The Unimax Anti-Fog Solution 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.

Device Description

The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Unimax Anti-Fog Solution." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving new acceptance criteria for an AI device. Therefore, the requested information about AI device acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance is not available in the given text.

The document states that a series of safety and effectiveness tests were performed to assess the Unimax Anti-Fog Solution. The results of these tests demonstrate that the device meets its predefined acceptance criteria and intended uses.

1. A table of acceptance criteria and the reported device performance

The document mentions that all test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses. However, it does not explicitly list the acceptance criteria or specific performance values for the fog resistance test, cleaning ability test, extractable test, or prolonged fog resistance test. It only states that the results indicate the new device is "as safe and effective as the predicate device."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document as it refers to a medical device's physical properties, not an AI model requiring ground truth from experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 information is not provided in the document. This is not an AI device.

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

This information is not provided in the document. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided in the document. This is not an AI device. The tests performed are laboratory standard tests.

8. The sample size for the training set

This information is not provided in the document. This is not an AI device and does not involve training sets.

9. How the ground truth for the training set was established

This information is not provided in the document. This is not an AI device and does not involve training sets.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle.

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

Unimax Medical Systems, Inc. % Aemebiotechs Co., Ltd. Mr. Michael Lee No. 45, Minshen Road Danshui Town - Taipei County Taiwan 251, China

JUL 2 7 2015

Re: K11622 Trade/Device Name: Unimax Anti-Fog Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCT Dated (Date on orig SE ltr): August 4, 2011 Received (Date on orig SE ltr): August 4, 2011

Dear Mr. Lee,

This letter corrects our substantially equivalent letter of September 9, 2011.

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

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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 (reporting of medical device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance 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" (21CFR 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/Safetv/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours.

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Unimax Anti-Fog Solution

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Indications for Use

510(k) Number (if known): K || 622

Device Name: Unimax Anti-Fog Solution

Indications for Use:

The Unimax Anti-Fog Solution 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Ogle for 3KM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111622

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Unimax Anti-Fog Solution

KIII622

510(k) Summary

5.1 Type of Submission:	Traditional
5.2 Preparation Date:	Jun 10, 2011
5.1 Revise Date:	Jul 29, 2011
5.2 Submitter:	Unimax Medical Systems Inc.
Address:	8F-2, No. 127, Lane 235, Pao Chiao Rd., Hsin Tien City,Taipei, Taiwan
Phone:	886-2-89191698
Fax:	886-2-89191528
Contact:	Sophia Chiu
Establishment Registration Number:	3007791595

ડ.3 Identification of the Device:

Proprietary/Trade name:	Unimax Anti-Fog Solution
Common Name:	Anti-Fog Solution
Classification Name:	Endoscope And/ Or Accessories
Device Classification:	II
Regulation Number:	876.1500
Panel:	Gastroenterology/Urology
Product Code:	KOG

5.4 Identification of the Predicate Device:

Predicate Device Name:	Xodus Medical Anti-Fog Solution
Manufacturer:	Xodus Medical, Inc.
510(k) Number or Clearance Information:	K063587

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5.5 Intended Use and Indications for Use of the subject device.

The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic instruments which are likely to fog during use.

5.6 Device Description

5.7 Non-clinical Testing

A series of safety tests were performed to assess the safety and effectiveness of the Unimax Anti-Fog Solution. The tests were conducted in accordance with ISO 10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing, ISO 10993-5 Biological Evaluation of medical devices- Part 5: Test for in vitro cytotoxicity, ISO 10993-10 Biological evaluation of medical devices- Part10: Tests for irritation and delayed-type hypersensitivity, ISO 10993-12 Biological evaluation of medical devices- Par112: Sample preparation and reference material, ISO 11137-1: 2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices. All the test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses.

The results of the non-clinical testing demonstrate that the Unimax Anti-Fog Solution is as safe and effective as the predicate devices.

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Unimax Anti-Fog Solution

5.8 Safety and Effectiveness

The result of bench testing listed below indicates that the new device is as safe and effective as the predicate device:

Fog Resistance Test .
Cleaning Ability Test .
Extractable Test .
Prolonged Fog Resistance Test ●

5.9 Substantial Equivalence Determination

The Unimax Anti-Fog Solution submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Xodus Medical Anti-Fog Solution which is the subject of K063587. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item	Proposed Device(Unimax Anti-Fog Solution)	Predicate Device(Xodus Medical Anti-Fog Solution)
Intended Use	The Unimax Anti-Fog Solution isintended to be used to prevent "fogging"(caused by condensation) on the lensesof endoscopic/laparoscopic instrumentswhich are likely to fog during use.	Anti-Fog is intended to be used toprevent "fogging" (caused bycondensation) on the lenses ofendoscopic/laparoscopic instrumentswhich are likely to fog during use.
Consisted	Bottled solution	Bottled solution
Instruments	Foam pad	Foam pad
Models	With alcoholAlcohol free	With alcohol
ComprisedElements	With alcohol:DPGMME (=2%)Isopropyl alcohol(=6%)Deionized water(=92%)	Alcohol free:DPGMME (=2%)Deionized water(=98%)	Predominantly water (=95%)Surfactant (<5%)Isopropanol (<1%)Ethanol (<0.5%)

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Unimax Anti-Fog Solution

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: :

・:"

: .. ·

Dimension	Bottle: 10cc	Bottle: 10cc
	Foam pad: 4.54.50.5 (LWH)	Foam pad: 1 3/4" x 1 1/2"
Sterilization	Gamma irradiation	Gamma irradiation
Safetystandards	ISO 10993-1	ISO 10993-1
	ISO 10993-5	ISO 10993-5
	ISO 10993-10	ISO 10993-10
	ISO 10993-12	ISO 10993-12
Performancestandards	Not Applicable	Not Applicable

5.10 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that Unimax Anti-Fog Solution is as safe and effective as the predicate device.

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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.