Cutting: Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeeurotic Repair, Levator Resection, Arthroscopic Procedures.
Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
Hemostasis: Control of Bleeding, Epilation, Telangiectasia

Device Description

Surgitron Radiolase is a high frequency, medium power output electrosurgical device. The design is unique, simple, energy efficiency, safe, and user friendly. Furthermore, it equips the essential operational modes that are most often used in electrosurgical application. The unit has a maximum 50 watt output power and provides the capability of precision cutting, coagulating, and hemostasis in four megacycle frequency electrical current. It is designed to comply with international safety standards.

AI/ML Overview

This document describes the Surgitron Radiolase, an electrosurgical device, and its substantial equivalence to predicate devices, not acceptance criteria for a study proving device performance in the context of AI/medical imaging or diagnostics.

Therefore, many of the requested elements (like "device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," "training set size," and "ground truth for training set") are not applicable to this 510(k) summary. This document is focused on demonstrating that the new device is as safe and effective as previously cleared devices.

Here's a breakdown of what can be extracted or inferred from the provided text, aligning with the intent of the request as much as possible given the nature of the document:

Acceptance Criteria and Study for Surgitron Radiolase

The "acceptance criteria" in the context of this 510(k) summary are primarily based on demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety standards. There isn't a "study" reported in the traditional sense of a clinical trial proving a specific performance metric against a numerical acceptance criterion. Instead, the "study" is the comparison made by Ellman International to show that the Surgitron Radiolase is similar enough to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on Predicate Devices)	Reported Device Performance (Surgitron Radiolase)
Intended Use: Identical to predicate devices (Cutting, Blended Cutting & Coagulation, Hemostasis).	Intended Use: "Same As New Device" (explicitly stated for predicate), confirming the new device meets the same broad range of electrosurgical applications.
Design Specification: Compliance with IEC 601-1 and 601-2-2, and CE aspects of Council Directive 93/42/EEC.	Design Specification: Complies with IEC 601-1 and 601-2-2, and CE aspects of Council Directive 93/42/EEC.
Output Energy: While the predicates have higher output (100W and 200W), the new device's 50W output is noted, implying it's acceptable for its intended use without being a safety concern. This is a difference but considered allowable given its overall equivalence.	Output Energy: 50 Watts (lower than predicates, but implies suitable for indicated uses).
Output Waveform(s): Similar waveform types to the IEC predicate (e.g., Sine-shaped, Fully Rectified, Partially Rectified). Frequencies differ but the type of waveform is comparable.	Output Waveform(s): 4.0MHz Sine-shaped, Fully Rectified, Partially Rectified.
Monopolar/Bipolar: Can operate in Monopolar mode (the new device is Monopolar only, which is a subset of the predicate capabilities).	Monopolar/Bipolar: Monopolar.
Standards Met: Compliance with IEC 601-1, 601-2-2, BSI5724:Section 2.2, and UL2601.	Standards Met: IEC 601-1, 601-2-2, BSI5724:Section 2.2, and UL2601.
Biocompatibility Tests: Monopolar electrodes identical to predicate device.	Biocompatibility Tests: Monopolar Electrodes identical to predicate device.
Sterilization Method(s): Identical to predicate device.	Sterilization Method(s): "Refer to Note II" (although Note II is not provided, the table indicates it's "Same As New Device" as the predicate).

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

Sample Size: Not applicable. This is not a clinical study involving a test set of patients or data. The evidence for "performance" is based on technical comparison to predicate devices, compliance with standards, and the known safety/efficacy of the underlying technology (radiofrequency electrosurgery).
Data Provenance: Not applicable. The data provided is a technical comparison of device specifications.

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

Not applicable. There is no "ground truth" established by experts in this context. The determination of substantial equivalence is made by the FDA based on the manufacturer's submission and comparison to predicate devices. The manufacturer's team (e.g., Frank Lin, Ph.D. Director of R&D Engineering) performs the comparative analysis.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process as typically understood in a clinical study. The FDA reviews the submitted technical data and makes a determination of substantial equivalence.

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. This device is an electrosurgical unit, not an AI-powered diagnostic or imaging tool.

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

Not applicable. This device is an electrosurgical unit, not an algorithm. The document explicitly states: "There is no software component in this new device."

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

Not applicable in the traditional sense of a clinical study. The "ground truth" for demonstrating substantial equivalence relies on:
- Pre-amendment device history / Established Clinical Practice: The safety and effectiveness of the technology (radiofrequency electrosurgery) and its indications for use are well-established through years of medical practice and prior FDA clearances. The predicate device "Surgitron IEC" is referenced as a pre-amendment device.
- Regulatory Standards: Compliance with recognized international safety and performance standards (IEC, UL, BSI).
- Technical Specifications: Direct comparison of physical and electrical characteristics with legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no training set for an algorithm.

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

Not applicable. There is no training set for an algorithm.

Summary

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OCT 1 4 1999

Surgitron Radiolase 510(k) Summary

992382

1. Submitter Name and Address:

Frank Lin, Ph.D. Director of R&D Engineering Ellman International 1135 Railroad Ave. Hewlett, NY 11557

2. Device Name and Classification

2.1 Device Name: Surgitron Radiolase 2.2 Classification: Class 2 Device, 21 CFR 878.4400

3. Description of The Device

@liman Surgitron Radiolase is a high frequency, medium power output electrosurgical device. The design is unique, simple, energy efficiency, safe, and user friendly. Furthermore, it equips the essential operational modes that are most often used in electrosurgical application. The unit has a maximum 50 watt output power and provides the capability of precision cutting, coagulating, and hemostasis in four megacycle frequency electrical current. It is designed to comply with international safety standards.

4. The intended use/indication for use of the device

4.1. Cutting
Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.

4.2. Blended Cutting and Coagulation

Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

4.3. Hemostasis

Control of Bleeding, Epilation, Telangiectasia

5. Identification to predicate devices

5.1. Surgitron IEC with general use indication K980177
5.2. ERBOTOM ICC 200 with indication K933157

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1. Summary of the technological characteristics of the new device in comparison to the predicate devices

In Technological Characteristics Comparison
FEATURE	SURGITRONRADIOLASE(NEW)*	SURGITRON IECWITH GENERALUSE INDICATIONK980177PREDICATE	ERBOTOMICC 200WITHINDICATIONK933157PREDICATE
Indications For Use	Refer to Note 1	Same As New Device	Same As New Device
Design Specification	IEC 601-1 and 601-2-2The CE Aspects ofCouncil Directive93/42/EEC TheMedical DeviceDirective	IEC 601-1 and 601-2-2The CE Aspects ofCouncil Directive93/42/EEC TheMedical DeviceDirective	UL544
Output Energy	50 Watts	100 Watts	200 Watts
Output Waveform (s)	4.0MHz Sine-shaped,Fully Rectified,Partially Rectified.	1.7MHz, Sine-shapedFully Rectified,Partially Rectified,Fulgurating-Spark-Gap	350kHz Sine-shaped1MHzPulse-modulated
Monopolar/Bipolar	Monopolar	Monopolar and Bipolar	Monopolar and Bipolar
Standards Met	IEC 601-1, 601-2-2,BSI5724:Section 2.2,and UL2601	IEC 601-1, 601-2-2,BSI5724:Section 2.2,and UL2601	IEC 601-1
Biocompatibility Tests	Monopolar Electrodesidentical to predicatedevice	Same As New Device	Same As New Device
Sterilization Method(s)	Refer to Note II	Same As New Device	Not Indicated

Substantial Equivalence In Technological Characteristics Comparison

There is no software component in this new device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 1999

Mr. Frank Lin Director of Engineering Research and Development Ellman International, Inc. 1135 Railroad Avenue Hewlett, New York 11557

K992382 Re:

Trade Name: Surgitron Radiolase Regulatory Class: II Product Code: GEI Dated: July 14, 1999 Received: July 16, 1999

Dear Mr. Lin:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Frank Lin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510K Notification Surgitron Radiolase - General Use page 5

ellman international

510(k) Number (if known): k992 382

Device Name: SURGITRON RADIOLASE

Indication For Use: is idendical to the Surgitron as a preammendment device such as:

- Cutting
  Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures.
- Blended Cutting and Coagulation
  Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
- Hemostasis Control of Bleeding, Epilation, Telangiectasia
  (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K992382

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
------------------------------------------	------------------------------------------	----	----------------------

(Optional Format 1-2-96)

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.