(95 days)
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No
The document describes a standard soft contact lens made from a specific material, focusing on its physical properties and intended use for vision correction. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device, a contact lens, is indicated for the "correction of visual acuity" and acts as a "refracting medium to focus light rays on the retina," which describes a corrective function rather than a therapeutic one.
No
The device is a contact lens used for vision correction, not for diagnosing medical conditions.
No
The device is a physical contact lens made from a specific material, not a software program.
Based on the provided text, 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 aphakic and/or non-aphakic persons with non-diseased eyes. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the material and how the lens acts as a refracting medium to focus light on the retina. This is consistent with a medical device for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of disease or impairment.
IVD devices are used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This contact lens does not perform such tests.
N/A
Intended Use / Indications for Use
METRO-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphapic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons with up to1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity.
METRO-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZETRO-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and nonaphakic persons with with non-diseased eyes. The toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.
The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermal) or the chemical (not heat) disinfection system.
Product codes
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Device Description
METRO-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical The Toric has a Toric Base Curve. The non-ionic shell . material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA).
The copolymer consists of 52% METRO-G 3X (hioxifileon B) and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The lens METRO-G 3X (hioxifilcon B) is made from BENZ-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it 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
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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)
Pre Clinical
- Toxicology: Toxikon ran all pre-clinical studies necessary for review for Class II daily wear soft (hydrophilic) contact lenses. Results were within normal limits.
- Microbiology: Relevant studies have been run and are included with this 510(k) notification. This includes autoclave validation.
- Tens compatibility: Studies were run by the developer of the polymer and are referenced in his 510(k) Notification. Conclusion: Within Normal Limits.
- Lens Stability: The Shelf life studies have been started by Metro Optics of Austin, Inc. and will be complete early in 1997. The procedure is based on sample supplied by FDA in Guidance Document for 510)k) for Daily Wear Contact Lenses, May 1994. Study will be completed in late January 1997 to assure sterility to the one year duration. No product will be distributed until tests are complete and the FDA has approved manufacture and distribution.
- Preservative Uptake: Tests were run by ATCON and were referenced by the developer of the polymer in his 510 (k). Results were within normal limits.
Disinfection: In house tests showing that heat has no injurious effect on the lenses made of this polymer (hioxifilcon B), which is non-ionic.
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.
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
Not Found
§ 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.
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MAR 1 1 1997
SUPPLEMENT to K964902 METRO-G 3X (hioxifilcon B) JAN. 20. 1997
6.0 SUMMARY of SAFETY AND EFFECTIVENESS
General Information: I .
hioxifilcon B A. Generic (USAN) Name:
- METRO-G 3X (hioxifilcon B) B. Device Trade Name: Spherical and Toric Soft (Hydrophilic) Contact Lenses for Daily Wear in Clear and with a Blue Visibility Tint
Sponsor's Name and t METRO OPTICS of AUSTIN, INC. Address : 15802 Vision Drive Pflugerville, TX 78660 (800) 223-1858
K964902 D. 510(k) Number:
II. Indications
MFTRO-G 3X Spherical (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or a blue visibility tint are indicated in daily wear for the correction of visual acuity in aphapic and/or non-aphakic persons with with non-diseased eyes. The Spherical lenses are available from +20.00 to - 20.00 Diopters for persons with up to1.50 Diopters of astigmatism where the astigmatism does not interfere with visual acuity.
METRO-G 3X Toric (hioxifilcon B) soft (hydrophilic) contact lenses made from BENZETRO-G 3X (hioxifilcon B) optical blanks in clear or blue visibility tint are indicated in daily wear for the correction of visual acuity in aphakic and nonaphakic persons with with non-diseased eyes. The toric lenses are available from +20.00 to -20.00 Diopters and up to 4.50 Diopters of astigmatic correction.
The material. BENZ-G 3X (hioxifilcon B), is a non-ionic polymer that may be disinfected using either the heat (thermal) or the chemical (not heat) disinfection system.
III. Device Description
METRO-G 3X (hioxifilcon B) Spherical or Toric is lathed into a soft (hydrophilic) contact lens which is a hemispherical The Toric has a Toric Base Curve. The non-ionic shell . material, hioxifilcon B is a copolymer of 2-hydroxyethyl methrylate (2-HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA).
The copolymer consists of 52% METRO-G 3X (hioxifileon B) and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
ini
1
6.0 SUMMARY OF SAFETY AND EFFECTIVENESS
The lens METRO-G 3X (hioxifilcon B) is made from BENZ-G 3X (hioxifilcon B) optical buttons. When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.
BENZ-G 3X (hioxifilcon B) optical buttons with visibility tint were subjected to extraction studies and showed no identifiable evidence of tint pigment leeching.
-
IV. Alternative Practices or Procedures
Alternative practices or procedures are in the use of available prescription products Soft and RGP Contact Lenses and spectacles for the same indication. -
V. Technical Summaries
- A. Pre Clinical
-
- Toxicology
-
- A. Pre Clinical
Toxikon ran all pre-clinical studies necessary for review for Class II daily wear soft (hydrophilic) contact lenses. Results were within normal limits.
-
- Microbiology
Relevant studies have been run and are included with this 510(k) notification. This includes autoclave validation.
- Microbiology
-
- Tens compatibility studies were run by the developer of the polymer and are referenced in his 510(k) Notification.
Conclusion: Within Normal Limits
- Tens compatibility studies were run by the developer of the polymer and are referenced in his 510(k) Notification.
-
- Lens Stability The Shelf life studies have been started by Metro Optics of Austin, Inc. and will be complete early in 1997. The procedure is based on sample supplied by FDA in Guidance Document for 510)k) for Daily Wear Contact Lenses, May 1994. Study will be completed in late January 1997 to assure sterility to the one year duration. No product will be distributed until tests are complete and the FDA has approved manufacture and distribution.
-
- Preservative Uptake Tests were run by ATCON and were referenced by the developer of the polymer in his 510 (k) . .
Results were within normal limits.
2
510(k) NOTIFICATION for METRO-G 3X (hioxifilcon B) Jan. 20, 1997
6.0 SUMMARY OF SAFETY AND EFFECTIVENESS
This application includes application for Heat and Chemical (Not Heat) disinfection as the polymer as the polymer is Non-ionic. In house tests showing that heat has no injurious effect on the lenses made of this polymer .
This summary of safety and effectiveness enclosed covers the hioxifilcon B lathe-cut lens made by METRO OPTICS of AUSTIN, INC.
A favorable recommendation from the FDA for the METRO-G 3X (hioxifilcon B) Spherical and Toric Contact Lenses made from BENZ-G 3X (hioxifilcon B) optical blanks in clear or with blue visibility tint for daily wear use is anticipated. We feel that a review of notification will show that this polymer is close enough to the approved METRO-G 55 (5X) (hioxifilcon A) (48% water as opposed to 58% water). The METRO-G 55 (5X) was both safe and effective for its intended purpose of a daily wear contact lens.
Should additional information be desired, please contact 770-Wally Stirling, South East Regulatory Associates, Inc. 475-1668.
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