(176 days)
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.
This 510(k) submission for the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System (henceforth referred to as NEBULAE® SRS) covers the following product codes:
• NEBULAE® SRS Pump (7-700-00)
• NEBULAE® SRS CO₂ Gas Filtration Tubing Sets (7-510-57)
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.
The provided text describes the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System. It primarily focuses on the device's design, intended use, and non-clinical testing to demonstrate its performance and substantial equivalence to a predicate device. This document is a 510(k) summary, which is a premarket notification to the FDA. As such, it details non-clinical testing, not necessarily clinical studies involving human performance or diagnostic accuracy.
Therefore, many of the requested details, particularly those related to human-in-the-loop performance, ground truth establishment for a test set, expert consensus, and multi-reader multi-case studies, are not applicable or available in this document, as it concerns a physical medical device for smoke removal, not a diagnostic AI/CADe/CADx system.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Run the NEBULAE® SRS device for two hours, with the two tubing lines connected to flow meters, connected to two standard laparoscopic trocars, inserted into a laparoscopy simulation pressure chamber, insufflated with CO2 gas. Log the flow rate through each side of the Tubing Set. | Design Verification, Software Validation - Functionality; Flow Rate | Verify that the device maintains a minimum flow rate of 10L/min, on each side of the disposable Tubing Set, throughout the two hours. | Pass. |
| Connect the two NEBULAE® SRS tubing lines connected to two standard laparoscopic trocars, and introduce various sources of occlusion to the flow. Test introducing the occlusion before and after starting the flow. | Design Verification, Software Validation - Functionality; Occlusion Detection | Verify that the device detects each of the following sources of occlusion, stops flow, and produces an audiovisual alert: gas blocking moisture accumulations within the tubing line, closure of the trocar valve, obstruction of the trocar cannula, a kink in the tubing line, or a disconnected tubing line. | Pass. |
| Connect the in-line gas warmer to the device, and use a thermal camera to measure the temperature of the in-line gas warmer. Introduce each of the various fault conditions to the warmer. | Design Verification, Software Validation— Functionality, Essential Performance; In-Line Warmer | Verify that the in-line warmer reaches and maintains the set temperature. Verify that the user interface generates the designed audiovisual alert for each warmer fault condition. | Pass. |
| IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) | Electrical Safety | Test procedure: Informative. Standard test methods. | Pass. |
| IEC 60601-1-2:2014 (Emissions) | Electrical Safety – Electromagnetic Compatibility; Emissions: General, Harmonic, Flicker | Class A/ Group 1, IEC 61000-3-2:2014, IEC 61000-3-3:2013 | Pass. |
| IEC 60601-1-2:2014 (Immunity) | Electrical Safety – Electromagnetic Compatibility; Immunity: Electrostatic Discharge, Radiated Electromagnetic, Fast Transient, Surge, Conducted, Magnetic Field, Voltage Dips/ Interruptions/ Variations/fluctuations | IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000-4-11 | Pass. |
| ISO 10993-1:2018 | Biocompatibility | ISO 10993-5:2009 /(R) 2014: Fluid Extract / L929 Mouse Fibroblast (Preliminary Assessment) and Fluid Extract / L929 Mouse Fibroblast; ISO 10993-10:2010 /(R)2014: Dermal Sensitization Guinea Pig Maximization (Cottonseed Oil and 0.9% NaCl) and Intracutaneous Test; ISO 10993-11:2017: Rabbit Pyrogen Test and Acute Systemic Toxicity Test | Pass. |
| ISO 11137-1:2006, ISO 11137-2:2006 | Sterilization Validation | Microbiological Validation of 25kGy Radiation Sterilization by ANSI/AAMI/ISO 11137-2 Method VDmax25 | Pass. |
| ISO 11607-1: 2006, ISO 11607-2: 2006, ISTA 3A:2018, Dye Penetration Test, Seal Strength Test, Pull strength Test | Packaging Integrity | (Implicitly, to meet these standards) | Pass. |
| Condition the NEBULAE® SRS device per ISTA 3A:2018 and subsequently, per the shipping and storage environmental conditions of IEC 60601-1-11: 2015. | Shipping and Storage | Verify that the device still meets all the functional requirements that were previously verified in manufacturing (FQC). | Pass. |
| Qualitative assessment of users' ability to perform operational tasks and troubleshoot clinical use scenarios in a simulated environment. | Validation- Usability | Greater than 80% successful usability by subjects (clinicians) | Pass. |
| Qualitative evaluation of surgical environment visual clarity while running the NEBULAE® SRS, during monopolar and bipolar electrocautery and ultrasonic coagulation, in a simulated environment. | Validation- Device Performance | ≤ 20% of subjects (surgeons) disagree that the NEBULAE® SRS helped maintain visual clarity by removing smoke and particulates from the field of vision. | Pass. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical performance and usability testing in simulated environments.
- Performance/Functionality Tests: The sample size for device functionality tests (flow rate, occlusion detection, in-line warmer) is not explicitly stated as a number of distinct units tested, but the results indicate successful verification against stated criteria. These are engineering/device performance tests, not data sets for an algorithm.
- Usability Study: The acceptance criteria mentions "subjects (clinicians)," implying human participants. The specific number of subjects is not provided.
- Device Performance (Visual Clarity) Study: The acceptance criteria mentions "subjects (surgeons)," implying human participants. The specific number of subjects is not provided.
- Data Provenance: The studies are described as "simulated environments" and "non-clinical testing." No information is provided regarding country of origin or whether it's retrospective or prospective, as these are device performance tests, not clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the document describes a physical medical device for smoke removal, not a diagnostic AI/CADe/CADx system that would typically require expert-established ground truth for a test set. The "ground truth" for these tests is based on objective measurements of device performance, adherence to standards, and qualitative user feedback in simulated settings.
For the "Usability" and "Device Performance" (visual clarity) qualitative assessments, the "ground truth" is based on the subjects' (clinicians/surgeons) direct experience and agreement/disagreement with the device's performance in the simulated environment. The number and qualifications of these subjects (clinicians/surgeons) are not specified beyond their professional titles.
4. Adjudication Method for the Test Set
This section is not applicable as the testing described focuses on device functionality and usability in simulated environments, not a diagnostic task requiring adjudication of expert opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI algorithms where human readers' performance is evaluated with and without AI assistance across multiple cases. The NEBULAE® SRS is a smoke removal system, not a diagnostic imaging device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This section is not applicable in the context of an AI algorithm. The device itself (NEBULAE® SRS pump and tubing set) has standalone performance characteristics (e.g., flow rate, occlusion detection, in-line warmer function) that were tested. These are device-specific functions, not an "algorithm" in the typical sense of AI/machine learning.
7. The Type of Ground Truth Used
The "ground truth" for the tests is derived from:
- Objective device performance measurements: E.g., maintaining a minimum flow rate, correctly detecting occlusions, maintaining set temperature for the warmer.
- Adherence to recognized industry standards: Such as IEC 60601 series for electrical safety and electromagnetic compatibility, ISO 10993 for biocompatibility, and ISO 11137 for sterilization.
- Qualitative user feedback: For usability (successful task completion) and perceived visual clarity improvement by clinicians/surgeons in simulated settings.
There is no "pathology" or "outcomes data" ground truth as this is a non-diagnostic device.
8. The Sample Size for the Training Set
This section is not applicable. The NEBULAE® SRS is a physical medical device. It is not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for an AI/machine learning algorithm.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Exempt Activities (If 1.077, 101-2, or 101-3, please specify): |
|---|
| 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.1591 Scottsdale CourtElgin, Illinois 60123Telephone: 224-856-2222Fax: 847-608-9405 |
|---|---|
| Contact Person: | Todd GattoDirector of Quality Assurance and Regulatory AffairsTelephone: 224-856-2250Fax: 847-608-9405Email: TGatto@NTISurgical.com |
| 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)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:• NEBULAE® SRS Pump (7-700-00)• 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® SRSImage: NEBULAE SRS device | LapEvac™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 theperitoneal cavity | Recirculates CO2 gas within theperitoneal 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 generatedby tissue combustion duringlaparoscopic surgery via filtration ofgaseous media contained within thedistended pneumoperitoneum in orderto improve visualization. NEBULAE®SRS may be used in any laparoscopicsurgery, as appropriate. | To remove airborne particlesgenerated by tissue combustionduring laparoscopic surgery viafiltration of gaseous mediacontained within the distendedpneumoperitoneum in order tosignificantly improve visualization.LapEvac may be used in anylaparoscopic surgery, asappropriate. | Same |
| Weight | Device: 8.6 lbs. (3.9 kg)Disposable: 0.9 lbs (0.4 kg) | 0.84 lbs. (0.38 kg) | Thedisposableweight issimilar. |
| 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(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 filter99.999% efficacy | 0.1 μ ULPA activated carbon filter99.999% efficacy | Same |
| Tubing Connectivity | Attaches to standard luer lock fittings | Attaches to standard luer lockfittings | Same |
| Tubing Length | 120" of conjoined tubing | 24" of tubing on each end | Different |
| Power Source/InputVoltage | Auto Voltage Adjustment for use in allcountries (100/240 V) | 4 AA Batteries | Different |
| Sterilization Method | Device is ReusableDisposable is sterilized by GammaIrradiation | Method not precisely known | Not Clear |
| Heat Capable | In-line Gas Warmer as an optionalaccessory | No | Different |
| Condensation Control | One or two in-line fluid traps within theTubing Set | No | Different |
| Operating Noise Level | ≤ 55 dB | ≤ 47 dB | Similar |
| Operational Life | Device: 6 years (7020 hours)Disposable: ≥ 2 hours of uninterruptedusage | 3.5 – 4 hours | Different |
| Procedure Usage | All laparoscopic procedures that utilizeCO2 gas for insufflation | All laparoscopic procedures thatutilize 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 OcclusionDetection | Automatic detection of occlusionscaused by gas blocking moistureaccumulations within the tubing line,obstruction of the trocar sleeve, a kinkin the tubing line, or a disconnectedtubing line. | None | TheNEBULAE®SRS utilizes areusabledevice to effectair flow in thedisposable.This devicealso verifiesfunction, andincludes logicfor proper, andsafe operation.The LAPEVACdoes not offersuchfunctionality. |
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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 fortwo hours, with the two tubing linesconnected to flow meters, connectedto two standard laparoscopic trocars,inserted into a laparoscopysimulation pressure chamber,insufflated with CO2 gas. Log theflow rate through each side of theTubing Set. | Design Verification, SoftwareValidation-Functionality; Flow Rate | Verify that the device maintains aminimum flow rate of 10L/min, oneach side of the disposableTubing Set, throughout the twohours. | Pass. |
| Connect the two NEBULAE® SRStubing lines connected to twostandard laparoscopic trocars, andintroduce various sources ofocclusion to the flow. Test | Design Verification, SoftwareValidation-Functionality; OcclusionDetection | Verify that the device detectseach of the following sources ofocclusion, stops flow, andproduces an audiovisual alert:gas blocking moisture | Pass. |
| Test Methodology | Purpose | Acceptance Criteria | Results |
| introducing the occlusion before andafter starting the flow. | accumulations within the tubingline, closure of the trocar valve,obstruction of the trocar cannula,a kink in the tubing line, or adisconnected tubing line. | ||
| Connect the in-line gas warmer tothe device, and use a thermalcamera to measure the temperatureof the in-line gas warmer.Introduce each of the various faultconditions to the warmer. | Design Verification, SoftwareValidation—Functionality, EssentialPerformance; In-Line Warmer | Verify that the in-line warmerreaches and maintains the settemperature.Verify that the user interfacegenerates the designedaudiovisual alert for each warmerfault condition. | Pass. |
| IEC 60601-1:2005, COR1:2006,COR2:2007, AMD1:2012(or IEC 60601-1:2012 reprint)IEC 60601-1-2:2014 | Electrical Safety | Test procedure: Informative.Standard test methods. | Pass. |
| Electrical Safety –Electromagnetic Compatibility;Emissions:General, Harmonic, Flicker | Class A/ Group 1,IEC 61000-3-2:2014,IEC 61000-3-3:2013 | Pass. | |
| Electrical Safety –Electromagnetic Compatibility;Immunity:Electrostatic Discharge,Radiated Electromagnetic,Fast Transient, Surge,Conducted, Magnetic Field,Voltage Dips/ Interruptions/Variations/fluctuations | IEC 61000-4-2,IEC 61000-4-3,IEC 61000-4-4,IEC 61000-4-5,IEC 61000-4-6,IEC 61000-4-8,IEC 61000-4-11 | Pass. | |
| ISO 10993-1:2018 | Biocompatibility | ISO 10993-5:2009 /(R) 2014:Fluid Extract / L929Mouse Fibroblast(PreliminaryAssessment) and Fluid Extract /L929Mouse FibroblastISO 10993-10:2010 /(R)2014:Dermal SensitizationGuinea PigMaximization(Cottonseed Oil and 0.9% NaCl)and Intracutaneous TestISO 10993-11:2017: RabbitPyrogen Test and Acute SystemicToxicity Test | Pass. |
| ISO 11137-1:2006 | Sterilization Validation | Microbiological Validation of25kGy Radiation Sterilization by | Pass. |
| ISO 11137-2:2006 | |||
| Test Methodology | Purpose | Acceptance Criteria | Results |
| ISO 11607-1: 2006ISO 11607-2: 2006ISTA 3A:2018Dye Penetration TestSeal Strength TestPull strength Test | Packaging Integrity | ANSI/AAMI/ISO 11137-2 MethodVDmax25 | Pass. |
| Condition the NEBULAE® SRSdevice per ISTA 3A:2018 andsubsequently, per the shipping andstorage environmental conditions ofIEC 60601-1-11: 2015. | Shipping and Storage | Verify that the device still meetsall the functional requirementsthat were previously verified inmanufacturing (FQC). | Pass. |
| Qualitative assessment of users'ability to perform operational tasksand troubleshoot clinical usescenarios in a simulatedenvironment. | Validation- Usability | Greater than 80% successfulusability by subjects (clinicians) | Pass. |
| Qualitative evaluation of surgicalenvironment visual clarity whilerunning the NEBULAE® SRS, duringmonopolar and bipolarelectrocautery and ultrasoniccoagulation, in a simulatedenvironment. | Validation-Device Performance | ≤ 20% of subjects (surgeons)disagree that the NEBULAE®SRS helped maintain visual clarityby removing smoke andparticulates from the field ofvision. | 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.
§ 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.