The Soring MBC200/BCC140 devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.

Device Description

Soring MBC200/BCC140 device has 2 configurations. Depending on the unit variant, the user can choose from the following functions:

. MBC200: Monopolar cutting and Coaqulation and Bipolar Coagulation
. BCC140: Bipolar Cutting and Coagulation
Electrosurgical devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms or in outpatient procedures. Electrosurgery is performed using an Electrosurgical Generator (also referred to as Power Supply or Waveform Generator) and a handpiece including one or several electrodes, sometimes referred to as an RF Knife. Lower RF-voltages (below 150) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coaqulation. During the use of the Soring MBC200/BCC140 device, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts.

AI/ML Overview

The provided 510(k) summary is for an electrosurgical cutting and coagulation device (Soring MBC200/BCC140), which is a hardware medical device. The information requested regarding acceptance criteria, study data, sample sizes, expert involvement, and ground truth is typically applicable to AI/ML-enabled devices or diagnostic devices that rely on complex algorithms and data analysis for performance claims.

For a device like the Soring MBC200/BCC140, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on engineering specifications, electrical safety, electromagnetic compatibility, and biocompatibility, as demonstrated through compliance with recognized consensus standards and internal (non-clinical) verification and validation testing.

Therefore, I cannot populate the requested table and answer many of the questions (2 through 9) in the manner typically expected for AI/ML or diagnostic devices. The 510(k) summary provided does not contain the type of clinical study data with patient samples, expert ground truth, or statistical power calculations that would be found in the approval for a device making diagnostic or predictive claims based on data analysis.

However, I can extract the relevant information regarding safety and performance criteria and the testing performed, reinterpreting some of the prompts to fit the context of this type of device.

Acceptance Criteria and Device Performance (Reinterpreted for a Hardware Electrosurgical Device)

Acceptance Criteria (Performance/Safety Objectives based on Standards Compliance)	Reported Device Performance (Summary of Non-Clinical Test Results)
Safety: Device meets general requirements for safety of medical electrical equipment. (IEC 60601-1)	Software verification and product validation tests were performed and meet the acceptance criterion. The device complies with IEC 60601-1, Amendment 1, Amendment 2.
Electromagnetic Compatibility (EMC): Device meets requirements for EMC. (EN 60601-1-2)	The device complies with EN 60601-1-2.
Specific Safety for High Frequency Surgical Equipment: Device meets particular safety requirements for high-frequency surgical equipment. (EN 60601-2-2)	The device complies with EN 60601-2-2.
Biological Compatibility: Materials in contact with patient are biologically compatible. (ISO 10993-1)	The device complies with ISO 10993-1:1998.
Risk Management: Risks associated with the device are identified, analyzed, evaluated, and controlled to acceptable levels. (EN ISO 14971)	The device complies with EN ISO 14971.
Functional Performance: Device effectively cuts and coagulates soft biological tissue as intended.	Software verification and product validation tests were performed and meet the acceptance criterion. The device performs monopolar cutting and coagulation and bipolar cutting and coagulation.
Substantial Equivalence: Device performs in a manner similar and is intended for the same use as the predicate device (K024059, MBC Series).	The 510(k) contains adequate information and data to enable FDA to determine substantial equivalence. The device functions in a manner similar and is intended for the same use as the predicate device.

Inapplicable or Not Provided Information

The following questions are not applicable or the information is not provided in the context of this 510(k) summary for a hardware electrosurgical device:

Sample sizes used for the test set and the data provenance: This device is not an AI/ML or diagnostic device that uses a "test set" of patient data in the conventional sense. Testing involved non-clinical engineering validation and verification.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML or diagnostic devices (e.g., expert consensus on image interpretation) is not relevant for proving the safe and effective operation of an electrosurgical unit.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic or interpretation device.
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 type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, "ground truth" relates to objective engineering measurements (e.g., power output, safety limits, thermal effects on tissue models in a lab setting) and compliance with recognized standards, rather than clinical outcomes or pathology from patient data.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Device Approval Context:

The 510(k) for the Soring MBC200/BCC140 relies on demonstrating "substantial equivalence" to a predicate device (K024059) and compliance with established performance and safety standards. The "study" that proves the device meets the criteria consists of non-clinical verification and validation tests conducted against the enumerated international and national standards (e.g., ISO 10993-1, EN 60601-1-2, IEC 60601-1, EN 60601-2-2, EN ISO 14971). These tests ensure the device meets electrical safety, electromagnetic compatibility, biological compatibility, and specific performance requirements for electrosurgical equipment without raising new issues of safety or effectiveness. The standard approach for such devices does not involve clinical studies with patient data or expert read-outs in the same way an AI diagnostic algorithm would.

Summary

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KC93511
APR 1 6 2010

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

April 13, 2010

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Jan Schueller-lwersen

Director Regulatory Affairs

Soering GmbH Medizintechnik

Justus-v.Liebig Ring 2

25451 Quickborn, Germany

+49 (4106) 6100 - 0 Tel:

Fax: +49 (4106) 6100 - 10

Email: Jan.Schuller-Iwersen@Soering.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Product Name: Soring MBC200/BCC140

Common Name: Electrosurgical cutting device

Classification Name: electrosurgical cutting and coagulation device and accessories Class II, Product Code: GEI,

Regulation: 21 CFR 878.4400

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name	electrosurgical, cutting & coagulation & accessories
510(k) Number	K024059
Device Name	MBC SERIES
Applicant	SORING GMBH MEDIZINTECHNIK
Regulation Number	878.4400
Classification Product Code	GEI
Date Received	12/09/2002
Decision Date	01/08/2003
Decision	substantially equivalent (SE)
Classification Advisory Committee	General & Plastic Surgery
Reviewed by Third Party	No

Device Description: 21 CFR 807 92(a)(4)

Soring MBC200/BCC140 device has 2 configurations. Depending on the unit variant, the user can choose from the following functions:

. MBC200: Monopolar cutting and Coaqulation and Bipolar Coagulation
. BCC140: Bipolar Cutting and Coagulation

Electrosurgical devices are frequently used during surgical operations helping to prevent blood loss in hospital operating rooms or in outpatient procedures. Electrosurgery is performed using an Electrosurgical Generator (also referred to as Power Supply or Waveform Generator) and a handpiece including one or several electrodes, sometimes referred to as an RF Knife. Lower RF-voltages (below 150) lead to a slower heat-up of the tissue, resulting in coagulation with no separation. Short RF-impulses with high voltage lead in a build-up of sparks together with a strong surface coaqulation. During the use of the Soring MBC200/BCC140 device, power is transmitted via an electrode in the contact zone to tissue. When RF energy reaches a certain upper limit, an arc will occur at

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the contact zone of the active electrode to the tissue. This leads to a quick warm-up of the intercellular fluid. This vaporization of the intercellular fluid results into a burst of the cells and the tissue looses its cohesion, the electrode then cuts.

Indications for Use: 21 CFR 807 92(a)(5)

The Soring MBC200/BCC140 devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.

Contraindications:

Any use exceeding and/or deviating from the intended use of the device may lead to dangerous situations. Therefore: Use the device only in accordance with its intended purpose. Strictly adhere to all instructions provided in this operating manual. In particular, the device must not be used for any of the following purposes, as they are considered to be improper:

। Use during open-heart surgery.
l Use during eye surgery
-Monopolar use during neurosurgery
-Continuous operation,
-Use in direct combination with passive instruments (e.g. scalpels and forceps in contact with the active electrode).
-Use of incompatible or non-compliant accessories.
-Use of incompatible device combinations.
--Use of accessories whose rated voltage is not equal to the maximum output voltage of the device, and
l Use of the device close to a magnetic resonance tomograph (MRT)

Technological Characteristics: 21 CFR 807 92(a)(6)

Technical characteristics for the subject device are described briefly in this section. Monopolar - During monopolar application, the high-frequency current flows along the shortest distance from the active electrode, through the cross section of the patient's body, and to the neutral electrode.

Bipolar - During a bipolar application, the high-frequency current flows directly between two adjacent electrodes of the surgical instrument (e. g. legs of a pair of forceps). The current does not flow through the patient's body, but only through the area intended for the surgical application. Damage to the tissue is mostly avoided.

Cutting (electrotomy) - The high-frequency surgical device can be used to perform smooth cuts which are largely similar to those made with a common scalpel but cause only little blood flow thanks to the coagulating effect of the device.

-The cutting effect is achieved by the rapid, locally limited heating
100°C of the fluid inside and outside of the cells, which evaporates explosively and, thereby, bursts the tissue cells and cell connections.
-The active electrodes should have the smallest possible surface at the transition with the tissue.
-The quality of the cut varies with the cutting speed, the condition of the tissue and the current waveform.
-A low culting speed or the use of a pulse-modulated high frequency current will lead to highly coagulated or scabbed cuts.
-The output necessary depends on the shape of the electrode and the tissue type. If the output is too low, the cells will not burst, and the tissue will stick to the electrode.
If the output is too great, arcs may form between electrode and tissue and carbonize the cut surfaces.
Electrotomy requires highly effective high-frequency voltage which is provided by the -CUT output.

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Contact coagulation - If the electric current flowing from an electrode that is in contact with the tissue heats up the tissue to more than approx. 60°C, the extra and intracellular protein will coagulate.

As the cells contract due to the fluid they lose, the cell walls will be fused together. ।
। The coagulation requires a lower effective high-frequency voltage which is supplied as pulse-modulated voltage from the COAG output.

The subject device is substantially equivalent to other legally marketed devices in the United States and functions in a manner similar and is intended for the same use as the predicate device.

Brief summary of Non-clinical Tests and Results

Software verification and product validation tests were performed and meet the acceptance criterion. The subject device has been designed and tested to applicable safety standards (see below) and does not raise any new issues of safety, efficacy, or performance of the product.

Standard	Title
ISO 10993-1:1998	Biological Compatibility of medical devices - Part 1: Evaluation andTesting
EN 60601-1-2	Medical electrical equipment - Part 1-2: General requirementsfor safety -Collateral standard: Electromagnetic compatibility -Requirements and tests
IEC 60601-1	Medical Electrical Equipment - Part 1: General Requirements forSafety, 1988; Amendment 1, 1991-11, Amendment 2,1995. (General)
EN 60601-2-2	Medical electrical equipment - part 2-2: particularrequirements for the safety of high frequency surgicalequipment
EN ISO 14971	Medical devices - application of risk management to medicaldevices

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) for the MBC200/BCC140 device contains adequate information and data to enable FDA to determine substantial equivalence to the predicate device. The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three thick, curved lines, and below the eagle are three wavy lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Soring GmbH Medizintechnik % Mr. Jan Schueller-Iwersen Director Regulatory Affairs Justus-v.Liebig Ring 2 25451 Quickborn, Germany

APR 1 6 2010

Re: K093511

Trade/Device Name: Soring MBC200/BCC140 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 25, 2010 Received: April 8, 2010

Dear Mr. Schueller-Iwersen:

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

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Page 2 - Mr. Jan Schueller-Iwersen

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 (OS) 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/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/Industry/default.htm.

Sincerely yours,

Mark N. Mallemat

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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Indications for Use

510(k) Number: K093511

Device Name: Soring MBC200/BCC140

Indications for Use:

The Soring MBC200/BCC140 devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures.

Typical users of this system are trained medical professionals.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature Sign Off

(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093511

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.