(90 days)
The D.O.R.C. HEXON Illumination System is indicated for intraocular illumination in vitreoretinal surgery.
The D.O.R.C. HEXON Illumination System consists of the Illumination Unit and accessories. The Illumination Unit uses a metal halide discharge lamp and utilizes an internal focusing system to focus the light into the end of the optical fiber. Accessories to the Illumination Unit include adapters and color filters. Accessories to the system include single use and reusable fiberoptic probes, fibers, and microinstruments which require storilization prior to use.
The provided text is a 510(k) premarket notification summary for the D.O.R.C. HEXON Illumination System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to prove novel performance or efficacy. Therefore, much of the requested information regarding acceptance criteria, specific study design, expert involvement, and detailed performance metrics as would be found in a clinical trial for a new therapeutic or diagnostic device is not applicable or not provided in this document.
Here's a breakdown based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it demonstrates performance by comparing the device's characteristics to those of predicate devices to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate - "YES") | Reported Device Performance (HEXON Illum. System) |
|---|---|---|
| Indication: Endoillumination for vitreoretinal surgery | YES (Matches Predicate) | YES |
| Lamp Type | Acceptable (Differences noted vs. Grieshaber) | Metal Halide |
| Lamp Rating | Not specified by Predicate | 24 watts |
| Light Output (lumens) | Not specified by Predicate | 1850 |
| Color Temperature (degrees K) | Acceptable (Similar to VitLite I) | 4700 |
| Variable Intensity | YES (Matches Predicate) | Yes |
| Wavelength Range (nm) | Acceptable (Similar to VitLite I) | 400-800 |
| UV filtration | YES (Matches Predicate) | Yes |
| Infrared filtration | YES (Matches Predicate) | Yes |
| Additional color filtration (Green, Yellow, Red, Blue) | YES (Matches Grieshaber) | Yes (for all listed) |
| Additional color filtration (Daylight) | Not specified by Predicate (HEXON offers it) | Yes |
| Multiple probe diameters | YES (Matches Predicate) | Yes |
| Panoramic light probe | YES (Matches VitLite I) | Yes |
| Straight probe | YES (Matches Predicate) | Yes |
| Illuminated accessories | YES (Matches Predicate) | Yes H |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a study assessing device performance on patient samples. The "test set" here refers to the characteristics of the device itself and its comparison to predicate devices, not data from patients.
- Data Provenance: Not applicable in the context of clinical data. The data provenance relates to the specifications and characteristics of the D.O.R.C. HEXON Illumination System and the predicate devices (Grieshaber Light Source and Escalon VitLite I), derived from engineering specifications and existing market information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth in a clinical or diagnostic sense is not being established. The "truth" here is the stated technical specifications of the devices being compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no expert adjudication of clinical findings in this type of submission. The comparison is based on documented device specifications.
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 device is an ophthalmic illumination system, not an AI or diagnostic tool that would involve "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is the technical specifications and intended use of the legally marketed predicate devices. The D.O.R.C. HEXON Illumination System demonstrates substantial equivalence by showing that it has similar technological characteristics and the same intended use as these predicates.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of device development for a 510(k) involving an illumination system.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.