Aesculap's Bipolar Coagulator (GN160) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.

Device Description

Aesculap's Bipolar HF Device is a non-sterile, reusable electrosurgical generator capable of generating high frequency electrical current, driven through a software based program, for coaqulation with existing Aesculap bioolar instruments (e.g. forceps). It is equipped with a bipolar outlet. The device is fitted with a universal power adapter for mains voltages 100-120V and 220-240V. All software and electrical components are housed within a combination metallic and thermoplastic enclosure. A bipolar cord connects the instruments to the unit. The unit is activated by means of a foot control.

AI/ML Overview

The provided document, K110695, describes the Aesculap Bipolar High Frequency (HF) Device. Here's an analysis of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criteria	Reported Device Performance
Safety and Effectiveness	Demonstrated substantial equivalence to predicate devices (Aesculap Bipolar Coagulator (K952524), Wolf Model 2352 (K945914), Valleylabs Force FZ (K953195), and Valleylabs Forcetriad (K102913)) in terms of intended use, labeling, and basic operating principles. Adherence to recognized international standards for medical electrical equipment.	"Testing of the subject device was found to be similar in performance to the previously cleared device with similar indications."
Standard Compliance	- IEC 60601-1: Medical electrical equipment - Part 1: General requirement for safety	Device conforms to this standard.
	- IEC 60601-2-2: Medical electrical equipment - Part 2: Particular requirements for the safety of high frequency surgical equipment	Device conforms to this standard.
	- IEC 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility EMC Requirements and Tests	Device conforms to this standard.
	- IEC 62304: Medical device software Software life cycle process	Device conforms to this standard.
Clinical Performance	(Implicit) No requirement for clinical trials, as substantial equivalence was demonstrated through non-clinical testing and comparison to predicates.	"No clinical testing was performed."

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

The document does not explicitly state a "test set" in the context of clinical or large-scale performance testing with human subjects or a dataset. The evaluation for this device focused on non-clinical bench testing and comparison to predicate devices. Therefore:

Sample Size for Test Set: Not applicable in the context of human subject or image-based test sets. The "test set" would refer to the specific device units built and tested against engineering specifications and international standards.
Data Provenance: The data provenance is from internal engineering and regulatory compliance testing of the Aesculap Bipolar HF Device. There is no indication of country of origin of data in terms of patient or clinical records, as no clinical testing was performed. All testing appears to be retrospective in the sense that it was conducted on manufacturing units to demonstrate compliance with pre-existing standards and equivalence to predicate devices.

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

This section is not applicable to the K110695 submission. The "ground truth" for this type of device (an electrosurgical unit) is established through:

Engineering specifications and performance metrics: The device must generate a specific electrical output within defined parameters.
Adherence to recognized safety and performance standards (IEC standards): These standards define acceptable performance limits.
Comparison to predicate devices: The "ground truth" for substantial equivalence is the established safety and effectiveness of the legally marketed predicate devices.

There is no mention of human experts establishing a "ground truth" for a test set in the way one would for diagnostic imaging or a medical AI algorithm.

4. Adjudication Method for the Test Set

This is not applicable. Since there's no "test set" involving subjective human interpretation or a need for consensus among experts for a diagnostic task, no adjudication method was used. The evaluation involved objective measurements and comparisons to engineering specifications and standards.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, which is not what the Aesculap Bipolar HF Device is. The device is a electrosurgical generator, not a diagnostic tool with human readers.

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

This is not applicable. The device is an electrosurgical unit, not an AI algorithm. Its performance is inherent to its electrical output and safety features, which are tested in a standalone capacity (the device itself) against engineering specifications and standards. There is no distinction between "algorithm only" and "human-in-the-loop" performance in this context.

7. The Type of Ground Truth Used

The "ground truth" for the Aesculap Bipolar HF Device was established by:

Engineering specifications: The device must produce electrical currents within defined parameters (e.g., frequency, power output for coagulation).
Compliance with international safety and performance standards (IEC 60601-1, 60601-2-2, 60601-1-2, 62304): These standards define the acceptable range of performance and safety characteristics.
Performance of legally marketed predicate devices: The fundamental "ground truth" for substantial equivalence is that the new device performs "similarly" to these already cleared devices for their intended use.

This is a form of regulatory and engineering ground truth, not a clinical ground truth derived from pathology, expert consensus on images, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable. The Aesculap Bipolar HF Device is an electrosurgical generator, not an AI/ML algorithm. There is no "training set" in the machine learning sense. The device's operation is based on pre-programmed software and hardware, not learned from data.

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

This is not applicable for the reasons stated in point 8.

Summary

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K110695

B. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

JUN 2 8 2011

lof 2

Aesculap Bipolar High Frequency (HF) Device June 13, 2011

Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714 CONTACT Lisa M. Boyle, Sr. RA Specialist 800-258-1946 x 5274 (phone) 610-791-6882 (fax) lisa.bovle@aesculap.com TRADE NAME: Aesculap Bipolar High Frequency (HF) Device COMMON NAME: Bipolar HF Electrosurgical Unit CLASS. NAME: Electrosurgical, Cutting & Coagulation & Accessories (GEI) REG. NUMBER: 878.4400 (Class II)

SUBSTANTIAL EQUIVALENCE

The Aesculap Bipolar HF Device as described in this premarket notification is substantially equivalent to the following predicate devices:

Aesculap Bipolar Coagulator (K952524) .

Wolf Model 2352 {K945914} .
Vallevlabs Force FZ (K953195) .
. Vallevlabs Forcetriad (K102913)

DEVICE DESCRIPTION

INDICATIONS FOR USE

Aesculab's Bipolar Coagulator (GN160) is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are use in Neurosurgery, ENT surgery, urology, laparoscopy and plastic surgery.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap Bipolar HF Device described in this premarket notification share similar features and functions such as intended use, labeling, and basic operating principles to the following predicate devices: Aesculap Bipolar Coaqulator (K952524), Wolf Model 2352 (K945914), Valleylabs Force FZ (K953195), and the Valleylabs Forcetriad (K102913).

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K110695

Pg 2 of 2

Testing of the subject device was found to be similar in performance to the previously cleared device with similar indications.

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices. The Aesculap Bipolar HF Device conforms to the following IEC standards:

IEC 60601-1: Medical electrical equipment - Part 1: General requirement for safety, ●
IEC 60601-2-2: Medical electrical equipment - Part 2: Particular requirements for the safety . of high frequency surgical equipment,
. IEC 60601-1-2: Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility EMC Requirements and Tests.
IEC 62304: Medical device software Software life cycle process .

Testing results demonstrate that the Aesculap Bipolar HF Device is safe and effective. No clinical testing was performed.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Aesculap, Inc. % Ms. Lisa M. Boyle Sr. Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

JUN 28 2011

Re: K110695

Trade/Device Name: Bipolar HF Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: June 15, 2011 Received: June 16, 2011

Dear Ms. Boyle:

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

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Page 2 - Ms. Lisa M. Boyle

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 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/ucm11118800.html 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/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/ResourcesforYou/Industry/default.htm.

Sincerely vours

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

Enclosure

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Special 510(k) Premarket Notification

Aesculap Bipolar HF Device (GN160)

Page 1 of 1

A. INDICATIONS FOR USE STATEMENT

KII 0695 510(k) Number:________________________________________________________________________________________________________________________________________________________________

Device Name: Aesculap Bipolar HF Device

Indications for Use:

Prescription Use	X	and/or Over-the-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 801 Subpart C)

(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 Surgical, Orthopedic, and Restorative Devices

510(k) Number K110695

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.