The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.

Device Description

The Epix Irrigation Pump (model C7000) is reusable and operates outside of the sterile field. The Epix Suction Irrigation Tubing Set (model C7100) is a sterile, single use device, used in conjunction with the Epix Irrigation Pump and the house vacuum to deliver sterile irrigation fluids and to evacuate blood, tissue debris, and smoke from the surgical site.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Epix® Suction Irrigation System, based on the provided 510(k) summary:

This device is a suction irrigator, not an AI/ML powered device. As such, many of the typical categories for AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for a diagnostic algorithm) are not applicable. The study predominantly focuses on benchtop performance testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary doesn't explicitly state quantitative acceptance criteria with numerical targets for each test. Instead, the "acceptance criteria" are implied to be that the subject device performs comparably to the predicate device in the specified functional tests, demonstrating substantial equivalence. The reported device performance is that these tests confirmed substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Subject device performs comparably to predicate in Irrigation Fluid Flow.	Testing demonstrated substantial equivalence to the predicate.
Subject device performs comparably to predicate in Irrigation Fluid Leak.	Testing demonstrated substantial equivalence to the predicate.
Subject device performs comparably to predicate in Aspiration Fluid Flow.	Testing demonstrated substantial equivalence to the predicate.
Subject device performs comparably to predicate in Smoke Evacuation Flow.	Testing demonstrated substantial equivalence to the predicate.
Subject device meets tubing collapse requirements based on ISO 10079-3.	Device was evaluated by a tubing collapse test based on ISO 10079-3.

2. Sample Size Used for the Test Set and Data Provenance

The summary describes "bench top tests" where "the devices were tested side-by-side." It does not specify a numerical sample size (e.g., number of devices tested, number of trials). The data provenance is a laboratory setting from Applied Medical Resources Corporation. This is a prospective test, as the protocol was created specifically to confirm substantial equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a functional performance test for a physical device, not an AI/ML diagnostic device requiring expert ground truth for classification or interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a functional performance test for a physical device.

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, and no MRMC study was conducted.

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. The "standalone" test refers to the device's functional performance in a laboratory setting, as described in the benchtop tests.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is the expected physical and functional performance according to engineering and safety standards (e.g., IEC 60601-1, ISO 10993, ISO 10079-3) and by comparison to the established performance of the predicate device.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

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

Summary

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K122619

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510(k) Summary

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

510(K) Submitter:	22872 Avenida Empresa(949) 713-8000	Applied Medical Resources CorporationRancho Santa Margarita, CA, 92688	ОСТ2 2012
Contact Person:	Jessica ChoRegulatory Affairs SpecialistApplied Medical Resourcesjcho@appliedmedical.comTel: (949) 713-8470 ext. 6697Fax: (949) 713-8205
Date of Preparation:	August 24, 2012
Trade Name:	Epix® Suction Irrigation System
Common Name:	Suction Irrigator
Classification:	Table 5-1 - Classifications
	Product Code	ClassificationRegulation
	GCX	21 CFR 880.6740	Vacuum-powered Body FluidSuction Apparatus
	HET	21 CFR 884.1720	Gynecologic Laparoscope andaccessories
	KQT	21 CFR 876.4370	Gastroenterology-urologyevacuator
Predicate Device:	Stryker® Cassette Pump510(k) #: K042454Product codes: GCX, HET, KQT
Device Description:	The Epix Irrigation Pump (model C7000) is reusable and operatesoutside of the sterile field. The Epix Suction Irrigation Tubing Set(model C7100) is a sterile, single use device, used in conjunction withthe Epix Irrigation Pump and the house vacuum to deliver sterileirrigation fluids and to evacuate blood, tissue debris, and smoke fromthe surgical site.
Intended Use:	The Epix Suction Irrigation System is intended as a general purposesuction and/or irrigation device for use in laparoscopic and opengeneral surgery, laparoscopic and open gynecological surgery,laparoscopic and open urologic surgery. This device delivers sterileirrigant solution and serves as a conduit for suction.

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Summary of Technological Characteristics:

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The Epix® Suction Irrigation System is substantially equivalent in safety and effectiveness to the Stryker® Cassette Pump (K042454).

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The subject and predicate systems are technologically similar in that they are both designed to provide controlled suction from and irrigation to the operative site during laparoscopic and open procedures. For each device, the pump is capable of increasing the rate of fluid delivery and has multiple flow rate settings. The tubing set connects with IV fluid bags and the house vacuum. Suction and irrigation are actuated by the valves on the handpiece. Both systems flush blood and tissue debris from the operative site during surgery.

Discussion of Testing:

The Epix Suction Irrigation System is designed to the following safety and performance standards: IEC 60601-1 Medical electrical equipment - General requirements for safety, IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests, and ISO 10993 Biological Evaluation of Medical Devices.

Applied Medical created a testing protocol to confirm substantial equivalency between the subject and predicate. The devices were tested side-by-side to evaluate substantial equivalence in performance in a laboratory setting. The bench top tests seen in Table 5-2 were designed to focus on the functional performance of both the suction and irrigation features.

Table 5-2 - Performance Tests
Irrigation	Suction
Irrigation Fluid Flow Test	Aspiration Fluid Flow Test
Irrigation Fluid Leak Test	Smoke Evacuation Flow Test

The subject device was also evaluated by a tubing collapse test based on an applicable section of ISO 10079-3 - Medical suction equipment - Part 3: Suction equipment powered from a vacuum or pressure source.

Conclusions Drawn from Testing:

Testing demonstrates that the subject Epix Suction Irrigation System is substantially equivalent to the predicate Stryker Cassette Pump.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized wing segments.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ОСТ

Applied Medical % Ms. Jessica Cho Regulatory Affairs Specialist 22872 Avenida Empresa Rancho Santa Margarita, California 92688

Re: K122619

Trade/Device Name: Epix® Suction Irrigation System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: August 24, 2012 Received: August 28, 2012

Dear Ms. Cho:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set `

2 2012

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Page 2 - Ms. Jessica Cho

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K122 6.19

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Epix® Suction Irrigation System

Indications for Use: The Epix® Suction Irrigation System is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, and laparoscopic and open urologic surgery. This device delivers sterile irrigant solution and serves as a conduit for suction.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil Re. Bohn for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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510(k) Number K122619

Section 4 | INDICATIONS FOR USE STATEMENT

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Regulation Number and Section

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.