(39 days)
Not Found
No
The device description details a chemical solution and application pad, with no mention of software, algorithms, or AI/ML terms.
No
This device is an anti-fog solution for surgical instruments, not a device that directly treats a condition or disease in a patient.
No
Explanation: The device description states its function is to prevent "fogging" on endoscopic/laparoscopic instrument lenses by reducing surface tension of water, which is a maintenance or facilitative function, not a diagnostic one. It does not analyze patient data or provide information for diagnosis.
No
The device description clearly states it is a solution and includes physical components like a bottle and foam pad, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent fogging on the lenses of endoscopic/laparoscopic instruments. This is a functional purpose related to the performance of a medical device (the endoscope/laparoscope), not a diagnostic purpose.
- Device Description: The description details a solution and an application pad used to alter the surface tension of water on a lens. It does not describe a test or assay performed on biological samples to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis, treatment, or prevention of disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is purely to improve the visibility during a medical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KOG
Device Description
The Anti-Fog solution is a clear / colorless, water soluble solution comprised of predominantly water (~95%) with small percentages of surfactant (
§ 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.
0
510(k) Summary
JAN - 9 2007
510(k) Owner: Xodus Medical, Inc. Westmoreland Business & Research Park 702 Prominence Drive New Kensington, PA 15068 Phone: 724-337-5500 Fax: 724-337-0555 Contact: Brenda Niel (Quality Assurance Manager)
Establishment Registration Number: 2530138
Date Prepared: November 28, 2006
Device Information
Trade/Device Name: Anti-Fog Solution Common Name: Anti-Fog Solution Classification Name: Endoscope And/ Or Accessories Regulation Number: 21 CFR 876.1500 Product Code: KOG Regulatory Class: II
Predicate Device
Device Name: Clear it Anti-Fog Common Name: Anti-Fog Solution 510 (k) Number: K022826 510 (k) Owner: Preservation Solutions, Inc. Classification Name: Endoscope And/Or Accessories Regulation Number: 21 CFR 876.1500 Product Code: KOG Regulatory Class: II
1
510(k) Summary
Device Description
The Anti-Fog solution is a clear / colorless, water soluble solution comprised of predominantly water (~95%) with small percentages of surfactant (510(k) Number L063587 |