(194 days)
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No
The document describes a contact lens and its physical properties and testing, with no mention of AI or ML.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a contact lens used to correct refractive errors (ametropia), which are optical conditions, not diseases, and it does not treat or prevent any pathological condition. Its purpose is to act as a "refracting medium to focus light rays on the retina," serving as a corrective aid.
No
Explanation: The device is a contact lens intended for correcting refractive ametropia, not for diagnosing medical conditions.
No
The device is a contact lens, which is a physical medical device, not software. The description details the material and physical properties of the lens.
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 refractive ametropia (vision correction) by acting as a refracting medium on the cornea. This is a therapeutic/corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and function of the contact lens in focusing light, which is consistent with a vision correction device.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue), detect biomarkers, or provide information for diagnosing a disease or condition.
- Performance Studies: The performance studies described focus on physical and chemical properties, toxicity, and manufacturing processes, which are relevant to the safety and efficacy of a contact lens, not a diagnostic test.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. This device is used in vivo (on the body) for vision correction.
N/A
Intended Use / Indications for Use
The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and notaphakic persons with non-diseased eyes.
Product codes
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Device Description
The HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens is available as a spherical or astigmatic (toric) lens. The lens material, methafilcon B, is a copolymer of random methacrylic acid.
When placed on the cornea in its hydrated state the HYDRASOFT (East) Contact Lens act 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)
Physical and chemical properties testing was performed on lenses made using the alternate manufacturing method and polymerization process as called or in the May 1994 Premarket Notification (510(k)) Guidance Document For Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by the Systemic Injection Test and Cytotoxcity Test along with company data incorproceded by reference to an identical manufacturing process for ferrafilizion A lenses.
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 document indicates that the legally marketed device is "Hydrasoft and Hydrasoft Toric (methafilcon B)" and that "The technological characteristics of the HYDRASOFT (East) spherical lens and HYDRASOFT TORIC (East) Lens are the same as the predicate device, Hydrasoft" and Hydrasoft a Toric." No K/DEN numbers are provided.
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
sion of
DEC 17 1996
510 (k) SUMMARY J. Page 1 of 2
East Coast Office 200 WillowBrook Office Park Fairport, New York 14450 (716) 385-6810 (800) 538-7824 Fax (716) 264-3279
West Coast Office 10 Faraday Irvine, California 92718 (714) 597-8130 (800) 341-2030 Fax (800) 209-0154
Submitter's Name: 1.
CooperVision, Inc. 711 North Road Scottsville, NY 14546 Phone: (716) 385-6810 FAX: (716) 889-5688
Bernard Hallatt Contact Person: 2 . Phone: (716) 264-3222 FAX: (716) 889-5688
May 1, 1996 3 . Date Summary Prepared:
Name of Device: 4 .
- Hydrasoft (East) · Trade Name:
- Soft Contact Lens · Common Name:
- Soft (hydrophilic) Contact Lens · Classification Name: (Per 21 CFR § 886.5925)
- Legally Marketed Device: Hydrasoft and Hydrasoft® Toric 5 . (methafilcon B)
6 . Description of Device:
The HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens is available as a spherical or astigmatic The lens material, methafilcon B, is a (toric) lens. hydroxyethylmethacrylate and copolymer of random methacrylic acid.
When placed on the cornea in its hydrated state the HYDRASOFT (East) Contact Lens act as a refracting medium to focus light rays on the retina.
1
510(k) SUMNARY (Cont'd)
Page 2 of 2
7. Intended Use:
The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and notaphakic persons with non-diseased eyes.
8. Technological Characteristics:
The technological characteristics of the HYDRASOFT (East) spherical lens and HYDRASOFT TORIC (East) Lens are the same as the predicate device, Hydrasoft" and Hydrasoft a Toric.
9 . Summary of Non-Clinical Tests:
Physical and chemical properties testing was performed on lenses made using the alternate manufacturing method and polymerization process as called or in the May 1994 Premarket Notification (510(k)) Guidance Document For Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by the Systemic Injection Test and Cytotoxcity Test along with company data incorproceded by reference to an identical manufacturing process for
ferrafilizion A lenses.
The determination of substantial equivalence is based on the results of non-clinical testing. Review of the all test data demonstrates methafilcon B lenses manufactured with the alternate manufacturing method and polymerization process are equivalent to the currently marketed Hydrasoft" and Hydrasoft" Toric contact lenses. The Hydrasoft (East) and Hydrasoft Toric (East) contact lenses have the same design, indication_and directions for use as the Hydrasoft® and Hydrasoft® Toric contact lenses. CooperVision, Inc. concludes, therefore, that the Hydrasoft (East) and Hydrasoft Toric (East) contact lenses are substantially equivalent to the Hydrasoft and HydrasoftR Toric contact lenses.