(175 days)
Not Found
No
The description focuses on the mechanical and electrical components of a vacuum pump system for smoke evacuation, with no mention of AI or ML capabilities.
No.
The device removes smoke generated during procedures, it does not directly treat a medical condition or disease.
No
The device is designed to remove and filter smoke generated during electrosurgical and laser procedures, which is a therapeutic function rather than a diagnostic one.
No
The device description explicitly details hardware components such as a vacuum pump, filter, and pump control, indicating it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove and filter smoke generated during electrosurgical and laser procedures." This is a physical process performed during a medical procedure on a patient, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a vacuum pump and filter system designed to aspirate smoke from the surgical site. This aligns with a device used for environmental control and safety during surgery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The SafeAir Smoke Evacuator compact does not fit this definition.
N/A
Intended Use / Indications for Use
SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.
Product codes
FYD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/clinic environment
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)
Nonclinical performance data includes electrical safety testing per AAMI / ANSI ES60601-1, IEC 60601-1-2, and Software Validation and Verification per IEC 62304.
The SafeAir Smoke Evacuator compact passed all applicable testing in accordance with internal requirements, national standards, and international standards.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Filtration: The ULPA filter is 99.999% with efficiency at 0.1 microns particle size.
Maximum flow rate (claimed): 110 l/min
Maximum flow rate (suction pencil): 97.1 l/min
Maximum flow rate (suction tube): 66.2 l/min
Minimum flow rate (suction pencil): 41.2 l/min
Minimum flow rate (suction tube): 26.0 l/min
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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 ApS
Formervangen 5
DK-2600 Glostrup, Denmark
Telephone: +48 61 222 21 43 |
|---------------------------|------------------------------------------------------------------------------------------------|
| Contact Person: | Kevin MacDonald,
Regulatory Consultant
Email: kma@lina-medical.com
Tel. 415-609-9875 |
| Date Summary
Prepared: | 04 Feb 2019 |
| Trade Name of
Device: | 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 is | ||
| designed to remove and filtrate smoke | |||
| generated during electrosurgical and | |||
| laser procedures in the vicinity of its | |||
| source. | The VISICLEAR Smoke Evacuation System is | ||
| designed to remove and filter smoke, | |||
| aerosols produced during electrosurgical | |||
| and laser procedures. | Same | ||
| Direct Body Contact | |||
| Materials | Not intended to come in contact with | ||
| patient | Same | Same | |
| Energy used | Electrical current | Same | Same |
| Operational Settings | On/Off Switch, Suction level buttons for | ||
| Motor Control | Same | Same | |
| Intended marketed | |||
| accessories | Electrosurgical pencils, tubing, hoses & | ||
| adaptors - sterile and non sterile | Same | Same | |
| Filtration | The ULPA filter is 99.999% with | ||
| efficiency at 0.1 microns particle size | The ULPA-grade filter is 99.999% efficiency | ||
| at 0.1 to 0.2 micron particle size. | Same | ||
| Filter Life | 5 hours | 35 hours | Use life of the filter is established with performance |
| testing 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 instructed |
| to change the filter. | |||
| Electrical safety | Tested and compliant with IEC 60601-1 | ||
| and 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 result | ||
| in harmful temperatures tested and | |||
| compliant 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 to |
| effectively 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 |
6
*All values obtained from simulated use testing
7
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.