The LENSERVER Automatic Contact Lens Cleaning Accessory is intended for use as an adjunct in cleaning both soft hydrophilic and rigid gas permeable contact lenses using approved contact lens cleaning solutions.

Examples of approved cleaning solutions indicated for use with the LENSERVER Automatic for soft hydrophilic lenses are the Allergan Soft Mate Consept-1 Cleaning and Disinfecting Solution, Allergan Soft Mate Consept-2 Neutralizing and Rinsing Solution, or Spray. The LENSERVER Automatic is indicated for cleaning rigid gas permeable lenses in conjunction with approved solutions such as Allergan Gas Permeable Daily Cleaner and Allergan ComfortCare Gas Permeable Wetting and Soaking Solution.

Device Description

The LENSERVER Automatic Contact Lens Cleaning Accessory is an electro-mechanical contact lens cleaning device designed to be used in conjunction with approved contact lens cleaning solutions. The cleaning components of the LENSERVER Automatic consist of a motorized cleaninq unit and a partitioned fluid reservoir functioning as the cleaning beaker.

The motorized unit is manufactured from a polymer and houses the battery compartment. motor and control circuits. The fluid reservoir or lens receptacle/cleaning beaker is partitioned and injection molded from medical grade polymer. Fill marks are engraved on the outer wall of the beaker indicating a fluid volume sufficient to completely submerge contact lenses. Each contact lens would be placed into the appropriate compartment. designated "L' or 'R'.

The base of the fluid reservoir or cleaning beaker fits snugly onto a vibrating platform on the motorized cleaning unit. When placed on the vibrating platform and the power button is actuated, the cleaning beaker vibrates, and after a predetermined period the timing mechanism halts rotation of the motor.

AI/ML Overview

The provided 510(k) summary describes the LENSERVER Automatic Contact Lens Cleaning Accessory and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria with quantifiable metrics. Instead, the study focuses on demonstrating safety and compatibility with contact lenses, which are indirect measures of "performance" in this context.

However, based on the information provided, we can infer some "acceptance criteria" and describe the study that addresses them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Device Safety	Acute Ocular Irritation: Solutions cycled through the LENSERVER Automatic (LENSERVER test solution) showed no acute ocular irritation, concluding that materials used in the device were safe.
Lens Compatibility	No Detectable Damage/Changes to Lenses: No detectable damage or changes were demonstrated in test lenses (soft hydrophilic: FDA groups I and IV; rigid gas permeable) following the evaluation program. Parameters measured (power, base curve, diameter, clarity) for new lenses before and after cleaning cycles showed no significant alterations. The device was deemed safe and compatible with both soft hydrophilic and rigid gas permeable contact lenses.
Cleaning Efficacy (Implied)	"Assist in cleaning": While not directly quantified in terms of bacterial reduction or debris removal, the device is intended to "assist in cleaning" in conjunction with approved solutions. The electro-mechanical agitation is presented as functionally equivalent to the cleaning mechanisms of predicate devices. The study doesn't provide a direct metric for the effectiveness of cleaning, but rather the safety of the cleaning process on the lenses.

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

Sample Size:
- Acute Ocular Irritation Test: The document mentions "saline cycled through the device" and "LENSERVER test solution," but does not explicitly state the number of samples or animal subjects used for this test.
- Lens Compatibility Test:
  - 10 lenses of each lens type.
  - Total of 30 cleaning cycles for each individual lens.
  - Lens types: 2 types of soft hydrophilic lenses (FDA groups I and IV) and 2 different rigid gas permeable lenses of different manufacture.
  - "Ten different LENSERVER Automatic devices" were used.
Data Provenance: The tests were conducted by:
- An independent testing facility for the acute ocular irritation test.
- Highly trained and expert investigators at a recognized college of optometry (specifically, Southern California College of Optometry, Fullerton, California) for the lens compatibility test.
Retrospective or Prospective: These appear to be prospective studies specifically conducted for this 510(k) submission.

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

Acute Ocular Irritation Test: Performed by an "independent testing facility" according to USP XXII guidelines. The specific number or qualifications of experts are not detailed, but the reference to USP XXII suggests adherence to recognized standards for such tests.
Lens Compatibility Test: "Highly trained and expert investigators" at the Southern California College of Optometry. The document does not specify the exact number of investigators or their detailed qualifications (e.g., "radiologist with 10 years of experience"), but their affiliation with a recognized optometry college implies relevant expertise.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in either test.

For the Acute Ocular Irritation Test, results were determined by the "independent testing facility" according to USP XXII guidelines, which would have defined assessment criteria.
For the Lens Compatibility Test, the "trained investigators" at the optometry college measured lens parameters ("power, base curve, diameter and clarity") before and after cleaning cycles. The determination of "no detectable damage or changes" would likely have been based on established clinical or optical tolerances for these parameters, not necessarily inter-expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a cleaning accessory, not an diagnostic imaging tool where human readers assess cases. The studies performed focused on the device's safety and compatibility with lenses.

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

This question is not applicable as the device is a physical electro-mechanical accessory, not an AI algorithm. Its performance is inherent in its physical operation. The "standalone" performance refers to the device's ability to clean without causing harm to the lenses or eyes.

7. The Type of Ground Truth Used

Acute Ocular Irritation Test: The ground truth for safety was based on the biological response observed in the test (e.g., lack of irritation) compared to established toxicity standards (USP XXII guidelines). This could be considered a form of outcomes data in a controlled biological setting.
Lens Compatibility Test: The ground truth for lens compatibility was established through objective measurements of lens parameters (power, base curve, diameter, clarity) before and after cleaning cycles, and the absence of visually detectable damage or changes. This is a form of objective measurement data interpreted by experts.

8. The Sample Size for the Training Set

This device does not involve an AI algorithm; therefore, there is no training set in the context of machine learning. The device's design and operation are based on engineering principles comparable to predicate devices.

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

As there is no AI algorithm or training set, this question is not applicable.

Summary

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JAN 1 3 1999

510(k) Summary

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

The assigned 510(k) number is Filed on 12 June, 1998

Submitted by: Address:

Telephone: Facsimile: Contact person:

Daniel Hsu. Ph.D. Rim-Wide Companies, Inc. P.O. Box 910184 San Diego, CA 92191-0184 619-622-9956 619-622-9953 Daniel Hsu, Ph.D.

K982115

Identification of the device Device name: Proprietary/Trade name:

Common name: Device classification:

LENSERVER Automatic LENSERVER Automatic Contact Lens Cleaning Accessorv Contact Lens Cleaning Accessory Unclassified

Identification of predicate devices

Predicate device name: 1. Manufacturer: 510(k) number/clearance information:
1. Predicate device name: Manufacturer: 510(k) number/clearance information: Predicate device labeling:
Predicate device name: 3. Manufacturer: 510(k) number/clearance information: Predicate device labeling:
1. Predicate device name: Manufacturer: 510(k) number/clearance information: Predicate device labeling:

ട. Predicate device name: Sola/Barnes-Hind Hydra-Mat Barnes-Hind, Inc. P810017, P840066

Sola/Barnes-Hind Soft Mate Barnes-Hind. Inc. K852386 SOFT MATE Automatic Contact Lens Cleaning Unit

Clensatron 700 CL Questech International, Inc. K884414 CLENSATRON Automatic Contact Lens Cleaner

Visonic Dome Vista Vision, Inc. K902306 VISONIC DOME Contact Lens Cleaning Accessory

Lensonic

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Manufacturer: 510(k) number/clearance information: Predicate device labeling:

Predicate device name: 6. Manufacturer: 510(k) number/clearance information: Predicate device labeling:
Predicate device name: 7. Manufacturer: 510(k) number/clearance information: Predicate device labeling:

Personal Professional Products, Inc. K921615 Lensonic Contact Lens Care Accessory

Lens Comfort Lens Comfort. Inc. K921615 Lens Comfort Ultrasonic Contact Lens Care Accessory

New Comfort Lens Comfort, Inc. K974724 New Comfort Contact Lens Care Accessory

Description of device and reason for submission

This Premarket Notification is submitted prior to our intent of introducing this device in the United States for the purposes of cleaning contact lenses in conjunction with approved contact lens cleaning solutions.

Intended use

Demonstration of substantial equivalence

The LENSERVER Automatic is preceded by seven approved devices for contact lens cleaning as listed under 'Identification of predicate devices' for use in conjunction with approved solutions. The LENSERVER Automatic is also indicated for use as an accessory for cleaning contact lenses with approved lens solutions. Three of these devices use mechanical or electro-mechanical means of generating hydrodynamic

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turbulence that assist in cleaning and the other four listed predicate devices effect tansaling by piezoelectric-induced cavitation. Lens cleaning in the LENSERVER Automatic is also assisted by electro-mechanical agitation of the lenses in cleaning solutions.

Predicate devices contain a fluid reservoir in which lenses and a defined volume of lens solution are placed during cleaning cycles. The LENSERVER Automatic also uses a reservoir in which lenses and defined volumes of solution are in contact during the cleaning cycles. During cleaning in all predicate devices, lenses are individually identified by physical separation and labeling. In the LENSERVER Automatic, lenses are also physically separated in appropriately, and easily identifiable compartments during cleaning cycles.

Physical contact with lenses in all predicate devices occur with medical grade polymers and physical contact with lenses in the LENSERVER Automatic are also with medical grade polymers. These polymers are also used in the predicate devices, or are similar in chemical composition to previously used polymers.

Predicate devices have timing circuits that terminate cleaning after pre-determined periods. The LENSERVER Automatic also has a pre-determined cleaning period.

During lens cleaning the LENSERVER Automatic vibrates by electro-mechanical means. Predicate devices are also electro-mechanical in operation. Other predicate devices use ultrasonic cavitation in assisted cleaning.

The fluid reservoir in LENSERVER Automatic is manufactured by injection molding from medical grade polymer. Fluid reservoirs in predicate devices are manufactured from medical grade polymer or stainless steel.

Pre-Clinical Testing of the LENSERVER Automatic Contact Lens Cleaning Accessory

In vivo Testing

An acute ocular irritation test of solutions from the LENSERVER Automatic was also performed by an independent testing facility, with the conclusion that materials used in the device were safe, as recommended by the Center for Devices and Radiological Health for contact lens care devices.

Compatibility of the LENSERVER Automatic with soft hydrophilic and rigid gas permeable contact lenses in its intended application

The design and indicated use of the LENSERVER Automatic has been determined to be safe and compatible with soft hydrophilic and rigid gas permeable contact lenses. No detectable damage or changes were demonstrated in test lenses following the evaluation program by an independent testing facility.

Device evaluation was performed by highly trained and expert investigators at a recognized college of optometry using a modified protocol obtained from the Division of Ophthalmic Devices at the Office of Device Evaluation. Lens parameters of each new lens were measured prior to and after the series of cleaning cvcles. Ten lenses of each

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lens type were cycled in ten different LENSERVER Automatic devices for a total of 30 cleaning cvcles for each individual lens. The lenses used were two types of soft hydrophilic lenses. FDA groups I and IV, and two different rigid gas permeable lenses of different manufacture.

Clinical testing for this device is not suggested, and was not performed.

The preceding tests conclude that the LENSERVER Automatic is safe when used on contact lenses, and the materials used in construction of this device meet the standards suggested by the FDA for biocompatibility. The LENSERVER Automatic also references the same lens solutions as predicate devices. The LENSERVER Automatic may thus be concluded to be substantially equivalent to predicate devices.

In conclusion, the LENSERVER Automatic Contact Lens Cleaning Accessory is mechanically similar to predicate devices, and like predicate devices, is indicated for use with approved contact lens care solutions, and references the same solutions. Just as predicate devices this device is manufactured with identical or chemically similar medical grade polymers where contact with lenses and solutions occur. Like predicate devices. the LENSERVER Automatic has also been independently demonstrated to be safe and compatible with contact lenses. These data provide justification for the LENSERVER Automatic to be substantially equivalent to predicate devices.

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Differences between the LENSERVER Automatic and predicate devices: During lens cleaning the LENSERVER Automatic vibrates by electro-mechanical means at approximately 900 Hz, while the Clensatron 700 CL rotates at approximately 300 Hz by electro-mechanical means and the Hydra-Mat rotates at approximately 1-10 Hz by manual agitation. The Visonic Dome, Lensonic and Lens Comfort devices generate ultrasonic vibrations at approximately 40,000 Hz to 60,000 Hz.

The LENSERVER Automatic is solely powered by batteries. Predicate devices use UL approved transformers plugged into 110 V AC wall sockets for power, or a combination of transformers and batteries for power.

The fluid reservoir in LENSERVER Automatic is manufactured by injection molding from medical grade polymethylpentene. Fluid reservoirs in predicate devices Lens Comfort and Visonic Dome are manufactured from medical grade stainless steel, while Clensatron and Lensonic use injection molded, medical grade polycarbonate.

In vivo and in vitro tests

Acute ocular irritation test of the LENSERVER Automatic:

Since acute ocular irritation test results of the medical grade polymers used in construction of the LENSERVER Automatic were not available on Material Safety Data Sheets or manufacturers, this test was performed according to guidelines listed in USP XXII using saline cycled through the device in a manner similar to the following test for evaluation of device compatibility with contact lenses. The solution recovered from the LENSERVER Automatic was labeled 'LENSERVER test solution' and unprocessed solution 'Control solution'. These solutions were shipped on ice to a testing facility where the acute ocular irritation tests were performed. The acute ocular irritation test resulted in a conclusion favorable for the LENSERVER Automatic (test results on pages 4.2-4.4),

Compatibility of the LENSERVER Automatic with soft hydrophilic and rigid gas permeable contact lenses in its intended application:

Device evaluation was performed by trained investigators at the Southern California College of Optometry, Fullerton, California, using a modified protocol obtained from the Division of Ophthalmic Devices at the Office of Device Evaluation. The following lens parameters of each new lens were measured prior to and after the series of cleaning cycles: power, base curve, diameter and clarity. Ten lenses of each lens type were cycled in ten different LENSERVER Automatic devices for a total of 30 cleaning cycles for each individual lens. The lenses used were two types of soft hydrophilic lenses, FDA groups 1 and IV, and two different rigid gas permeable lenses of different manufacture.

A detailed report of the evaluation protocol and results appears in Appendix III.

Clinical testing for this device is not indicated, and is not included with this filing.

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Substantially equivalent:

The LENSERVER Automatic Contact Lens Cleaning Accessory is mechanically similar to predicate devices, and like predicate devices, is indicated for use with approved contact lens care solutions, and reference the same solutions. Just as predicate devices this device is manufactured with identical or chemically similar medical grade polymers where contact with lenses and solutions occur. Like predicate devices, the LENSERVER Automatic has also been independently demonstrated to be safe and compatible with the indicated contact lenses. These data strongly favor the LENSERVER Automatic to be substantially equivalent to predicate devices.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 1999

Rim - Wide Companies Daniel K. Hsu, Ph.D. President P.O. Box 910184 San Diego, California 92191-0184

Re: K982115 Trade Name: LensServer Automatic Contact Lens Cleaning Accessory Regulatory Class: (unclassified) Product Code: LYL Dated: December 1, 1998 Received: December 7, 1998

Dear Dr. Hsu:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 -Mr. Daniel K. Hsu, Ph.D.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K982115 510(k) NUMBER (IF KNOWN): _

LenServer Automatic Contact Lens Cleaning Accessory DEVICE NAME:

INDICATIONS FOR USE:

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

Concurrence of CDRH Office of Device Evaluation (ODE)
	Daniel W.C. Brown, Ph.D.
	(Division Sign-Off)
	Division of Ophthalmic Devices
Prescription Use	510(k) Number K982115	Over-The-Counter-Use \u2713
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

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