(82 days)
The spherical design lens of the Menicon ZTM ( tisilfocon A ) Rigid Gas Permeable Contact Lens
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No
The summary describes a conventional contact lens with standard materials and designs, with no mention of AI/ML in its function, design, or testing.
No.
The contact lens is indicated for the correction of visual acuity, which means it aids vision, but it does not treat or cure a disease or condition.
No
The device is a contact lens intended for correcting visual acuity, not for diagnosing medical conditions.
No
The device description clearly states it is a contact lens made of a specific material (tisilfocon A) and describes its physical properties and composition, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of visual acuity in non-aphakic persons with non-diseased presbyopic eyes. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a medical device used to correct vision by being placed on the surface of the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. IVDs are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- No Mention of Samples: The description does not involve the collection or analysis of any biological samples.
Therefore, the Menicon Z contact lens, as described, is a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.
Product codes
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Device Description
The alternate designs of the Menicon Z (tisilfocon A) contact lens are bifocal and trifocal design contact lenses. Conventional bifocal / trifocal designs are employed in the alternate designs of Menicon Z (tisilfocon A) rigid gas permeable contact lenses.
The lens material, tisilfocon A, is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is classified fluoro-silicone acrylate, group III, page 16, FDA's premarket notification (510(k)) guidance document for daily wear contact lenses. May 12. 1994. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (2-(5-Chloro-2Hbenzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol)) is added.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The applicant performed non-clinical and clinical testing on the spherical design of the Menicon Z (tisilfocon A) contact lens in accordance with the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses (May, 1994).
The non-clinical testing supports the safety and effectiveness of the device from microbiological, toxicological, chemistry, and manufacturing perspectives. The applicant sponsored a randomized, controlled clinical trial in which subjects were randomly assigned in a two-to-one ratio to the spherical design of the Menicon Z™ Rigid Gas Permeable Contact Lens and to that of the Menicon SF-PTM Rigid Gas Permeable Contact Lens.
It was determined that the clinical findings i.e., adverse reactions, positive slit lamp findings, patient symptoms, problems and complaints, visual acuity, lens replacements, discontinued patients, lens wearing time and keratometry changes were within the expected limits for daily wear lens wearers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The spherical design lens of the Menicon ZTM ( tisilfocon A ) Rigid Gas Permeable Contact Lens
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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
MAR 2 5 1997
VI 510(k) Summary for the Alternate Designs of Menicon Z™ ( tisilfocon A ) Rigid Gas Permeable Contact Lens
Menicon Co., Ltd. Applicant's Name and Address: 21-19, Aoi 3-Chome Naka-ku, Nagoya 460 Japan Phone 011 81 52 937 5021 011 81 52 935 1121 Fax
Contact Person:
Mr. Taiji Higaki President Menicon U.S.A. Inc. 333 West Pontiac Way Clovis, CA 93612
Summary Prepared
December 27, 1996
Trade Name:
Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens Bifocal design contact lens Trifocal design contact lens
Device Generic Name:
tisilfocon A ( rigid gas permeable contact lens )
Classification Name :
Rigid gas permeable contact lens
1
Predicate Device:
The spherical design lens of the Menicon ZTM ( tisilfocon A ) Rigid Gas Permeable Contact Lens
Device Description:
The alternate designs of the Menicon Z (tisilfocon A) contact lens are bifocal and trifocal design contact lenses. Conventional bifocal / trifocal designs are employed in the alternate designs of Menicon Z (tisilfocon A) rigid gas permeable contact lenses.
The lens material, tisilfocon A, is a thermoset copolymer derived from fluoromethacrylate and siloxanylstyrene, bound by crosslinking agents. The lens is classified fluoro-silicone acrylate, group III, page 16, FDA's premarket notification (510(k)) guidance document for daily wear contact lenses. May 12. 1994. The lens is tinted light blue with color additive D&C Green No. 6 (21 CFR 74.3206). Also, UV absorber (2-(5-Chloro-2Hbenzotriazol-2-yl)-6-(1,1-dimethylethyl)-4-methylphenol)) is added.
Indications for Use:
The alternate designs of the Menicon Z (tisilfocon A) contact lens are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.00 Diopters (D) or less that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.
Substantial Equivalence:
The alternate designs of the Menicon Z (tisilfocon A) contact lens are substantially equivalent to the spherical design of the Menicon Z (tisilfocon A) contact lens, which is a lens with an existing USAN
2
The applicant performed non-clinical and clinical testing on the spherical design of the Menicon Z (tisilfocon A) contact lens in accordance with the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses (May, 1994).
The non-clinical testing supports the safety and effectiveness of the device from microbiological, toxicological, chemistry, and manufacturing perspectives. The applicant sponsored a randomized, controlled clinical trial in which subjects were randomly assigned in a two-to-one ratio to the spherical design of the Menicon Z™ Rigid Gas Permeable Contact Lens and to that of the Menicon SF-PTM Rigid Gas Permeable Contact Lens.
It was determined that the clinical findings i.e., adverse reactions, positive slit lamp findings, patient symptoms, problems and complaints, visual acuity, lens replacements, discontinued patients, lens wearing time and keratometry changes were within the expected limits for daily wear lens wearers.
Conclusion:
The alternate designs of the Menicon Z (tisilfocon A) contact lens are a class II medical device. The information submitted in the 510(k) notification established the device is substantially equivalent to the spherical design of the Menicon Z (tisilfocon A) contact lens in that the device has the comparable characteristics as the predicate device and is as safe and effective as the predicate device and does not raise different types of safety and effective questions.
117