing it shares the same fundamental scientific technology and intended use without raising new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This device is hardware and does not utilize a training set in the context of machine learning.

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

Not applicable. As above, no training set for this type of device.

Summary

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K994256

3 2000 FEB

510(k) Summary As Required by 21 section 807.92 ( c )

1-Submitter Name:	A & A Medical, Inc.
2-Address:	9370 Industrial TraceAlpharetta, GA 30004
3-Phone:	(770) 343- 8400
4-Fax:	(770) 343- 8985
5-Contact Person:	Jihad Mansour
6-Date summary prepared:	December 16th, 1999
7-Device Trade or Proprietary Name:	Suction Irrigation Trumpet valve set
8-Device Common or usual name:	Suction Irrigation Handpiece
9-Device Classification Name:	Laparoscope, general and plastic surgery
10-Substantial Equivalency is claimed against the following device:

Trump-It II and Magnum 250 ڊيم 172 م �

11-Description of the Device:

This device consists of the following parts already connected to each other:

Main Body to control suction and irrigation. A pool suction tip may be connected to the body
10 ft Twin tubing to allow for suction and irrigation. The blue color tube allows for irrigation and the clean color tube allows for suction.

A "Y" connector connects the blue tube to two branch tubes (clear color, 12" each). Each branch ends with spike with guard, allowing connection to saline bags. Also, each branch includes a clamp intended to avoid back-flow to the disconnected branch. Clamps may not be used if both branches are simultaneously connected.

An adapter at the end of the other clear color tube allows connection to a suction machine.

12-Intended use of the device:

13-Safety and Effectiveness of the device:

This device (Suction Irrigation Trumpet valve set) is safe and effective as the other predicate device cited above.

This is better expressed in the tabulated comparison ( Paragraph 14 below )

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14-Summary comparing technological characteristics with other predicate device:

Please find below a tabulated comparison supporting that Suction Irrigation Trumpet Valve set is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.

FDA file reference number	510k 973814
Attachments inside notification submission file	510k summary as downloaded from www.fda.gov
TECHNOLOGICALCHARACTERISTICS	Comparison result
Indications for use	Equivalent
Target population	Equivalent
Design	Equivalent
Materials	Equivalent
Performance	Equivalent
Sterility	Similar
Biocompatibility	Equivalent
Mechanical safety	Equivalent
Chemical safety	Equivalent
Anatomical sites	Equivalent
Human factors	Equivalent
Energy used and/or delivered	Equivalent
Compatibility with environment and other devices	Equivalent
Where used	Equivalent
Standards met	Equivalent
Electrical safety	Equivalent (not applicable)
Thermal safety	Equivalent (not applicable)
Radiation safety	Equivalent (not applicable)

F. 2.)

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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 an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the bird symbol in a circular fashion.

Public Health Service

3 2000 FizB

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jihad Mansour Quality & Regulatory Manager A&A Medical. Inc. 9370 Industrial Trace Alpharetta, Georgia 30004

Re: K994256

Trade Name: Suction Irrigation Trumpet Valve Set, Model Q65-823 Regulatory Class: II Product Code: GCJ Dated: December 16, 1999 Received: December 17, 1999

Dear Mr. Mansour:

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 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 docs 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.

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.

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Page 2 – Mr. Jihad Mansour

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 Compliance and please contact the Office of Compliance at (31) 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 obtainsd 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,

ill.ell.l/7-

Sar James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page | 06 -

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: SUL-110 J 188164 1100 TRUBILT VALUE SET Indications For Use: PATIENTS ﻟﺮ ﺍ For USE INDICATED DEVICE ાં ર THIS

LAPAROSCOPIC TREATMENT VIA GENERAL ELIGIBLE

SURGICAL PROCEDURES

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ahmed/Liyan
(Division Sign-Off)

Division of General Restorative Devices K 994256 510(k) Number.

Prescription Use
(Per 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Formal 1-2-96)

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.