SafeAir combi (SFR-combi-US)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 26, 2023 LiNA Medical ApS % Scott Blood Director of Regulatory Services MEDIcept. Inc. 200 Homer Ave Ashland, Massachusetts 01721 Re: K223932 Trade/Device Name: SafeAir combi (SFR-combi-US) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, FYD Dated: December 28, 2022 Received: March 30, 2022 Dear Scott Blood: 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. Although this letter refers to your product as a device, please be aware 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 {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed by Mark Mark Trumbore -S Date: 2023.04.26 14:06:27 Trumbore -S -04'00 Mark Trumbore, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Submission Number (if known) K223992 Device Name SafeAir combi (SFR-combi-US) #### Indications for Use (Describe) The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Date: Company: April 26, 2023 LiNA Medical ApS Formervangen 5 DK-2600 Glostrup, Denmark Jarosław Mrówczyński Regulatory Affairs Manager Email: imr@lina-medical.com Office number: +48 61 222 21 21 #### Official Contact: Scott Blood Director of Regulatory Services MEDIcept Inc. 200 Homer Avenue Ashland, MA 01721 Email: SBlood@medicept.com Office number: +1 978-729-5978 ## Proprietary or Trade Name: SafeAir combi | Common/Usual Name: | Electrosurgical cutting and coagulation device and accessories | |-------------------------------------------|----------------------------------------------------------------------------------------| | Classification Name: | Electrosurgical, Cutting & Coagulation & Accessories | | Regulation Number: | 21 CFR 878.4400, Class II<br>Classification Product Code: GEI, FYD | | Predicate Device:<br>Reference Predicate: | K143161: Covidien Force FX Generators<br>K182224: LiNA Medical Smoke Evacuator compact | #### Device Description: SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories. Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed. Formervangen 5 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "LiNA" in red, with the "i" in "LiNA" having a black dot above it. To the right of the word "LiNA" is a red target symbol. The target symbol has a dot in the center, and two curved lines around the dot. ## Indications for Use: The SafeAir Combi generator is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures. #### Substantial Equivalence: | | Subject Device<br>LiNA Medical | Predicate Device<br>Covidien | Reference device<br>LiNA Medical | Comparison | |--------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------| | | SafeAir Combi | Force FX Generators | SafeAir Smoke<br>Evacuator compact | | | | This Submission | K143161 | K182224 | | | Indications for<br>Use | The SafeAir Combi generator<br>is an electrosurgical generator<br>containing an integrated<br>surgical smoke evacuator. The<br>unit is intended to deliver high<br>frequency energy for cutting<br>and/or coagulating tissues<br>using monopolar and bipolar<br>tools in surgical procedures.<br>When used with an<br>electrosurgical pencil capable<br>of surgical smoke evacuation,<br>the console is also intended to<br>remove and filtrate smoke<br>generated during<br>electrosurgical procedures | The Force FX™<br>Electrosurgical<br>Generator is an<br>electrosurgical<br>generator containing<br>monopolar and bipolar<br>technology. It is<br>intended for use with<br>accessories during<br>surgical procedures<br>where the surgeon<br>requires electrosurgical<br>cutting (resecting,<br>dividing, or separating)<br>and coagulating<br>(hemostasis). | SafeAir Smoke Evacuator<br>compact is designed to<br>remove and filter smoke<br>generated during<br>electrosurgical and laser<br>procedures. | Same with<br>predicate device,<br>reference device | | | Subject Device<br>LiNA Medical<br>SafeAir Combi<br>This Submission | Predicate Device<br>Covidien<br>Force FX Generators<br>K143161 | Reference device<br>LiNA Medical<br>SafeAir Smoke<br>Evacuator compact<br>K182224 | Comparison | | Input power | 110 - 230 V, 50-60 Hz | 100 - 240 V, 50-60 Hz | 100-120V/220-240V,<br>50Hz/60Hz | Similar | | Energy output | HF energy for electrosurgery | HF energy for<br>electrosurgery | Not applicable | Identical | | Dimensions and<br>weight | 17 x 40 x 40 cm, 22 kg | 11 x 35.6 x 35.6 cm, 8.2<br>kg | 14 x 30 x 38, 13.5 kg | Different | | Working<br>conditions | Temperature: 10 to 35 °C<br>Relative Humidity: 15-75%,<br>non-condensing<br>Atmospheric Pressure: 800 to<br>1060 hPa | Temperature: 10 to 40<br>°C<br>Relative Humidity: 30-<br>75%<br>Atmospheric Pressure:<br>700 to 1060 hPa | Temperature: 10 to 35 °C<br>Relative Humidity: 30%-<br>75%, non-condensing<br>Atmospheric Pressure: n/a | Similar | | Transport and<br>storage | Circumstance Temperature: -<br>10°C to +60°C<br>Relative Humidity: 10% to<br>90%<br>Atmospheric Pressure: 500 to<br>1060 hPa | Circumstance<br>Temperature: -40 to +70<br>°C<br>Relative Humidity: 25-<br>85 %<br>Atmospheric Pressure:<br>500 to 1060 hPa | Circumstance<br>Temperature: -10 to 60 oC<br>Relative Humidity: 25-<br>85% non-condensing<br>Atmospheric Pressure: n/a | Similar | | Display | One LCD touchscreen min. 7<br>inch diagonal | No touchscreen, buttons<br>for power settings | No touchscreen, buttons<br>for power settings | Different | | Electrical<br>protective class | Class I | Class I | Class I | Identical | | Duty cycle | 25% on max power (10s<br>activation and 30s off) | 25% on max power (10s<br>activation and 30s off) | Not applicable | Identical | | CQM | Acceptable resistance range<br>(for monopolar activation):<br>- 10 to 130 Ohms<br>- or up to a 30% increase in the<br>initial measured contact<br>resistance<br>(whichever is less) | Acceptable resistance<br>range (for monopolar<br>activation):<br>- 5 to 135 Ohms<br>- or up to a 40%<br>increase in the initial<br>measured contact<br>resistance<br>(whichever is less) | Not applicable | Different | | Monopolar | ESU generator connects its<br>electrosurgical accessories and<br>a neutral ESU pad to form a<br>cyclic circuit, the HF current<br>generated from the generator<br>and through the accessory to<br>achieve CUT or COAG, and<br>then return to generator by the<br>neutral pad. | ESU generator connects<br>its electrosurgical<br>accessories and a<br>neutral ESU pad to<br>form a cyclic circuit, the<br>HF current generated<br>from the generator and<br>through the accessory to<br>achieve CUT or COAG,<br>and then return to<br>generator by the neutral<br>pad. | Not applicable | Identical | | Bipolar | HF current generated from the<br>generator and the cyclic circuit<br>formed between the two tips of<br>the bipolar forceps, the HF<br>power through the two tips to<br>work on patient obtaining<br>COAG, no need extra ESU<br>pad. | HF current generated<br>from the generator and<br>the cyclic circuit formed<br>between the two tips of<br>the bipolar forceps, the<br>HF power through the<br>two tips to work on<br>patient obtaining<br>COAG, no need extra<br>ESU pad. | Not applicable | Identical | | Subject Device<br>LiNA Medical<br>SafeAir Combi<br>This Submission | Predicate Device<br>Covidien<br>Force FX Generators<br>K143161 | Reference device<br>LiNA Medical<br>SafeAir Smoke<br>Evacuator compact<br>K182224 | Comparison | | | Output mode<br>MONOPOLAR | 2 Different CUT modes<br>CUT Pure:<br>- Power: 200 W max,<br>- Rated load (max): 400 Ω,<br>- Crest factor: 1.5<br>- Frequency: 472 kHz<br>CUT Blend:<br>- Power: 200 W max,<br>- Rated load (max): 400 Ω,<br>- Crest factor: 2.1<br>- Frequency: 472 kHz | 3 Different CUT modes<br>including<br>CUT Pure with<br>following parameters:<br>- Power: 300W max<br>- Rated load: 300 Ohm<br>- Crest Factor: 1.5<br>- Frequency: 390 kHz<br>and CUT Blend with<br>following parameters:<br>- Power: 200W max<br>- Rated load: 300 Ohm<br>- Crest Factor: 2.5<br>- Frequency: 390 kHz | Not applicable | Different | | | 2 Different COAG modes<br>COAG Fulg:<br>- Power: 120 W max,<br>- Rated load (max): 400 Ω,<br>- Crest factor: 6.6<br>- Frequency: 472 kHz<br>COAG Spray:<br>- Power: 120 W max,<br>- Rated load (max): 400 Ω,<br>- Crest factor: 7.5<br>- Frequency: 472 kHz | 4 Different COAG<br>Modes, including<br>COAG Fulgurate with<br>following parameters:<br>- Power: 120W max<br>- Rated load: 500 Ohm<br>- Crest Factor: 7.0<br>- Frequency: 470 kHz<br>COAG Spray with<br>following parameters:<br>- Power: 120W max<br>- Rated load: 500 Ohm<br>- Crest Factor: 8.0<br>- Frequency: 470 kHz | Not applicable | | | Output mode –<br>Bipolar | BIPOLAR:<br>- Power: 100 W max,<br>- Rated load (max): 100 Ω,<br>- Crest factor: 1.6<br>- Frequency: 472 kHz | 3 Different BiPolar<br>modes, including<br>BIPOLAR Standard<br>with following<br>parameters:<br>- Power: 70W max<br>- Rated load: 100 Ohms<br>- Crest factor: 1.5<br>- Frequency: 470 kHz | Not applicable | Different | | Instant response<br>technology | Automatically senses resistance<br>and adjusts the output voltage<br>to maintain a consistent effect<br>across different tissue density | Automatically senses<br>resistance and adjusts<br>the output voltage to<br>maintain a consistent<br>effect across different<br>tissue density | Not applicable | Similar | | Power ON self<br>diagnostics | After pressing ON/OFF button,<br>device initiates self testing<br>procedure, which verifies<br>correct functioning of the<br>device. If problems occur, then<br>alarm condition is highlighted<br>on screen, and generator cannot<br>be activated. | When the generator<br>senses a system alarm<br>conditions, an alarm<br>sounds and an alarm<br>number is displayed on<br>the front panel. A<br>system alarm condition<br>deactivates the | Not applicable | Similar | | | Subject Device<br>LiNA Medical<br>SafeAir Combi<br>This Submission | Predicate Device<br>Covidien<br>Force FX Generators<br>K143161 | Reference device<br>LiNA Medical<br>SafeAir Smoke<br>Evacuator compact<br>K182224 | Comparison | | Filtration rate | The ULPA filter is 99.999%<br>with efficiency at 0.1 microns<br>particle size, SFR-FIL-C filter | Not applicable | The ULPA filter is<br>99.999% with efficiency<br>at 0.1 microns particle<br>size, SFR-FIL-C filter | Identical to<br>reference device | | Filter Life | 5 hours | Not applicable | 5 hours | Identical to<br>reference device | | Levels of smoke<br>evacuation | 10 levels | Not applicable | 10 levels | Identical to<br>reference device | | Levels of smoke<br>evacuation stop<br>delay | 10 levels | Not applicable | 10 levels | Identical to<br>reference device | | Maximum flow<br>rate at filter<br>(claimed in IFU) | 110 l/min | Not applicable | 110 l/min | Identical to<br>reference device | | Maximum flow<br>rate measured on<br>pencil tip | 94,2 l/min | Not applicable | 97,8 l/min | Similar to<br>reference device | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "LiNA" in red font. The "i" in "LiNA" has a black dot above it. To the right of the word "LiNA" is a red target symbol. The target symbol has a vertical line going through the center of it. ಿ ಸ · www.lina-medical.com {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for LiNA Medical. The logo is primarily red and features the word "LiNA" in bold, capital letters. To the right of the word is a target symbol, with a dot in the center and concentric circles around it. The overall design is simple and professional. ಿ ಸ {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for LINA, which is written in red letters. The "i" in LINA has a black dot above it. To the right of the word LINA is a red target symbol. The target symbol has a vertical line going through the center of it. From the comparison above, the subject device and predicate device have similar intended use, are both prescription use, and have the same operating principle. The differences in the devices have been assessed and do not raise new questions of safety or effectiveness. ## Non-clinical performance testing: ## Electrical Safety: Electrical safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1, IEC 60601-1-2 and IEC 60601-2-2 to demonstrate the basic safety, essential performance and emissions and immunity characteristics of the device. The testing demonstrated the appropriate electrical safety and electromagnetic compatibility profile for the device. ## Bench / Performance Testing: Comparative performance testing included: - Human factors testing - Transportation simulation - Smoke evacuation functionality - Testing in accordance with FDA Guidance "Premarket Notification (510(k)) Submissions ● for Electrosurgical Devices for General Surgery" - Thermal effects on tissue 0 - ESU performance O - COM functionality ol - Accessories compatibility O The results demonstrated that the device performance was met and was substantially equivalent to the predicate device. ## Substantial Equivalence Conclusion LiNA Medical AnS · Formervangen 5 {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for LINA. The logo is red and white. The word "LINA" is in large, bold, red letters. To the right of the word is a red target symbol. The subject device and predicate device are intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. The smoke evacuation function is not a novel feature and there are several cleared devices already used in the US today. Smoke evacuation is recommended to be used in clinical procedures such as electrosurgery in which tissue smoke plume and aerosols can be generated due to concerns about potential carcinogenic effects. The technological characteristics between the subject and predicate devices are in most cases identical, for those cases where they are similar or different, those differences have been properly tested and evaluated. Design Verification and Validation activities carried out on the SafeAir combi device confirms that device meets specification and performs as intended. Based on above comparison and discussion, the SafeAir Combi is deemed as safe and effective as and substantially equivalent to the predicate device.