The Surgitron 4.0 Dual RF S5 - IEC is intended to deliver electrosurgical output to perform cutting, coagulation, and hemostasis of soft tissues and to heat tissue in the non-ablative treatment of mild to moderate facial wrinkles and rhytids. The device is used with compatible Ellman International electrodes and handpieces which are used for these various applications in physician offices and surgical centers.

The Surgitron 4.0 Dual RF S5 - IEC indications are the same as those cleared in K082835:

Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin . . phototypes I-IV
. Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
. Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
. Hemostasis: control of bleeding, epilation, telangiectasia.
Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, . hemostasis.
. Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Device Description

The Surgitron 4.0 Dual RF S5 - IEC is a radiofrequency energy generator employed for a variety of electrosurgical procedures. The action is achieved by selection of the desired waveform and power level on the front panel. Selections are activated by push buttons and indicated on the digital display giving the operator feedback on device setting status. Device output is controlled via foot and/or hand switch. Monopolar and bipolar electrodes may be used with the device. The generator includes the following accessories:

IEC Power Cord ●
Dual Footswitch & Cable .
IEC Foot controlled Handpiece ●
. Bipolar Cable
. Monopolar cables
Disposable Neutral Plate .
Multi-Button Finger switch Handpiece .

AI/ML Overview

Acceptance Criteria and Study Details for Surgitron 4.0 Dual RF S5 - IEC

The provided submission, K123366, for the Surgitron 4.0 Dual RF S5 - IEC, focuses on demonstrating substantial equivalence to a predicate device (Surgitron 4.0 Dual RF – IEC) through compliance with recognized electrical safety and performance standards. It does not involve a study of clinical performance or diagnostic accuracy as would be typical for AI-powered devices. Therefore, many of the requested categories are not applicable to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Required Standard)	Reported Device Performance
IEC 60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)	The Surgitron 4.0 Dual RF S5 - IEC functioned as intended and in conformance with all applicable standards.
IEC 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)	The Surgitron 4.0 Dual RF S5 - IEC functioned as intended and in conformance with all applicable standards.

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

This device clearance did not involve a "test set" in the context of clinical data or algorithm performance. The testing was physical and electrical conformance testing of the electrosurgical unit itself.

Sample Size: Not applicable (referring to patient data or images). The "sample" would be the manufactured device(s) subjected to the tests.
Data Provenance: Not applicable. The testing pertains to the device's adherence to international safety and performance standards.

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

Not applicable. "Ground truth" in this context typically refers to clinical diagnosis or pathology, which is not relevant for an electrosurgical unit's electrical safety and performance testing. The "ground truth" here is the established requirements of the IEC standards themselves.

4. Adjudication Method for the Test Set

Not applicable. This was conformance testing to standards, not a clinical study requiring expert adjudication of patient cases.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of device submission, which focuses on the safety and performance of an electrosurgical generator against established standards, not its comparative effectiveness in a diagnostic or clinical interpretation task involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an electrosurgical generator, not an AI algorithm. Its performance is always predicated on human operation.

7. The Type of Ground Truth Used

The "ground truth" in this submission is the requirements outlined in the IEC 60601-1 and IEC 60601-2-2 standards. The device's performance was measured against these predefined safety and performance specifications.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set.

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

Not applicable. There is no training set for this device.

Summary

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K123366

510(k) SUMMARY

JUL 1 2 2013

Ellman International - Surgitron 4.0 Dual RF S5 - IEC

Submission Correspondent and Owner:

Name:	Ellman International
Address:	3333 Royal AvenueOceanside NY 11572-3625
Phone:	513.658.8960
Facsimile:	516.267.6750
Contact:	Alison Sathe
Email:	asathe@ellman.com
Date Prepared:	October 25, 2012
Trade Name:	Surgitron 4.0 Dual RF S5 - IEC
Common Name:	Electrosurgical, cutting & coagulation & accessories
Classification:	Class II, 21 CFR 878.4400, Product Code GEI
Predicate Devices:	Ellman International - Surgitron 120 IEC (Surgitron 4.0 Dual RF)(K013255, K082834)

Device Description:

IEC Power Cord ●
Dual Footswitch & Cable .
IEC Foot controlled Handpiece ●
. Bipolar Cable
. Monopolar cables
Disposable Neutral Plate .
Multi-Button Finger switch Handpiece .

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Indications for Use:

The Surgitron 4.0 Dual RF S5 - IEC indications are the same as those cleared in K082835:

Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin . . phototypes I-IV
. Cutting: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin incisions, biopsy, cysts, abscesses, tumors, cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
. Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma, nevi, fistulas, epithelidma, cosmetic repairs, cysts, abscesses, and development of skin flaps.
. Hemostasis: control of bleeding, epilation, telangiectasia.
Fulguration: basal cell carcinoma, papilloma, cyst destruction, tumors, verrucae, . hemostasis.
. Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Technological Characteristics:

The Surgitron 4.0 Dual RF S5 - IEC system consists of: RF generator, footswitch and cable, handpieces, neutral plate and cables (bipolar and power cord). The device operates at approximately 4 MHz and is used with various electrodes and handpieces to deliver RF energy to tissue. The Surgitron 4.0 Dual RF S5 - IEC has five modes of energy delivery which operate over a range of power outputs: cut, cut/coag (Blend), hemo (Coag), fulgurate, and bipolar.

Performance Data

The Surgitron 4.0 Dual RF S5-IEC has been tested to IEC 60601-1 and 60601-2-2 standards. In all instances, the Surgitron 4.0 Dual RF S5 - IEC functioned as intended and in conformance with all applicable standards.

Substantial Equivalence

There are no unique applications, intended uses, materials or specifications presented herein. The Surgitron 4.0 Dual RF S5-1EC is as safe and effective as the Surgitron 4.0 Dual RF - IEC

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predicate device. The Surgitron 4.0 Dual RF S5 – IEC has the same intended uses, indications and principles of operation and similar technological characteristics as the predicate. The minor technological upgrades to the Surgitron 4.0 Dual RF S5 – IEC raise no new issues of safety or effectiveness. Thus, the Surgitron 4.0 Dual RF S5 – IEC is substantially equivalent to the predicate.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.

DEPARTMENT OF HEALTH & HUM AN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

July 12, 2013

Ellman International, Inc. % Ms. Alison Sathe Director of Regulatory and Clinical Affairs 3333 Royal Avenue Oceanside, New York 11572-3625

Re: K123366

Trade/Device Name: Surgitron 4.0 Dual RF S5 - IEC Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagniation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 12, 2013 Received: June 13, 2013

Dear Ms. Sathe:

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

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Page 2 - Ms. Alison Sathe

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/deliault.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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K123366

Indications for Use: The Surgitron 4.0 Dual RF S5 - IEC is indicated for:

Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin . phototypes I-IV
. Cutting: snoring. submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control. epistaxis treatment. turbinate shrinkage. skin incisions, biopsy, cysts, abscesses, tumors. cosmetic repairs, development of skin flaps, skin tags and blepharoplasty.
Blended Cutting and Coagulation: snoring, submucosal palatal shrinkage, traditional . uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, turbinate shrinkage, skin tags, papilloma keloids, keratosis, verrucae, basal cell carcinoma. nevi. fistulas, epithelidma, cosmetic repairs. cysts, abscesses, and development of skin flaps.
Hemostasis: control of blecding, epilation, telangiectasia. .
Fulguration: basal cell carcinoma. papilloma. cvst destruction, tumors. verrucae, . hemostasis.
Bipolar: pinpoint precise coagulation, pinpoint hemostasis in any field (wet or dry), . snoring, submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment and turbinate shrinkage.

Prescription Use x (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)

DSD-DIVISION SIGN-OFF	Joshua C.
Division of Surgical Devices	Nipper -S
510(k) Number:	K123366

Page 11 of 262

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.