(175 days)
SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.
SafeAir Smoke Evacuator compact is a device with a vacuum pump that aspirates the surgical smoke produced during cauterization. The main purpose of smoke evacuation systems is to remove surgical smoke plume as close as possible to the surgical site. The component of the system ensuring that this is achieved is a diathermy pencil with integrated smoke evacuation function or a click-on tubing set connected to a surgical smoke evacuator. SafeAir Smoke Evacuator compact is designed for use in the hospital/clinic environment. It is built around a vacuum pump with a replaceable filter at the entry point. A specially designed pump control is centrally placed in the machine. The SafeAir Smoke Evacuator compact is designed with a pump with different activation functions; manual activation on the front panel, footswitch activation through diathermy pencil with smoke evacuation tubing. Synchronization is possible with most of the electrosurgical units.
The provided document is a 510(k) summary for the SafeAir Smoke Evacuator compact, a device designed to remove and filter smoke generated during electrosurgical and laser procedures. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance using AI or clinical studies. Therefore, much of the requested information regarding AI-specific studies, expert involvement, and ground truth establishment is not present in this regulatory submission.
However, I can extract information related to the device's functional performance and comparisons to the predicate device.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are not explicitly stated as separate acceptance criteria in the sense of predefined thresholds for clinical performance. Instead, the document demonstrates substantial equivalence by comparing technological characteristics and performance test results with the predicate device (Visiclear Smoke Evacuation System - K131402). The "acceptance" is implied by the similarity in performance to the predicate and compliance with relevant safety standards.
Here's a table based on the provided "Technological Characteristic Comparison Table" (Table 3), interpreted as performance demonstration against the predicate. The "Acceptance Criteria" column is derived from the predicate device's reported performance or general safety standards.
| Variable | Acceptance Criteria (Based on Predicate/Standards) | Reported Device Performance (SafeAir Smoke Evacuator compact) | Comparison |
|---|---|---|---|
| Filtration efficiency | 99.999% efficiency at 0.1 to 0.2 micron particle size (ULPA-grade) | 99.999% with efficiency at 0.1 microns particle size (ULPA filter) | Same |
| Filter Life | 35 hours (Predicate) | 5 hours | Use life of the filter is established with performance testing and is consistent with intended claims. (Different but justified) |
| Filter life indicator | Shut down (Predicate) | Indicator light | When the indicator light is on, the user is instructed to change the filter. (Different but justified) |
| Electrical safety | Compliant with IEC 60601-1 and IEC 60601-1-2 | Tested and compliant with IEC 60601-1 and IEC 60601-1-2 | Same |
| Mechanical safety | Compliant with IEC 60601-1 | Tested and compliant with IEC 60601-1 | Same |
| Chemical safety | Neutral pH, non-patient contact | Neutral pH, non-patient contact | Same |
| Thermal safety | Operation does not result in harmful temperatures per IEC 60601-1 | Operation of the device does not result in harmful temperatures tested and compliant per IEC 60601-1 | Same |
| Radiation safety | Non-radioactive | Non-radioactive | Same |
| Maximum flow rate (claimed) | 839 l/min (Predicate) | 110 l/min | Flow rate for the subject device is demonstrated to effectively entrain surgical smoke. (Different but justified as effective) |
| Maximum flow rate (suction pencil)* | 93.2 l/min (Predicate) | 97.1 l/min | Similar |
| Maximum flow rate (suction tube)* | 62.2 l/min (Predicate) | 66.2 l/min | Similar |
| Minimum flow rate (suction pencil)* | 43.1 l/min (Predicate) | 41.2 l/min | Similar |
| Minimum flow rate (suction tube)* | 25.9 l/min (Predicate) | 26.0 l/min | Similar |
*All values obtained from simulated use testing.
2. Sample size used for the test set and the data provenance
The document mentions "simulated use testing" for flow rates. It does not specify a "test set" in terms of a dataset for AI evaluation, nor does it provide a sample size (number of tests or cases) for these simulated use tests. There is no information on data provenance (country of origin, retrospective/prospective) as this is a physical device performance test rather than an AI data study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The performance testing described is engineering/validation testing against physical parameters and standards, not clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method is described, as the testing involves objective measurements against engineering specifications and comparison with a predicate device, not subjective expert reviews.
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
No MRMC study was conducted or is relevant to this device. This is a smoke evacuator, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to AI algorithm performance. No such study was conducted as the device is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is compliance with recognized electrical, mechanical, thermal, and chemical safety standards (e.g., IEC 60601-1, IEC 60601-1-2) and demonstrated functional performance (e.g., filtration efficiency, flow rates) that is "as safe, as effective and performs as well as or better than" the predicate device. This is primarily engineering and performance verification, not clinical ground truth.
8. The sample size for the training set
Not applicable. This device does not involve an AI algorithm with a training set.
9. How the ground truth for the training set was established
Not applicable. No AI training set.
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February 7, 2019
LiNA Medical APS % Kevin MacDonald Regulatory Consultant Kevin F. MacDonald 4297 D Street Sacramento, California 95819
Re: K182224
Trade/Device Name: SafeAir Smoke Evacuator compact Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus for a Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: January 8, 2019 Received: January 9, 2019
Dear Kevin MacDonald:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray Iii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K182224
Device Name SafeAir Smoke Evacuator compact
Indications for Use (Describe)
SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary: K182224
| 510(k) Owner: | LiNA Medical ApSFormervangen 5DK-2600 Glostrup, DenmarkTelephone: +48 61 222 21 43 |
|---|---|
| Contact Person: | Kevin MacDonald,Regulatory ConsultantEmail: kma@lina-medical.comTel. 415-609-9875 |
| Date SummaryPrepared: | 04 Feb 2019 |
| Trade Name ofDevice: | SafeAir Smoke Evacuator compact |
| Common Name : | Air-handling apparatus for a surgical operating room |
| Classification: | Class II |
| Product Code: | FYD |
| Panel: | General and Plastic Surgery Devices |
| Regulation Number: | 21CFR 878.5070 |
| Predicate Device: | Visiclear Smoke Evacuation System - K131402 |
Device Description
SafeAir Smoke Evacuator compact is a device with a vacuum pump that aspirates the surgical smoke produced during cauterization.
The main purpose of smoke evacuation systems is to remove surgical smoke plume as close as possible to the surgical site. The component of the system ensuring that this is achieved is a diathermy pencil with integrated smoke evacuation function or a click-on tubing set connected to a surgical smoke evacuator.
SafeAir Smoke Evacuator compact is designed for use in the hospital/clinic environment. It is built around a vacuum pump with a replaceable filter at the entry point. A specially designed pump control is centrally placed in the machine. The SafeAir Smoke Evacuator compact is designed with a pump with different activation functions; manual activation on the front panel, footswitch activation through diathermy pencil with smoke evacuation tubing. Synchronization is possible with most of the electrosurgical units.
| Table 1: Models number – main device | |
|---|---|
| Reference number | Description |
| SFR-compact-US | SafeAir Smoke Evacuator compact |
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| Table 2: Accessories | |
|---|---|
| Reference Number | Description |
| SFR-FSW-US | SafeAir footswitch |
| SFR-FIL-C-US | SafeAir ULPA filter with active carbon |
| SFR-CON-US | SafeAir tubing for bottle connection |
| SFR-TUB-7-US | SafeAir 7m Tubing Set for external exhaust |
| SFR-GC-US | SafeAir Grounding cable |
| SFR-compact-KIT-1-US | SafeAir 1 Year Service KIT for SFR-compact-US |
| SFR-compact-KIT-3-US | SafeAir 3 Year Service KIT for SFR-compact-US |
Indications for Use
SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.
Technological Characteristic Comparison
Table 3 compares the SafeAir Smoke Evacuator compact to the predicate devices with respect to indications for use, principles of operation, technological characteristics, and performance testing.
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| Table 3 - Technological Characteristic Comparison Table | |||
|---|---|---|---|
| Variable | SafeAir Smoke Evacuator compact(Subject Device) | Visiclear Smoke Evacuation System(Predicate - K131402) | Comparison |
| 510(k) number | K182224 | K131402 | |
| Product Code | FYD | Same | Same |
| Regulatory Class | II | Same | Same |
| Regulation Number | 21 CFR 878.5070 | Same | Same |
| Intended Use | SafeAir Smoke Evacuator compact isdesigned to remove and filtrate smokegenerated during electrosurgical andlaser procedures in the vicinity of itssource. | The VISICLEAR Smoke Evacuation System isdesigned to remove and filter smoke,aerosols produced during electrosurgicaland laser procedures. | Same |
| Direct Body ContactMaterials | Not intended to come in contact withpatient | Same | Same |
| Energy used | Electrical current | Same | Same |
| Operational Settings | On/Off Switch, Suction level buttons forMotor Control | Same | Same |
| Intended marketedaccessories | Electrosurgical pencils, tubing, hoses &adaptors - sterile and non sterile | Same | Same |
| Filtration | The ULPA filter is 99.999% withefficiency at 0.1 microns particle size | The ULPA-grade filter is 99.999% efficiencyat 0.1 to 0.2 micron particle size. | Same |
| Filter Life | 5 hours | 35 hours | Use life of the filter is established with performancetesting and is consistent with intended claims. |
| Table 3 - Technological Characteristic Comparison Table | |||
| Variable | SafeAir Smoke Evacuator compact(Subject Device) | Visiclear Smoke Evacuation System(Predicate - K131402) | Comparison |
| Filter life indicator | Indicator light | Shut down | When the indicator light is on, the user is instructedto change the filter. |
| Electrical safety | Tested and compliant with IEC 60601-1and IEC 60601-1-2 | Same | Same |
| Mechanical safety | Tested and compliant with IEC 60601-1 | Same | Same |
| Chemical safety | neutral pH, non-patient contact | Same | Same |
| Mechanical safety | Tested and compliant with IEC 60601-1 | Same | Same |
| Chemical safety | neutral pH, non-patient contact | Same | Same |
| Thermal safety | Operation of the device does not resultin harmful temperatures tested andcompliant per IEC 60601-1 | Same | Same |
| Radiation safety | non-radioactive | Same | Same |
| Maximum flow rate(claimed) | 110 l/min | 839 l/min | Flow rate for the subject device is demonstrated toeffectively entrain surgical smoke |
| Maximum flow rate(suction pencil)* | 97.1 l/min | 93.2 l/min | Similar |
| Maximum flow rate(suction tube)* | 66.2 l/min | 62.2 l/min | Similar |
| Minimum flow rate(suction pencil)* | 41.2 l/min | 43.1 l/min | Similar |
| Minimum flow rate(suction tube)* | 26.0 l/min | 25.9 l/min | Similar |
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*All values obtained from simulated use testing
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The SafeAir Smoke Evacuator compact shares the same indications for use, device operation, overall technical and functional capabilities as the predicate devices. In addition, the SafeAir Smoke Evacuator compact is similar in design and function to the Visiclear Smoke Evacuation System (K131402) in terms of mode of operation and use.
The technological differences between the SafeAir Smoke Evacuator Compact and predicate device are limited to maximum flow and under-pressure values defined by the manufacturers. These technological differences do not have an impact on the actual clinical use parameters. As confirmed through the design verification testing, both the predicate and subject devices performed as intended, meeting the performance specification independent of the technological differences.
In the design verification testing, accessories representative of components that would be used in a commercial setting were used to assess the clinically relevant flow rate and under-pressure parameters. The accessories included Smoke Evacuation pencils or Smoke Tubing, commonly used in electrosurgical or laser procedures. Both the predicate and subject devices were tested utilizing the same method and accessories and as reported in Table 3, the test results were comparable between the predicate and subject devices.
The SafeAir Smoke Evacuator compact shares the same indications for use, device operation, overall technical and functional capabilities as the predicate devices. In addition, the SafeAir Smoke Evacuator compact is similar in design and function to the Visiclear Smoke Evacuation System (K131402) in terms of mode of operation and use.
Sterilization and Biocompatibility
Based on the intended use, both the predicate and subject devices are not intended to come in direct contact with the patient and therefore, do not require sterilization or to be tested for biocompatibility.
Nonclinical Performance Data
The SafeAir Smoke Evacuator compact meets all the requirements for overall design, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The SafeAir Smoke Evacuator compact was subjected to safety performance testing in accordance with. AAMI / ANSI ES60601-1.
The SafeAir Smoke Evacuator compact passed all applicable testing in accordance with internal requirements, national standards, and international standards shown below:
- Electrical safety testing per AAMI / ANSI ES60601-1, IEC 60601-1-2,
- Software Validation and Verification per IEC 62304
Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate 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.