(61 days)
Protego Air Water Connector: The single use Protego Air Water Connector is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures.
Protego Air Water Bottle Tubing: Protego Air Water Bottle Tubing is to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastrointestinal endoscopic procedures. It is a 24-hour multi-patient use device.
Protego Hybrid Tubing: Protego Hybrid Tubing is intended to connect an air/CO2 source, a sterile water source and an endoscope to supply air/CO2, water and irrigation during endoscopic procedures in conjunction with an irrigation pump. It is a 24-hour multi-patient use device.
The Protego Air Water Connector is intended for single use then discarded. The Protego Air Water Bottle Tubing and Protego Hybrid Tubing are intended for 24-hour use then discarded. All Protego Air Water Connector, Protego Air Water Bottle Tubing and Protego Hybrid Tubing are provided sterile. The Air Water Connector is used in conjunction with air water bottle tubing or hybrid tubing, intended to supply air/CO2 and water during gastro-intestinal endoscopic procedure. It is connected to the air/water port of the endoscope to provide connection from the air/water bottle tubing to the endoscope. The Air Water Bottle Tubing is connected to the air/water port of the endoscope and the sterile water bottle to supply air/ CO2 or sterile water during the GI endoscopic procedure. The Hybrid Tubing is composed of air/water bottle tubing and irrigation tubing, which is intended to connect an air/CO2 source, a sterile water source (water bottle), and an endoscope to supply air/CO2 and water during gastro-intestinal endoscopic procedure.
The provided text describes a 510(k) summary for medical devices (Protego Air Water Connector, Protego Air Water Bottle Tubing, and Protego Hybrid Tubing) and does not contain information about an AI-based diagnostic device. Therefore, it does not include details on acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for such devices.
The document details the substantial equivalence of the subject devices to predicate devices based on:
- Intended Use: The devices are intended to connect air/CO2 and sterile water sources to an endoscope for gastrointestinal endoscopic procedures, with some variations in single-use vs. 24-hour multi-patient use.
- Technological Characteristics: Comparisons are made regarding product code, regulatory classification, regulation number, regulation description, environment of use, single-use/reusable nature, materials, manufacturing method, packaging, sterilization, and shelf life.
- Performance Testing: Bench testing was performed to support substantial equivalence.
Here's a breakdown of the information that is present in the document, which pertains to the physical medical devices, not an AI diagnostic system:
1. Acceptance Criteria and Reported Device Performance (as listed in the document for the physical devices):
| Acceptance Criteria (Bench Testing Performed) | Reported Device Performance (Summary) |
|---|---|
| Endoscope compatibility test | Met established specifications |
| Connector pulling force test | Met established specifications |
| Connector/tubing pulling force test | Met established specifications |
| Backflow prevention test (Air Water Connector) | Met established specifications |
| Air flow test (Air Water Bottle Tubing) | Met established specifications |
| Water flow test (Air Water Bottle Tubing) | Met established specifications |
| Water leak test (Air Water Bottle Tubing) | Met established specifications |
| Bottle cap compatibility test (Air Water Bottle Tubing) | Met established specifications |
| Air flow test (Hybrid Tubing) | Met established specifications |
| Water flow test (Hybrid Tubing) | Met established specifications |
| Air leak test (Hybrid Tubing) | Met established specifications |
| Flow clamp test (Hybrid Tubing) | Met established specifications |
| Backflow prevention test (Hybrid Tubing) | Met established specifications |
| Sterility Assurance Level (SAL) | 10^-6 (Validated EO sterilization cycle) |
| EO residuals | Below maximum levels defined in ANSI/AAMI/ISO 10993-7 |
| Shelf Life (Packaging Integrity) | Maintained for at least 3 years (based on accelerated aging and packaging tests) |
| Biocompatibility | Biocompatible (based on ISO 10993-5 and ISO 10993-10) |
2. Sample size used for the test set and the data provenance:
- The document mentions "bench testing was performed to support substantial equivalence on both the subject device and the predicate device" (Page 7, Section 9).
- It does not specify the precise sample sizes used for each of these bench tests, nor does it detail data provenance (country of origin, retrospective/prospective) as these are physical device tests, not clinical data sets in the diagnostic sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is not an AI diagnostic device where expert ground truth is established for image interpretation or similar. The "performance" here refers to physical and functional characteristics of the tubing/connectors.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, for the same reason as point 3.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is measured directly through bench testing of its physical and functional properties.
7. The type of ground truth used:
- The "ground truth" for these devices is objective, measurable engineering and material specifications (e.g., flow rates, pulling forces, leakage, sterility, biocompatibility standards). It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic AI device would be.
8. The sample size for the training set:
- Not applicable. There is no AI training set for these devices.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
§ 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.