The Nebulae™ I 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, Minimally Invasive Vessel Harvesting.

Device Description

The Nebulae™ I 50 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) High Flow Insufflator has touch screen control and multiple operating modes. The System can be used for General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic, and Minimally Invasive Vessel Harvesting procedures.

AI/ML Overview

The Nebulae™ I 50 LPM Insufflator is a medical device designed to provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The acceptance criteria and the study proving the device meets these criteria are detailed below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Device Flow Rates	Bench testing in simulated use environment for all operating modes confirmed device performed within specified flow rates.
Fill Time (Abdomen Simulator)	Bench testing in simulated use environment proved the Nebulae™ I could fill an abdomen simulator within the specified time period.
Flow Accuracy	Bench testing proved the Nebulae™ I could maintain specified flow accuracy for the flow rates in all modes, performing within the specified flow accuracy range.
Overpressure Relief	Bench testing proved the Nebulae™ I relieves overpressure conditions of 5mmHg above the preset and returns to the preset within the specified time range. Tested with different size abdominal simulators (to address all modes and sizes of pediatric patients) and at all specified flow rates, the device relieved pressure within the specified time. This also includes the functional requirement of "Relieves over pressure conditions of 5mmHg above the preset and returns to the preset in three (3) seconds or less."
Comparative Flow Rate (vs. Predicate)	The Nebulae™ I was tested along with predicate devices using an 11mm trocar with a 10mm laparoscope. Highest flow rates measured were 32 LPM. (Implies satisfactory comparative performance).
Pediatric Mode Comparative Testing	Tested along with predicate device in pediatric mode (various weight modes, with Veress needle and trocar, appropriate simulated abdomen sizes). Response times to introduced/removed leaks and over/under pressure conditions were measured. Nebulae™ I performed as well as, or better than, the predicate device.
Tissue Desiccation Effect	Cross-comparison test with 40L Abdominal Insufflator at maximum flow rates (5mm trocar, 5mm laparoscopic instrument, moist bovine liver, 30 and 60-second exposures). Results showed negligible change to tissue surface and no perceivable depth of desiccation. Concluded that 50LPM and 40LPM insufflators were identical relative to tissue desiccation and drying.
Electrical Safety (IEC 60601-1:2005)	Device shown to conform to standard.
EMC (EN 60601-1-2:2007)	Device shown to conform to standard.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the numerical sample sizes for each test (e.g., number of units tested, number of simulated abdomens, number of tissue samples). The testing appears to be solely bench testing in a simulated use environment; therefore, the data provenance is not from human subjects/patients, but rather from laboratory/bench testing, typically conducted in the country of manufacture (implied to be the USA, based on the applicant's address). The studies are prospective in nature, as they were conducted to evaluate the performance of the newly developed device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. The described studies are purely bench testing and do not involve human interpretation or subjective assessment of results by experts in a clinical context to establish ground truth. Performance was measured objectively against pre-defined specifications or through comparative measurements with predicate devices.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human experts establishing ground truth or making subjective assessments requiring agreement, no adjudication method was used. The performance was determined by direct measurement and comparison with objective criteria.

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 conducted as this device is a hardware insufflator and does not involve human readers interpreting images or data where AI assistance would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes. All reported performance testing was conducted as standalone bench testing, evaluating the algorithm's control of the device's mechanical and gas delivery functions without human intervention in the device's operational performance measurements. The "algorithm" in this context refers to the device's internal microprocessor control logic.

7. The Type of Ground Truth Used

The ground truth used for these studies consisted of:

Pre-defined engineering specifications/performance ranges: For criteria like flow rates, fill time, flow accuracy, and overpressure relief.
Objective measurements: Direct quantitative measurements obtained during bench testing.
Comparative performance against predicate devices: Performance of the Nebulae™ I was measured and directly compared to the performance of legally marketed predicate devices under similar conditions. This established an "equivalency ground truth" for certain aspects.
Standard conformity: Adherence to recognized electrical safety (IEC 60601-1:2005) and EMC (EN 60601-1-2:2007) standards.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device, and the submission describes verification and validation testing for a solidified design, not the iterative training of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML development. The design, however, would have undergone extensive internal development and testing during its engineering phase, which could be considered analogous to "training" in a broad sense, but specific data sets for algorithm training are not relevant here.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As explained above, there is no "training set" in the AI/ML context for this device. The underlying engineering principles and design parameters were established through conventional medical device design and development practices.

Summary

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K120151
pg. 1 of 5
August 15, 2012

High Flow Insufflation Unit Nebulae™ I

AUG 1 7 2012

General Information

Applicant Name:

Northgate Technologies Inc. 1591 Scottsdale Court Elgin, IL 60123 Telephone: 224-856-2222 Fax: 847-608-9405

ontact Person

Casey Kurek Regulatory Manager Telephone: 224-856-2222 Fax: 847-608-9405 E-Mail: ckurek@northgate-tech.com

Manufacturer:

Northgate Technologies Inc. 1591 Scottsdale Court Elgin, IL 60123 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · Telephone: 224-856-2222 Fax: 847-608-9405 :

Registration #:

1450997

2. Device Identification

Device Trade Name: Common Name:

Classification Name:

Nebulae TM I 50 LPM Insufflator / REF# 7-650-00 Carbon Dioxide Insufflator for Laparoscopy and Endoscopic Vessel Harvesting

Insufflator, Laparoscopic 21 CFR 884.1730, Insufflator, Carbon Dioxide for Endoscope 21 CFR 876.1500

Regulatory Class:

Product Code:

HIF. FCX. OSV

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3. Predicate Device Information

	Device Name:	45L CORE Insufflator F114
Common Name:	Carbon Dioxide Insufflator for Laparoscopy andEndoscopic Vessel Harvesting
Manufacturer:	W.O.M. World of Medicine
510(k) No.	K063367

INSUFFLATOR,	Device Name:	40LPM ABDOMINA
	CATALOG #	72-00203-0
Common Name:		Insufflator
Manufacturer:	Northgate Technologies Inc.
510(k) No.		K022052

4. Device Description

The system includes the following major components:

· Selectable Power Supply, 100, 115 or 230 VAC + 10%, 47-63 Hz
· True Abdominal Pressure Sensing (TAP™) feature
· Variable Volume Alarm
· Recognizes Wall or Bottle CO2 Gas Source
· Touch Screen Buttons work in timed, auto increment / decrement manner
· Interfaces to control or work with data collection systems, such as a RS232
· Display indicates "Restriction"
· Supports a minimum of one (1) gas warmer
· Fifty (50) LPM at output port of the Insufflator when utilizing a standard Northgate style (#7-510-28) Tubing Set. Approximately 9 LPM at the Veress Needle, 22 LPM at most Trocars.

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· Relieves over pressure conditions of 5mmHg above the preset and returns to the preset in three (3) seconds or less.
The following are cleared medical devices that may be used with this device: tubing Sets, 7-510-28 (General Use) and 7-510-31 (TAP™ set that provides continuous pressure information when connected to the insufflator) cleared under K983326 on February 5, 1999; and the 6-820-00 (In-Line Warmer) cleared under K022052 on January 24, 2003.

5. Indications for Use

General Laparoscopic Pediatric Laparoscopic Bariatric Laparoscopic Minimally Invasive Vessel Harvesting
Typical Endoscopic Surgical Procedures requiring the need for CO2 Insufflation:

6. Technological Differences

The Nebulae™ I device is like the 40L Abdominal Insufflator (K022052) except it flows 50LPM out of a single output port, has a touchscreen, and has one warmer port.

The Nebulae™ I device is like the 45L CORE Insufflator F114 (K063367) except it flows 5LPM more, has Custom Mode, and does not contain a proprietary connection for a tubing set.

7. Performance Data

Both Design Verification and Design Validation have been completed.

Performance testing was completed to demonstrate that the Nebulae™ I functions as intended and performs as intended for safety purposes.

Device Flow Rates- Bench testing was done in a simulated use environment for all operating modes and the device performed within the specified flow rates.

Fill Time - Bench testing was done in a simulated use environment and proved that the Nebulae I could fill an abdomen simulator within the specified time period.

Flow Accuracy - Bench testing was done to prove that the Nebulae™ I could maintain specified flow accuracy for the flow rates in all modes and the device performed within the specified flow accuracy range.

Overpressure Relief - Bench testing was done to prove that the Nebulae™ I would relieve over pressure conditions of 5mmHg above the preset and return to the preset within the specified time range. The device was tested with different size abdominal simulators (to address all modes and sizes of pediatric patients) and at all flow rates specified, the device relieved pressure within the specified time range.

Comparative Flow Rate Testing - The predicate devices were tested along with the Nebulae ™ I to compare the flow rates of the devices using an 11mm trocar with a 10mm laparoscope. The highest flow rates measured were 32 LPM.

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K120151
Pg. 5 of 5

Pediatric Mode Comparative Testing - The Nebulae™ I was tested along with the predicate device in pediatric mode, in each of the weight modes, with a veress needle and also with a trocar. A simulated abdomen of an appropriate size for each weight mode was used. During testing in each of the weight modes, a leak was introduced and removed, and then overpressure and under pressure conditions were created. The response times were measured and compared with the predicate device and the Nebulae™ I was found to perform as well as, or better, than the predicate device.

Tissue Desiccation Effect Testing - The Nebulae™ I and the 40L Abdominal Insufflators were used in a cross comparison test to demonstrate the tissue desiccation or drying effect at their maximum flow rates while connected to a standard 5mm trocar. A typical 5mm laparoscopic instrument was inserted into the trocar sleeve to simulate an actual usage scenario. Moist bovine liver was used to show the drying effect.

Both Insufflators were set to allow their maximum achievable flow rates of CO2 to come in contact with the moist liver tissue samples. The gas flow was to remain on for 30 seconds and 60 seconds. The 5mm trocar sleeve distal opening was set in close proximity to the surface of the tissue sample. Results in both cases showed a negligible change to the tissue surface with no perceivable depth of desiccation. This was clearly evident in the crosssectional tissue samples. It was concluded that the 50LPM and the 40LPM insufflators described above were identical relative to tissue desiccation and drying.

The Nebulae™ I was tested and shown to conform to the following standards: Electrical Safety - IEC 60601-1:2005

EMC - EN 60601-1-2:2007

8. Conclusion

The different technological characteristics and information submitted to the FDA do not raise new questions of safety and efficacy. Testing has shown that the device is at least as safe and effective as the legally marked predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 17 2012

Ms. Casey Kurek Regulatory Manager Northgate Technologies Inc. 1591 Scottsdale Court ELGIN IL 60123

Re: K120151

Trade Name: Nebulae™ I 50 LPM Insufflator Regulation Number: 21 CFR § 884.1730 Regulation Name: Laparoscopic insufflator Regulatory Class: II Product Code: HIF, OSX, FCX Dated: August 2, 2012 Received: August 3, 2012

Dear Ms. Kurek:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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Page 2 -

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher, Ph.D.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Nebulae™ | 50 LPM Insufflator/ REF #7-650-00 Device Name:

Indications For Use:

General Laparoscopic

Pediatric Laparoscopic Bariatric Laparoscopic Minimally Invasive Vessel Harvesting

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Airns 222

(Division Sign-Oit)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K120151

Page 1 of _ 1

Regulation Number and Section

§ 884.1730 Laparoscopic insufflator.

(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.