The Nutrifill preservative free insertion solution is indicated as an insertion solution for large diameter (scleral), hybrid and rigid gas permeable (RGP) contact lenses following proper lens care disinfection as recommended by the eye care practitioner. This solution may also be used for rinsing debris and lens cleaners from rigid gas permeable, hybrid and hard contact lenses, as a rinse for contact lens cases and may be used as needed throughout the day to rinse contact lenses.

Device Description

The Nutrifill preservative free insertion solution is a sterile isotonic buffered solution containing electrolytes (calcium, magnesium, phosphate, sodium) in a single dose, carry-on size 10ml vial. It rinses loose debris and cleaning solution off rigid gas permeable (RGP), hard and hybrid contact lenses prior to insertion. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

AI/ML Overview

The provided text describes a 510(k) summary for a contact lens insertion solution called Nutrifill. It outlines the device's characteristics and compares it to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of a medical imaging or AI device.

The "Performance Data" section explicitly states:

Non-Clinical Studies: "A series of studies were completed to demonstrate the substantial equivalence of the Nutrifill preservative free insertion solution to the predicate device. Results of non-clinical testing demonstrate:
- The Nutrifill solution is non-toxic and non-irritating
- The final packaging is non-toxic and non-irritating"
Clinical Studies: "Clinical studies involving the Nutrifill solution were unnecessary for this application. Lens care solutions used with this Nutrifill solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses."

Therefore, I cannot provide the requested information for acceptance criteria and a study proving the device meets those criteria, as this information is not present in the given document. The submission focuses on demonstrating substantial equivalence to predicate devices for a contact lens care product, rather than reporting performance against specific acceptance criteria for a diagnostic or AI-driven device.

Summary

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K181566

I. SUBMITTER

Sept 18th 2018 Date Prepared:
Name: Contamac Ltd. Address: Carlton House Shire Hill Saffron Walden Essex CB11 3AU Contact Person: Robert McGregor Managing Director Phone number: 01799 514800 Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln. West Linn, OR 97068 Phone number: (503) 372-5226

II. DEVICE

Trade Name:	Nutrifill
CommonName:	Contact Lens Insertion Solution
ClassificationName:	Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918)
RegulatoryClass:	Class II
Product Code:	MRC

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III. PREDICATE DEVICE

The Nutrifill preservative free insertion solution is substantially equivalent in terms of actions and indications to the following predicate device(s):

. "LensGiene™ Sterile Saline Solution (Alternate Trade Name: ScleralFil)" By Bausch + Lomb, Inc. 510(k) number: K161622 Device Classification: II
. "Menicon Saline Rinse Solution" By Menicon Co., Ltd. 510(k) number: K151768 Device Classification: II

DEVICE DESCRIPTION IV.

V. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Nutrifill preservative free insertion solution is substantially equivalent to the predicate devices in terms of the following:

트 Intended use
트 Indications for use
Actions
I Classification - Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918)
트 How supplied (sterile, single dose)
Preservative free formulation

The Nutrifill preservative free insertion solution is unique from the predicate device in terms of the

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following:

י Nutrifill contains additional electrolytes (calcium, magnesium, potassium, phosphate)
י Nutrifill is buffered with a phosphate buffer at normal ocular pH and osmolarity

The following matrix illustrates the intended use and other characteristics of the Nutrifill preservative free insertion solution, as well as the predicate device.

	Contamac, Ltd.Nutrifill	Bausch + Lomb, Inc.LensGiene™ Sterile SalineSolution (ScleralFil)	Menicon Co., Ltd.Menicon Saline RinseSolution
	New Device	Predicate Device (K161622)	Predicate Device (K151768)
Intended Use	The Nutrifill preservative freeinsertion solution is indicatedas an insertion solution forlarge diameter (scleral) andhybrid contact lenses followingproper lens care disinfection asrecommended by the eye carepractitioner. This solution mayalso be used for rinsing debrisand lens cleaners from rigid gaspermeable, hybrid and hardcontact lenses, as a rinse forcontact lens cases and may beused as needed throughout theday to rinse contact lenses.	The LensGiene™ Sterile SalineSolution is indicated for usefollowing proper lens disinfectionas recommended by the eye carepractitioner. The LensGiene™Sterile Saline Solution is forrinsing soft (hydrophilic), rigidgas permeable and hard contactlenses prior to lens insertion. Thissolution may also be used as aninsertion solution for largediameter (scleral) contact lenses,as a rinse for contact lens cases,and may be used as neededthroughout the day to rinsecontact lenses.	For use following properlens disinfection asrecommended by the eyecare practitioner. TheMenicon Saline RinseSolution is for rinsing soft(hydrophilic), rigid gaspermeable and hard contactlenses prior to lens insertion.This solution may also beused as an insertion solutionfor large diameter (scleral)contact lenses, as a rinse forcontact lens cases, and maybe used as neededthroughout the day to rinsecontact lenses.
Classification	21 CFR 886.5918	21 CFR 886.5918 ; 21 CFR886.5928	21 CFR 886.5918 ; 21 CFR886.5928
Product Code	MRC	MRC; LPN	MRC; LPN
Class	Class II	Class II	Class II
Volume	10 mL per dose	10 mL per dose	5 mL per dose
Preservative Free	Yes	Yes	Yes
Single or Multi Dose	Single Dose	Single Dose	Single Dose
Sterility	Sterile	Sterile	Sterile
Container	Plastic resin container withtwist off cap	Plastic resin container with twistoff cap	Plastic resin container withtwist off cap
Contains Electrolytes(Calcium, Magnesium,Potassium, Phosphate)	Yes	No	No

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VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

A series of studies were completed to demonstrate the substantial equivalence of the Nutrifill preservative free insertion solution to the predicate device. Results of non-clinical testing demonstrate:

The Nutrifill solution is non-toxic and non-irritating
The final packaging is non-toxic and non-irritating ●

~ Clinical Studies ~

Clinical studies involving the Nutrifill solution were unnecessary for this application. Lens care solutions used with this Nutrifill solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses.

VIII. CONCLUSIONS

Substantial Equivalence

Based on the composition of the solution and results of non-clinical testing presented in this Premarket Notification, the Nutrifill preservative free insertion solution is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

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October 22, 2018

Contamac Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn. OR 97068

Re: K181566

Trade/Device Name: Nutrifill Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC Dated: September 18, 2018 Received: September 21, 2018

Dear Bret Andre:

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. 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 located 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Regulation Number and Section

§ 886.5918 Rigid gas permeable contact lens care products.

(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”