(250 days)
The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.
GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.
The provided document describes the GOLFF Sterile Anti-Fog Solution, a medical device intended to prevent fogging on endoscopic and laparoscopic camera lenses during surgery. The device's substantial equivalence to predicate devices is established through a series of tests and comparisons.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Name) | Reported Device Performance (Result) |
|---|---|
| Product Functional Testing | |
| Deformation/Degradation | Pass |
| Easy Removal of Release Liner | Pass |
| Adhesive Backing Functional | Pass |
| Squeeze Test | Pass |
| Transparency of Bottle | Pass |
| Bottle Shape | Pass |
| Anti-Fog Functional Test | Pass |
| Biocompatibility Testing | |
| Cytotoxicity Test (ISO 10993-5:2009) | Pass: Non-Cytotoxic |
| Sensitization Test (ISO 10993-10:2010) | Pass: Non-Sensitizing |
| Intracutaneous Reactivity Test (ISO 10993-10:2010) | Pass: Non-Irritating |
| Sterilization Validation & Shelf-Life Study | |
| Product designed to undergo gamma-radiation sterilization | Passed (per ISO 11137-2:2013, ISO 11737-1:2018, ISO 11737-2:2019) |
| Product Aging Validation Study (Accelerated aging simulating 4 years) | |
| Package Integrity Test (Dye penetration Test, ASTM F1929-15) | Pass |
| Seal Peel Strength Test (ASTM F88/F88M-15) | Pass |
| Product Sterility Test (ISO 11737-2:2019) | Pass |
| Product Stability Studies (Fog Resistance Test, internal protocol) | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each individual test. It states "A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution." The data provenance is internal testing performed by Batrik Medical Manufacturing Inc. The document does not specify the country of origin of the data, nor whether the studies were retrospective or prospective, but given they are for a premarket notification, they are by nature prospective for the device under consideration.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily benchtop, biocompatibility, and sterilization validation tests, which rely on standardized protocols and empirical measurements rather than expert human interpretation to establish a "ground truth."
4. Adjudication method for the test set
This information is not applicable and not provided. The types of tests conducted (e.g., functional, biocompatibility, sterility) typically involve objective measurements against predefined acceptance criteria, rather than subjective interpretation requiring adjudication among experts.
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
This is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is an anti-fog solution for endoscopes, not an AI-powered diagnostic or imaging device that would involve "human readers" or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is a physical product (anti-fog solution), not an algorithm or software.
7. The type of ground truth used
The "ground truth" for the tests performed can be characterized as follows:
- Product Functional Testing: Defined physical and performance characteristics of the device (e.g., non-deformation, effective anti-fogging as per internal protocols).
- Biocompatibility Testing: Compliance with established international standards (ISO 10993 series) for biological responses (cytotoxicity, sensitization, irritation).
- Sterilization Validation: Achievement of sterility assurance levels as defined by international standards (ISO 11137, ISO 11737).
- Product Aging Validation: Maintenance of package integrity, seal strength, sterility, and fog resistance over a simulated shelf-life, as per relevant ASTM and ISO standards and internal protocols.
8. The sample size for the training set
This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product.
§ 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.