(29 days)
The Clarus Model 5197 SightLite is intended as a illumination source for endoscopes. These endoscopes would be legally marketed Clarus Medical Systems devices. The SightLite is intended for multiple use. It is sold non-sterile.
The Clarus Model 5197 SightLite is a hand held illumination device for endoscopy. The device has a means of attaching a legally marketed optical assembly manufactured by Clarus Medical Systems that is sold separately. The image connector on the endoscope attaches to the optical assembly. The male illumination receptacle on the endoscope attaches to the female receptacle on the Model 5197 SightLite. The power source is four 1.5 volt AA lithium batteries. The illumination source is a Tungsten Halogen lamp.
The SightLite is intended for multiple use. It is sealed for cleaning and disinfecting.
The optical assembly used with the SightLite endoscopic light source is a separate, legally marketed, Clarus Medical Systems device that can be attached to the SightLite by means of a machined clasp that is an intrical part of the SightLite.
This is a summary of the provided text, focusing on the acceptance criteria and study details for the Clarus Model 5197 SightLite.
Device Description:
The Clarus Model 5197 SightLite is a handheld illumination device for endoscopy. It attaches to a legally marketed optical assembly (sold separately) from Clarus Medical Systems. The device is intended for multiple use, is sealed for cleaning and disinfecting, and is sold non-sterile. It uses four 1.5 volt AA lithium batteries and a Tungsten Halogen lamp as its illumination source.
Intended Use:
The Clarus Model 5197 SightLite is an illumination source for legally marketed Clarus Medical Systems endoscopes and is intended for multiple use.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria/Methodology | Reported Device Performance |
|---|---|---|---|
| Material Safety | Biocompatibility Testing | All exposed materials used in construction must pass biocompatibility testing. | All materials passed biocompatibility testing and are suitable for this application. |
| Durability/Sterilization | Cold Disinfectant Exposure Testing | Tested for exposure to glutaraldehyde (a common cold disinfectant). | Acceptable results. |
| Integrity | Liquid Leak Testing | Not specified, but implies testing for fluid ingress/egress. | Acceptable results. |
| Functionality | Battery Life Testing | Not specified, but implies measuring the operational duration of the batteries. | Acceptable results. |
| Manufacturing Quality | Dimensional Measurements and Visual Examination | Verification of physical dimensions and visual inspection for workmanship. | All testing yielded acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "all exposed materials" for biocompatibility and "the product" for other tests, implying a representative sample of the device was used for each test, but specific numbers are not provided.
- Data Provenance: Not specified, but implied to be internal testing conducted by Clarus Medical Systems, Inc. The document does not indicate the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable/not mentioned. The testing described primarily involves engineering and material science tests, not clinical or diagnostic assessments requiring expert consensus on ground truth for medical imaging or diagnostics.
- Qualifications of Experts: Not applicable/not mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. The tests performed are objective measurements and evaluations (e.g., passing/failing biocompatibility, acceptable liquid leak results, acceptable battery life). There is no mention of a human adjudication process for interpreting these engineering test results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The provided document is for a medical device (illumination source) and does not describe any MRMC comparative effectiveness study, nor does it address human reader performance with or without AI assistance. This type of study is not relevant to the evaluation of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done: No. This device is not an AI algorithm but a physical illumination device. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for the performance criteria is based on established engineering and materials testing standards (e.g., "passed biocompatibility testing," "acceptable results" for physical and functional tests). There is no clinical "ground truth" (like pathology, outcomes data, or expert consensus on a diagnosis) as the device itself does not make a diagnosis or produce diagnostic images to be interpreted.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This device is a physical product and does not involve machine learning algorithms that require a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this device.
§ 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.