The iSurg(MC6B) is an isolated output monopolar electrosurgical generator configured as a table top standalone device, Height 3.5in (89mm), Width 10.5in (267mm), Depth 6.5in (165mm), Weight 6lb (2,73kg) It produces 50 watts into 500 ohms at 3.0 MHz.

The iSurg(MC6B) generates RF current via an AM modulated power oscillator comprised of a class C beam power vacuum tube Hartley oscillator. The power oscillator runs at full power when actuated. Power control is by means of an attenuator in the form of variable air capacitor.

MOPP (Means of Patient Protection) is in the form of magnetic coupling to an isolated winding on a separate core in the RF coil providing type BF floating patient applied parts in accordance with IEC 60601-2-2. The RF coil primary serves as an intermediate stage with PE connection. MOOP is provided by the low voltage control board (61.010) which galvanically isolates the foot pedal from mains and earth and couples to the oscillator through opto-coupler and relay. SELV common on this board floats. The 81.001A Switch Board uses high isolation relays powered by the low voltage board to isolate the relay coils from the oscillator board. Oscillator actuation is by means of earthing the cathode of the beam power tube via a relay; oscillator OFF state is when the cathode of the beam power tube floats. Tube bias is by means of grid leak via the 10K grid load. The 10K grid load resistor is wire wound type with significant inductance: the current to ground through it is close to DC accordingly. It is current through this resistor that is sensed for the RF ON indicator and active tone (a function of the low voltage control board). The low voltage board also includes a warm up delay to prevent cathode stripping of the vacuum tube.

AI/ML Overview

The provided text does not describe acceptance criteria for a device, nor a study proving the device meets said criteria.

Instead, the document is an FDA 510(k) Premarket Notification for an electrosurgical cutting and coagulation device called iSurg (MC6B). The purpose of this notification is to demonstrate "substantial equivalence" to a predicate device already on the market, not to prove the device meets specific performance acceptance criteria through clinical or standalone studies as requested in the prompt.

Here's a breakdown of why the requested information cannot be extracted from this document:

Acceptance Criteria & Reported Performance: The document does not specify quantitative performance acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or report such performance against established criteria. It focuses on comparing the technological characteristics of the iSurg (MC6B) to predicate devices.
Study That Proves the Device Meets Acceptance Criteria: No such study is described. The document explicitly states: "No clinical testing was performed in association with this submission." It also dedicates a section to "Non-Clinical Testing" which details a "Histology Study," but this appears to be for characterization of the device's effects rather than proving it meets specific performance acceptance criteria for regulatory approval.

However, I can provide information based on the Histology Study presented, although it does not align with the definition of a study proving devices meet acceptance criteria:

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

As stated above, no specific acceptance criteria for performance metrics (like diagnostic accuracy, sensitivity, or specificity) are defined or reported against. The "Histology Study" describes observations of the device's effect on tissue.

Observations from Histology Study (Not Acceptance Criteria):

Feature/Condition	Reported Observation (Worst-Case)
Incision Electrode - Cut Mode (Group 1)
Maximal Power	0.421 mm (width), 0.125 mm (depth) of cautery effect
Nominal Power	0.210 mm (depth) of cautery effect (slightly greater than maximal power depth)
Minimal Power	No cautery effect appreciable
Incision Electrode - Blend Mode (Group 2)
Nominal Power	0.473 mm (width), 0.190 mm (depth) of cautery effect
Maximal Power	0.369 mm (depth), 0.148 mm (width) of cautery effect
Minimal Power	No cautery effect appreciable
Excision Electrode - Cut Mode (Group 3)
Maximal Power	6.239 mm (width), 1.612 mm (depth) of cautery effect
Minimal Power	No cautery effect appreciable
Excision Electrode - Cut Mode (Group 4)
Maximal Power	6.039 mm (width), 0.917 mm (depth) of cautery effect
Minimal Power	No cautery effect appreciable
Ball Electrode - Hard Coagulation Mode (Group 5)
Nominal Power	2.256 mm (width), 1.209 mm (depth) of cautery effect
Minimal Power	No cautery effect appreciable

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 (Histology Study): Not explicitly stated as a total number of samples. It mentions "Three different electrodes were used," and "Five different electrocautery test article effects... were each evaluated at minimal, nominal, and maximal power in triplicate." This implies $3 \text{ electrodes} \times 5 \text{ combinations} \times 3 \text{ power levels (min, nom, max)} \times 3 \text{ triplicates} = N$ samples if each combination was tested with each electrode, or more likely $5 \text{ test effects} \times 3 \text{ power levels} \times 3 \text{ triplicates} = 45$ distinct evaluations (some test effects might combine electrode and waveform). The description is somewhat ambiguous regarding the exact number of tissue samples.
Data Provenance: "ex-vivo pig skin." The country of origin is not specified.
Retrospective or Prospective: Prospective (experimental setup).

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. This was a histological evaluation of tissue effect, not a diagnostic study with "ground truth" derived from expert consensus. The "ground truth" here is the physical tissue effect observed via histology. The evaluation would typically be performed by a pathologist or histologist, but their number and qualifications are not provided.

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

Not applicable. This was an experimental study on tissue, not a diagnostic study requiring adjudication of expert readings.

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 MRMC comparative effectiveness study was done. The device is an electrosurgical generator, not an AI-assisted diagnostic tool.

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

This refers to an electrosurgical device, not a diagnostic algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. The device's performance is its physical effect on tissue.

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

The "ground truth" for the histology study was the observed pathological/histological effect on the ex-vivo porcine skin samples. This involved assessing the "length and depth of electrocautery effect."

8. The sample size for the training set

Not applicable. This document describes a new medical device, not an AI/machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 2, 2017

JACO , LLC dba Macan Manufacturing and BNA Burz North America % Bill Mclain President and Principal Consultant Keystone Regulatory Services, LLC 342 East Main Street, Suite 207 Leola, Pennsylvania 17540

Re: K170054

Trade/Device Name: iSurg (MC6B) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: January 5, 2017 Received: January 6, 2017

Dear Bill McLain:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
Indications for Use
510(k) Number (if known)K170054
Device NameESU (Electrosurgical Unit) Generator Model MC6B/iSurg

Indications for Use (Describe)

Cutting and coagulation of skin.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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Office of Chief Information Officer

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740 EF

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Section 5

510(k) Summary - K170054

5.1 Submission Correspondent and Owner

Sponsors (Co-Owners)

JACO, LLC dba Macan Manufacturing 21 Shay Lane Milton, DE 19968 Contact: John Marsillo Phone: 302-645-8068 Email: johnmarsillo@optonline.net

BNA Burz North America, Inc. 906 Wateredge Pl Hewlett, NY 11557 Contact: Jon Garito Phone: 1-800-971-2261 Email: jgarito@bnaburz.com

Submission Correspondent

Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: William McLain Phone: 717-656-9656 E-Mail: bill.mclain@keystoneregulatory.com

5.2 Date Summary Prepared

September 27, 2017

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Device Trade Name 5.3

iSurg(MC6B)

Device Common Name 5.4

Electrosurgical Generator and Electrodes.

5.5 Device Classification Name

Electrosurgical, Cutting and Coagulation and Accessories. Product code GEI. Classified at 21 CFR Part 878.4400.

5.6 Legally Marketed Device To Which The Device Is Substantially Equivalent

The iSurg(MC6B) is substantially equivalent to the Surgi-Max Ultra cleared under K170107and the JACO, LLC dba Macan Manufacturing RadioSurge™ Model MC6A cleared under K050735.

5.7 Description Of The Device

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5.8 Intended Use

The indication for use statement is as follows:

Cutting and coagulation of skin.

5.9 Technological Characteristics

The iSurg(MC6B) has identical characteristics in relation to the predicate Surgi-Max Ultra and reference JACO, LLC dba Macan Manufacturing RadioSurge™ Model MCGA when considered together. The characteristics are identical in relation to:

· Indication for Use,
· Specifications,
· Operating Modes,
· Nominal Power
· Cut, Blend, and Coag Output Energies,
· Output Voltages,
· Source Impedance,
· Operating Frequency,
· Power Control, and
· Operational Duty Cycle.

Summary of Substantial Equivalence 5.10

The following table summarizes the basis for substantial equivalence.

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Features	iSurg(MC6B)(Proposed Device)	Surgi-Max Ultra (K170107) (Predicate)	JACO, MacanRadioSurge TM Model MC6A(K050735) (Predicate)
Indications	Cutting and coagulating skin	Cutting, coagulation, hemostasis, skin surgery (Paraphrased)	Dental applications (Paraphrased)
Prescription or OTC Use	Prescription	Prescription	Prescription
FDA Code	GEI Electrosurgical	GEI Electrosurgical	EKZ Dental
Specifications	Monopolar, Type BF	Monopolar and Bi-Polar, Type BF	Monopolar, Type BF
Operating Mode	Cut, Cut/Coag, Coag	Cut, Blend, Hemo, Bipolar, Bipolar Turbo	Cut, Cut/Coag, Coag
Nominal Power	50W Nominal	170W Nominal	50W Nominal
Cut Output Energy	50W Nominal into 500 ohms	Not stated in the 510(k) Summary	50W Nominal into 100 ohms
Blend Output Energy	50W Nominal into 500 ohms	Not stated in the 510(k) Summary	50W Nominal into 100 ohms
Coag Output Energy	25W Nominal into 500 ohms	Not Stated in the 510(k) Summary	25W Nominal into 100 ohms
Output Voltage	520V pk	1200V pk	520V pk
Source Impedance	500 ohms	Not stated in the 510(k) Summary	500 ohms
Operating Frequency	3.0 MHz	4.0 MHz in Monopolar Mode	3.0 MHz
Power Control	Analong, continously variable	Not stated in 510(k) Summary	Analong, continously variable
Operational Duty Cycle	10 seconds ON, 20 seconds OFF	10 seconds ON, 30 seconds OFF	10 seconds ON, 20 seconds OFF

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	Table 5.1: (continued)

Features	Proposed Device	Predicate Device	Reference Device
Software	None	Contains Software	None
Accessories	As cleared in K052622. Hand-piece, Dispersive Pad, Disper-sive Cord, Foot Switch, Elec-trodes(RF1, RF11, RL33, RL34,RC51, RC52)	Unknown	As cleared in K052622. Hand-piece, Dispersive Pad, Disper-sive Cord, Foot Switch, Elec-trodes(RF1, RF11, RL33, RL34,RC51, RC52)

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Non-Clinical Testing 5.11

JACO, LLC dba Macan Manufacturing and BNA Burz North America, Inc. have declared conformity to the following relevant consensus standards:

· AAMI ANSI 60601-1 C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
· IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
· IEC 60601-2-2 Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories [Including: Technical Corrigendum 1 (2014)] 1/27/2015

Histology Study

A histological evaluation of the cutting modes on porcine skin was conducted. The purpose of this study was to assess the length and depth of electrocautery effect (with these two dimensions defining the area of effect) on ex-vivo pig skin using histologic evaluation. Three different electrodes were used representing worst-case scenarios.

Five different electrocautery test article effects (comprising combinations of the specified electrodes with different waveforms designated as Groups 1-5) were each evaluated at minimal, nominal, and maximal power in triplicate. No cautery effect was appreciable within any group at minimal power. However, in all nominal and maximal power samples, distinct regions of cautery effect were evident within the dermis.

The incision electrode employing cut and blend waveforms had V shaped incisions that extended into the mid-dermis accompanied by small halos of cautery effect. Nominal and maximal power levels had similarly-sized areas of cautery effect for both waveforms.

The excision electrode employing cut and blend waveforms provided broad, shallow excisions with a curvilinear appearance and slightly raised margins extending into the superficial dermis accompanied by a thin halo of cautery effect. A direct relationship was observed with increased area of cautery effect occurring with increasing power levels.

The ball electrode employing a hard coagulation waveform affected a small focal area (approximately 2x1 mm), had a slightly convex central area on histology, and was accompanied by a small, focal halo of cautery effect within the superficial dermis. The relationship of cautery area to waveform power is somewhat uncertain; although average area of effect was slightly greater for nominal vs. maximal power, the small dimensions of test article effect could have lead to slight underestimation of maximal power effect due to sectioning variation.

At minimal power, no cautery effect was evident for any treatment group. For Group 1, with the incision electrode utilizing cut mode, the largest width of cautery effect was observed with maximal power as 0.421 mm (width); nominal power had slightly greater depth at 0.210 mm but was similar to maximal power (0.125 mm depth). For Group 2, with the incisoin electrode utilizing blend mode the largest area of cautery effect was observed with nominal power and was 0.473mm (width) and 0.190 mm (depth); but was similar to maximal values (0.369 mm for depth) and (0.148mm for width). For Group 3, with the excision electrode utilizing cut mode the largest area of cautery effect was observed with maximal power and was 6.239 mm (width) and 1.612 mm (depth). For Group 4, with the excision electrode utilizing cut mode the largest area of cautery effect was observed with

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maximal power was 6.039 mm (width) and 0.917 mm (depth). For Group 5, with the ball electrode utilizing the hard coagulation mode the largest area of cautery effect was observed with with nominal power and was 2.256 mm (width) and 1.209 mm (depth), although small size of test article effect could have slightly underestimated cautery effect within the maximal cohort for this electrode and waveform combination.

5.12 Biocompatibilty

Biocompatibility testing was not submitted in association with this 510(k). Rather, patient contacting materials associated with electrodes were referenced in relation to the reference device JACO, LLC dba Macan Manufacturing RadioSurge™ Model MC6A cleared under K050735.

5.13 Clinical Testing

No clinical testing was performed in association with this submission.

5.14 Conclusions

The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate device.

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.