The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or The Malis irrigation module 1000.

Device Description

The device is single use and is used to connect an irrigation bipolar forceps to electrosurgical generator and irrigation module for coagulation and delivering saline to the tip of forceps simultaneously. The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis irrigation module 1000.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called "Single Use Irrigation Bipolar Cable." It focuses on demonstrating the device's substantial equivalence to a predicate device, not on proving new clinical effectiveness or diagnostic accuracy. Therefore, the typical "acceptance criteria" and study details you're asking about for AI/diagnostic devices (e.g., sensitivity, specificity, reader studies, ground truth establishment, sample sizes for training/test sets) are not present or applicable in this type of submission.

This document details the engineering and material equivalence of the proposed device to a legally marketed predicate device. The "performance testing" here refers to non-clinical tests to verify safety, electrical performance, sterility, and shelf life, not clinical diagnostic accuracy or AI performance.

Here's how to address your request based on the provided document:

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

The acceptance criteria here are focused on demonstrating substantial equivalence to the predicate device and meeting international safety standards. There isn't a table of quantitative performance metrics in the way you'd expect for a diagnostic or AI device.

Acceptance Criteria Category	Reported Device Performance (Summary from the text)
Indications for Use	Substantially equivalent to predicate: "The device is intended to provide irrigation and energy simultaneously to standard bipolar forceps specifically designed for irrigation. The device is used with Malis bipolar coagulators or the compatible generators and the Malis CMC-II Irrigation Module or the Malis irrigation module 1000."
Regulation, Product Code, Use	Same as predicate: 21 CFR 878.4400, GEI, Prescription use.
Energy Delivery/Technology	Same as predicate: High frequency electrical current/energy, for monopolar electrosurgery.
Design	Same as predicate: Combined of Irrigation tubing with bipolar cable.
Material of Components	Mostly same as predicate (e.g., Copper wire/PVC insulation for cable, PVC for tubing, PC for Luer lock, ABS for puncture utensil, PP for pinch clamp). Difference noted: Protector for luer and puncture utensil: Proposed device uses ABS, Predicate uses LDPE/PP. Comment: "Similar, provide the same function."
Rated Accessory Voltage	500Vp. Predicate listed as 500Vp-p. Comment: "Both meets IEC safety requirements."
Sterility	EO sterile (same as predicate). Validation and Verification testing performed in accordance with ISO 11135:2014.
Shelf Life	3 years (same as predicate). Supported by packaging integrity and accelerated aging tests.
Electrical Safety and EMC	Comply with IEC60601-1, IEC60601-1-2, IEC60601-2-2. (Predicate listed as Comply with AAMI HF-18). Comment: "Same."
Biocompatibility	Comply with ISO10993. (Same as predicate). Comment: "Meet biocompatibility requirements so it does not raise any safety issue for [user/patient - cut off text]."
Packaging Integrity	Tests completed to support proposed shelf life (ISO 11607-1:2019).
Accelerated Aging	Tests completed to support proposed shelf life (ASTM F1980-16).

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

For this type of device, the "test set" would refer to samples of the device itself undergoing engineering and biocompatibility testing. The document doesn't specify sample sizes for these non-clinical tests (e.g., how many cables were tested for dielectric strength or sterility).

Data Provenance: Not applicable in the context of clinical data for AI/diagnostic devices. The data here comes from internal laboratory testing and compliance with international standards.

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

This is not applicable. "Ground truth" in this context would implicitly be the established performance parameters of the predicate device and the requirements of the relevant IEC/ISO standards. There are no clinical "experts" establishing ground truth in the sense of image interpretation or diagnosis for this specific submission.

4. Adjudication method for the test set

Not applicable. There's no human interpretation or adjudication in the context of device performance testing for substantial equivalence for this electrosurgical accessory.

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 or diagnostic imaging device.

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

Not applicable. This is not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is:

The performance specifications and characteristics of the predicate device (Codman Integrated Irrigation Tubing and Bipolar Cord Set with 510(k) number K052449).
The requirements outlined in relevant international standards (e.g., IEC 60601-1, IEC60601-2-2, IEC60601-1-2, ISO10993-1, ASTM F1980-16, ISO 11607-1:2019) for electrical safety, biocompatibility, sterility, and packaging.

8. The sample size for the training set

Not applicable. There is no training set as this is not a machine learning/AI device.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 19, 2021

Modern Medical Equipment Manufacturing, LTD. Philip Hung Management Representative Flat A, 11/F., Mai Wah Ind. Bldg., 1-7 Wah Sing Street, Kwai Chung, N.T. Hong Kong, China

Re: K211170

Trade/Device Name: Single Use Irrigation bipolar cable Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 14, 2021 Received: September 20, 2021

Dear Philip Hung:

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 ffor 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/cfpm/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 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 (0S) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (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

Enclosure

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Indications for Use

510(k) Number (if known) K211170

Device Name

Sterile Single Use Irrigation Bipolar Cable

Indications for Use (Describe)

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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1. 510(k) OwnerName:	Modern Medical Equipment Manufacturing Limited
Address:	Modern Medical Equipment Mfg., Ltd.Flat A, 11/F., Mai Wah Ind. Bldg.,1-7 Wah Sing Street,Kwai Chung, N.T., Hong Kong, China.
Telephone:	(852) 2420 9068
Fax:	(852) 2481 1234
Contact person:	Philip Hung
Date of preparation:	16 October 2021
2. DeviceName of Device:	Sterile Single Use Irrigation Bipolar Cable
Trade or proprietary name:	Sterile Single Use Irrigation Bipolar Cable
Common or usual name:	Sterile Single Use Irrigation Bipolar Cord
Classification name:	Electrosurgical Cutting & CoagulationDevice & Accessories
Classification number:	21 CFR 878.4400
Classification Panel:	General & Plastic Surgery
Product Code:	GEI
Class:	II

3. Predicate device

Codman Integrated Irrigation Tubing and Bipolar Cord Set with 510(k) number K052449.

4. Device description

The socket connector of the cable is to fit Codman irrigating bipolar forceps. The fixed 2-pin plug is connected to any compatible generators or the flying lead connectors are connected to Malis bipolar coagulators or any compatible generators. The tubing set of the cable can be used with the Malis CMC-II irrigation module or the Malis

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irrigation module 1000.

5. Indication for use

6. Substantial Equivalence

The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject devices and the predicate device.

ComparedItems	Proposed Device(K211170)Single UseIrrigation bipolarcable (CD933)	Predicate Device(K052449)Coeman IntegratedIrrigation Tubing andBipolar Cord Set	Comments ondifference
Indication foruse	The device isintended to provideirrigation andenergysimultaneously tostandard bipolarforceps specificallydesigned forirrigation. Thedevice is used withMalis bipolarcoagulators or thecompatiblegenerators and theMalis CMC-IIIrrigation Moduleor the Malisirrigation module1000.	The device is intended toprovide irrigation andenergy simultaneously tobipolar forceps specificallydesigned for irrigation.They are intended for usewith Codman/Malis CMC-IIand the Codman/MalisCMC III I.E.C. IrrigationModules and theCodman/Malis BipolarCoagulators.	Same
Regulationnumber	21 CFR 878.4400	21 CFR 878.4400	Same
Product code	GEI	GEI	Same
OTC orprescription	For prescriptionuse	For prescription use	Same
Energydelivery	High frequencyelectricalcurrent/energy	High frequency electricalcurrent/energy	Same
Technology	For monopolarelectrosurgery	For monopolarelectrosurgery	Same
Design	Combined ofIrrigation tubingwith bipolar cable	Combined of Irrigationtubing with bipolar cable	Same
Material of thecomponents
-Cable wirewith plug	Copper wire andPVC insulation	Copper wire and PVCinsulation	Same
-Tubing	PVC	PVC	Same
-Luer lock	PC	PC	Same
-Punctureutensil	ABS	ABS	Same
-Protectorfor luer andpunctureutensil	ABS	LDPE/PP	Similar,provide thesame function
-Pinchclamp	PP	PP	Same
Ratedaccessoryvoltage	500Vp	500Vp-p	Both meetsIEC safetyrequirements
Sterile	EO sterile	EO sterile	Same
Shelf life	3 years	3 years	Same
Electricalsafety andEMC	Comply withdielectric strengthin with accordanceIEC60601-1,IEC60601-1-2 &IEC60601-2-2	Comply with dielectricstrength in with accordanceAAMI HF-18	Same
Biocompatibility	Comply withISO10993	Comply with ISO10993	Meetbiocompatibilityrequirements soit does not raiseany safety issuefor

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7. Non-clinical Performance Testing Data

Validation and Verification testing was performed on device sterility in accordance with ISO 11135:2014.

The safety performance of the subject device passed all the testing according to internal requirements and international standards shown below to support the substantial equivalence of the subject device

IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment Part 1: -General requirements for basic safety and essential performance
-IEC60601-2-2: 2017 (Fifth Ed), Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surqical equipment and high frequency surqical accessories.
IEC60601-1-2:2014, Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance - Collateral Standard. Electromagnetic Disturbances - Requirements and Tests
-ISO10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems

Furthermore, the packaging integrity and accelerated aging test were completed on the subject device to support the proposed shelf life.

8. Conclusion

The non-clinical testing demonstrates that the subject device, the Single Use Irrigation Bipolar Cable, is substantially equivalent as the predicate device (K052449).

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.