(140 days)
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No
The description focuses on the material properties, design, and clinical performance of a contact lens, with no mention of AI or ML.
No
This device is a contact lens intended for correcting visual acuity, not for treating 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 describes a physical contact lens made of a specific material with defined physical characteristics and manufacturing processes. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Menicon Z™ Rigid Gas Permeable Contact Lens is a medical device that is placed on the surface of the eye to correct vision. It does not analyze samples from the body.
- Intended Use: The intended use clearly states it's for "correction of visual acuity" in individuals with certain refractive errors. This is a therapeutic/corrective function, not a diagnostic one.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) 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 Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens is a lathe-cut nonpolished firm contact lens with spherical front and back surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea. The lens material, tisilfocon A, is a thermoset copolymer derived form fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. The lens colors are light blue or clear. The lens is tinted light blue with color additive D & C Green No. 6. A UV absorber 2-(5-Chloro-2H- benzotriazol-2-y1)-6-(1,1dimethylethyl)-4-methylphenol is also 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
eyes
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 device 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 Menicon Z™ Rigid Gas Permeable Contact Lens and to the predicate device, the Menicon SF-PTM Rigid Gas Permeable Contact Lens. A total of 118 eyes were enrolled in the 3 month study. Based on the analysis of the detailed data presented in the SIO(k), it was determined that the clinical findings for the device, 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 expected limits for daily wear contact lens wearers. Visual acuity results demonstrated that the Menicon Z™ Rigid Gas Permeable Contact Lens was comparable to the predicate lens.
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.
Menicon SF-PTM (melafocon 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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§ 886.5916 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
OCT - 9 1996
510(k) Summary
for the
Menicon ZTM 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 81 529 37 5021 011 81 529 32 1121 Fax
Contact Person:
Mr. Taiji Higaki President Menicon USA, Inc. 333 West Pontiac Way Clovis, CA 93612
Summary Prepared:
August 14, 1996
Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens Trade Name: Device Generic Name: tisilfocon A rigid gas permeable contact lens Classification Name: rigid gas permeable contact lens
Menicon SF-PTM (melafocon A) Rigid Gas Permeable Contact Lens Predicate Device:
Device Description:
The Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens is a lathe-cut nonpolished firm contact lens with spherical front and back surfaces. The posterior curve is selected so as to properly fit an individual eye and the anterior curve selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface
1
allows tear exchange between the lens and the cornea. The lens material, tisilfocon A, is a thermoset copolymer derived form fluoro-methacrylate and siloxanylstyrene, bound by crosslinking agents. The lens colors are light blue or clear. The lens is tinted light blue with color additive D & C Green No. 6. A UV absorber 2-(5-Chloro-2H- benzotriazol-2-y1)-6-(1,1dimethylethyl)-4-methylphenol is also added.
Indications for Use:
The Menicon Z™ Rigid Gas Permeable Contact Lens for Daily Wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes who are myopic or hyperopic and have an astigmatism of up to 3.00 Diopters (D) that does not interfere with visual acuity. The lens may be disinfected using a chemical disinfection only.
Substantial Equivalence:
The Menicon Z™ (tisilfocon A) Rigid Gas Permeable Contact Lens for Daily Wear is substantially equivalent to the Menicon SF-P™ (melafocon A) Rigid Gas Permeable Contact Lens. Both are Hydrophobic Material Group III (fluoro silicone acrylate) and have less than 0.5% water content.
The applicant performed non-clinical and clinical testing on the device 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 Menicon Z™ Rigid Gas Permeable Contact Lens and to the predicate device, the Menicon SF-PTM Rigid Gas Permeable Contact Lens. A total of 118 eyes were enrolled in the 3 month study. Based on the analysis of the detailed data presented in the SIO(k), it was determined that the clinical findings for the device, 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 expected limits for daily wear contact lens wearers. Visual acuity results
2
demonstrated that the Menicon Z™ Rigid Gas Permeable Contact Lens was comparable to the predicate lens.
Conclusion:
Menicon Z™ (tisilfocon A), a Daily Wear Rigid Gas Permeable (nonhydrophobic) contact lens, is a class II medical device. The information submitted in the 510(k) notification established that the device is substantially equivalent to the Menicon SF-P™ Rigid Gas Permeable Contact Lens in that it has the same intended use and comparable technological characteristics as the predicate device and is as safe and effective as that device and does not raise different types of safety and effectiveness questions.