VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.

Device Description

The device, VitreOx®, is a biocompatible, aqueous solution, when used as indicated. In addition, the solution is alcohol-free. It functions in the same manner as the predicate device. The device is intended to be used prior and during minimal invasive surgeries, to prevent fogging of the lens of devices (laparoscope) that provide visualization during the procedure. The device accessory VitreOx®, can be removed from the lens with typical surgical cleaning methods such as scrubbing with soap and water, autoclaving, etc.

It is a sterile, single-use, disposable, long-lasting (beyond average surgery time of 90 minutes) anti-fog solution that can be applied on endoscope and laparoscope lenses, as well as endoscope sheaths. It is effective instantaneously, wet; but is even more lasting if allowed to dry, or applied prior to surgery to lenses.

AI/ML Overview

The provided text describes the performance testing of the VitreOx Anti-fogging Device. However, it does not explicitly state specific acceptance criteria in a quantifiable manner, nor does it present the study results in a formal table directly comparing the device's performance against predefined acceptance metrics. Instead, it describes comparative performance against a control and a predicate device.

Here's an attempt to structure the information based on the provided text, while acknowledging the lack of explicit acceptance criteria and formal reporting:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not provided in the document, I will infer them from the reported observations and comparisons to the predicate device and control. The primary goal of an anti-fogging device is to prevent fogging and maintain visualization.

Acceptance Criteria (Inferred)	VitreOx® Reported Device Performance
Primary Criteria:
1. Prevention of fogging during surgical procedures.	No fogging observed on the endoscope with VitreOx® throughout the 90-minute procedure.
2. Maintenance of clear visualization of the surgical site.	Maintained clear visualization, as fogging was not observed.
3. Long-lasting anti-fog effect (beyond average surgery time).	Anti-fog effect lasted throughout the 90-minute procedure without reapplication.
Secondary Criteria (Ease of Use/Safety):
4. Does not require heating.	Did not require heating, unlike the predicate device.
5. Does not require reapplication during procedure.	No reapplication needed during the 90-minute procedure.
6. Biocompatibility and safety with no adverse reactions.	No adverse reactions or complications observed in swine; no signs of skin reaction. Swine discharged as "healthy." Monitored for a year with no adverse reactions.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Animal Study): 2 male Yucatan swine (from the same litter).
Data Provenance: Prospective animal study conducted in Peoria, Arizona, USA (All Pets Animal Hospital).
Sample Size (Bench Studies):
- One handheld endoscope (Clarus 30000-10).
- One electronic endoscope (generic electronic endoscope 14.55 mm, wide angle).
- Various diameters of endoscope lenses (1, 1.2, 1.9, 2.7, 3.5, 4, 10 mm) were tested with the solution application methods.
Data Provenance (Bench Studies): In vitro, simulated closed-body cavity surgical conditions. Location of bench study not explicitly stated but implied to be part of the manufacturer's testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text describes "veterinarians" monitoring and maintaining surgical conditions during the animal study. It does not explicitly state these veterinarians were establishing ground truth for fogging observation or if "experts" formally adjudicated video footage for fogging.
Qualifications of Experts: "Veterinarians" who administered anesthesia and monitored vitals. Their specific qualifications (e.g., years of experience, board certification) are not detailed.
Ground Truth Establishment for Fogging Observation: The text states, "Fogging is noted in the experiment: When there is a change of the light reflection on tissue, the light reflection will not be as crisp. In addition, veins on the tissue as also observed, because it will look less defined when fogging is present." This suggests direct visual observation by the study personnel (likely including the veterinarians) during the procedure. It doesn't mention a separate panel of experts for ground truth.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated as a formal adjudication process using multiple reviewers. The description implies direct observation and documentation by the study team during the animal procedure. There is no mention of 2+1, 3+1, or similar consensus methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was NOT done. The study involved comparing the device's performance against a control and a predicate device in an animal model and bench tests. It did not involve multiple human readers assessing cases with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the VitreOx® is a physical anti-fogging device (an solution/coating), not an AI algorithm. Its performance is entirely "standalone" in the sense that its anti-fogging effect is inherent to the solution itself, without requiring human real-time intervention beyond initial application.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Ground Truth for Fogging: Direct visual observation of fogging characteristics (change in light reflection, clarity of tissue/veins) during live animal procedures.
Ground Truth for Safety: Clinical observation of the animals post-procedure (for 2 weeks and then 1 year), including physical health, discharge status ("healthy"), and absence of adverse reactions or complications.

8. The Sample Size for the Training Set

This question is not applicable. The VitreOx® is a physical device/solution, not a machine learning algorithm, so there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as above (not an AI algorithm).

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

SiO2 Nanotech, LLC Ms. Clarizza Watson Chief Executive Officer 275 N. Gateway Drive, Suite 126 Phoenix, Arizona 85034

Re: K163257

Trade/Device Name: VitreOx Anti-fogging Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OCT, GCJ Dated: May 11, 2017 Received: May 15, 2017

Dear Ms. Watson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

Sincerely,

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Jennifer R. Stevenson -

Enclosure

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Indications for Use

510(k) Number (if known) K163257

Device Name VitreOx®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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FDA 510(k) Summary

1. Applicant & Co-SpecificationDeveloper	SiO2 Nanotech, LLC275 N Gateway Drive, Suite 126Phoenix, AZ 85034 USATel #: (602)-565-3447
SubmitterAddress	SiO2 Nanotech, LLC275 N Gateway Drive, Suite 126Phoenix, AZ 85034 USATel #: (602)-565-3447
Trade/Proprietary Name	VitreOx®
Common Names	Endoscope Anti-fogging Device
Establishment Number	404323
Proposed Classification	OCT Anti-fogging solutions andaccessories, endoscopyClass II

Prepared: October 3, 2016, Revised May 22, 2017

Legally marketed devices to which we are claiming equivalence

The different components of the VitreOx® device are functionally equivalent to the following supplies and devices: K062779 Defogging Endoscope Lens Protector.

Substantial Equivalence:

The different components of the VitreOx® device are functionally equivalent to the following supplies and devices:

Predicate devices using sterile anti-fog solutions in laparoscopic and endoscopic procedures: K062779 Defogging Endoscope Lens Protector.

When compared to the primary predicate D.E.L.P. (K062779), it is substantially equivalent, and does not pose any new risk or safety concerns.

Device Description:

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Intended Use:

VitreOx® is a single use laparoscopic accessory device, to be used prior and during endoscopic and laparoscopic procedures, to facilitate defogging the laparoscopic lens thereby maintaining visualization of the surgical site.

Indications for Use:

Summary of Technological Characteristics

The VitreOx® device accessory, is an anti-fog solution comprised of components that provide similar physical characteristics as the listed predicate devices. The VitreOx is a transparent, water-soluble solution that is packaged in a syringe or bottle for easy use. In addition to preparing the solution in cleanroom conditions, the product can be autoclaved or irradiated to ensure sterility. During in vitro and in vivo studies, the VitreOx® was sterilized via autoclave for sterility.

Similarly to the predicate device D.E.L.P. that uses ShurClens to clean and coat the lens, the VitreOx® solution utilizes a solution on the lens of the endoscope or laparoscope to combat fogging. However, unlike the primary predicate (K062779), it does not utilize the additional component of a heat source, to heat the lens.

The mechanism of defogging or anti-fogging action of the VitreOx® device, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as "wetting".

Summary of Performance Testing

The VitreOx® device accessory underwent successful bench and animal studies, to determine effectiveness and safety of the product. The performance was compared to the predicate device, Defogging Endoscope Lens Protector (K062779).

Bench Studies: The bench studies involved testing the VitreOx 100 in simulated closed-body cavity surgical conditions.

The VitreOx® application on the surgical lens, was tested using three different methods of delivery, to adapt to the various diameters of endoscope lenses including, but not limited to 1, 1.2, 1.9, 2.7, 3.5, 4, 10 mm:

1. Syringe.
1. Bottle with dropper applicator, and
1. A customized, patented, sterile, single-use applicator.

Steam from 2 Mega Ohm deionized water was heated in a Pyrex container, using a VWR hotplate. Different steam temperatures were tested, from 98° Fahrenheit (32° Celsius), to 122° Fahrenheit (50° Celsius). The steam was directed to a handheld endoscope (Clarus 30000-10), using a stainless steel vessel. Additionally, an electronic endoscope (generic electronic endoscope 14.55 mm, wide angle) was also tested during the bench studies, similarly, steam was directed to the electronic endoscope.

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Animal Studies: The VitreOx® device was applied using a bottle with dropper applicator, on a Karl Storz endoscope. The endoscope was used in an exploratory gastrointestinal procedure on 2 male Yucatan swine from the same litter, for 90 minutes. Performance was compared between a control (no anti-fog), and the primary predicate device (New Wave D.E.L.P.).

Surgical conditions were carefully monitored and maintained by the help of veterinarians, who also administered the proper anesthesia for the swine. The surgical room was maintained between 68°F and 73°F. CO2 was used to inflate the swine's abdominal cavity, and the following vitals on the swine were monitored throughout the procedure: Pulse, oxygen level, respiratory rate, and body temperature.

Fogging is noted in the experiment: When there is a change of the light reflection on tissue, the light reflection will not be as crisp. In addition, veins on the tissue as also observed, because it will look less defined when fogging is present. Fogging was observed on the control scope within 9 minutes. Fogging was first observed on the endoscope treated with New Wave D.E.L.P. within 8 minutes, but distortion due to fogging was more evident after 31 minutes. Fogging was not observed on the endoscope with VitreOx®, throughout the 90-minute procedure.

After the exploratory gastrointestinal procedures, the 2 male Yucatan swine were kept at All Pets Animal Hospital in Peoria, Arizona for 2 weeks, for observation. The 2 male Yucatan swine did not suffer from effects of the procedure, and were discharged as "healthy", with no adverse reactions or complications from the procedures. Additionally, there were no signs of a reaction from the VitreOx® device on the swine's skin that came into contact with it. After the swine were discharged, they were monitored for a year to observe any adverse reactions, which there were not.

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Comparison Table

Characteristicand Material	VitreOx®	D.E.L.P(K)062779

Intended Use	VitreOx™ is intended to beused prior to endoscopic andlaparoscopic procedures, toeliminate fogging due tocondensation for scopesranging from 5 to 10 mm. Inaddition, it can also be usedfor microscopic lenses,goggles, surgical loupes, andother devices that may fog.	Commonly known as DHELP inthe market, is intended to be usedprior to and during endoscopicand laparoscopic procedures toprevent fogging of the scope lensfor 5mm and 10 mm scopes.
Solution	Sterile Water,Hydroxylpropylmethylcellulose (HPMC)	FDA Approved ShurClens, awound cleaning surfactant
Sponge	Yes	Yes
Mechanism ofAction	Applying the solution to thelens of the endoscope with asponge (if needed).	Heating and dipping distal end ofendoscope into solution
Size ofendoscopes usedfor oraccommodatedby device	5 mm, 10 mm, and all othersizes.	5mm and 10 mm
Sterility	Sterile	Sterile
Reusable/Disposable	Disposable	Disposable
MeetsBiocompatibilityneeds	Yes	Yes
Level ofBiocompatibility	External communicatingdevice (Tissue/bone/dentincommunicating)	External communicating device(Tissue/bone/ Dentincommunicating)
Duration ofBiocompatibility	Limited	Limited

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Assessment of Performance:

The VitreOx® device testing was conducted with two live, anesthetized Yucatan swine of the same sex (males) and litter. Two 4 mm Karl Storz endoscopy systems was used, one straight endoscope, the other 45° angle. A gastrointestinal exploratory procedure was conducted for 90 minutes with the VitreOx TM device. The performance of the VitreOx® device was compared to a control (endoscope with no treatment, and the same gastrointestinal procedure conducted for 90 minutes, using the D.E.L.P. device (primary predicate).

Conclusion:

Our evaluation concluded that VitreOx® raises no new issues of safety and effectiveness. There was no fogging on the scope that VitreOx® was applied through the entire duration of the 90-minute procedure. Unlike the D.E.L.P. device, the VitreOx® device did not require heating, and reapplication during procedure.

Regulation Number and Section

§ 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.