(176 days)
Not Found
No
The description mentions a "microprocessor driven" device and "software validation" for basic functions like flow rate and occlusion detection. There is no mention of AI, ML, deep learning, or any algorithms that would suggest learning or complex pattern recognition beyond simple control logic.
No.
The device's intended use is to remove airborne particles and improve visualization during laparoscopic surgery, not to treat or diagnose a disease or condition directly.
No
The device is designed to remove airborne particles and surgical smoke to improve visualization during laparoscopic surgery. It does not provide any diagnostic information or interpret patient data for diagnosis.
No
The device description explicitly details hardware components including a pump, tubing sets, filters, and a microprocessor-driven, mains-powered device with a DC motor. The performance studies also include testing of hardware functionality and electrical safety.
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 airborne particles generated during laparoscopic surgery to improve visualization. This is a therapeutic/surgical support function, not a diagnostic one.
- Device Description: The device is a system for recirculating and filtering CO2 gas within the pneumoperitoneum. It physically removes smoke and particulates. This is a mechanical process, not a test performed on a biological sample to diagnose a condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device's function is to improve the surgical environment by clearing the field of vision, which is a direct support for the surgical procedure itself, not a diagnostic test.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FYD
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)
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pneumoperitoneum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
- Design Verification, Software Validation-Functionality; Flow Rate: 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. Verify that the device maintains a minimum flow rate of 10L/min, on each side of the disposable Tubing Set, throughout the two hours. Results: Pass.
- Design Verification, Software Validation-Functionality; Occlusion Detection: 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. 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. Results: Pass.
- Design Verification, Software Validation—Functionality, Essential Performance; In-Line Warmer: 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. 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. Results: Pass.
- Electrical Safety (IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint)): Standard test methods. Results: Pass.
- Electrical Safety – Electromagnetic Compatibility; Emissions: General, Harmonic, Flicker (IEC 60601-1-2:2014): Class A/ Group 1, IEC 61000-3-2:2014, IEC 61000-3-3:2013. Results: 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. Results: Pass.
- Biocompatibility (ISO 10993-1:2018): 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. Results: Pass.
- Sterilization Validation (ISO 11137-1:2006, ISO 11137-2:2006): Microbiological Validation of 25kGy Radiation Sterilization by ANSI/AAMI/ISO 11137-2 Method VDmax25. Results: Pass.
- Packaging Integrity (ISO 11607-1: 2006, ISO 11607-2: 2006, ISTA 3A:2018, Dye Penetration Test, Seal Strength Test, Pull strength Test): Results: Pass.
- Shipping and Storage: Condition the NEBULAE® SRS device per ISTA 3A:2018 and subsequently, per the shipping and storage environmental conditions of IEC 60601-1-11: 2015. Verify that the device still meets all the functional requirements that were previously verified in manufacturing (FQC). Results: Pass.
- Validation- Usability: Qualitative assessment of users' ability to perform operational tasks and troubleshoot clinical use scenarios in a simulated environment. Greater than 80% successful usability by subjects (clinicians). Results: Pass.
- Validation- Device Performance: Qualitative evaluation of surgical environment visual clarity while running the NEBULAE® SRS, during monopolar and bipolar electrocautery and ultrasonic coagulation, in a simulated environment. ≤ 20% of subjects (surgeons) disagree that the NEBULAE® SRS helped maintain visual clarity by removing smoke and particulates from the field of vision. Results: Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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, 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
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/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 Court
Elgin, Illinois 60123
Telephone: 224-856-2222
Fax: 847-608-9405 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Todd Gatto
Director of Quality Assurance and Regulatory Affairs
Telephone: 224-856-2250
Fax: 847-608-9405
Email: 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) |
4
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.
5
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 | ||
| Image: NEBULAE SRS device | LapEvac™ | ||
| Image: LapEvac device | different |
6
| 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 | ||
| peritoneal cavity | Recirculates CO2 gas within the | ||
| peritoneal cavity | Same |
7
| 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 | ||
| 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. | To remove airborne particles | ||
| generated by tissue combustion | |||
| during laparoscopic surgery via | |||
| filtration of gaseous media | |||
| contained within the distended | |||
| pneumoperitoneum in order to | |||
| significantly improve visualization. | |||
| LapEvac may be used in any | |||
| laparoscopic surgery, as | |||
| appropriate. | Same | ||
| Weight | Device: 8.6 lbs. (3.9 kg) | ||
| Disposable: 0.9 lbs (0.4 kg) | 0.84 lbs. (0.38 kg) | The | |
| disposable | |||
| weight is | |||
| 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 | |
| (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 | ||
| 99.999% efficacy | 0.1 μ ULPA activated carbon filter | ||
| 99.999% efficacy | Same | ||
| Tubing Connectivity | Attaches to standard luer lock fittings | Attaches to standard luer lock | |
| fittings | Same | ||
| Tubing Length | 120" of conjoined tubing | 24" of tubing on each end | Different |
| Power Source/Input | |||
| Voltage | Auto Voltage Adjustment for use in all | ||
| countries (100/240 V) | 4 AA Batteries | Different | |
| Sterilization Method | Device is Reusable | ||
| Disposable is sterilized by Gamma | |||
| Irradiation | Method not precisely known | Not Clear | |
| Heat Capable | In-line Gas Warmer as an optional | ||
| accessory | No | Different | |
| Condensation Control | One or two in-line fluid traps within the | ||
| Tubing Set | No | Different | |
| Operating Noise Level | ≤ 55 dB | ≤ 47 dB | Similar |
| Operational Life | Device: 6 years (7020 hours) | ||
| Disposable: ≥ 2 hours of uninterrupted | |||
| usage | 3.5 – 4 hours | Different | |
| Procedure Usage | All laparoscopic procedures that utilize | ||
| CO2 gas for insufflation | All laparoscopic procedures that | ||
| 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 | |||
| Detection | Automatic detection of occlusions | ||
| caused by gas blocking moisture | |||
| accumulations within the tubing line, | |||
| obstruction of the trocar sleeve, a kink | |||
| in the tubing line, or a disconnected | |||
| tubing line. | None | The | |
| NEBULAE® | |||
| SRS utilizes a | |||
| reusable | |||
| device to effect | |||
| air flow in the | |||
| disposable. | |||
| This device | |||
| also verifies | |||
| function, and | |||
| includes logic | |||
| for proper, and | |||
| safe operation. | |||
| The LAPEVAC | |||
| does not offer | |||
| such | |||
| functionality. |
8
9
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 | |||
| 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 | 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 | Pass. | ||
| Test Methodology | Purpose | Acceptance Criteria | Results |
| introducing the occlusion before and | |||
| after starting the flow. | 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. | |||
| 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) | |||
| 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 / 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 | Sterilization Validation | Microbiological Validation of | |
| 25kGy Radiation Sterilization by | Pass. | ||
| ISO 11137-2:2006 | |||
| Test Methodology | Purpose | Acceptance Criteria | Results |
| ISO 11607-1: 2006 | |||
| ISO 11607-2: 2006 | |||
| ISTA 3A:2018 | |||
| Dye Penetration Test | |||
| Seal Strength Test | |||
| Pull strength Test | Packaging Integrity | ANSI/AAMI/ISO 11137-2 Method | |
| VDmax25 | 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. |
10
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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.