The Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not-aphakic persons with non-diseased eyes.

The lenses may be prescribed in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

The lenses may be disinfected using a chemical disinfection system only.

Device Description

The Menicon Z lens material, tisilfocon A is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (benzotriazol) is added.

Lens designs for the management of irregular corneas include: 1) progressively flattening peripheral curves, 2) a reverse curve or series of reverse curves in the peripheral design, or 3) decentered optic zone and resulting peripheral curves, or 4) a combination of the first three systems.

AI/ML Overview

The provided 510(k) summary for the Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses does not contain specific acceptance criteria, nor does it describe a study designed to prove the device meets such criteria in the way typically expected for novel devices demonstrating performance metrics.

Instead, the submission relies on the concept of substantial equivalence to predicate devices and previously cleared or approved applications for the same material.

Therefore, the following information is not present in the provided text:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set, data provenance, number of experts for ground truth, adjudication method, MRMC study details, or standalone study details related to the performance of the device against specific criteria.
The type of ground truth used for such a study.
Sample size for a training set or how ground truth for a training set was established.

Here's an analysis based on the available information:

1. Acceptance Criteria and Reported Device Performance

The submission does not define specific performance acceptance criteria for the Menicon Z lenses in terms of efficacy or safety metrics. Instead, "acceptance" is based on substantial equivalence to predicate devices and previously cleared/approved applications for the material (tisilfocon A).

The reported device performance is summarized qualitatively:

"Results of a retrospective case study using the Menicon Z lenses for the management of keratoconus and other irregular corneal conditions demonstrated that the lenses effectively maintained corneal physiology and visual acuity."

This statement acts as the performance claim, but it's not tied to specific, quantifiable acceptance criteria.

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

The document mentions a "retrospective case study," but it does not provide any details regarding:

The sample size of this study.
The country of origin of the data.
Whether the study was retrospective or prospective (though it explicitly states "retrospective").

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. The "retrospective case study" is mentioned, but the methodology for establishing "ground truth" (e.g., what constitutes "maintained corneal physiology" or "effectively maintained visual acuity") and who assessed it is not detailed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided.

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

An MRMC study is not mentioned in this 510(k) summary. This type of study is typically relevant for AI/CADe devices, which this contact lens is not.

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

This is not applicable as the device is a physical contact lens, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the retrospective case study would likely have been clinical assessments by ophthalmologists or optometrists, focusing on:

Corneal physiology: Assessed through slit lamp examination, fluorescein staining, etc., to check for signs of hypoxia, edema, infiltrates, or other adverse events.
Visual acuity: Measured using standard Snellen charts or equivalent.

However, the specific methods or whether this was expert consensus, pathology, or outcomes data is not explicitly stated.

8. The Sample Size for the Training Set

A "training set" isn't applicable in the context of this submission. The device is a physical product based on a known material, not an AI algorithm. The material itself has been previously studied and cleared/approved.

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

This is not applicable as there is no "training set" in the context of this device.

Summary of the Study and its Role in Acceptance:

The core of the submission for Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses relies on:

Substantial Equivalence: The primary basis for clearance is that the Menicon Z material (tisilfocon A) has been previously cleared/approved in multiple 510(k)s (K962006, K970019) and PMAs (P990018, P990018/S002) for various wear durations and designs. This implies its safety and basic efficacy (biocompatibility, oxygen permeability, etc.) are already established.
Predicate Devices: The device is considered substantially equivalent to other legally marketed RGP lenses for the correction of refractive ametropia and for the management of irregular corneal conditions (e.g., Rose K Post Graft, Dyna Intra-Limbal, Boston XO/EO/ES). This means the FDA found that the Menicon Z lens is as safe and effective as these existing devices, and does not raise new questions of safety or effectiveness.
Retrospective Case Study (for Irregular Corneas Indication):
- Purpose: To support the additional indication for the management of irregular corneal conditions (e.g., keratoconus, post-surgical).
- Finding: The study "demonstrated that the lenses effectively maintained corneal physiology and visual acuity."
- Details Missing: Specific details about the study (sample size, exact metrics, and ground truth establishment) are not provided in this summary. However, the FDA's acceptance of this statement implies they found it sufficiently supportive for the expanded indication, likely in conjunction with the established safety profile of the material.
- Clinical Study Necessity: The document explicitly states: "Clinical study for the Menicon Z (tisilfocon A) material has been deemed as not necessary in support of this clearance, as no new or additional questions of safety or effectiveness have been raised." This indicates that the retrospective case study was likely a supportive piece of evidence rather than a primary, meticulously designed clinical trial to establish new safety/efficacy metrics from scratch.

Summary

{0}------------------------------------------------

510(k) summary MENICON Z (tisilfocon A) RIGID GAS PERMEABLE CONTACT LENSES May 2008

1. Applicant Information

Menicon Co., Ltd.
21-19, Aoi 3-chome,
Naka-ku, Nagoya, Aichi 460-0006
JAPAN
Contact Person:	Takahiro Ochi
Telephone No.:	+81-52-937-5021
Fax No.:	+81-52-935-1121
E-mail:	t-ochi@menicon-net.co.jp

2. Device Information

Classification name: Lenses, Rigid Gas Permeable, Daily Wear Contact Lenses Device classification: Class II Regulation number: 21 CFR 886.5916 Product code: HQD Proprietary name: Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses

3. Predicate Devices

Menicon claims substantial equivalence of the Menicon Z (tisilfocon A) to the following predicate devices.

Rose K Post Graft Rigid Gas Permeable Contact Lenses: K013646 .
. Dyna Intra-Limbal lens (enflufocon A & hexafocon A): K020006
. Boston XO (hexafocon A), Boston EO (enflufocon B) and Boston ES (enflufocon A) Rigid Gas Permeable Contact Lenses: K013762, K053124, K071043.

4. Description of device

{1}------------------------------------------------

K081443

5. Indications for use

The lenses may be disinfected using a chemical disinfection system only.

6. Description of safety and substantial equivalence

The safety and efficacy of the Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lens material was demonstrated in 510(k) Premarket Notifications and Premarket Approvals (PMA) as follows.

. K962006 cleared on October 9, 1996
. K970019 cleared on March 25, 1997 (multifocal designs)
P990018 approved on July 11, 2000 (up to 7 days extended wear) �
P990018/S002 approved on July 12, 2002 (up to 30 days continuous wear)

Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to Rose K Post Graft Rigid Gas Permeable Contact Lenses, cleared in 510(k) Premarket Notification K013646 and Dyna Intra-Limbal lens Rigid Gas Permeable Contact Lenses, cleared in 510(k) Premarket Notification K020006, including an indication for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.

7. Clinical data:

Clinical study for the Menicon Z (tisilfocon A) material has been deemed as not necessary in support of this clearance, as no new or additional questions of safety or effectiveness have been raised.

Results of a retrospective case study using the Menicon Z lenses for the management of keratoconus and other irregular corneal conditions demonstrated that the lenses effectively maintained corneal physiology and visual acuity.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle.

SEP 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Menicon Co. Ltd. c/o Beverley D. Venuti, Ph.D., R.A.C. Staff Consultant Foresight Regulatory Strategies, Inc. 269A Ballardvale Street Wilmington MA 01887

Re: K081443

Trade/Device Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Codc: HQD Dated: August 21, 2008 Received: August 25, 2008

Dear Dr. Venuti:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.

{3}------------------------------------------------

Page 2 - Beverley D. Venuti, Ph.D., R.A.C.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Malvina B. Estrada, M.D.

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

{4}------------------------------------------------

Indications for Use

510(k) Number (if known):

KO81443

Device Name: Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lenses

Indications for Use:

The lenses may be disinfected using a chemical disinfection system only.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Ophthalmic Ear,Nose and Throat Devices
510(k) Number	K081443

Page 1 of 1

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.