The “candidate device” is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.
The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.
The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.

Device Description

The “candidate device” consists of a Disposable Pump Head, pump motor, clamp & bracket, power supply and power cord(s) for use in laparoscopy. The Disposable Pump Head is a sterile, single-use device, composed of Stainless Steel, glass filled Polypropylene, Medical Grade EPDM, ABS plastic, plastic and flexible PVC tubing. It has an interface dock for attachments of the reusable pump motor. The pump motor, clamp, power supply and power cord are reusable components.

AI/ML Overview

This 510(k) summary does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as typically expected for AI/ML-enabled devices.

The document discusses a traditional medical device (an irrigation pump) and focuses on substantial equivalence to a predicate device based on its intended use and technological characteristics rather than performance metrics from a specific study.

Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies, as this information is not present in the provided text.

Based on the provided text, here's what can be inferred (and what cannot):

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

Explanation: The document states that the "candidate device has the same technological characteristics as a legally marketed predicate device." It claims comparability based on features, specifications, materials, and mode of action. However, it does not define specific performance metrics or acceptance criteria (e.g., flow rate accuracy, pressure limits, sterile barrier integrity) that would typically be evaluated in a study for this type of device. There are no performance results reported.

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

Sample size: Not applicable/Not specified. This document describes a traditional device notification, not a study involving a test set of data.
Data provenance: Not applicable.

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

Not applicable. This is not an AI/ML device, and no ground truth establishment by experts for a test set is mentioned.

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

Not applicable. No test set or 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 is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

Not applicable. No ground truth is mentioned in the context of a performance study.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device.

Summary of available information from the text provided:

The provided text is a 510(k) summary for a traditional medical device, the MultApump™ System, an irrigation pump used in laparoscopic surgical procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Davol (Bard) - K961492) based on its intended use and technological characteristics.

The document states:

The candidate device provides "controlled powered irrigation during laparoscopic surgical procedures."
It is explicitly stated that "The candidate device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent."

The notification includes an "MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE" which reiterates the intended use and states that "The candidate device has the same technological characteristics as a legally marketed predicate device."

Crucially, the document does not describe any specific performance study with acceptance criteria, test sets, or data analysis typically associated with evaluating the performance of AI/ML-enabled devices. The clearance (K981940) was granted based on the determination of substantial equivalence to an existing device rather than a detailed performance study with quantifiable metrics.

Summary

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F: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY

1)	Submitter:	Dexide, Inc.7509 Flagstone DriveFort Worth, TX 76118-6995Phone No.: (817) 589-1454
	Contact Person:	Lynette CaldwellDirector of Quality Assurance
	Date Prepared:	Friday, May 29, 1998
2)	Name of Device:	MultApump™ System
	Common Name:	Irrigation Pump
3)	Predicate Device:	Davol (Bard) -K961492
4)	Description of Device:	The “candidate device” consists of a Disposable PumpHead, pump motor, clamp & bracket, power supply andpower cord(s) for use in laparoscopy. The DisposablePump Head is a sterile, single-use device, composed ofStainless Steel, glass filled Polypropylene, Medical GradeEPDM, ABS plastic, plastic and flexible PVC tubing. It hasan interface dock for attachments of the reusable pumpmotor. The pump motor, clamp, power supply and powercord are reusable components.
5)	Intended Use:	The “candidate device” is designed to be used inconjunction with a laparoscopic irrigation/suction device toprovide controlled powered irrigation during laparoscopicsurgical procedures.

Technological characteristics the candidate device is comparable to the predicate device 6) in that both devices provide controlled powered irrigation during laparoscopic surgical procedures.

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SECTION G:

MANUFACTURER'S STATEMENT OF SUBSTANTIAL EQUIVALENCE

(To be provided with 510(k) notification for tier 2 devices)

STATEMENT OF INDICATIONS FOR USE: The "candidate device" is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectomy and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.

CLAIMS: The pump motor, clamp, bracket, power supply and power cord are reusable components. The Disposable Pump is supplied as a sterile, single-use product.

This notification contains all of the information required by 21 CFR 807.87. A completed copy of the "DRAERD Premarket Notification 510(k) Reviewer's Screening Checklist" is attached.

The candidate device conforms to the following voluntary and mandatory standards:

There are no existing mandatory performance standards that Dexide, Inc is aware.

The candidate device has the same technological characteristics as a legally marketed predicate device. Specifically, the features, specifications, materials, and mode of action are equivalent. If the candidate device is a kit, all of the contents of the kit are either pre-Amendment devices or have been cleared for marketing through previous 510(k)'s. The kit contains no drug or biologic products.

The above statements are accurate representations of this 510(k) Premarket Notification and of the device this firm intends to market. All data and information submitted in this Premarket Notification is truthful and accurate and no material fact has been omitted (21 CFR 807.87(J)).

MANUFACTURER:	Dexide, Inc.
OFFICIAL CORRESPONDENT:	Lynette Caldwell	(signature)
	Lynette Caldwell	(printed name)
TITLE:	Director of Quality Assurance
DATE:	August 4, 1998

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 1998

Ms. Lynette Caldwell Director of Quality Assurance Dexide, Inc. 7509 Flagstone Drive Fort Worth, TX 76118-6995

K981940 Re: Trade Name: MultApump Disposable Pump Head and Accessories Regulatory Class: II Product Code: GCJ Dated: August 10, 1998 Received: August 21, 1998

Dear Ms. Caldwell:

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 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. ਸੇ 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 requlation may result in requlatory 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 regulations.

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Page 2 - Ms. Lynette Caldwell

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.qov/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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Page	1
of	1

510(k) Number (if known):	K981940
Device Name:	MultApump™ System

Intended Use:

. . . . . .

The MultApump™ System is designed to be used in conjunction with a laparoscopic irrigation/suction device to provide controlled powered irrigation during laparoscopic surgical procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices	K981940
510(k) Number

Prescription Use	OR	Over-The-Counter Use
------------------	----	----------------------

(Optional Format 1-2-96) __

Prescription Use
(Per 21 CFR 801.109)

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.