This document describes a 510(k) premarket notification for a medical device called the "Megadyne Foot Switch." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comprehensive clinical study as one might see for an AI/ML device.

Therefore, many of the typical acceptance criteria and study elements you've asked for (e.g., sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific submission. This is a hardware device (a foot switch), not an AI/ML diagnostic or therapeutic device.

Here's how to interpret the provided document in the context of your questions:

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

For a hardware device seeking 510(k) clearance, the "acceptance criteria" are typically demonstrating compliance with relevant industry standards and showing that the new device is as safe and effective as a predicate device. Performance is shown through non-clinical testing.

Acceptance Criteria (Demonstrated Equivalence and Safety/Performance)	Reported Device Performance (Summary of Non-Clinical Testing)
Substantial Equivalence to Predicate Device: Functionally similar (on/off inputs for compatible smoke evacuation systems).	The Megadyne Foot Switch controls the same on/off inputs as the predicate. The key difference is wired vs. wireless connection.
Electrical Safety: Compliance with relevant medical device safety standards.	Tested and compliant with IEC 60601-1 (electrical safety).
Electromagnetic Compatibility (EMC): Compliance with relevant medical device EMC standards.	Tested and compliant with IEC 60601-1-2 (electromagnetic compatibility).
Durability/Ingress Protection: Ability to withstand environmental factors and maintain labeling integrity.	Meets IPX8 rating per IEC 60529 Ed. 2.2. Legibility of Label and Durability of marking per IEC 60601-1 Ed. 3.1.
Mechanical Safety/Durability: Withstanding shipping, storage, and operational demands.	Meets IEC 60601-1 Ed. 3.1 standard for Shipping, Storage and ME Test.
Biocompatibility: Safe for patient contact (or non-contact, as applicable).	Non-patient contact (same as predicate).
Radiation Safety: Non-radioactive.	Non-radioactive (same as predicate).

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

Sample Size: Not applicable in the context of a "test set" for a clinical study. The device itself (Megadyne Foot Switch) was tested. The "sample size" would refer to the number of units tested during the engineering validation and verification processes (e.g., how many foot switches were subjected to durability testing), but this detail isn't provided in the summary.
Data Provenance: Not applicable. This involves non-clinical engineering and laboratory testing, not human patient data.

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

Not applicable. There's no "ground truth" established by experts in the sense of clinical annotations (e.g., for images or patient outcomes). Ground truth for a foot switch relates to its functional performance (e.g., does it turn on/off when pressed, does it resist water intrusion as specified). This is verified through engineering tests against predefined specifications.

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

Not applicable. This is a method used for reconciling discrepant expert opinions in clinical studies; it is not relevant for hardware performance testing.

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. An MRMC study is relevant for evaluating the impact of a diagnostic tool (often AI) on human reader performance. This is a simple hardware accessory (a foot switch for a smoke evacuation system).

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

Not applicable. This is a hardware device; there is no algorithm or AI component to evaluate in a standalone manner. Its "standalone performance" would be its ability to pass the electrical, mechanical, and durability tests, which was summarized as "compliant with" relevant standards.

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

The "ground truth" for this device's performance is objective engineering and electrical/mechanical standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60529). The device's performance is measured directly against these quantifiable standards (e.g., Does it meet the IPX8 rating? Does it pass defined electrical safety tests?).

8. The sample size for the training set

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

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

Not applicable. No training set for an AI/ML model was used.

Summary

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July 26, 2019

Megadyne Medical Products, Inc. % Ryoji Sakai Associate Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K191328

Trade/Device Name: Megadyne Foot Switch Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: May 15, 2019 Received: May 16, 2019

Dear Ryoji Sakai:

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

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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) 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 (QS) 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 medical devices and radiation-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,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K191328 Device Name Megadyne Foot Switch

Indications for Use (Describe)

The Megadyne Foot Switch is an accessory that is interface with compatible smoke evacuation systems to control on/off inputs for manual operation.

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

Company Megadyne Medical Products, Inc. 11506 South State St. Draper, UT 84020

Contact Ryoji Sakai Associate Director, Regulatory Affairs Ethicon Endo-Surgery, Inc. Telephone: (513) 337-8586 Email:rsakai3@its.jnj.com

Date Prepared

July 17, 2019

Device Name

Trade Name: Megadyne Foot Switch Common Name: Foot Switch

Classification Name

Air-handling apparatus for surgical operating room (21 CFR 878.5070, Product Code FYD)

Regulatory Class

Class II

Predicate Devices

IR Wireless Foot Switch cleared under K053510 on March 20, 2006

Device Description

The Megadyne Foot Switch is used with a compatible smoke evaluation system to control on/off inputs for manual operation.

Indications for Use

The Megadyne Foot Switch is an accessory that is intended to interface with compatible smoke evacuation systems to control on/off inputs for manual operation.

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Comparison with The Predicate Device

Indications for Use
Megadyne Foot Switch(Subject device)	IR Wireless Foot Switch(Predicate device)
The Megadyne Foot Switch is an accessory thatis intended to interface with compatible smokeevacuation systems to control on/off inputs formanual operation.	The Linemaster wireless foot switch will be anaccessory to and provide foot switch inputcontrol to any medical device that uses aswitch closure (on/off), to activate said device.
Contraindications
None	None

Device Comparison Table - Technology, and Performance Specifications

Characteristic/Specification	Megadyne Foot Switch(Subject device)	IR Wireless Foot Switch(Predicate device)
Sterility Method	Non-Sterile	Same
Connection method	Wired connection	Wireless connection
Compatible generator	Smoke evacuation system(Classification Name:Air-handling apparatus forsurgical operating room)	Any class II medical devicethat uses a foot switch
Electrical Safety/ Mechanical Safety	Tested and compliant with IEC60601-1 and IEC 60601-1-2	Same
Biocompatibility Safety	Non-patient contact	Same
Radiation Safety	Non-radioactive	Same

The subject Megadyne Foot Switch and predicate IR Wireless Foot Switch control the same on/off inputs, however the Megadyne Foot Switch does not have the wireless capability. Electromagnetic Compatibility and Electrical Safety testing were performed to ensure that the different technological characteristics do not raise different questions of safety and effectiveness.

Summary of Non-Clinical Testing

Electrical safety and electromagnetic compatibility (EMC )

Electrical safety and EMC testing were conducted on the Megadyne Foot Switch to comply with IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-1 for electrical safety.

Durability of Marking Test

This footswitch meets the requirements for an IPX8 rating per IEC 60529 Ed. 2.2 and Legibility of the Label and Durability of the marking per IEC 60601-1 Ed. 3.1.

Mechanical Test Report

The footswitch meets the IEC 60601-1 Ed. 3.1 standard for Shipping, Storage and ME Test.

Clinical Studies

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Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the Megadyne Foot Switch is as safe, as effective, and performs as well as or better than the legally marketed device.

Regulation Number and Section

§ 878.5070 Air-handling apparatus for a surgical operating room.

(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.