(71 days)
Not Found
No
The device description and performance studies focus on basic electrical and mechanical functionality, with no mention of AI or ML.
No
Explanation: The Megadyne Foot Switch is an accessory to control on/off inputs for smoke evacuation systems. It does not directly provide a therapeutic effect.
No
Explanation: The device is described as an accessory to control on/off inputs for smoke evacuation systems. It does not collect, analyze, or interpret data for medical diagnosis.
No
The device is described as a "Foot Switch" and the performance studies include electrical safety, EMC, durability, and mechanical testing, all of which are characteristic of a hardware device. There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control a smoke evacuation system, which is a device used during surgical procedures to remove smoke and debris. This is a therapeutic or procedural function, not a diagnostic one.
- Device Description: The description reinforces its function as an accessory for a smoke evacuation system, controlling its operation.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on electrical safety, EMC, durability, and mechanical testing, which are relevant for a medical device used in a clinical setting, but not specifically for an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Megadyne Foot Switch does not fit this definition.
N/A
Intended Use / 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.
Product codes
FYD
Device Description
The Megadyne Foot Switch is used with a compatible smoke evaluation system to control on/off inputs for manual operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Electrical safety and electromagnetic compatibility (EMC): tested to comply with IEC 60601-1-2 for electromagnetic compatibility and IEC 60601-1 for electrical safety.
- Durability of Marking Test: 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: meets the IEC 60601-1 Ed. 3.1 standard for Shipping, Storage and ME Test.
Clinical Studies:
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 that | |
| is intended to interface with compatible smoke | |
| evacuation systems to control on/off inputs for | |
| manual operation. | The Linemaster wireless foot switch will be an |
| accessory to and provide foot switch input | |
| control to any medical device that uses a | |
| switch 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 for
surgical operating room) | Any class II medical device
that uses a foot switch |
| Electrical Safety
/ Mechanical Safety | Tested and compliant with IEC
60601-1 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
5
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.