(153 days)
K091107, K84403
Not Found
No
The summary describes a standard electrosurgical device and does not mention any AI or ML components or capabilities.
Yes
The device is indicated for "cutting and coagulation of soft tissue," which are actions aimed at treating or alleviating a medical condition (e.g., during surgery).
No
Explanation: The device description states its purpose is for "cutting and coagulation of soft tissue" and "to remove tissue and control bleeding." There is no mention of diagnosing conditions.
No
The device description clearly outlines hardware components including a generator, handpiece, and optional footswitch, and the performance studies involve testing of these physical components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cutting and coagulation of soft tissue." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is described as an "electrosurgical cutting and coagulation device" that uses high-frequency electrical current to remove tissue and control bleeding. This is a surgical tool.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The Domain Surgical System is a surgical device used during a procedure on a patient, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
Indications for Use: The Domain Surgical System is indicated for cutting and coagulation of soft tissue.
Product codes
GEI
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 handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing was performed with the Domain Surqical System to assure that it functions as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece tip corresponds 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.
The software that controls the operation of the generator has 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.
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. Live animal testing was performed that demonstrates that the Domain Surgical System is as effective at cutting and coagulating soft tissue as other legally marketed electrosurgical devices.
Key Metrics
Not Found
Predicate Device(s)
K091107, K84403
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
JUL 1 8 2011
510(k) SUMMARY
Domain Surgical System Date of Summary: February 7, 2011
General Provisions
| Submitter's Name: | Domain Surgical |
|---|---|
| Submitter's Address: | 1370 South 2100 East |
| Salt Lake City, Utah 84108 | |
| Contact Person: | Curtis Jensen, Director 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)
- Hemostatix Medical Technologies, LLC Model P8400 Hemostatix Therma! Scalpel . System, (Product Code GEI) 510(k) #K091107
- Valleylab Force 2 Electrosurgical Generator (Product Code GEI) 510(K) #K84403 .
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 handpiece.
Technological Comparison
The Domain Surgical System employs ferromagnetic heating to generate heat in the handpiece tip. This method of heating differs from the predicate device (Hemostatix Thermal Scalpel System), which employs only the electrical resistance of the materials in the handpiece tip to produce heat. The Domain Surgical System differs from the Hemostatix device in that it employs active cooling of the handpiece, outputs a unique generator electrical waveform and the provided footswitch specifies a different moisture resistance rating. It differs from the Valleylab device in that no current is passed through the patient and the impedance of the tissue is not employed to create the heat necessary to cut and coagulate soft tissue. The Domain device also differs from the Valleylab device in that it employs active cooling of the handpiece and outputs a unique generator electrical waveform.
Indications for Use
Indications for Use: The Domain Surgical System is indicated for cutting and coagulation of soft tissue.
The indications for use statement for the Domain Surgical System is the same as the predicate devices with minor differences that provide clarity and have no effect on safety or effectiveness.
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Safety and Biocompatibility Summary
Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other similar devices on the market. Bench testing was performed with the Domain Surqical System to assure that it functions as intended. Bench tests verified that the generator output was within specification and that the thermal output of the handpiece tip corresponds 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.
The software that controls the operation of the generator has 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.
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. Live animal testing was performed that demonstrates that the Domain Surgical System is as effective at cutting and coagulating soft tissue as other legally marketed electrosurgical devices.
Conclusion
The Domain Surqical System is substantially equivalent to the Hemostatix Model P8400 Thermal Scalpel System (510(k)# K091107) and the Valleylab Force 2 Electrosurgical Generator (510(k) #K84403). The intended use of the Domain Surgical System is the same as the predicate devices, with the exception of the 'vessel sealing' claim by the Henostatix System. Furthermore, the indications for use statement is the same as the predicate devices with only minor differences that provide clarity and have no effect on safety or effectiveness. The Domain Surgical System differs from the predicate devices in technological characteristics; however the differences do not raise different types of questions of safety and effectiveness. The information presented in the 510(k), including the bench and animal testing, demonstrates that the Domain Surgical System is as safe and effective as the predicate device for its intended use.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 18 2011
Domain Surgical, Inc. % Mr. Curtis Jensen 1370 South 2100 East Salt Lake City, Utah 84108
Re: K110439
Trade/Device Name: Domain Surgical System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 01, 2011 Received: July 05, 2011
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
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Page 2 - Mr. Curtis Jensen
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/CDRHQffices/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.
ely yours,
For
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 (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Domain Surgical System
Indications for Use: The Domain Surgical System is indicated for cutting and coagulation of soft tissue.
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)
(Division Sign-Off)
KII0439
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number .