The ACE Monopolar Attachment is intended to be used with the compatible ERBE Monopolar Disposable Electrosurgical Pencil (model: No.20190-109) for coagulation and cutting of soft tissue when used in conjunction with compatible ERBE Electrosurgical Generator (ESU) Systems.

Device Description

The ACE Monopolar Attachment is used with compatible ERBE Electrosurgical Generator (ESU) Systems which deliver High Frequency (HF) energy through the electrode tip of the ACE Monopolar Attachment for coagulation and cutting of soft tissue. The ACE Monopolar Attachment is an electrode tip, made of stainless steel, and compatible with marketed plastic insulation handle. The compatible ERBE Electrosurgical Unit (ESU) to be used must have a Monopolar 3-pin bovie receptacle. The Monopolar Attachment is provided single-use.

AI/ML Overview

The ACE Monopolar Attachment is a medical device designed for electrosurgical procedures involving soft tissue coagulation and cutting. The device underwent non-clinical testing to demonstrate its safety and effectiveness.

Here is a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE Monopolar Attachment are derived from established international and national standards for medical device safety, biocompatibility, and electromagnetic compatibility. Performance criteria are based on comparative testing against a predicate device.

Acceptance Criteria Category	Specific Standard/Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	ISO 10993-1:2009	Evaluation and testing within a risk management process for biological evaluation of medical devices.	Met the requirements.
	ISO 10993-5:2003	Tests for In Vitro cytotoxicity.	Met the requirements.
	ISO 10993-10:2002/Amd. 1:2006(E)	Tests for irritation and delayed-type hypersensitivity.	Met the requirements.
Electrical Safety	IEC 60601-1 (1988, Amend. 1991, Amend. 1995)	General Requirements for Safety of Medical Electrical Equipment.	Met the requirements.
Electromagnetic Compatibility	IEC 60601-1-2:2007	General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3).	Met the requirements.
High Frequency Surgery Equipment	IEC 60601-2-2:2009	Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories.	Met the requirements.
Sterilization	ISO 11137-2:2006	Establishing the sterilization dose for radiation sterilization of health care products.	Met the requirements (Gamma irradiation for single-use).
Surface Wettability (Material)	ASTM D7334-08	Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement. (Likely for electrode tip or insulation material properties).	Met the requirements.
Ex Vivo Performance (Comparative)	Arcing Test	Performance similar to or better than the predicate device (GEIGER Disposable Electrosurgical Electrode). No excessive arcing that would compromise safety or effectiveness.	All test results demonstrated safety and performance met requirements.
	Charring Test	Performance similar to or better than the predicate device. Minimized charring to prevent tissue damage and ensure effective cutting/coagulation.	All test results demonstrated safety and performance met requirements.
	Thermal Spread Test	Performance similar to or better than the predicate device. Controlled thermal spread to limit collateral tissue damage.	All test results demonstrated safety and performance met requirements.
Mechanical Performance (Comparative)	Dropping Test	Device integrity and functionality maintained after dropping test, similar to the predicate device.	All test results demonstrated safety and performance met requirements.
	Pulling Test	Device components (e.g., electrode tip attachment to insulation) maintain integrity under specified pulling forces, similar to the predicate device, ensuring safe use and preventing accidental detachment during a procedure.	All test results demonstrated safety and performance met requirements.

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

The document does not explicitly state the specific sample sizes for each non-clinical test (e.g., number of devices tested for arcing, charring, dropping, etc.). It generally states that "A series of preclinical physical, mechanical and biocompatibility tests were performed" and that "The Performance Tests were conducted on the subject device and the predicate device."

Test Set Description: The test set for performance was a comparative study, meaning both the subject device (ACE Monopolar Attachment) and a predicate device (GEIGER Disposable Electrosurgical Electrode) were tested for Ex vivo and Mechanical performance.
Data Provenance: The tests were "in vitro and in vivo" for biocompatibility, and "ex vivo" for performance. The location of testing is not explicitly mentioned, but the submitter "BioEconeer Inc." is based in Cupertino, CA, U.S.A., implying the testing was likely conducted in a controlled laboratory environment. The tests were retrospective in the sense that they were conducted to secure premarket clearance.

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

This information is not provided in the given document. The non-clinical tests described are primarily objective physical, mechanical, and biological evaluations based on established standards, rather than subjective expert interpretation of output. Therefore, "ground truth" as typically defined for clinical or diagnostic studies (e.g., expert interpretation of images) is not directly applicable here. The "ground truth" is defined by the passing criteria of the international and national standards or the comparative performance against the predicate device.

4. Adjudication Method for the Test Set

This information is not provided and is generally not applicable for the type of non-clinical bench and lab testing described. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or studies involving subjective human assessment (e.g., reading medical images) to resolve discrepancies in expert interpretation. For physical, mechanical, and biological tests, objective measurements and adherence to specified test protocols determine the outcome.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (often AI-assisted) that involve human readers interpreting data. The ACE Monopolar Attachment is an electrosurgical accessory, not a diagnostic device, and its evaluation focuses on its physical, mechanical, and biological performance, as well as its functional equivalence to a predicate device.

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

This question is not applicable as the ACE Monopolar Attachment is a physical medical accessory, not an algorithm or AI-driven system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established through:

Compliance with published International and National Standards: For biocompatibility (ISO 10993 series), electrical safety (IEC 60601 series), sterilization (ISO 11137-2), and material properties (ASTM D7334-08). The acceptance criteria are the requirements defined within these standards.
Comparative Performance against a Predicate Device: For ex vivo tests (Arcing, Charring, Thermal Spread) and mechanical tests (Dropping, Pulling), the subject device's performance was evaluated relative to the legally marketed predicate device (GEIGER Disposable Electrosurgical Electrode). The "ground truth" here is that its performance must be "similar to or better than" the predicate device, demonstrating substantial equivalence and not raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

This question is not applicable. The ACE Monopolar Attachment is a physical device, not an AI or machine learning model that requires a "training set" for algorithm development.

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

This question is not applicable for the same reason as point 8.

Summary

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BioEconeer Inc. 510(k) Notification

5.4

ACE Monopolar Attachment

AUG 1 3 2

K123061

510(k) Summary

5.1 Type of Submission: Traditional

5.2 Preparation Date: Sep 28, 2012

5.3 Revised Date: August 09 , 2013

Submitter: BioEconeer Inc. Address: 10355 Norwich Avenue, Cupertino, CA 95014, U.S.A Phone: +886-989-103981 Fax: 408-252-6996 Contact: Tony ChaoFu Chang Establishment Registration Number: N/A

ર્સ્ટ Identification of the Device:

Proprietary/Trade name:	ACE Monopolar Attachment
Common Name:	Electrosurgical, Cutting & Coagulation & Accessories
Classification Name:	Electrosurgical, Cutting & Coagulation & Accessories
Device Classification:	II
Regulation Number:	878.4400
Panel:	General & Plastic Surgery
Product Code:	GEI

5.6 Identification of the Predicate Device:

Predicate Device Name:	GEIGER DISPOSABLE ELECTROSURGICAL
	ELECTRODE
Manufacturer:	GEIGER MEDICAL TECHNOLOGIES, INC.
510(k) Number or Clearance Information:	K994075

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ACE Monopolar Attachment

5.7 Intended Use and Indications for Use of the subject device.

5.8 Device Description

5.9 Non-clinical Testing

A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the ACE Monopolar Attachment. The safety tests were conducted in vitro and in vivo in accordance with ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5: 2003, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, ISO 10993-10:2002/Amd. 1:2006(E), Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity AMENDMENT 1, IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995, IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3), IEC 60601-2-2:2009, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgery equipment and high frequency surgical accessories, ISO 11137-2:2006, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose, and ASTM D7334-08 Standard Practice for Surface Wettability of Coatings, Substrates and Pigments by Advancing Contact Angle Measurement.

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BioEconeer Inc. 510(k) Notification ACE Monopolar Attachment

The Performance Tests were conducted on the subject device and the predicate device for the ex vivo test and mechanical test items listed below:

Ex vivo test: Arcing Test, Charring Test, Thermal Spread Test Mechanical test: Dropping Test, Pulling Test

All the test results demonstrate the safety and performance of ACE Monopolar Attachment meets the requirements of its pre-defined acceptance criteria and intended uses.

5.10Safety and Effectiveness

The results of the non-clinical testing demonstrate that the ACE Monopolar Attachment is substantially equivalent to the predicate devices.

5.11Substantial Equivalence Determination

The ACE Monopolar Attachment submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared GEIGER Disposable Electrosurgical Electrode which is the subject of K994075. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	Predicate Device(GEIGER DisposableElectrosurgical Electrode)	Proposed Device(ACE Monopolar Attachment)
Similarity
Classification	Class II	Class II
Code or Federal Regulations	878.4400	878.4400
Prescription MedicalDevices	YES	YES
Intended Use	The Geiger DisposableElectrosurgical Electrode isintended to be utilized for basicnon-sterile electrosurgicalprocedures. Examples of non-sterileprocedures include the removal of	The ACE MonopolarAttachment is intended to beused with the compatible ERBEMonopolar DisposableElectrosurgical Pencil (model:No.20190-109) for coagulation

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BioEconeer Inc. 5 10(k) Notification

ACE Monopolar Attachment

		moles, warts and skin tags. Theelectrodes are a standard 3/32" indiameter and will fit the majority ofelectrosurgical generators andhandpieces in the marketplace.	and cutting of soft tissue whenused in conjunction withcompatible ERBEElectrosurgical Generator (ESU)Systems.
Material of electrode tip		Stainless Steel	Stainless Steel
Dimension		Shaft: 3/32"	Shaft: φ 2.35mm
Safety Standards		ISO 10993-1ISO 10993-5ISO 10993-10IEC 60601-1IEC 60601-1-2IEC 60601-2-2ISO 11137-2ASTM D7334-08	ISO 10993-1ISO 10993-5ISO 10993-10IEC 60601-1IEC 60601-1-2IEC 60601-2-2ISO 11137-2ASTM D7334-08
Performance Standards		Not applicable	Not applicable
ComparativePerformanceTest Items	Ex vivo	Arcing TestCharring TestThermal Spread Test
	Mechanical	Dropping Test
		Pulling Test
Differences
Material of insulation		polystyrene	Nylon
Sterilization		non-sterile	Gamma irradiation (Single Use)

The differences between the subject device and predicate device are on the material of insulation and sterilization. The subject device has tested on safety and performance tests and the test results were complied with the test requests. Therefore, the differences of subject device and predicate device didn't raise any problems of safety or effectiveness. The ACE Monopolar Attachment is substantially equivalent to the predicate device in design, operation, intended use, method of preparation, and performance claims.

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BioEconeer Inc. 5 10(k) Notification ACE Monopolar Attachment

5.12Conclusion

After analyzing bench tests. electrical safety testing data, it can be concluded that ACE Monopolar Attachment is substantially equivalent to the predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the figure. The logo is black and white.

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

BioEconeer Incorporated % Michael Lee President AcmeBiotechs Company, Ltd. No.45, Minsheng Road, Danshui District New Taipei City, Taiwan 251

August 13, 2013

Re: K123061

Trade/Device Name: ACE Monopolar Attachment Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 19, 2013 Received: July 26, 2013

Dear Mr. Lee:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Michael Lee

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ReportalProblem/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 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/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Image /page/6/Picture/7 description: The image shows the name "Peter De Rumm -S" in a bold, sans-serif font. The letters are black against a white background, creating a high contrast. The letters "D" and "R" have a decorative pattern within them, adding a unique visual element to the text. The overall impression is clean and legible, with a touch of artistic flair in the letter design.

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

Enclosure

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BioEconeer Inc. 510(k) Notification ACE Monopolar Attachment 510(k) Number:K123061

Indications for Use

510(k) Number (if known): K123061

Device Name: ACE Monopolar Attachment

Indications for Use:

Prescription Use _ X (Pari 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 Page I of __

DSD-DIVISION SIGN-OFF	Joshua C. Nipper -
Division of Surgical Devices	S
510(k) Number: K123061

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.