(114 days)
Not Found
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components or capabilities.
No
The device is used for cutting and coagulation of soft tissue during surgical procedures, which are interventional actions rather than therapeutic.
No
The device is described as an electrosurgical cutting and coagulation device, indicated for removing tissue and controlling bleeding during surgical procedures. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly outlines hardware components including a generator, handpiece, and optional footswitch, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the Domain Surgical System is an electrosurgical device used for "cutting and coagulation of soft tissue during surgical procedures." This is a direct intervention on the body during surgery, not an analysis of a specimen outside the body.
- Lack of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens.
The device is a surgical tool used directly on the patient's tissue during an operation.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
GEI, HGI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, Gynecologic (open transabdominal only)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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.
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.
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,
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
88
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
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