(59 days)
No
The summary describes a rigid gas permeable contact lens and its material properties, intended use, and predicate devices. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No.
The device is indicated for the correction of refractive error and management of irregular corneal conditions, not for treating or curing a disease.
No
Explanation: The device is a contact lens indicated for the correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of a thermoset copolymer, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Menicon Z™ lens is a contact lens designed to correct refractive errors in the eye. It is a physical device placed on the surface of the eye.
- Intended Use: The intended use clearly states the correction of refractive error and management of irregular corneal conditions. It does not involve testing biological samples.
- Device Description: The description details the material composition of the contact lens, not components for performing diagnostic tests.
Therefore, the Menicon Z™ lens falls under the category of a medical device, but specifically a contact lens for vision correction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses in all diameters are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.
Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal lenses in diameters ≤ 12.0 mm are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.
The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.
The lenses may be prescribed for daily wear 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 lens may be disinfected using a chemical disinfection system only.
Product codes
HQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes, corneal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eyecare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical study data for the Menicon Z™ (tisilfocon A) material in large diameters have been deemed as not necessary in support of this clearance, as no new or additional questions of safety or effectiveness have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962006, K970019, K081443, K071266, K071043, K022128
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) summary MENICON Z ™ (tisilfocon A) RIGID GAS PERMEABLE CONTACT LENSES February 2011
FEB - 3 2011
1. Applicant Information
Menicon Co., Ltd. 21-19, Aoi 3-chome, Naka-ku, Nagoya, Aichi 460-0006 JAPAN Contact Person: Takahiro Ochi Telephone No.: 481-52-935-1676 Fax No.: +81-52-935-1633
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 ZTM (tisilfocon A) to the following predicate devices.
-
- Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lenses (K071266)
-
- Boston XO (hexafocon A) Rigid Gas Permeable Contact Lenses (K071043)
-
- Boston Equalens II (oprifocon A) (K022128) (Rigid Gas Permeable Contact Lenses
4. Description of device
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.
1
5. Indications for use
Menicon Z™ (tisilfocon A) spherical, aspheric, prism ballast toric and prism ballast multifocal lenses in all diameters are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes.
Menicon Z™ (tisilfocon A) spherical, aspheric, non-prism ballast toric and non-prism ballast multifocal lenses in diameters ≤ 12.0 mm are indicated for extended wear (from 1 to 30 days between removals for cleaning and disinfection of the lenses, as recommended by the eyecare professional) for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in non-aphakic persons with non-diseased eyes.
The lens may be prescribed in spherical and aspheric powers ranging from -25.00 D to +25.00 D for daily wear and -25.00 D to +8.00 D for up to 30 days extended wear. Toric lenses are designed to correct up to 5.00 D of astigmatism and multifocal lenses to provide up to +3.00 D of reading add power for up to 30 days extended wear.
The lenses may be prescribed for daily wear 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 lens 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 as follows.
- K962006 cleared on October 9, 1996 .
- K970019 cleared on March 25, 1997 (multifocal designs) .
- K081443 cleared on September 23, 2008 (irregular corneas/postsurgical)
2
Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to
- Menicon Z (tisilfocon A) Rigid Gas Permeable Contact Lenses for already . approved indications and designs (as noted above).
- Boston XO2 (hexafocon B) (K071266), Boston XO (hexafocon A) . (K071043) and Boston Equalens II (oprifocon A) (K022128) (Rigid Gas Permeable Contact Lenses for indications for use, material properties, lens designs in diameters up to 21 mm, manufacturing/packaging methods and biocompatibility.
The indication for use for the lenses is for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. Additionally, the Menicon Z, Boston XO and Boston XO2 lenses may be prescribed for daily wear 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 following table compares the physical/optical properties of the Menicon Z material with the predicate lens materials:
| Property | Menicon Z | Boston XO | Boston XO2 | Boston
Equalens II |
|-----------------------------|---------------|---------------|------------|-----------------------|
| Specific Gravity | 1.20 | 1.27 | 1.19 | 1.24 |
| Refractive Index | 1.436 | 1.425 | 1.424 | 1.423 |
| Visible Light Transmittance | >95% | 92% Average | 83-90% | ≥70% |
| Water Content |