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