(191 days)
Not Found
No
The device is a chemical solution for preventing lens fogging and does not involve any computational processing or learning.
No.
The device, VitreOx®, is an anti-fog coating for surgical instruments, specifically laparoscope lenses, intended to maintain visualization of the surgical site. It does not directly diagnose, cure, mitigate, treat, or prevent disease, nor does it affect the structure or any function of the body. Its purpose is to facilitate the use of another medical device (the laparoscope) by preventing fogging.
No
The device is an anti-fog coating for surgical lenses, which aids visualization during surgery but does not diagnose any condition.
No
The device is described as a biocompatible, aqueous solution, which is a physical substance, not software.
Based on the provided information, the device VitreOx® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent fogging of surgical lenses (laparoscopes, endoscopes) during minimally invasive surgeries to maintain visualization of the surgical site. This is a direct interaction with a medical device used during a surgical procedure, not a test performed on a sample taken from the body.
- Device Description: The device is an anti-fog coating applied to the lens of a surgical instrument. It functions to improve the performance of the surgical instrument itself.
- Lack of Diagnostic Purpose: The device does not analyze any biological sample (blood, urine, tissue, etc.) to provide information about a patient's health, disease state, or condition. Its purpose is purely functional – to improve visualization during surgery.
- No Mention of Biological Samples: The description focuses on the application to and performance on surgical lenses, not on any interaction with biological materials for diagnostic purposes.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. VitreOx® does not fit this definition. It is a surgical accessory designed to improve the functionality of a surgical instrument.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OCT, GCJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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, 2) Bottle with dropper applicator, and 3) 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.
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.). 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. The 2 male Yucatan swine were observed for 2 weeks and then for a year, with no adverse reactions or complications.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features an eagle-like symbol with three stylized human profiles forming its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
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.
1
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
2
Indications for Use
510(k) Number (if known) K163257
Device Name VitreOx®
Indications for Use (Describe)
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.
| 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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3
FDA 510(k) Summary
| 1. Applicant & Co-Specification
Developer | SiO2 Nanotech, LLC
275 N Gateway Drive, Suite 126
Phoenix, AZ 85034 USA
Tel #: (602)-565-3447 |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Submitter
Address | SiO2 Nanotech, LLC
275 N Gateway Drive, Suite 126
Phoenix, AZ 85034 USA
Tel #: (602)-565-3447 |
| Trade/Proprietary Name | VitreOx® |
| Common Names | Endoscope Anti-fogging Device |
| Establishment Number | 404323 |
| Proposed Classification | OCT Anti-fogging solutions and
accessories, endoscopy
Class 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:
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.
4
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:
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.
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:
-
- Syringe.
-
- Bottle with dropper applicator, and
-
- 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
| Characteristic
and Material | VitreOx® | D.E.L.P
(K)062779 |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Intended Use | VitreOx™ is intended to be
used prior to endoscopic and
laparoscopic procedures, to
eliminate fogging due to
condensation for scopes
ranging from 5 to 10 mm. In
addition, it can also be used
for microscopic lenses,
goggles, surgical loupes, and
other devices that may fog. | Commonly known as DHELP in
the market, is intended to be used
prior to and during endoscopic
and laparoscopic procedures to
prevent fogging of the scope lens
for 5mm and 10 mm scopes. |
| Solution | Sterile Water,
Hydroxylpropylmethylcellulo
se (HPMC) | FDA Approved ShurClens, a
wound cleaning surfactant |
| Sponge | Yes | Yes |
| Mechanism of
Action | Applying the solution to the
lens of the endoscope with a
sponge (if needed). | Heating and dipping distal end of
endoscope into solution |
| Size of
endoscopes used
for or
accommodated
by device | 5 mm, 10 mm, and all other
sizes. | 5mm and 10 mm |
| Sterility | Sterile | Sterile |
| Reusable/Dispos
able | Disposable | Disposable |
| Meets
Biocompatibility
needs | Yes | Yes |
| Level of
Biocompatibility | External communicating
device (Tissue/bone/dentin
communicating) | External communicating device
(Tissue/bone/ Dentin
communicating) |
| Duration of
Biocompatibility | 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.