(39 days)
Anti-Fog is intended to be used to prevent "fogging" caused by condensation on the lenses of endoscopic/laparascopic instruments which are likely to fog during use.
The Anti-Fog solution is a clear / colorless, water soluble solution comprised of predominantly water (~95%) with small percentages of surfactant (
This 510(k) submission (K063587) for the Xodus Medical, Inc. Anti-Fog Solution is based on substantial equivalence to a predicate device, the Clear it Anti-Fog (K022826) by Preservation Solutions, Inc. It does not contain a study with explicitly defined acceptance criteria and device performance metrics in the typical sense of a novel medical device.
Instead, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to a legally marketed predicate device. This means the new device has the same intended use and similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.
Here's how to break down the information based on your request, even though it's not a performance study in the traditional sense:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as demonstrated by similarity to predicate) |
|---|---|
| Intended Use: Prevent fogging on endoscopic/laparoscopic instrument lenses | Match: Anti-Fog is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use. (Identical to predicate's intended use according to Section 510(k) Summary, "Technological Characteristics Comparison") |
| Technological Characteristics: Similar physical characteristics and chemical composition to predicate device. | Match: Has the same physical characteristics, chemical composition, and packaging design as the predicate device (Clear it Anti-Fog). Chemical composition confirmed by two separate deformulations of the predicate. (Section 510(k) Summary, "Technological Characteristics Comparison") |
| Safety and Effectiveness: No new questions of safety or effectiveness raised by differences (or lack thereof) from the predicate device. | Assumed: No adverse events or safety concerns were mentioned, implying no new questions of safety or effectiveness. The similarity to a previously cleared device suggests equivalent safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
This submission does not involve a "test set" in the context of clinical or performance data collection for the new device. The "testing" was primarily analytical comparison to the predicate device.
- Sample Size: Not applicable in the sense of patient or experimental samples. The comparison was based on deformulation of the predicate device and comparison of physical characteristics of the new device.
- Data Provenance: Deformulations of the predicate device (Clear it Anti-Fog) were performed presumably by Xodus Medical, Inc. This is an internal, analytical process rather than a clinical study with patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: No "ground truth" in the sense of clinical expert assessment was established for a test set. The comparison was chemical and physical.
4. Adjudication Method for the Test Set
- Not Applicable: No adjudication method was used as there was no test set requiring multi-reader review or consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: This type of study (MRMC) was not performed. The device is an anti-fog solution, not an interpretive diagnostic system where human reader performance is pertinent.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable: This is a physical solution, not an algorithm. Therefore, a standalone performance study in that context was not performed.
7. Type of Ground Truth Used
The "ground truth" in this context is the established physical and chemical characteristics and performance of the predicate device.
- This was determined through:
- Deformulation (reverse engineering of chemical composition) of the predicate device.
- Direct comparison of physical characteristics (e.g., clear/colorless, water-soluble, bottling, packaging) between the new device and the predicate.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" in the context of an algorithm or machine learning. The comparison is based on the characteristics of the predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there's no training set, this question is not relevant. The basis for comparison ("ground truth" of predicate device characteristics) was established through deformulation and direct observation.
In summary, K063587 is a 510(k) submission based on substantial equivalence. The "study" demonstrating this involves analytical chemistry (deformulation) and direct comparison of physical and functional characteristics to a previously cleared predicate device, rather than a clinical trial or performance study with acceptance criteria for quantitative metrics like sensitivity or specificity.
§ 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.