(209 days)
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No
The summary describes a standard soft contact lens with a specific material and geometry, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is indicated for visual acuity (vision correction) and not for treating or curing a disease or condition.
No
Explanation: The device is a contact lens intended for correcting visual acuity in non-aphakic patients with non-diseased eyes, acting as a refracting medium to focus light. It does not identify or detect a disease or condition.
No
The device description clearly states it is a contact lens made of polymacon, which is a physical material, not software.
Based on the provided text, 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 provide information about a person's health.
- Device Function: The description clearly states that the METRO FOCAL 38 ASPHERIC contact lenses are used to correct vision by acting as a refracting medium on the cornea. They are placed on the eye, not used to test samples from the body.
- Intended Use: The intended use is for "visual acuity in non-aphakic patients with non-diseased eyes," which is a direct treatment for a visual condition, not a diagnostic test.
The text describes a medical device used for vision correction, which falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The METRO FOCAL 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses for daily wear are available in clear and with a blue visibility tint. The lenses are indicated for visual acuity in non-aphakic patients with with non-diseased eves. The lenses are available in powers of -20.00 up to +10.00 Diopters of and up to 2.50 Diopters of add. These lenses will mask 2.00 Diopters of astigmatism where it does not interfere with visual aculty.
Product codes
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Device Description
The METRO FOCAT 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses are lathe cut into an aspherical contact lens geometry which becomes a hemispherical shell. The polymer. polymacon was the first soft (hydrophilic) material and is one of the most frequently used polymers of HEMA at this time. Tt consists of 62% polymacon and 38% water by weight when fully hydrated in normal saline solution buffered with sodium bicarbonate.
The METRO FOCAT ASPHERTC (polymacon) soft (hydrophilic) contact lenses when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina.
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
cornea
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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
Sublement to K961606 METRO FOCAT. 38 ASPHERTC (oolvmacon) Soft (Hydroophilia) Contact Tenses for Daily Wear ANG. 28, 1996
NOV 20 1996
SECTION 8 SUMMARY of SAFFTY AND EFFECTIVENESS
- T . General Information:
- A. Generic (USAN) Name: polymacon
- R. Device Trade Name: METRO FOCAL 38 ASPHERIC ( polymacon )
C. Sponsor's Name and Address :
METRO OPTICS of AUSTIN. Inc. 15802 Vision Drive Pfluaerville. TX 78660 (512) 251-2382
D. 5101k) Number: K961606
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TT. Indications
The METRO FOCAL 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses for daily wear are available in clear and with a blue visibility tint. The lenses are indicated for visual acuity in non-aphakic patients with with non-diseased eves. The lenses are available in powers of -20.00 up to +10.00 Diopters of and up to 2.50 Diopters of add. These lenses will mask 2.00 Diopters of astigmatism where it does not interfere with visual aculty. -
TTT. Device Description
The METRO FOCAT 38 ASPHERIC (polymacon) soft (hydrophilic) contact lenses are lathe cut into an aspherical contact lens geometry which becomes a hemispherical shell. The polymer. polymacon was the first soft (hydrophilic) material and is one of the most frequently used polymers of HEMA at this time. Tt consists of 62% polymacon and 38% water by weight when fully hydrated in normal saline solution buffered with sodium bicarbonate.
The METRO FOCAT ASPHERTC (polymacon) soft (hydrophilic) contact lenses when hydrated and placed on the cornea acts as a refracting medium to focus light rays on the retina.
-
TV. Alternative Practices or Procedures
Alternative practices or procedures are in the use of available prescription products soft (hydrophilic) contact lenses. RGP or Rigid Gas Permeable contact lenses or spectacles . -
V. Technical Summaries
- A. Pre Clinical
K 961606
1
Supplement to K961606 METRO FOCAT 38 ASPHERTC (polymacon) Soft (Hydroophilic) Contact Tienses for Daily Wear ANG. 28, 1996
1. Toxicology
This had been run on the polymer (polymacon) and included in another submission. Results were within normal limits.
2. Microbiologv
Tncluded in same submission as above Toxicology results. Results were within normal limits.
3. Compatibility
This had been run on this polymacon polymer in 1990. Results were within normal limits.
4. Stabilitv
This had been run on the polymer polymacon in another submission in 1990. Results were within normal limits. Metro Optics has on-going stability studies validating the expiration date of four years at this time for the clear and a lesser time for the blue visibility tint
5. Preservative Uptake Tests ...
This had been run on polymer polymacon in another submission in 1990. Results were within normal limits.
B. Clinical
The Sponsor is referencing the fact that there are eighteen Contact Lens companies producing aspheric contact lemses for the correction of presbyopia. Thirteen of these lenses are made from the same polymer , polymacon. as is the lens in question. All these lenses are generated on similar equipment in a similar manner. The equipment manufacturers of lathes, autoclaves, laminar flow units. polishing equipment may be different between any two companies however the end contact lens products are for all intents equivalent.
The manufacturing materials. manufacturing methods, and quality control methods employed by most companies are equivalent. The results are all approximately the same.
This contact lens manufacturing facility has been producing soft (hydrophilic) contact lenses for over fourteen years and was last inspected by the FDA on October 8. 1993
1.8
2
Supplement to K961606 METRO FOCAT, 38 ASPHERIC (polymacon) Soft, (Hvdrophilic) Contact Tenses for Daily Wear AUG. 28. 1996
- C. Potential Safety and Effectiveness as well as Adverse Rffects of the Device would be about the same as that of any other aspheric polvmacon lens.
- D. Conclusion drawn from Study
This lens should be the equivalent of any other lens of aspheric configuration.
- m. A favorable recommendation from the FDA is anticipated for the manufacture and distribution of aspheric soft (hydrophilic) contact lenses made by Metro Optics of Austin, Tnc. Any additional information will be supplied by the individual whose name and address is on the cover letter of this 510(k) Notification.