(41 days)
No
The description focuses on pressure and flow rate control using traditional electronic and mechanical components, with no mention of learning, adaptation, or data-driven decision making beyond user-defined settings.
Yes.
The device is designed to deliver CO2 to distend the gastrointestinal tract during endoscopic procedures to improve visualization, increase patient comfort, and increase procedure efficiency, which are all therapeutic effects. While not directly treating a disease, it provides a functional benefit to the patient during a medical procedure that aids in diagnosis and treatment.
No
The device is an insufflator designed to deliver CO2 to distend the gastrointestinal tract for improved visualization during endoscopic procedures. It does not perform any diagnostic function itself; rather, it aids in making the anatomical site visible for a diagnostic procedure performed by a physician.
No
The device description clearly states it is a "reusable electronic medical device" that delivers CO2 and includes hardware components like regulators, valves, and a touchscreen user interface. While it contains software, it is not solely software.
Based on the provided information, the Nexcore GI Insufflator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to deliver CO2 as a distention media in the gastrointestinal tract during endoscopic procedures. This is a therapeutic/procedural function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device delivers gas to the patient's body. It does not analyze biological samples (blood, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing samples, detecting analytes, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Nexcore GI Insufflator's function is to facilitate a medical procedure by providing distention, not to perform a diagnostic test.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
FCX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician;
hospitals and outpatient endoscopy suites.
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)
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.
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.
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.
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
§ 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.
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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.
1
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
2
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.
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.
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 Avenue |
| Waldwick, NJ 07463 USA | |
| Submitter Contact: | Milton Frank |
| CEO | |
| mfrank@nexcoretech.com | |
| Telephone: 201-968-9400 x202 | |
| Fax: 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) |
| Predicate | |
| 510(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.
4
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.
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.
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.
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
5
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.
6
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: General |
| Requirements for Basic Safety and Essential | |||
| Performance | |||
| EN 60601-1-2 | 03-2007 | 3.0 | Medical Electrical Equipment Part 1-2: General |
| Requirements for Basic Safety and Essential | |||
| Performance- Collateral Standard: Electromagnetic | |||
| Disturbances- Requirements and Tests | |||
| IEC 60601-1-8 | 11-2012 | 2.1 | Medical Electrical Equipment Part 1-8: General |
| Requirements for Basic Safety and Essential | |||
| Performance- Collateral Standard: General | |||
| Requirements, Tests and Guidance for Alarm Systems | |||
| in Medical Electrical Equipment and Medical Electrical | |||
| Systems | |||
| AAMI/ANSI/IEC | |||
| 62304 | 05-2006 | 1.0 | Medical Device Software- Software Life Cycle |
| Processes | |||
| ISO 14971 | 07-2012 | 2012 | Medical Devices- Application of Risk Management to |
| Medical Devices | |||
| IEC 62366-1 | 02-2015 | 1.0 | Medical Devices- Part 1: Application of Usability |
| Engineering to Medical Devices (General 1 (QS/RM)) |
7
| AAMI/ANSI/ISO
10-2009
10993-1 | 2009 (R)
2013 | Biological Evaluation of Medical Devices Part 1:
Evaluation and Testing Within a Risk Management
Process |
| ------------------------------------- | ------------------ | ---------------------------------------------------------------------------------------------------------------- |
|---|
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.