The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

Device Description

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 (21 CFR §878.4400). It is classified as a Class II (510(k)) device.

The Domain Surgical System is a soft tissue cutting and coagulation device that consists of a generator that is electrically connected to a sterile, single-use handpiece and an optional footswitch. Like the predicate devices, the handpiece includes an actuation button that can be used to activate heating in the handpiece tip. Also like the predicate devices, an optional footswitch can be used to activate the system.

AI/ML Overview

The provided text is a 510(k) summary for the Domain Surgical System, which is an electrosurgical cutting and coagulation device. This submission is intended to modify the Indications for Use statement to add specificity, consistent with its intended use and the indications for use for the legally marketed Peak Surgery System. The device itself was previously cleared by FDA through 510(k) #K110439.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Test/Standard Compliance)	Reported Device Performance
Generator output within specification	Bench tests verified that the generator output was within specification.
Thermal output of the handpiece tip corresponded to target values	Bench tests verified that the thermal output of the handpiece tip corresponded to the target values.
Compliance with applicable electrical safety standards for medical electrosurgical devices (IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2)	Tested by an accredited independent testing laboratory to assure compliance with the applicable electrical safety standards for medical electrosurgical devices, including the applicable sections of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2.
Software meets design requirements and operates safely and effectively (controlling output power and providing audio/visual information)	Software undergone proper design verification and validation to assure that it meets design requirements and operates safely and effectively for the device's intended use, including controlling output power and providing audio and visual information during use.
Biocompatibility of patient contacting materials (ISO 10993-1 and 510(k) Memorandum G95-1)	Successful biocompatibility testing of applicable parts of the system completed by accredited independent testing laboratories according to ISO 10993-1 and 510(k) Memorandum G95-1.

It's important to note: This submission is an amendment to specify the indications for use, not a new device clearance. All the performance data described above was previously reported and accepted as part of 510(k) #K110439.

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

The document primarily discusses bench testing and compliance with standards. It does not mention a "test set" in the context of a clinical study with human or animal subjects for this specific submission (K121881). The tests described are engineering and laboratory tests.

Sample Size for Test Set: Not applicable to this type of regulatory submission and the tests described.
Data Provenance: Not applicable. The data is from laboratory and engineering bench tests rather than clinical data from specific countries or retrospective/prospective studies.

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. The ground truth for the "test set" (bench testing) is based on engineering specifications and international standards, not expert human assessment.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical studies where multiple experts evaluate cases and a consensus or tie-breaking mechanism is used. The tests described are objective engineering and laboratory tests.

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 section is not applicable. This device is an electrosurgical cutting and coagulation device, not an imaging or diagnostic device that would typically involve "human readers" or AI assistance in the way described for an MRMC study.

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

This section is not applicable. This device is a surgical tool, not an algorithm. Its operation inherently involves a "human-in-the-loop" (the surgeon). The "software" mentioned controls the generator, which is part of the overall surgical system, not a standalone diagnostic or interpretive algorithm.

7. The type of ground truth used

The "ground truth" for the tests described are:

Engineering Specifications: For generator output and thermal output.
International Standards: For electrical safety (IEC 60601 series) and biocompatibility (ISO 10993-1).
Design Requirements: For software functionality and performance.

8. The sample size for the training set

This section is not applicable. The device is not an AI/ML algorithm that requires a "training set" in the context of machine learning. The "software" mentioned in the document is a control system software, not a learning algorithm trained on data.

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

This section is not applicable for the same reasons as #8.

Summary

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510(k) SUMMARY

OCT 1 8 2012

Domain Surgical System Date of Summary: June 25, 2012

General Provisions

Submitter's Name:	Domain Surgical
Submitter's Address:	1370 South 2100 East
	Salt Lake City, Utah 84108
Contact Person:	Curtis Jensen, Vice President of Quality and Regulatory Affairs
Phone Number:	(801) 924-4958
Classification Name:	Electrosurgical cutting and coagulation device and accessories
Proprietary Name:	Domain Surgical System
Common Name:	Electrosurgical cutting and coagulation device and accessories

Name of Predicate Device(s)

Domain Surgical System (Product Code GEI) 510(k) #K110439 W

Peak Surgery System (Product Code GEI) 510(k) #K082786. �

Intent of This Premarket Submission

The intent of this submission is to modify the Indications for Use statement to add specificity, consistent with our intended use for the device and the indications for use for the legally marketed Peak Surgery System (K082786).

The Domain Surgical System, as presented in this submission, has been previously cleared by FDA through 510(k) #K110439.

Device Description

The Domain Surgical System is identical to the device cleared by FDA in 510(k) #K110439.

Technological Comparison

The technological characteristics are the same as the predicate device (Domain Surgical System) as described in K110439 and the difference between the Domain Surgical System and the Peak Surgery System are no more significant that the differences between the Domain Surgical System and the predicate device cited in K110439.

Indications for Use

The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

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The proposed indications for use statement for the Domain Surgical System references a subset of the surgical specialties to add specificity, consistent with our intended use for the device and the indications for use for the legally marketed Peak Surgery System (K082786).

Safety and Biocompatibility Summary

The Domain Surgical System, as originally cleared in 510(k) #K110439, is intended to be used by surgeons independent of medical specialty. This premarket submission is to modify the indications for use for the Domain Surgical System to provide specificity, consistent with our intended use for the device and the indications for use for the legally marketed Peak Surgery System.

Questions of safety and effectiveness of the Domain Surgical System were assessed during the review and clearance of the original 510(k) (#K110439).

Bench testing was performed with the Domain Surgical System to assure that it functioned as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece tip corresponded to the target values. It was also tested by an accredited independent testing laboratory to assure that it complies with the applicable electrical safety standards for medical electrosurgical devices, including the applicable sections of IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-2. All of this testing was previously reported as part of 510(k) #K110439.

The software that controls the operation of the generator has previously undergone proper design verification and validation to assure that it meets design requirements and operates safely and effectively for the device's intended use, including controlling output power and providing audio and visual information during use. All of this testing was previously reported as part of 510(k) #K110439.

The patient contacting materials used in the Domain Surgical System were chosen for their biocompatibility, function and suitability for the intended use of this device. Successful biocompatibility testing of applicable parts of the system was completed by accredited independent testing laboratories according to ISO 10993-1 and 510(k) Memorandum G95-1. All of this testing was previously reported as part of 510(k) #K110439.

Conclusion

The technological characteristics are identical to the device described in K110439 and the difference between the Domain Surgical System and the Peak Surgery System are no more significant that the differences between the Domain Surgical System and the predicate device cited in K110439.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

OCT 1 8, 2012

Mr. Curtis Jensen
Vice President of Quality and Regulatory Affairs
Domain Surgical, Inc.
1370 South 2100 East
SALT LAKE CITY UT 84108

Re: K121881

Trade/Device Name: Domain Surgical System Regulation Number: 21 CFR§ 884.4120 Regulation Name: Gynecologic electrocautery and accessories Regulatory Class: II Product Code: HGI Dated: September 18, 2012 Received: September 24, 2012

Dear Mr. Jensen:

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

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Page 2.

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/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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin K. Kirk

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

ನ

510(k) Number (if known):

Device Name: Domain Surgical System

Indications for Use: The Domain Surgical System is indicated for cutting and coagulation of soft tissue during surgical procedures, including Gynecologic procedures (open transabdominal only).

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: (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)

Haland Remer

ivision Sign-Off ductive, Gastro-Renal, and of Re 10(k) Numb

6-2

Regulation Number and Section

§ 884.4120 Gynecologic electrocautery and accessories.

(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).