(88 days)
Adjustable Chandelier Illuminator family of ophthalmic illuminators is for wide angle illumination during ophthalmic surgery.
The 23ga and 25ga Adjustable Chandelier Illuminators are made to work with the Bausch and Lomb surgical system and Bausch and Lomb Valved ESA (Entry Site Alignment) systems (K012435). These devices are to be manufactured with distally located "Infusion Cannulas" that adequately secure themselves within 23ga and 25ga Bausch and Lomb Valved ESA Systems. The 23ga and 25ga Adjustable Chandelier Illuminators consist of a PMMA (Polymethylm-ethacrylate with Flourinated Polymer Cladding) acrylic fiber (for light transmission), white acetal handle assembly with finger slide for adjustability, PTFE (Polytetrafluor-oethylene) jacket (for fiber) and Stellaris style light connector to fit into the Bausch and Lomb Stellaris PC Vision Enhancement System (K133486). The 23ga and 25ga Adjustable Chandelier Illuminators are to be provided sterile to the user, is a single-use device and is packaged in double Tyvek-to-poly pouches to facilitate introduction to the sterile environment. These provide illumination for eye surgery.
This document describes the premarket notification (510(k)) for the Peregrine 23ga and 25ga Adjustable Chandelier Illuminator. The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical performance tests conducted to evaluate the device. The reported performance is that all results were "acceptable" and the device "satisfactorily met the requirements." Specific numerical acceptance criteria or performance metrics are not provided in this summary.
| Test | Test Method | Reported Device Performance |
|---|---|---|
| Sterility | ISO 11135-1 | Acceptable |
| Shelf-life | ASTM F1980 | Acceptable |
| Biocompatibility | ISO 10993-01 | Acceptable (fully biocompatible device) |
| Light Output | Internal Test Method(ITP04-20) | Satisfactorily met requirements (specific value of 3.7 lumen is provided in Table 5.2 for both) |
| Light Field | Internal Test Method (ITP04-30) | Satisfactorily met requirements |
| Thermal Inspection | Internal Test Method (ITP04-40) | Satisfactorily met requirements |
| Bond Strength | Internal Test Method (ITP03-75) | Satisfactorily met requirements |
| Cannula & Fiber Inspection | Internal Test Method (ITP52-00) | Satisfactorily met requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for individual tests. However, it indicates that "Biocompatibility and sterility testing has been conducted on the 25ga Adjustable Chandelier Illuminators as a 'worst case device' and a family representative." This suggests a limited sample size, focusing on one representative (25ga).
The data provenance is internal, originating from Peregrine Surgical Ltd. It is retrospective, as these are bench tests conducted to support a premarket submission. No information about the country of origin of the data is provided beyond the company's location (New Britain, PA, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth on a test set. The tests performed are bench tests evaluating physical and functional characteristics of a medical illuminator. The "ground truth" for these tests would be the established standards and specifications outlined in the referenced ISO and ASTM methods, or the company's internal test protocol specifications.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic assessment requiring adjudication among experts. The tests are objective measurements against defined standards.
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 not an AI/ML device, and no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device. The "standalone" performance refers to the device's functional characteristics as an illuminator, which were assessed through the listed bench tests.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical performance data is the defined acceptance criteria and specifications within the referenced ISO, ASTM, and Internal Test Methods. For example:
- Sterility: The device must meet the sterility assurance level (SAL) specified in ISO 11135-1.
- Biocompatibility: The device materials must meet the biological safety requirements outlined in ISO 10993-01.
- Light Output: The device's light output must meet the specified lumen value (3.7 lumen, as indicated in Table 5.2).
8. The Sample Size for the Training Set
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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.