The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The Nexcore GI Insufflator allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the light source of the endoscopic equipment.

Device Description

The Nexcore GI Insufflator is a reusable electronic medical device that delivers CO2, via a gastrointestinal (GI) endoscope, to provide improved visualization, increase patient comfort, and increase procedure efficiency during GI endoscopic procedures. The insufflator operates by receiving CO2 from a pressurized cylinder or hospital infrastructure supply and regulating it down in stages to a lower pressure by means of primary and secondary regulators. Each stage of pressure, including the output pressure, has a pressure relief valve as a redundant safety backup for the regulator system. The flow rate is controlled by an electronically controlled proportional valve, which utilizes differential pressure across an in-line orifice to measure flow rate. The output flow rate is user adjustable with four pre-defined settings: high, medium, low and ultra-low.

The device contains software that receives inputs from a touchscreen user interface and controls the operation of the device, including the delivery of CO2 to the endoscope. There are no direct patient-contacting components in this device, other than the delivered CO2 gas. The device is reusable and is not sterile. The Nexcore GI Insufflator is used in hospitals and outpatient endoscopy suites. The device operates from mains power.

There is one model (NX-350) of this device. The accessories sold with the device are the line (power) cord and a pin-indexed high pressure hose for CO2 cylinder connection.

The Nexcore GI Insufflator is used with commercially available, separately cleared devices, including a GI endoscope and tube set. The appropriate compatible tube set is intended to provide CO2 or air (if CO2 is not used) to an endoscope for endoscopic procedures and must have a ≤0.2 micron hydrophobic filter, check valve, and luer fittings at both ends. The tubing ID must be sufficient to deliver 4L/min.

AI/ML Overview

The provided text describes the Nexcore GI Insufflator, a device designed to use CO2 as a distention medium in the gastrointestinal tract during endoscopic procedures. The document is a 510(k) premarket notification approval, establishing substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might see in a detailed performance study for an AI algorithm. Instead, it describes compliance with various standards and functional equivalence to a predicate device. The "acceptance criteria" are implied by the standards and the comparison to the predicate.

Acceptance Criterion (Implied)	Reported Device Performance
Functional Equivalence to Predicate Device	The proposed device and predicate device (Bracco CO2MPACT Endoscopic Insufflator) have identical intended uses and identical principles of operation. Fundamental technological characteristics are the same. Specifications are substantially equivalent, with only minor differences not raising different safety/effectiveness questions. Performance data demonstrate safety and effectiveness.
Output Pressure Control / Max Delivered Pressure	Nexcore GI Insufflator limits output pressure to 5psi (by controlling flow rate). Maximum delivered pressure does not exceed average anatomical maximum pressure for the GI tract.
Overpressure Safety	Staged/redundant overpressure method: audible alarm/on-screen alert at 7.5psi; shutdown switch at 8psi; mechanical relief valve opens at 10psi. (Predicate has mechanical relief valve at 7.25psi).
Flow Rate Control	User adjustable with four pre-defined settings: high, medium, low, and ultra-low.
Timer Functionality	Offers an intermediate 90-minute timer (Addressing market needs; predicate does not have this specific setting).
Software Functionality	Software verification and validation testing conducted, complying with FDA Guidance for "moderate" level of concern.
Electrical Safety	Complies with IEC 60601-1 standard.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2 standard.
Biocompatibility	Complies with ISO 10993-1 for biocompatibility (evaluated in comparison to Xylog Insufflator K945970).
General Safety and Essential Performance	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8 (alarm systems).
Medical Device Software Life Cycle Processes	Complies with AAMI/ANSI/IEC 62304.
Application of Risk Management	Complies with ISO 14971.
Application of Usability Engineering	Complies with IEC 62366-1.
CO2 Cylinder Connection (Accessories)	Pin-indexed high-pressure hose for CO2 cylinder connection (accessory).
Compatible Tube Set Requirements	Used with commercially available, separately cleared tube sets intended to provide CO2/air to an endoscope, which must have a ≤0.2 micron hydrophobic filter, check valve, luer fittings, and sufficient tubing ID to deliver 4L/min.

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

The document describes "non-clinical testing" and "performance (bench) testing." It states: "The purpose of the testing was to compare the output the predicate device against the Nexcore GI Insufflator. Follow up non-clinical testing was performed to further focus and define the software's control algorithms. This testing also included a distal pressure test."

Sample Size: The document does not specify a "sample size" in terms of number of patients or cases, as this is a non-clinical, benchtop device. The testing likely involved multiple repetitions of measurements or simulations, but the exact number of test runs or devices tested is not provided.
Data Provenance: The data is from non-clinical bench testing. There is no mention of human or animal data, retrospective or prospective studies, or country of origin for such data.

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

This information is not applicable and not provided. The device is an insufflator, a mechanical/electronic medical device. Its performance is evaluated against technical specifications and safety standards, not against human expert diagnoses or interpretations. Therefore, there is no "ground truth" established by experts in the context of diagnostic performance.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used for diagnostic studies involving human readers and AI where there might be disagreements in interpretation. This device's performance is measured against objective physical parameters and engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., imaging AI) assessing how AI assistance impacts human reader performance. The Nexcore GI Insufflator is a therapeutic/procedural accessory device.

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

The document describes "non-clinical testing," "software verification and validation testing," and "electrical safety and EMC testing." These are essentially standalone performance evaluations of the device and its embedded software. The device itself operates autonomously to deliver CO2 based on user settings. While it interacts with an endoscope and is controlled by a physician, the performance tests described (e.g., pressure control, flow rate, safety mechanisms, software algorithms) are evaluating the device's intrinsic function without a human-in-the-loop performance measurement.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, recognized national and international safety standards (e.g., IEC, ISO), and the functional parameters of the predicate device. For example:

Pressure: Measured pressure output against desired settings and safety limits.
Flow Rate: Measured flow rate against desired settings.
Software: Code analysis and functional testing against design requirements.
Electrical Safety/EMC: Compliance with specific limits defined in the IEC standards.
Biocompatibility: Results of tests against ISO 10993-1 guidelines.

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this device's performance as an insufflator.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Nexcore GI Insufflator is not described as an AI/machine learning device that requires a "training set" in the conventional sense. Its "software" controls device operation but is not implied to be a learning algorithm. The software development follows traditional software engineering principles (verification and validation) rather than machine learning model training.

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

This information is not applicable and not provided, as there is no mention of a traditional "training set" for an AI/machine learning model. The software's operational parameters would have been established through engineering design, requirements specification, and validation against known physical principles and safety limits.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.

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

September 29, 2016

Nexcore Technology, LLC % Olaf Teichert Responsible Third Party Official TUV SUD AMERICA, INC. 1775 Old Highway 8 NW New Brighton, MN 55112-1891

Re: K162332

Trade/Device Name: Nexcore GI Insufflator Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCX Dated: August 30, 2016 Received: August 31, 2016

Dear Olaf Teichert,

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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

For Division

Douglas Silverstein -S 2016.09.29 14:07:51 -04'00'

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) K162332

Device Name Nexcore GI Insufflator

Indications for Use (Describe)

The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Nexcore Technology, LLC. The logo consists of a teal square with a white "X" inside of it, followed by the company name in black, sans-serif font. The word "NEXCORE" is in a larger font size than the words "TECHNOLOGY, LLC", which are stacked below it.

510(k) Summary

Submitter:	Nexcore Technology, LLC
Address:	150 Hopper AvenueWaldwick, NJ 07463 USA
Submitter Contact:	Milton FrankCEOmfrank@nexcoretech.comTelephone: 201-968-9400 x202Fax: 201-968-0597
Trade Name:	Nexcore GI Insufflator
Common Name:	Endoscopic Insufflator
Classification Name:	Insufflator, automatic carbon-dioxide for endoscope
Product Code:	FCX
Regulatory Class:	II
Regulation Number:	21 CFR Part 876.1500
Classification Panel:	Gastroenterology and Urology
Date Prepared:	July 21, 2016
Predicate Device:	Bracco CO2MPACT Endoscopic Insufflator (P/N: 710300)
Predicate510(k) Number:	K111648

Device Description:

The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

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There is one model (NX-350) of this device. The accessories sold with the device are the line (power) cord and a pin-indexed high pressure hose for CO2 cylinder connection.

Intended Use:

The Nexcore GI Insufflator is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Comparison to Predicate Device

The proposed and predicate devices have identical intended uses and identical principles of operation. The fundamental technological characteristics of the two devices are the same. Both are electronic medical devices that take in CO2 from a pressurized gas source and meter it to a tube set and GI endoscope in a controlled fashion. The proposed and predicate devices have substantially equivalent specifications, with only minor differences in a few specifications that do not raise different questions of safety and

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effectiveness. Performance data demonstrate that the proposed device is safe and effective.

Many aspects of the designs were compared including: biocompatibility, inlet mains power, hose sets, inlet pressure, outlet overpressure, selectable flow rates, selectable shutdown times, form factor and gas supply configurations. All aspects are fundamentally equivalent, with only minor differences.

The minor differences between the proposed and the predicate devices include:

The Nexcore GI Insufflator has a staged/redundant overpressure method as follows: an audible alarm with on-screen alert at 7.5psi; shutdown switch activated at 8psi; mechanical relief valve opens at 10psi. The predicate device has a mechanical relief valve that opens at 7.25psi. The Nexcore GI Insufflator limits output pressure to 5psi, by controlling flow rate. In order for these overpressure devices to react, the system would have to be in a fault mode where the 5psi limit is not functioning.
The Nexcore GI Insufflator offers an "Ultra-Low" flow rate setting. The predicate device does not offer an "Ultra-Low" flow rate setting. The Ultra-Low setting was added to address market needs.
The Nexcore GI Insufflator offers an intermediate 90 minute timer. The predicate o device does not offer an intermediate 90 minute timer. The 90 minute setting was added to address market needs.

The proposed and predicate devices are substantially equivalent.

Summary of Non-Clinical Testing

Performance (Bench) Testing

Non-clinical testing was performed on the Nexcore GI Insufflator. The purpose of the testing was to compare the output the predicate device against the Nexcore GI Insufflator. Follow up non-clinical testing was performed to further focus and define the software's control algorithms. This testing also included a distal pressure test. This was conducted to ensure the maximum delivered pressure does not exceed average anatomical maximum pressure for the GI tract.

In summary, the non-clinical testing proved equivalent performance to the existing FDA cleared product along with delivered pressure not exceeding maximum anatomical pressures. The Nexcore GI Insufflator meets its design inputs.

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Software Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a non-mitigated failure or latent flaw in the software could result in minor injury to the patient, perforated colon.

Electrical Safety and Electromagnetic Compatibility (EMC) Testing

Electrical safety and EMC testing were conducted on Nexcore GI Insufflator. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Biocompatibility

A biocompatibility evaluation was conducted on Nexcore GI Insufflator in comparison to a 510(k)-cleared reference device, the Xylog Insufflator (K945970). Based on this evaluation, the device complies with ISO 10993-1 for biocompatibility.

Standards Applied

The following standards were applied to the development and design of the Nexcore GI Insufflator:

Standard Code	Date Code	Edition/Revision	Description
IEC 60601-1	08-2012	3.1	Medical Electrical Equipment Part 1: GeneralRequirements for Basic Safety and EssentialPerformance
EN 60601-1-2	03-2007	3.0	Medical Electrical Equipment Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance- Collateral Standard: ElectromagneticDisturbances- Requirements and Tests
IEC 60601-1-8	11-2012	2.1	Medical Electrical Equipment Part 1-8: GeneralRequirements for Basic Safety and EssentialPerformance- Collateral Standard: GeneralRequirements, Tests and Guidance for Alarm Systemsin Medical Electrical Equipment and Medical ElectricalSystems
AAMI/ANSI/IEC62304	05-2006	1.0	Medical Device Software- Software Life CycleProcesses
ISO 14971	07-2012	2012	Medical Devices- Application of Risk Management toMedical Devices
IEC 62366-1	02-2015	1.0	Medical Devices- Part 1: Application of UsabilityEngineering to Medical Devices (General 1 (QS/RM))

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AAMI/ANSI/ISO10-200910993-1	2009 (R)2013	Biological Evaluation of Medical Devices Part 1:Evaluation and Testing Within a Risk ManagementProcess
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Conclusion

Non-clinical verification and validation activities were conducted to establish the performance and safety characteristics of the Nexcore GI Insufflator. The results of these activities demonstrate that the Nexcore GI Insufflator is safe and effective when used in accordance with its intended use and labeling. The Nexcore GI Insufflator has the same intended use and the same fundamental technological characteristics as the predicate device. The minor differences between the proposed and predicate devices do not raise different questions of safety and effectiveness. Performance data demonstrate that the proposed device is safe and effective. Therefore, the Nexcore GI Insufflator is considered substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.