(30 days)
The EVA5 Insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas.
The EVA5 insufflator is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. It is indicated to facilitate the introduction of various endoscopic instruments by filling the alimentary canal with gas to distend it. The EVA5 Insufflator is used in an operating room or endoscopic suite. It consists of the following major component (1) a micro-processor-controlled insufflation flow control system.
The EVA5 Insufflator is an active medical device, nonsterile and reusable and is intended to insufflate the alimentary canal via an endoscope. The EVA5 is powered by AC and uses a compressed 50 psi CO2 gas supply to supply the pneumatic circuitry for insufflation.
The EVA5 Insufflator is a medical device intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the gastrointestinal tract by filling it with gas. The document provides information regarding its non-clinical testing to demonstrate substantial equivalence to its predicate devices.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (EVA5) | Predicate Device (EVA15) Specification (K193520) |
|---|---|---|
| Flow accuracy | ±0.3 SLPM | ±1 SLPM |
| Switch-off time accuracy | Met acceptance criteria | Not explicitly stated (N/A in table) |
2. Sample Size and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is non-clinical, focusing on the device's technical specifications.
3. Number of Experts and Qualifications
This information is not provided as the described testing is non-clinical performance testing of the device's mechanical and electronic functions, not human interpretation of medical images or data.
4. Adjudication Method
This information is not applicable as the testing described is non-clinical performance testing, not involving human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The EVA5 Insufflator is a mechanical device, and its performance is evaluated based on technical specifications rather than human reader accuracy.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (the insufflator's flow control system). The "Non-clinical Testing" section states: "Performance testing of the insufflator demonstrated that the subject device met its acceptance criteria..." This refers to the device's intrinsic mechanical/electronic performance.
7. Type of Ground Truth Used
The ground truth for the non-clinical performance testing would be the precise, calibrated measurements of flow rate and timing. These would be established using validated testing equipment and methodologies.
8. Sample Size for the Training Set
This information is not applicable. The EVA5 Insufflator is a hardware device with a micro-processor-controlled insufflation flow control system. It is not an AI/ML algorithm that is "trained" on a large dataset in the conventional sense. Its "training" or calibration would occur during its manufacturing and quality control processes based on engineering specifications.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" and "ground truth" for a training set is not directly applicable to a hardware device like an insufflator. The device's operational parameters are designed and calibrated based on engineering principles and established medical device standards. The "ground truth" for its performance would be defined by these engineering specifications and validated through rigorous testing against calibrated measuring instruments.
§ 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.