(29 days)
The Reliance Endoscope Processing System is intended for washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-sensitive, semi-critical devices such as GI flexible endoscopes and their accessories. High level disinfection is achieved within the 50 - 57°C HLD Phase of the endoscope processing cycle (4 minute generation sequence followed by a 6-minute exposure sequence).
The Reliance Endoscope Processing System is a high level disinfection system that can wash and high level disinfect up to two manually precleaned, immersible, reusable, heatsensitive, semi-critical devices such as GI flexible endoscopes and related accessories. The system utilizes Reliance™ DG Dry Germicide, a proprietary, safe, and dry peracetic acid generating oxidative chemistry. The Reliance Endoscope Processing System was designed to be versatile in meeting the growing demands of the modern flexible endoscope processing department, while offering the highest level of patient and staff safety. The Reliance Endoscope Processing System is a combination of products that are used to wash and high level disinfect flexible endoscopes and their accessories.
The provided text describes a 510(k) premarket notification for a medical device called the "Reliance Endoscope Processing System." The submission is to demonstrate substantial equivalence to a legally marketed predicate device (K102244) and specifically addresses a change to the ink used on the label of the Reliance DG Dry Germicide.
Therefore, the study described is not for the primary performance of an AI/ML medical device, but rather a biocompatibility study related to a minor modification in a non-AI medical device's labeling. As such, many of the requested elements for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable (N/A) to this specific submission.
However, I can extract the relevant information regarding the acceptance criteria and the biocompatibility study performed.
Acceptance Criteria and Device Performance (Biocompatibility Study)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility with alternate ink used on the label of Reliance DG Dry Germicide | Extracts from devices processed in the Reliance EPS with Reliance DG with the alternate ink on the label shall meet the acceptance criteria for cytotoxicity in ISO 10993-5:2009, Annex A Neutral Red Assay | PASS |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of samples, but refers to "Extracts from devices processed in the Reliance EPS with Reliance DG with the alternate ink on the label." This is a laboratory-based biomechanical/biocompatibility test, not a clinical study with patients.
- Data Provenance: The study is a non-clinical, laboratory test (biocompatibility). Country of origin is not specified, but it's a verification activity performed by the manufacturer, STERIS Corporation. It is prospective testing for this specific change.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is a non-clinical biocompatibility test with a defined chemical/biological assay (ISO 10993-5:2009, Annex A Neutral Red Assay). The "ground truth" is measured objectively by the assay, not by expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Not applicable for a laboratory biocompatibility test. The result is a direct measurement against a predefined standard.
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:
- N/A. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this biocompatibility study: The "ground truth" is the objective measurement of cytotoxicity as defined by the ISO 10993-5:2009, Annex A Neutral Red Assay.
8. The sample size for the training set:
- N/A. This is not an AI/ML device, and no training set is described or relevant for this type of non-clinical testing.
9. How the ground truth for the training set was established:
- N/A. As no training set is relevant, this question is not applicable.
§ 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.