The CORE E3 Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes 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.

Device Description

The CORE E3TM Suction/Irrigator consists of a suction/irrigation handpiece and dual tubing that connects to a battery-powered mechanical pumping system to generate fluid output and can include a suction/irrigation probe. The device connects to a standard suction apparatus to deliver suction. Control of the flow (suction/irrigation) is generated by depressing the color-coded buttons on the handpiece. The handpiece can also be attached to separate compatible electrodes or probes, including reusable probes. The mechanical pumping system is powered with six (6) standard AAA alkaline batteries.

AI/ML Overview

The provided text describes the 510(k) summary for the CORE E3 Suction/Irrigator, a medical device. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The information provided in this document is primarily focused on demonstrating "substantial equivalence" based on design, materials, indications for use, principles of operation, and technological characteristics, supported by bench testing, electrical safety, EMC, biocompatibility, packaging, and sterilization data.

However, the provided text does not describe a study that would involve acceptance criteria for an AI/ML device, a test set with ground truth established by experts, or any MRMC (Multi-Reader Multi-Case) studies. The device in question is a surgical suction/irrigator, a physical medical device, not an AI-powered diagnostic or therapeutic software device.

Therefore, many of the specific questions about acceptance criteria and study design for AI/ML devices (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth) are not applicable to this document.

The document does provide information on performance criteria relevant to this specific physical device. I will extract the closest analogous information to your request based on the provided text.

Regarding the CORE E3 Suction/Irrigator:

This document is for a traditional medical device (a suction/irrigator for laparoscopic procedures), not an AI/ML-powered device. Therefore, the concepts of acceptance criteria, test sets, ground truth established by experts, MRMC studies, and training sets as typically understood for AI/ML devices do not apply in the same way.

Instead, the "acceptance criteria" for this device are demonstrated through various bench tests ensuring its physical and electrical functionality and safety. The "study" proving it meets these criteria refers to these performance tests.

Here's an attempt to answer your questions based on the provided FDA 510(k) summary for the CORE E3 Suction/Irrigator, interpreting the questions in the context of a physical medical device submission for substantial equivalence:

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

Acceptance Criteria (Bench Testing)	Reported Device Performance
Minimum Flow Rate (Irrigation)	Minimum flow rate of 1.2 L/min (as demonstrated by the predicate device and targeted for the subject device).
Achieved Flow Rate Range	Approx. 1.52 - 2.08 L/min (for the CORE E3 Suction/Irrigator - subject device)
Electrical Safety Compliance	Compliance with IEC 60601-1 standard
Electromagnetic Compatibility (EMC) Compliance	Compliance with IEC 60601-1-2 standard
Biocompatibility	Compliance with ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material-Mediated Pyrogenicity, Acute Systemic Toxicity, Hemocompatibility)
Sterilization Validation	Compliance with ISO 11135 (Ethylene Oxide Sterilization Validation) with a Sterility Assurance Level (SAL) of 10-6
Packaging Validation	Compliance with ISO 11607-1
Functionality	Demonstrated through Simulated use testing and Functionality verification testing (including flow rate and accessory testing).

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

Sample Size for Test Set: The document mentions "bench testing" and "simulated use testing." It does not specify the exact number of units or test runs performed for each test (e.g., how many devices were tested for flow rate, how many electrical safety tests were conducted). This level of detail is typically in the test reports, not the 510(k) summary. For device performance testing, multiple devices would be tested, often according to statistical sampling plans defined by internal quality systems and standards.
Data Provenance: The testing was conducted by ConMed Corporation. The country of origin of the data is implied to be within the US, where ConMed is based (Utica, NY). The tests are prospective in the sense that they are specifically performed for this regulatory submission on newly manufactured devices.

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 in the context of AI/ML experts. For this physical device, "ground truth" is established by direct measurement (e.g., flow rate meters, electrical test equipment) and adherence to recognized international standards (e.g., ISO, IEC). The "experts" would be the engineers, technicians, and quality assurance personnel conducting and verifying these tests, as well as the experts involved in drafting and interpreting the relevant ISO and IEC standards. Their qualifications are in engineering, quality assurance, and regulatory affairs, not clinical expertise for image interpretation.

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

Not Applicable in the context of AI/ML expert consensus. For physical device testing, "adjudication" typically refers to quality review processes. Test results are reviewed and approved by authorized personnel, and any deviations or non-conformances would be investigated and resolved according to quality system procedures. This is not an "adjudication method" in the sense of reconciling divergent human interpretations of clinical data.

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

No. Not applicable. This device is a physical surgical tool and does not involve human readers interpreting cases or AI assistance.

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

Not Applicable in the context of AI/ML algorithms. The device's "standalone" performance is its fundamental operation (e.g., delivering irrigation at a specified rate when activated). The "human-in-the-loop" is the surgeon using the device. The performance tests evaluate the device's ability to function as intended by itself.

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

Physical Measurements and Standard Compliance: The "ground truth" for this device's performance is based on objective physical measurements (e.g., measured flow rates) and compliance with established engineering and safety standards (ISO, IEC). It is not based on expert clinical consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

Not Applicable in the context of AI/ML training data. This device is not AI/ML-driven. There is no concept of a "training set" for an algorithm.

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

Not Applicable. See point 8.

Summary

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February 19, 2021

ConMed Corporation Tina Mornak Principal Regulatory Affairs Specialist 525 French Road Utica, New York 13502

Re: K202303

Trade/Device Name: CORE E3 Suction/irrigator Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 13, 2020 Received: August 14, 2020

Dear Tina Mornak:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K202303

Device Name CORE E3 Suction/Irrigator

Indications for Use (Describe)

The CORE E3 Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes to provide controlled powered irrigation during laparoscopic surgical procedures (e.g., laparoscopic cholecystectory and laparoscopic gynecological procedures). It may also be used for resection of filmy adhesions (i.e., hydrodissection) and peritoneal lavage.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

CORE E3™ Suction/Irrigator

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CER 807.92, ConMed Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K202303.

l. SUBMITTER

ConMed Corporation 525 French Road Utica, NY 13502 Company Contact: Tina Mornak Principal Regulatory Affairs Specialist t: 303-699-7600 x135086 christinamornak@conmed.com Date Prepared: January 21, 2021

II. DEVICE NAME

Proprietary Name:	CORE E3™ Suction/Irrigator
Model Numbers:	CD8185-B – CORE E3 Suction/Irrigator, 5mm x 32cm Probe
	CD81300-B - CORE E3 Suction/Irrigator, Handpiece Only
Common Name:	Laparoscope, General & Plastic Surgery
Panel:	Gastroenterology/Urology
Product Code:	GCJ
Device Class:	II
Regulation Number:	876.1500

lll. PREDICATE/LEGALLY MARKETED DEVICE

Primary Device Name:	Hydro-Surg® Laparoscopic Irrigator
Company Name:	Davol Inc.
510(k):	K961492
Reference Device Name:	StrykeFlow
Company Name:	Stryker
510(k):	K963646

IV. DEVICE DESCRIPTION

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V. INTENDED USE / INDICATIONS FOR USE

The CORE E3TM Suction/Irrigator is designed to be used in conjunction with the CORE Trumpet Handpiece and probes 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.

VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The CORE E3™ Suction/Irrigator is similar to the predicate device in that the design of both include a battery-powered pump, dual tubing, trumpet handpiece, and optional probe. As with the predicate, the CORE E3™ Suction/Irrigator continues to function as a single use suction/irrigation device to provide controlled powered irrigation during laparoscopic surgical procedures. The main difference in the subject device from the predicate device is the number and size of batteries that powers the device, and the average delivered irrigation flow rates. The CORE E3™ Suction/Irrigator is safe and effective and substantially equivalent to the predicate as demonstrated by non-clinical performance testing.

	Subject Device	Predicate Device
	CORE E3™ Suction/Irrigator	Hydro-Surg® LaparoscopicIrrigator
Indications for Use	The CORE E3 Suction/Irrigator isdesigned to be used in conjunctionwith the CORE Trumpet Handpieceand probes to provide controlledpowered irrigation/aspiration duringlaparoscopic surgical procedures(e.g., laparoscopic cholecystectomyand laparoscopic gynecologicalprocedures). It may also be used forresection of filmy adhesions (i.e.,hydrodissection) and peritoneallavage.	The Hydro-Surg Irrigator is designedto be used in conjunction with alaparoscopic probe handle and tip toprovide controlled poweredirrigation/aspiration duringlaparoscopic surgical procedures(e.g., laparoscopic cholecystectomyand laparoscopic gynecologicalprocedures). It may also be used forresection of filmy adhesions (i.e.,hydrodissection) and peritoneallavage.
Design	Battery-powered pump, dual tubing,trumpet handpiece, and optionalprobe.	Battery-powered pump, dual tubing,trumpet handpiece, and optionalprobe.
Materials	304 Stainless Steel, Polycarbonate,420 Stainless Steel, EPDM Rubber,ABS, and PVC. Six (6) AAA alkalinebatteries.	Plastic and metal components,material composition unknown. Eight(8) AA alkaline batteries.
Performance Testing	Device performance wastested through bench testingmethodologies to demonstratefunctionality and that thedevice met the minimum flowrate of 1.2 L/min. Flow Rate range approx..1.52-2.08 L/min Electrical safety per IEC60601-1 Electromagnetic Compatibility(EMC) per IEC 60601-1-2	Device performance was testedthrough bench testingmethodologies to demonstratethe device met the minimumflow rate of 1.2 L/min. Flow Rate range approx..1.42-1.5 L/min Electromagnetic Compatibility(EMC) per IEC 60601-1-2
Single Use / Reusable	Single Use	Single Use

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	Ethylene Oxide	Ethylene Oxide
Sterilization	Sterility Assurance Level (SAL) of10-6	Sterility Assurance Level (SAL) of10-6
Environment Use	Healthcare facility/hospital	Healthcare facility/hospital
Principle of Operation	Battery powered mechanicalpumping system	Battery powered mechanicalpumping system

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Bench testing was conducted on the CORE E3 device, including:

Simulated use testing ●
Functionality verification testing, including flow rate testing and accessory testing

Electrical safety and electromagnetic compatibility

Electrical safety and EMC testing were conducted on the CORE E3 device. The system complies with the IEC 60601-1 standard for electrical safety and IEC 60601-1-2 standard for EMC.

Biocompatibility

The biocompatibility evaluation for the CORE E3 device was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices - Part-1: Evaluation and testing within a risk management process and application of applicable principles detailed in FDA Guidance Use of International Standard ISO 10993-1. " Biological evaluation of medical devices – Part 1: Evaluation and Testing within a Risk Manaqement Process" (June 16, 2016). The following tests were completed:

. Cytotoxicity
Sensitization
Irritation or Intracutaneous Reactivity ●
Material-Mediated Pyrogenicity ●
Acute Systemic Toxicity ●
Hemocompatibility

The CORE E3 device is categorized as external communicating with a body contact of tissue/bone/dentin. The duration of body contact is limited (<24 hours).

Packaqing and Sterilization

Packaging and sterilization were conducted on the CORE E3 device, including:

Ethylene Oxide Sterilization Validation per ISO 11135 ●
. Packaging Validation per ISO 11607-1

CONCLUSION VIII.

The subject CORE E3 device is substantially equivalent in design, materials, indications for use, principles of operation and technological characteristics to the predicate Hydro-Surg® Laparoscopic Irrigator by Davol Incorporated. Based upon the findings of non-clinical testing, the differences present no issues of safety and efficacy and the subject CORE E3 device is substantially equivalent to the Hydro-Surg® Laparoscopic Irrigator (K961492).

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.