NEBULAE SRS Laparoscopic Surgical Smoke Removal System

K202944 · Northgate Technologies, Inc. · FYD · Mar 25, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202944
• Device Name: NEBULAE SRS Laparoscopic Surgical Smoke Removal System
• Applicant: Northgate Technologies, Inc.
• Product Code: FYD · General, Plastic Surgery
• Decision Date: Mar 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5070
• Device Class: Class 2

Intended Use

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.

Device Story

NEBULAE® SRS is a microprocessor-driven, mains-powered laparoscopic surgical smoke removal system. It recirculates CO2 gas within the pneumoperitoneum to remove smoke and particulates. The system comprises a reusable pump unit and a single-use, sterile tubing set containing a diaphragm pump, an in-line 0.1μ ULPA/activated carbon filter, and fluid traps. The pump unit is placed on a surgical trolley or IV pole in the OR. During surgery, the system draws CO2 from the patient, filters it, and returns it to the patient. An optional in-line gas warmer is available. The system provides continuous flow and includes automated occlusion detection (e.g., moisture, kinks, disconnected lines) with audiovisual alerts. Surgeons use the system to maintain visual clarity during procedures involving electrocautery or ultrasonic coagulation. The device benefits patients by maintaining a clear surgical field, potentially reducing procedure time and complications associated with poor visibility.

Clinical Evidence

Bench testing only. Testing included flow rate verification (min 10 L/min), occlusion detection functionality, in-line warmer performance, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), biocompatibility (ISO 10993), sterilization validation (ISO 11137), and packaging integrity. Usability validation and simulated surgical environment performance testing confirmed that >80% of clinicians successfully performed tasks and ≤20% of surgeons disagreed that the device maintained visual clarity during electrocautery/ultrasonic coagulation.

Technological Characteristics

Reusable pump unit (DC motor) and single-use sterile tubing set (DEHP-free PVC). Filtration: 0.1μ ULPA with activated carbon (99.999% efficacy). Flow: Continuous, min 10 L/min. Connectivity: Standard luer lock. Power: 100/240V auto-adjusting. Sterilization: Gamma irradiation for disposables. Software: Microprocessor-controlled with occlusion detection logic and user interface alerts. Dimensions: 8.6 lbs (pump), 0.9 lbs (disposable).

Indications for Use

Indicated for patients undergoing laparoscopic surgery requiring removal of airborne particles generated by tissue combustion from the pneumoperitoneum to improve visualization.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MEDTEK DEVICES, INC. LAPEVAC, Filtration device for the Peritoneum (K052797)

Submission Summary (Full Text)

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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 25, 2021

Northgate Technologies Inc. Todd Gatto Director of Quality Assurance and Regulatory Affairs 1591 Scottsdale Court Elgin, Illinois 60123

Re: K202944

Trade/Device Name: NEBULAE SRS Laparoscopic Surgical Smoke Removal System Regulation Number: 21 CFR 878.5070 Regulation Name: Air-Handling Apparatus For A Surgical Operating Room Regulatory Class: Class II Product Code: FYD Dated: February 25, 2021 Received: February 26, 2021

Dear Todd Gatto:

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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K202944

Device Name

NEBULAE® SRS Laparoscopic Surgical Smoke Removal System

Indications for Use (Describe)

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.

Type of Use (Select one or both, as applicable)

| <input checked="true" type="checkbox"/> Exempt Activities (If 1.077, 101-2, or 101-3, please specify): |
|--------------------------------------------------------------------------------------------------------|
| <input type="checkbox"/> For-Hire Operations (1.077) |

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 – K202944

| Submitter: | Northgate Technologies Inc.<br>1591 Scottsdale Court<br>Elgin, Illinois 60123<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Todd Gatto<br>Director of Quality Assurance and Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Preparation Date: | Tuesday, March 23, 2021 |
| Registration #: | 1450997 |
| Trade Name: | NEBULAE® SRS Laparoscopic Surgical Smoke Removal System / 7-700-00 |
| Common Name: | Laparoscopic Smoke Removal System |
| Classification Name: | Apparatus, Exhaust, Surgical 21 C.F.R. 878.5070 |
| Regulatory Class: | II |
| Product Code(s): | FYD |
| Predicate Devices: | MEDTEK DEVICES, INC. LAPEVAC, Filtration device for the Peritoneum (K052797)<br>MEDTEK DEVICES |
| Device Description: | This 510(k) submission for the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System (henceforth referred to as NEBULAE® SRS) covers the following product codes:<br>• NEBULAE® SRS Pump (7-700-00)<br>• NEBULAE® SRS CO₂ Gas Filtration Tubing Sets (7-510-57) |

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The NEBULAE® SRS is intended to recirculate CO2 gas in the pneumoperitoneum whilst removing surgical smoke during laparoscopic procedures. The system consists of two parts: a Pump and dedicated singleuse, sterile Tubing Sets.

The NEBULAE® SRS Pump is a microprocessor driven, mains-powered device containing a DC motor. The single-use, disposable Tubing Set consists of an integrated cartridge, containing a diaphragm pump, an in-line ultra-low particulate air (ULPA) with activated carbon filter, fluid trap(s), 10 feet of DEHP-free PVC tubing and two connectors for connecting the tubing to the trocars. The NEBULAE® SRS Pump's DC motor drives the pump head in the Tubing Set's cartridge to create the flow of CO2 gas from the patient's pneumoperitoneum, through the fluid trap(s) and filter before re-entering the patient.

The NEBULAE® SRS Pump can be positioned on a level surface (e.g. a surgical trolley in the operating room) or fixed to a vertical IV pole using a dedicated bracket, which is available as an accessory (See VOLUME 011 for further information).

The re-circulating CO2 gas can also be warmed by the addition of an in-line gas warmer, also available as an optional accessory.

Indications for Use: To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.

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Image /page/5/Picture/0 description: The image shows the logo for Northgate Technologies, Inc. The logo features the letters "NTI" in a bold, dark blue font, with a curved teal line above the letters and a teal dot above the "I". Below the letters, the words "Northgate Technologies, Inc." are written in a smaller, dark blue font.

1591 Scottsdale Court Elgin, IL 60123 847.608.8900 Main 847.608.9405 Fax www.ntisurgical.com

## Technological Characteristic Comparison Table:

In the table below is a technological comparison between the subject device and the predicate device.

| Manufacturer | Northgate Technologies, Inc. | MEDTECH DEVICES | Comparison |
|----------------------|-------------------------------------------|-----------------------------------|------------|
| Catalog Number | 7-700-00 | LAPEVAC | different |
| FDA Clearance 510(k) | K202944 | K052797 | different |
| Photo | NEBULAE® SRS<br>Image: NEBULAE SRS device | LapEvac™<br>Image: LapEvac device | different |

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| Manufacturer | Northgate Technologies, Inc. | MEDTECH DEVICES | Comparison |
|----------------------|------------------------------------------------------|------------------------------------------------------|------------|
| Catalog Number | 7-700-00 | LAPEVAC | different |
| FDA Clearance 510(k) | K202944 | K052797 | different |
| Functionality | Recirculates CO2 gas within the<br>peritoneal cavity | Recirculates CO2 gas within the<br>peritoneal cavity | Same |

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| Manufacturer | Northgate Technologies, Inc. | MEDTECH DEVICES | Comparison |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Catalog Number | 7-700-00 | LAPEVAC | different |
| FDA Clearance 510(k) | K202944 | K052797 | different |
| Indications for Use | To remove airborne particles generated<br>by tissue combustion during<br>laparoscopic surgery via filtration of<br>gaseous media contained within the<br>distended pneumoperitoneum in order<br>to improve visualization. NEBULAE®<br>SRS may be used in any laparoscopic<br>surgery, as appropriate. | To remove airborne particles<br>generated by tissue combustion<br>during laparoscopic surgery via<br>filtration of gaseous media<br>contained within the distended<br>pneumoperitoneum in order to<br>significantly improve visualization.<br>LapEvac may be used in any<br>laparoscopic surgery, as<br>appropriate. | Same |
| Weight | Device: 8.6 lbs. (3.9 kg)<br>Disposable: 0.9 lbs (0.4 kg) | 0.84 lbs. (0.38 kg) | The<br>disposable<br>weight is<br>similar. |
| Manufacturer | Northgate Technologies, Inc. | MEDTECH DEVICES | Comparison |
| Catalog Number | 7-700-00 | LAPEVAC | different |
| FDA Clearance 510(k) | K202944 | K052797 | different |
| Controls and Interface | Full Color, Touch Screen Technology | Toggle Power Switch | different |
| Configuration | Reusable Device + Disposable Tubing | Self-contained disposable<br>(Device + Tubing) | Different |
| Flow Range | Min. 10 L/min* | 4 L/min | Different |
| Flow Characteristics | Continuous Flow | Continuous Flow | Same |
| Gas Filtration | 0.1 μ ULPA activated carbon filter<br>99.999% efficacy | 0.1 μ ULPA activated carbon filter<br>99.999% efficacy | Same |
| Tubing Connectivity | Attaches to standard luer lock fittings | Attaches to standard luer lock<br>fittings | Same |
| Tubing Length | 120" of conjoined tubing | 24" of tubing on each end | Different |
| Power Source/Input<br>Voltage | Auto Voltage Adjustment for use in all<br>countries (100/240 V) | 4 AA Batteries | Different |
| Sterilization Method | Device is Reusable<br>Disposable is sterilized by Gamma<br>Irradiation | Method not precisely known | Not Clear |
| Heat Capable | In-line Gas Warmer as an optional<br>accessory | No | Different |
| Condensation Control | One or two in-line fluid traps within the<br>Tubing Set | No | Different |
| Operating Noise Level | ≤ 55 dB | ≤ 47 dB | Similar |
| Operational Life | Device: 6 years (7020 hours)<br>Disposable: ≥ 2 hours of uninterrupted<br>usage | 3.5 – 4 hours | Different |
| Procedure Usage | All laparoscopic procedures that utilize<br>CO2 gas for insufflation | All laparoscopic procedures that<br>utilize CO2 gas for insufflation | Same |
| Manufacturer | Northgate Technologies, Inc. | MEDTECH DEVICES | Comparison |
| Catalog Number | 7-700-00 | LAPEVAC | different |
| FDA Clearance 510(k) | K202944 | K052797 | different |
| Flow Occlusion<br>Detection | Automatic detection of occlusions<br>caused by gas blocking moisture<br>accumulations within the tubing line,<br>obstruction of the trocar sleeve, a kink<br>in the tubing line, or a disconnected<br>tubing line. | None | The<br>NEBULAE®<br>SRS utilizes a<br>reusable<br>device to effect<br>air flow in the<br>disposable.<br>This device<br>also verifies<br>function, and<br>includes logic<br>for proper, and<br>safe operation.<br>The LAPEVAC<br>does not offer<br>such<br>functionality. |

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## Summary of Non-clinical Testing:

Shown below is the non-clinical testing with the subject device to demonstrate that the subject device's
performance testing met the acceptance criteria of the standard descr

| Test Methodology | Purpose | Acceptance Criteria | Results |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Run the NEBULAE® SRS device for<br>two hours, with the two tubing lines<br>connected to flow meters, connected<br>to two standard laparoscopic trocars,<br>inserted into a laparoscopy<br>simulation pressure chamber,<br>insufflated with CO2 gas. Log the<br>flow rate through each side of the<br>Tubing Set. | Design Verification, Software<br>Validation-<br>Functionality; Flow Rate | Verify that the device maintains a<br>minimum flow rate of 10L/min, on<br>each side of the disposable<br>Tubing Set, throughout the two<br>hours. | Pass. |
| Connect the two NEBULAE® SRS<br>tubing lines connected to two<br>standard laparoscopic trocars, and<br>introduce various sources of<br>occlusion to the flow. Test | Design Verification, Software<br>Validation-<br>Functionality; Occlusion<br>Detection | Verify that the device detects<br>each of the following sources of<br>occlusion, stops flow, and<br>produces an audiovisual alert:<br>gas blocking moisture | Pass. |
| Test Methodology | Purpose | Acceptance Criteria | Results |
| introducing the occlusion before and<br>after starting the flow. | | accumulations within the tubing<br>line, closure of the trocar valve,<br>obstruction of the trocar cannula,<br>a kink in the tubing line, or a<br>disconnected tubing line. | |
| Connect the in-line gas warmer to<br>the device, and use a thermal<br>camera to measure the temperature<br>of the in-line gas warmer.<br>Introduce each of the various fault<br>conditions to the warmer. | Design Verification, Software<br>Validation—<br>Functionality, Essential<br>Performance; In-Line Warmer | Verify that the in-line warmer<br>reaches and maintains the set<br>temperature.<br>Verify that the user interface<br>generates the designed<br>audiovisual alert for each warmer<br>fault condition. | Pass. |
| IEC 60601-1:2005, COR1:2006,<br>COR2:2007, AMD1:2012<br>(or IEC 60601-1:2012 reprint)<br>IEC 60601-1-2:2014 | Electrical Safety | Test procedure: Informative.<br>Standard test methods. | Pass. |
| | Electrical Safety –<br>Electromagnetic Compatibility;<br>Emissions:<br>General, Harmonic, Flicker | Class A/ Group 1,<br>IEC 61000-3-2:2014,<br>IEC 61000-3-3:2013 | Pass. |
| | Electrical Safety –<br>Electromagnetic Compatibility;<br>Immunity:<br>Electrostatic Discharge,<br>Radiated Electromagnetic,<br>Fast Transient, Surge,<br>Conducted, Magnetic Field,<br>Voltage Dips/ Interruptions/<br>Variations/fluctuations | IEC 61000-4-2,<br>IEC 61000-4-3,<br>IEC 61000-4-4,<br>IEC 61000-4-5,<br>IEC 61000-4-6,<br>IEC 61000-4-8,<br>IEC 61000-4-11 | Pass. |
| ISO 10993-1:2018 | Biocompatibility | ISO 10993-5:2009 /(R) 2014:<br>Fluid Extract / L929<br>Mouse Fibroblast<br>(Preliminary<br>Assessment) and Fluid Extract /<br>L929<br>Mouse Fibroblast<br>ISO 10993-10:2010 /(R)2014:<br>Dermal Sensitization<br>Guinea Pig<br>Maximization<br>(Cottonseed Oil and 0.9% NaCl)<br>and Intracutaneous Test<br>ISO 10993-11:2017: Rabbit<br>Pyrogen Test and Acute Systemic<br>Toxicity Test | Pass. |
| ISO 11137-1:2006 | Sterilization Validation | Microbiological Validation of<br>25kGy Radiation Sterilization by | Pass. |
| ISO 11137-2:2006 | | | |
| Test Methodology | Purpose | Acceptance Criteria | Results |
| ISO 11607-1: 2006<br>ISO 11607-2: 2006<br>ISTA 3A:2018<br>Dye Penetration Test<br>Seal Strength Test<br>Pull strength Test | Packaging Integrity | ANSI/AAMI/ISO 11137-2 Method<br>VDmax25 | Pass. |
| Condition the NEBULAE® SRS<br>device per ISTA 3A:2018 and<br>subsequently, per the shipping and<br>storage environmental conditions of<br>IEC 60601-1-11: 2015. | Shipping and Storage | Verify that the device still meets<br>all the functional requirements<br>that were previously verified in<br>manufacturing (FQC). | Pass. |
| Qualitative assessment of users'<br>ability to perform operational tasks<br>and troubleshoot clinical use<br>scenarios in a simulated<br>environment. | Validation- Usability | Greater than 80% successful<br>usability by subjects (clinicians) | Pass. |
| Qualitative evaluation of surgical<br>environment visual clarity while<br>running the NEBULAE® SRS, during<br>monopolar and bipolar<br>electrocautery and ultrasonic<br>coagulation, in a simulated<br>environment. | Validation-<br>Device Performance | ≤ 20% of subjects (surgeons)<br>disagree that the NEBULAE®<br>SRS helped maintain visual clarity<br>by removing smoke and<br>particulates from the field of<br>vision. | Pass. |

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### Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.