The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.

Device Description

GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.

AI/ML Overview

The provided document describes the GOLFF Sterile Anti-Fog Solution, a medical device intended to prevent fogging on endoscopic and laparoscopic camera lenses during surgery. The device's substantial equivalence to predicate devices is established through a series of tests and comparisons.

Here's a breakdown of the requested information:

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

Acceptance Criteria (Test Name)	Reported Device Performance (Result)
Product Functional Testing
Deformation/Degradation	Pass
Easy Removal of Release Liner	Pass
Adhesive Backing Functional	Pass
Squeeze Test	Pass
Transparency of Bottle	Pass
Bottle Shape	Pass
Anti-Fog Functional Test	Pass
Biocompatibility Testing
Cytotoxicity Test (ISO 10993-5:2009)	Pass: Non-Cytotoxic
Sensitization Test (ISO 10993-10:2010)	Pass: Non-Sensitizing
Intracutaneous Reactivity Test (ISO 10993-10:2010)	Pass: Non-Irritating
Sterilization Validation & Shelf-Life Study
Product designed to undergo gamma-radiation sterilization	Passed (per ISO 11137-2:2013, ISO 11737-1:2018, ISO 11737-2:2019)
Product Aging Validation Study (Accelerated aging simulating 4 years)
Package Integrity Test (Dye penetration Test, ASTM F1929-15)	Pass
Seal Peel Strength Test (ASTM F88/F88M-15)	Pass
Product Sterility Test (ISO 11737-2:2019)	Pass
Product Stability Studies (Fog Resistance Test, internal protocol)	Pass

2. Sample size used for the test set and the data provenance

The document does not specify exact sample sizes for each individual test. It states "A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution." The data provenance is internal testing performed by Batrik Medical Manufacturing Inc. The document does not specify the country of origin of the data, nor whether the studies were retrospective or prospective, but given they are for a premarket notification, they are by nature prospective for the device under consideration.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The tests performed are primarily benchtop, biocompatibility, and sterilization validation tests, which rely on standardized protocols and empirical measurements rather than expert human interpretation to establish a "ground truth."

4. Adjudication method for the test set

This information is not applicable and not provided. The types of tests conducted (e.g., functional, biocompatibility, sterility) typically involve objective measurements against predefined acceptance criteria, rather than subjective interpretation requiring adjudication among experts.

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 is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is an anti-fog solution for endoscopes, not an AI-powered diagnostic or imaging device that would involve "human readers" or AI assistance.

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

This is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is a physical product (anti-fog solution), not an algorithm or software.

7. The type of ground truth used

The "ground truth" for the tests performed can be characterized as follows:

Product Functional Testing: Defined physical and performance characteristics of the device (e.g., non-deformation, effective anti-fogging as per internal protocols).
Biocompatibility Testing: Compliance with established international standards (ISO 10993 series) for biological responses (cytotoxicity, sensitization, irritation).
Sterilization Validation: Achievement of sterility assurance levels as defined by international standards (ISO 11137, ISO 11737).
Product Aging Validation: Maintenance of package integrity, seal strength, sterility, and fog resistance over a simulated shelf-life, as per relevant ASTM and ISO standards and internal protocols.

8. The sample size for the training set

This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product that requires a training set.

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

This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product.

Summary

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February 26, 2024

Batrik Medical Manufacturing Inc. Suzy Bairos President 2165 46th Ave Lachine, Quebec H8T 2P1 Canada

Re: K231822

Trade/Device Name: GOLFF Sterile Anti-Fog Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCT Dated: January 25, 2024 Received: January 25, 2024

Dear Suzy Bairos:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Shanil P. Haugen -S

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231822

Device Name GOLFF Sterile Anti-Fog Solution

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5.0-510 (k) Summary

Image /page/4/Picture/1 description: The image shows a partial view of a document or advertisement. At the top, there's a mathematical expression that includes the number 310 followed by '(K)'. Below this, there's a vertical block of text in a bold, sans-serif font. The text appears to be part of a brand name or title, with the letters 'TRIK' being prominently visible. The color scheme includes a bright, solid blue that contrasts with the white text.

Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, H8T 2P1, Canada Phone: (800) 661-5432 | Website: www.surgmed.com

1. Submitter Information:

Date of 510(k) Summary: 1/24/2024 Submitter: Batrik Medical Manufacturing Inc Preparer and Contact Name: Heli Thakkar, Regulatory and Quality Manager Email: hthakkar@surgmed.com 510(k) Owner: Suzy Bairos, President Email: sbairos@surgmed.com Address: 2165 46th Ave., Lachine, Quebec, H8T 2Pl, Canada Phone: 514-631-7988 Ext. 21 / Fax: 514-631-9083

2. Device Name and Classification:

Common Name of Device:	Anti-Fog Solution
Device Proprietary Name:	GOLFF Sterile Anti-Fog Solution
Review Panel:	Gastroenterology/Urology
Regulation Number:	21 CFR 876.1500
Regulation Name:	Endoscope and Accessories
Class:	II
Product Code:	OCT

3. Substantial Equivalence:

Legally marketed devices with equivalence are claimed:

Primary Predicate: Aspen Surgical Inc. Dr. Fog:510(k) K932449 .
. Secondary Predicate: Medline Anti-Fog Solution 510(k) Kl 52948

4. Device Description:

There are no additional accessories associated with the product.

Diseases/Conditions for diagnosis, treatment, prevention, cure, or mitigation: None

Prescription Use Medical Device

5. Indications for Use:

The GOLFF Sterile Anti-Fog Solution is a single-use, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.

6. Predicate Device:

Primary Predicate: Aspen Surgical Inc. Dr. Fog 510(k) K932449 dated 11-AUG-1993 is similar in intended use, a. handling and technology compared to the device described in this submission.
Secondary Predicate: Medline Anti-Fog Solution 510(k) K152948 dated 04-FEB-2016 is similar in intended use, b.

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SECTION 5.0-510 (k) Summary

Image /page/5/Picture/1 description: The image shows a logo for a company called "BATRIK MEDICAL". The logo features the company name in white text against a light blue background. Above the company name, there are several white triangles arranged in a row, resembling a mountain range. The overall design is simple and clean, with a focus on the company name and a visual element that suggests stability and reliability.

Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, H8T 2P1, Canada Phone: (800) 661-5432 | Website: www.surgmed.com

handling and technology compared to the device described in this submission.

Comparison of Technological Characteristics with the Predicate Device: C.

Company	Batrik Medical ManufacturingInc.	Primary PredicateAspen Surgical Inc.(K932449)	Secondary PredicateMedline(K152948)
Model	GOLFF Sterile Anti-Fog Solution	Dr. Fog	Medline Anti-Fog Solution
Classification	Class II Device, OCT	Class II Device, OCT	Class II Device, OCT
Indications forUse	The GOLFF Sterile Anti-Fog Solutionis a single-use, medical device, anti-fog solution used by hospital staff toapply on lenses of endoscopic andlaparoscopic cameras. The solution isprovided in an easy-to- squeeze bottleand comes with an adhesive-backedsponge for secure placement.	Intended as an anti-fog agent forendoscopic camera lenses. -Removes fog formation on lens andallows the procedure to beuninterrupted.	Intended as an anti-fog agent forendoscopic camera lenses. -Removes fog formation on lens andallows the procedure to beuninterrupted.
Description	GOLFF Sterile Anti-Fog Solution byRegulation 21 CFR 876.1500 underFDA product code, OCT. GOLFF isa single use, disposable medicaldevice provided sterile. GOLFF isoffered in a sterile, sealed pouch witha bottle filled with anti-fog solutionand a sponge with an adhesivebacking lined with a barium strip.	Sterile Anti-Fog Solution byRegulation 21 CFR 876.1500 underFDA product code, OCT. A singleuse, disposable medical deviceprovided sterile. Offered in a sterilesealed pouch with a bottle filledwith anti-fog solution and a spongewith an adhesive backing lined witha barium strip.	Sterile Anti-Fog Solution byRegulation 21 CFR 876.1500 underFDA product code, OCT. A single use,disposable medical device providedsterile. Offered in a sterile sealedpouch with a bottle filled with anti-fogsolution and a sponge with an adhesivebacking lined with a barium strip.
Material	Bottle, cap and tip: PolyethyleneSponge: open cell polyesterStrip: BariumSolution: deionized water, isopropylalcohol, surfactant	Bottle, cap and tip: PolyethyleneSponge: open cell polyesterStrip: BariumSolution: surfactant, isopropylalcohol, water	Unknown
Safety	The following biocompatibility testswere conducted.- Cytotoxicity Test- Sensitization Test- IntracutaneousReactivity TestAll of the tests passed therequirements as indicated in theapplicable standards	Unknown: All of thebiocompatibility tests that areindicated in the FDA recognizedstandards were performed.	Unknown: All of the biocompatibilitytests that are indicated in the FDArecognized standards were performed.
Sterility	Sterile	Sterile	Sterile
Use	Single Use, Disposable	Single Use, Disposable	Single Use, Disposable
Where is itused	Hospital O.R. Room	Hospital O.R. Room	Hospital O.R. Room
Sterilization	Gamma irradiation	Gamma irradiation	Gamma irradiation

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SECTION 5.0-510 (k) Summary

Image /page/6/Picture/1 description: The image features a logo for "BATRIK MEDICAL". The logo is predominantly blue, with the word "BATRIK" in a bold, sans-serif font stacked above the word "MEDICAL", which is in a smaller font. Below the text, there are three small circles in a horizontal row, colored blue, green, and dark blue, respectively.

Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, H8T 2P1, Canada Phone: (800) 661-5432 | Website: www.surgmed.com

i. Performance Data

A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution. The following test results conducted to confirm the product is safe and effective as indicated.

1. Product Functional Testing

Benchtop Test	Batrik Medical Manufacturing Inc.GOLFF Sterile Anti-Fog Solution
Deformation/Degradation	Pass
Easy Removal of Release Liner	Pass
Adhesive Backing Functional	Pass
Squeeze Test	Pass
Transparency of Bottle	Pass
Bottle Shape	Pass
Anti-Fog Functional Test	Pass

ii. Biocompatibility testing

Test	Batrik Medical ManufacturingInc.GOLFF Sterile Anti-Fog Solution
Cytotoxicity TestISO 10993-5:2009 Biological Evaluation of Medical Devices -Part 5: Tests For In Vitro Cytotoxicity	Pass: Non-Cytotoxic
Sensitization TestISO 10993-10:2010 Biological Evaluation of Medical Devices -Part 10: Tests For Irritation And Skin Sensitization	Pass: Non-Sensitizing
Intracutaneous Reactivity Test: ISO 10993-10:2010 BiologicalEvaluation Of Medical Devices - Part I 0: Tests For IrritationAnd Skin Sensitization	Pass: Non-Irritating

All tests mentioned above showed that GOLFF Sterile Anti-Fog Solution did not raise any safety issues and is biocompatible.

iii. Sterilization Validation and Shelf-Life Study

The product is designed to undergo gamma-radiation sterilization prior to place into the market. The gammaradiation sterilization validation study was performed, and passed, per the requirements of the FDA recognized consensus standards listed below:

ISO 11137-2:2013 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose
ISO 11737-1:2018 Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of A Population of Microorganisms on Products
ISO 11737-2:2019 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in The Definition, Validation, and Maintenance of a Sterilization Process

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SECTION 5.0 - 510 (k) Summary

Image /page/7/Picture/1 description: The image shows the logo for Batrik Medical. The logo features a blue square with a stylized mountain range at the top. Below the mountain range, the word "BATRIK" is written in large, bold, white letters, with the word "MEDICAL" written in smaller, white letters underneath. At the bottom of the logo are three small circles in different shades of blue and green.

Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, HST 2Pl, Canada Phone: (800) 661-5432 | Website: www.surgmed.com

1. Product Aging Validation Study (Accelerated aging testing)

The product aging validation study was performed to simulate 4 years of aging.

No.	Test Name	Applicable Standards	Comment
1	Package IntegrityTest(Dye penetrationTest)	ASTM F1929-15 Standard Test Method ForDetecting Seal Leaks In Porous MedicalPackaging By DyePenetration	Pass
2	Seal Peel StrengthTest	ASTM F88/F88M-15 Standard Test MethodFor Seal Strength Of Flexible Barrier Materials	Pass
3	Product SterilityTest	ISO 11737-2:2019 Sterilization Of MedicalDevices - Microbiological Methods - Part 2:Tests Of SterilityPerformed In The Definition,Validation And Maintenance Of ASterilization Process	Pass
4	Product StabilityStudies(Fog Resistance Test)	N/A (followed by the internal testing protocol)	Pass

iv. Conclusions

Based on the testing conducted and equivalency in performance demonstrated between the Batrik, Aspen Surgical Inc., and Medline Inc. devices, in conjunction with biocompatibility demonstrated via EN ISO 10993-5 and EN ISO 10993-10 evaluations, evidence has been submitted to demonstrate that GOLFF Sterile Anti-Fog Solution is substantially equivalent to the predicate.

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.