(41 days)
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.
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.
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.
§ 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.