Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.

Device Description

Dr. OPPEL ST-501 is a electrosurgical unit using high frequency current to cut and/or coagulate tissue. It consists of Electrosurgical Unit generator, Handpiece, Electrodes, a cable for disposable patient plate and foot switch. It is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of power level and time. All selection is effected through push buttons and lamps that give the operator feedback of status. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. Monopolar electrodes have needle, ball, loop and blade types. Electrodes are supplied non-sterile and reusable.

AI/ML Overview

The provided text is a 510(k) summary for the Dr. OPPEL ST-501 electrosurgical unit. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about acceptance criteria, study design, and ground truth establishment is not typically present in a 510(k) summary for this type of device.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit acceptance criteria or reported device performance metrics are provided in the 510(k) summary in the way you've described for an AI/diagnostic device. The submission demonstrates substantial equivalence primarily by comparing the technological characteristics and indications for use of the Dr. OPPEL ST-501 with its predicate devices.

Feature	Dr. OPPEL ST-501 Reported Performance / Characteristic
Indications for use	Intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator. (Substantially equivalent to predicate devices' indications for use.)
Design specification	IEC601-2-2, ANSI/AAMI HF-18
Output energy	100 Watt at 200Ω
Output waveform	4.0 MHz Partially rectified
Delivery system	Monopolar and Bipolar
Tip configuration	Needle, Blade, Ball, Loop, Bipolar Forceps
Sterilization method	Non-sterile
Standard	IEC601-1, IEC601-1-2, IEC601-2-2, ANSI/AAMI HF18

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

This information is not provided in the 510(k) summary. For electrosurgical units, performance is typically demonstrated through engineering testing, compliance with recognized standards, and potentially bench testing, rather than human subject clinical studies with "test sets" in the context of diagnostic algorithms.

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):

This information is not applicable/not provided. The concept of "ground truth established by experts" is relevant for diagnostic or AI-driven devices where human assessment is the gold standard for comparison. For an electrosurgical unit, the "ground truth" relates to its physical performance characteristics (e.g., power output, frequency), safety (e.g., electrical safety), and effectiveness in performing cutting and coagulation as designed, which is evaluated through engineering and bench testing, not expert consensus on a test set.

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

This information is not applicable/not provided. Adjudication methods are used in studies involving human interpretation or uncertain outcomes, which is not the primary focus of an electrosurgical unit's 510(k) submission.

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:

This information is not applicable/not provided. MRMC studies are relevant for diagnostic devices that involve human readers interacting with AI. This device is an electrosurgical unit that does not involve "human readers" or "AI assistance" in the sense of image interpretation or diagnostic aid.

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

This information is not applicable/not provided. This device is a physical electrosurgical unit, not a standalone algorithm.

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

The "ground truth" for an electrosurgical unit's submission to demonstrate substantial equivalence typically involves:

Engineering specifications and measurements: Verifying that the device meets its stated technical specifications (e.g., output power, frequency, waveform).
Compliance with recognized standards: Adherence to standards like IEC601-2-2, ANSI/AAMI HF-18 for safety and performance.
Bench testing: Demonstrating the ability to cut and coagulate tissue effectively and safely in a controlled environment.
Comparison to predicate devices: Showing that its technological characteristics and intended use are similar to legally marketed devices.

The submission implies that these types of data were used to support the substantial equivalence claim.

8. The sample size for the training set:

This information is not applicable/not provided. "Training set" is a concept used for machine learning models. This device does not use a training set.

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

This information is not applicable/not provided. As above, there is no training set for this type of device.

In summary: The provided 510(k) summary for the Dr. OPPEL ST-501 is for an electrosurgical unit, a physical medical device. The information requested (acceptance criteria, test sets, experts, MRMC, training sets, etc.) is primarily relevant for software-as-a-medical-device (SaMD) or AI/diagnostic products. For this electrosurgical unit, the demonstration of safety and effectiveness relies on adherence to design specifications, recognized standards, and comparison of technological characteristics to predicate devices.

Summary

{0}------------------------------------------------

510(k) Summary

051956

0009

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: JUNE 7, 2005

l. Submitter:

	Company
Name	SOMETECH INCORPORATED
Address	Byucksan Digital Valley III 212-13Guro-dong Guro-guSeoul, 152-050 Korea
Phone	+82 2 547-3422
Contact	Young-Soo Seol

2. Device:

Proprietary Name - Dr. OPPEL ST-501 Common Name - Electrosurgical unit and accessories

Classification Name - Electrosurgical cutting and coagulation device and Accessories

3. Predicate Device:

Aaron 900 High Frequency Desiccator/Handpiece, Aaron Medical Industries, K000961 Aaron Reusable Electrosurgical Electrode, Aaron Medical Industries, K014201 Surgitron 120 IEC, Ellman International, Inc., K013255

4. Classifications & Citations:

21CFR 878.4400, GEI Class 2 510(k) Guidance Document for General Surgical Electrosurgical Devices

5. Description:

Dr. OPPEL ST-501 is a electrosurgical unit using high frequency current to cut and/or coagulate tissue. It consists of Electrosurgical Unit generator, Handpiece, Electrodes, a cable for disposable patient plate and foot switch. It is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is action is achieved by front panel selection of power level and time. All selection is effected through push buttons and lamps that give the operator feedback of status. The final output power control is made through foot and/or hand switches.

Both Monopolar and Bipolar electrodes are provided. Monopolar electrodes have needle, ball, loop and blade types. Electrodes are supplied non-sterile and reusable.

1. Indication for use:
  Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.

. ﻳ

SOMETECH INCORPORATED

好:

{1}------------------------------------------------

510(k) Submission -- Dr. OPPEL ST-501

7. Technological characteristics

Feature	Dr. OPPEL ST-501	Aaron 900 High Frequency Desiccator/ Handpiece	Aaron Reusable Electrosurgical Electrode	Surgitron 120 IEC
Indicationsfor use	Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.	The Aaron 900 High Frequency Desiccator and Handpiece are intended for the removal and destruction of skin legions and the coagulation of tissue.	Aaron Reusable Electrosurgical Electrodes are non-sterile, the reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.	1. Cutting - Snoring, Submucosal palatal shrinkage, etc.2. Blended Cutting and Coagulation - Snoring, Submucosal palatal shrinkage, etc.3. Hemostasis - Control of Bleeding, Epilation, etc.4. Fulguration - Basa Cell Carcinoma, Papilloma, etc.5. Bipolar - Pinpoint, Precise Coagulation, etc.
Designspecification	IEC601-2-2ANSI/AAMI HF-18	IEC601-2-2UL2601-1	N/A	IEC601-2-2UL544
Outputenergy	100 Watt at 200Ω	30 Watt	N/A	120 Watt
Outputwaveform	4.0 MHz Partially rectified	550 kHz Partially rectified	N/A	4.0 MHz Continuous, Fully rectified, Partially rectified, 1.7MHz fulguration
Deliverysystem	Monopolar and Bipolar	Monopolar and Bipolar	N/A	Monopolar and Bipolar
Tipconfiguration	NeedleBladeBallLoopBipolar Forceps	N/A	NeedleBladeBallLoopBipolar Forceps	NeedleBladeBallLoopBipolar Forceps
Sterilizationmethod	Non-sterile	N/A	Non-sterile	Non-sterile
Standard	IEC601-1IEC601-1-2IEC601-2-2ANSI/AAMI HF18	UL2601-1EN60601-1-2IEC601-2-2	N/A	UL2601IEC601-1IEC601-2-2

SOMETECH INCORPORATED ":

い

{2}------------------------------------------------

051956

1. Similarities to, and differences from, the above predicate devices:
  、 :

4 :

Dr. OPPEL ST-501 is similar to the above predicate devices based on the intended use, Dr. OPPEL ST-501 1s Sinitial to the "alord" processor "processor of the mance characteristics.
technology used, the claims, the material composition employed and personal wou technology used, the claims, the material composition employ and output waveform.

9. Conclusions :

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's In accordance with the Techar 1000, Brug and Sectrosurgical Devices" and based on the "STU(K) Guldance Document for General Surgical Slouveaught - Previous Chat Dr.
information provided in this premarket notification Sometech Incorporated concludes desiress as information provided in this premarket notheation weeks. Interprises of the predicate devices as described herein.

END

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing and a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA". The eagle is positioned in the center of the circle, with its head facing to the right.

SEP - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sometech Incorporation c/o Mr. Marc M. Mouser Office Coordinator Underwriters Laboratories, Inc. Laboratory and Testing 2600 N.W. Lake Road Camas, Washington 98607-8542

Re: K051956

Trade/Device Name: Dr. OPPEL ST-501 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 22, 2005 Received: August 25, 2005

Dear Mr. Mouser:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

{4}------------------------------------------------

Page 2- Mr. Marc M. Mouser

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Neil R. Ogden

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number K _051956

Dr. OPPEL ST-501 Device Name: :::

Indication for use: Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.

Prescription Use AND/OR (Part 21CFR801 Subpart D)

Over-The-Counter Use (21CFR801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

NilRedglen
(Division Sign-Off) Sw.m.416

Division of General, Restorative. and Neurological Devices

510(k) Number K051956

.. •

. ﻳﺘﻢ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Indication for use Page # 1 of 1

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.