(134 days)
The Surnic Surclear Smoke Plume Evacuation System with accessories is intended to remove smoke created in surgical procedures at the surgical site.
The Surclear 8010 have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Surclear 8010 filter 8QF1 where the surgical smoke is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One 8QF1 filter contains four different stages within to capture the smoke plume.
The provided text describes the acceptance criteria and the results of non-clinical tests for the 8Q10 Surclear Smoke Plume Evacuation System. It does not contain information about a study proving the device meets the acceptance criteria in the context of an AI/human-in-the-loop performance evaluation, which is typically found in submissions for AI-powered devices.
The information provided pertains to the safety and functional performance of a medical device (a smoke plume evacuation system), not an AI/software as a medical device (SaMD). Therefore, many of the requested criteria (like sample size for test set, data provenance, number of experts, MRMC studies, etc.) are not applicable or not provided in this document.
However, I can extract and present the information that is available:
Acceptance Criteria and Reported Device Performance for the 8Q10 Surclear Smoke Plume Evacuation System
This document describes the non-clinical testing conducted to demonstrate the safety and functionality of the 8Q10 Surclear Smoke Plume Evacuation System.
1. Table of Acceptance Criteria and Reported Device Performance
| Title of Test | Purpose of Test | Acceptance Criteria | Results |
|---|---|---|---|
| Electrical Safety Testing | Evaluate Electrical Safety | Fulfil the requirement of IEC 60601-1:2012+2020 as applicable | Passed |
| Electromagnetic Compatibility | Evaluate Electromagnetic Compatibility | Fulfil the requirements of IEC 60601-1-2:2014+2020 as applicable | Passed |
| Software Validation | Evaluate Device Software | All test cases shall pass or deviations explained as to why it is acceptable | Passed |
| Flow Rate Testing | Evaluate flow rate against design requirement | The flow rates at each flow mode are within the defined tolerances. | Passed |
| Plume Evacuation Evaluate | Evaluate System for evacuation of plume generated by medical devices | Fulfil the requirements of ISO 16571:2014 as applicable | Passed |
Further Technological Characteristics and Comparison to Predicate Device:
| Characteristic | Subject Device (K233789) | Predicate Device (K131402) | Discussion |
|---|---|---|---|
| Indications for Use | Remove smoke created in surgical procedures at the surgical site. | Remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures. | Similar |
| Static Motor Suction | 25.69 kPa | 25.69 kPa | Same |
| Flow rates (Max) | 25 cfm (707 lpm) @7/8(22mm) tubing | 30 cfm (839 lpm) @7/8(22mm) tubing | Similar, (cfm) 25vs30 is due to different manufacturers' understanding of the maximum flow limit required in actual applications. |
| Suction control level | 10 Level | 10 Level | There are 10 control levels of suction rate from 10% to 100%. |
| Suction blockage warning | Yes | Yes | An occlusion warning safety feature alerts the operator when an occlusion has occurred. |
| Foot control | Yes | Yes | The operator can foot-control the suction of the device to turn on or off. |
| Filter life indication | Yes | Yes | Counter indicates filter status and lifetime. |
| Filter performance | 99.99% efficiency at 0.1-to-0.2-micron particle size with a filter life of up to 40 hours. | 99.99% efficiency at 0.1-to-0.2-micron particle size with a filter life of up to 35 hours. | Same filter efficiency, larger filters can increase application time from 35 to 40 hrs. |
| Power Supply | 100-120VAC, 50/60Hz, 9A max; 220-240VAC, 50/60Hz, 4.5A max | 100/240VAC, 50/60Hz; 220/240 VAC | Same |
Information Not Found in the Provided Text:
The following specific requested information is not available in the given document, as it pertains to AI/SaMD performance studies, which is not the subject of this 510(k) submission:
- Sample size used for the test set and the data provenance: Not applicable/not provided for a hardware device's functional testing. The tests are against specific engineering and safety standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a smoke evacuator's performance is based on physical measurements and compliance with engineering standards.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For this device, ground truth is based on established international (IEC, ISO) and industry standards for electrical safety, electromagnetic compatibility, software validation, flow rates, and plume evacuation.
- The sample size for the training set: Not applicable (not an AI/ML device).
- How the ground truth for the training set was established: Not applicable (not an AI/ML device).
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.