The Single Use Arthroscopic Electrodes are indicated for single-use under sterile conditions with an electrosurgical pencil, a generator, neutral electrode and contact quality monitor (CQM) to deliver monopolar radiofrequency (RF) energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures.

Device Description

Single Use Arthroscopic Electrodes are monopolar active devices, which consists of a conductive electrode tip, an insulated shaft and a conductive post. The conductive electrode tip configuration offers 90° Angled Hook, 45° Angled Hook and Blade to meet the needs of Arthroscopy. The conductive electrode tip is the conductive portion of the electrode which delivers RF energy to cut and excise tissue or coagulate blood vessels during arthroscopic surgical procedures. The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material (Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode. The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the "Single Use Arthroscopic Electrode (with Pencil)". It aims to demonstrate substantial equivalence to a predicate device, not to prove that the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in this regulatory submission.

However, I can extract information related to the performance testing conducted to support the substantial equivalence claim.

Here's a breakdown of the available information and a notation for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a formal table of explicit acceptance criteria with quantitative targets and corresponding reported device performance. The performance testing section describes comparative testing between the subject device and the predicate device, aiming to show "substantially equivalent" thermal effect and tissue stickiness.

Acceptance Criteria (Implied)	Reported Device Performance
Thermal effect on tissue (Cut mode) equivalent to predicate	Substantially equivalent thermal effect on porcine tissue (kidney, liver, muscle, bovine tendon) compared to predicate device.
Thermal effect on tissue (Coagulation mode) equivalent to predicate	Substantially equivalent thermal effect on porcine tissue (kidney, liver, muscle, bovine tendon) compared to predicate device.
Tissue stickiness on electrode tip (Cut mode) equivalent to predicate	Substantially equivalent tissue stickiness on electrode tip compared to predicate device.
Tissue stickiness on electrode tip (Coagulation mode) equivalent to predicate	Substantially equivalent tissue stickiness on electrode tip compared to predicate device.
Sterility	Validation and Verification testing performed in accordance with ISO 11135:2014.
Packaging integrity	Validation and Verification testing performed.
Electrical Safety	Complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) and IEC60601-2-2: 2009 (Fifth Ed).
Biocompatibility (Intracutaneous reactivity)	No biologically significant effect observed in tests conducted in accordance with ISO 10993.
Biocompatibility (in vitro cytotoxicity)	No biologically significant effect observed in tests conducted in accordance with ISO 10993.
Biocompatibility (Skin sensitization)	No biologically significant effect observed in tests conducted in accordance with ISO 10993.
Biocompatibility (Acute systemic toxicity)	No biologically significant effect observed in tests conducted in accordance with ISO 10993.
Biocompatibility (Pyrogenicity)	No biologically significant effect observed in tests conducted in accordance with ISO 10993.

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

Sample Size for performance testing: Not specified. The document states "comparative device use on porcine tissue: kidney, liver, muscle and bovine tendon". The number of samples for each tissue type or total samples is not provided.
Data Provenance: The performance testing involved animal models (porcine tissue and bovine tendon). The country of origin of the data is not specified, but the manufacturing company is based in Hong Kong. The testing is retrospective in the sense that it was conducted as part of the 510(k) submission process, not as a prospective clinical trial on human subjects.

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

This information is not provided. The performance testing involved objective measurements of thermal effect and tissue stickiness rather than subjective expert assessment of images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are typically relevant for studies involving subjective assessments (e.g., image interpretation), which is not the nature of the performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the performance of AI in assisting human readers, which is not relevant for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This device is a physical electrosurgical electrode, not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" was implicitly derived from direct observation and measurement of the biophysical effects (thermal effect and tissue stickiness) on the animal tissues under controlled experimental conditions. For sterility, packaging, electrical safety, and biocompatibility, the ground truth was established by adherence to and passing of specified international standards (ISO, IEC).

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense.

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

This information is not applicable/not provided for the same reason as point 8.

Summary

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May 31, 2018

Modern Medical Equipment Manufacturing Limited Jerry Cheung Regulatory Manager 35-41 Tai Lin Pai Rd, Unit F 5th Fl, Gold King Ind., Bldg., Kwai Chung, N.T. Hong Kong, China

Re: K170703

Trade/Device Name: Single Use Arthroscopic Electrode (with Pencil) Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, GEI Dated: April 11, 2018 Received: April 20, 2018

Dear Jerry Cheung:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170703

Device Name

Single Use Arthroscopic Electrode (with Pencil)

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) Owner Modern Medical Equipment Manufacturing Limited Name: 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: Mr. Jerry Cheung Date of preparation: 27 April, 2018 2. Device Name of Device: Single Use Arthroscopic Electrode (with Pencil) Trade or proprietary name: Single Use Arthroscopic Electrode: Push Button Pencil with Single Use Arthroscopic Electrode Rocker Switch Pencil with Single Use Arthroscopic Electrode Single Use Arthroscopic Electrode; Common or usual name: Push Button Pencil with Single Use Arthroscopic Electrode Rocker Switch Pencil with Single Use Arthroscopic Electrode Classification name: Arthroscope; Electrosurgical, Cutting & Coagulation Device & Accessories Classification Panel: General & Plastic Surgery Product Code: HRX. GEI II Class:

3. Predicate device

Aaron Arthroscopy Electrodes with 510(k) number K020579.

4. Device description

The insulated shaft is the mid portion of the electrode. It is insulated with non-conductive material

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(Polyolefin Shrinkage tube and / or PTFE Shrinkage tube) in order to prevent accidental conduction of the electrosurgical current from this point to the patient. An over-mold cap is attached at the end of electrode.

The conductive post is used to plug the electrode into the distal end of an electrosurgical pencil from which it receives the electrical current. The post size of electrode is 2.36mm in diameter which fits insertion to the distal end of electrosurgical pencils in the legal market. The maximum rated accessory voltage is 2.9kVp. The maximum power setting of electrosurgical generator is 120 Watts.

The Single Use Arthroscopic Electrodes are provided in the following designs:

A. Product Description (Electrode only):

Single Use Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 1. 213.5mm, Hex Lock
Single Use Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 2. 214.5mm, Hex Lock
Single Use Arthroscopic Angled Blade Electrode, insulated, , Total Length 214.5mm, 3. Hex Lock
1. Single Use Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm, Hex Lock
1. Single Use Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 213.5mm
Single Use Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 6. 214.5mm
Single Use Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm 7.
1. Single Use Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
1. Single Use Arthroscopic Hook Teflon coated, Electrode, 90° Angle, insulated, Total Length 213.5mm, Hex Lock
1. 1. Single Use Arthroscopic Hook Teflon coated, Electrode, 45° Angle, insulated, Total Length 214.5mm Hex Lock
1. 1. Single Use Arthroscopic Angled Blade Teflon coated Electrode, insulated, Total Length 214.5mm Hex lock
1. Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm, Hex Lock
1. Single Use Arthroscopic Hook Teflon coated Electrode, 90° Angle, insulated, Total Length 213.5mm
1. Single Use Arthroscopic Hook Teflon coated Electrode, 45° Angle, insulated, Total Length 214.5mm
1. Single Use Arthroscopic Angled Blade Teflon coated Electrode, insulated, Total Length 214.5mm
1. Single Use Arthroscopic Angled Blade Teflon coated Electrode, non-insulated, Total Length 214.5mm

B. Product Description (Push Button Pencil with electrode):

Single Use Push Button Pencil with Arthroscopic Hook Electrode, 90°

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Angle, insulated, Total Length 213.5mm

1. Single Use Push Button Pencil with Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 214.5mm
1. Single Use Push Button Pencil with Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm
1. Single Use Push Button Pencil with Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
1. Single Use Push Button Pencil with Arthroscopic Hook Teflon Coated Electrode, 90° Angle, insulated, Total Length 213.5mm
1. Single Use Push Button Pencil with Arthroscopic Hook Teflon Coated Electrode, 45° Angle, insulated, Total Length 214.5mm
1. Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, insulated, Total Length 214.5mm
1. Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated

Single Use Push Button Pencil with Arthroscopic Angled Blade Teflon Coated
14.5mm Electrode

C. Product Description (Rocker Button Pencil with electrode):

1. Single Use Rocker Switch Pencil with Arthroscopic Hook Electrode, 90° Angle, insulated, Total Length 213.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Hook Electrode, 45° Angle, insulated, Total Length 214.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Electrode, insulated, Total Length 214.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Electrode, non-insulated, Total Length 214.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Hook Teflon Coated Electrode, 90° Angle, insulated, Total Length 213.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Hook Teflon Coated Electrode, 45° Angle, insulated, Total Length 214.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, insulated, Total Length 214.5mm
1. Single Use Rocker Switch Pencil with Arthroscopic Angled Blade Teflon Coated Electrode, non-insulated, Total Length 214.5mm

Single Use Arthroscopic Electrodes do not have cloud communications, network connection, wireless communication in any form, USB / serial ports / removable media or software upgrades.

Single Use Arthroscopic Electrode is for "Adults only" use.

DO NOT USE a Single Use Arthroscopic Electrode with port, trocar or cannula. Capacitive coupling may be associated with unintended thermal injury.

5. Intended use

The Single Use Arthroscopic Electrode is intended for use to deliver monopolar radiofrequency energy.

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6. Indication for use

7 Technological characteristic

Single Use Arthroscopic Electrodes have substantially equivalent construction and performance as the predicate devices.

8. Substantial Equivalence

The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. .

9. Performance Testing Data

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

Performance Testing included comparative device use on porcine tissue: kidney, liver, muscle and bovine tendon in saline for both Cut mode and Coagulation mode in accordance with the Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff, Document issued on August 15, 2016.

The duty cycle is 10 seconds ON and 5 seconds OFF. This testing demonstrated that the thermal effect and tissue stickiness on the tip of electrode of the subject and predicate devices are substantially equivalent.

9. Safety and Biocompatibility testing data

Electrical Safety complies with IEC60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) IEC60601-2-2: 2009 (Fifth Ed)

The proposed device is an external device that contacts tissue/bone/dentin for limited contact duration (less than 24 hours). No biologically significant effect was observed in tests conducted in accordance with ISO 10993 for intracutaneous reactivity, in vitro cytotoxicity, skin sensitization, acute systemic toxicity or pyrogenicity.

10. Conclusion

Based on comparing technological characteristic and performance testing data, the subject device, Single Use Arthroscopic Electrodes is substantially equivalent to predicate device (K020579).

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.