(102 days)
No
The summary describes a contact lens and its material properties, with no mention of AI or ML.
No.
The device is indicated for the "correction of ametropia (myopia)" which is a refractive error, not a disease or condition that requires therapy. Its primary function is to improve vision, not to treat or cure a disease.
No
The device is a contact lens intended for vision correction (ametropia), not for diagnosing medical conditions.
No
The device is a physical contact lens made of polymacon, not a software program.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Eye Secret 38 UV Aspheric contact lens is a medical device worn on the eye to correct vision (ametropia). It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for the "correction of ametropia," which is a physical correction of vision, not a diagnostic test.
The provided information describes a contact lens, its material, manufacturing process, and clinical performance for vision correction. None of these aspects align with the definition or function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
Product codes
LPL, MVN
Device Description
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical study for Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is equivalent to the BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:
- Toxicity
- Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
- White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
- Cytotoxicity Test: The test article meets the requirements of ISO 10993-5.
- Extractables
- Finished Lens Parameters
- Light Transmittance
- Refractive Index
- Water Content
- pH and Osmolality
- Specific Gravity
- Physical Compatibility
- Oxygen permeability
- Mechanical Comparative Testing
- Shelf-life test
The results of the non-clinical testing demonstrated that the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
DEC 2 3 2013
.
Yung Sheng Optical Co., Ltd.
510(k) notification
.
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
510(k) Summary
:
| 1. Type of Submission: | Traditional |
|---|---|
| ------------------------ | ------------- |
| Submitter: | Yung Sheng Optical Co., Ltd. | ||
|---|---|---|---|
| Address: | 3F-1, No.6, Jhongke Road, Daya District, Taichung City 42881 | ||
| Taiwan | |||
| Manufacturing facility: | No.8, Keya 2nd Road, Daya District, Taichung City 42881, | ||
| Taiwan | |||
| Phone: | (04) 25658384 #156 、191 | ||
| Fax: | (04) 25658387 | ||
| Contact: | Wen-Han Chen / Mavis Kao | ||
| Date prepared: | December 17th, 2013 |
3. Identification of the Device
| Proprietary/Trade name: | Eye Secret 38 UV Aspheric (polymacon) Soft |
|---|---|
| (hydrophilic) Contact Lens for Daily Wear | |
| Common Name: | Contact Lens |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Device Classification: | II |
| Regulation Number: | 886.5925 |
| Panel: | Ophthalmic |
| Product Code: | LPL for Lenses, Soft Contact, Daily Wear |
| MVN for Lens, Contact, (Disposable) |
4. ldentification of the Predicate Device
| Predicate Device Name: | BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility
Tinted Contact Lens |
|-----------------------------------------|--------------------------------------------------------------------------------|
| Manufacturer: | BAUSCH & LOMB |
| 510(k) Number or Clearance Information: | K020927 |
1
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
5. Intended Use and Indications for Use of the subject device
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
6. Device Description
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4. The Lenses are available as aspheric lenses.
7. Summary of Clinical Study
Polymacon lenses have been used widely. Their safety and effectiveness have been well documented and cleared by FDA. BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927) submitted by BAUSCH & LOMB is an example.
Clinical study for Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
8. Non-dinical Testing
A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is equivalent to the
2
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens (K020927). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:
- Toxicity .
-
- Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
-
- White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
-
- Cytotoxicity Test: The test article meets the requirements of ISO 10993-5.
-
- Extractables .
- Finished Lens Parameters
- Light Transmittance +
- . Refractive Index
- Water Content .
- pH and Osmolality .
- . Specific Gravity
- . Physical Compatibility
- Oxygen permeability
- Mechanical Comparative Testing
- . Shelf-life test
.
The results of the non-clinical testing demonstrated that the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device.
ਰੋਂ Substantial Equivalence Determination .
The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear submitted in this 510(k) file is substantially equivalent in intended use, technology/principles of operation, materials and performance to the cleared BAUSCH & LOMB Soflens MultiFocal (polymacon) Visibility Tinted Contact Lens which is the subject of K020927. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.
3
Eye Secret 38 UV Aspheric (polymacon) Soft
| Item | Eye Secret 38 UV Aspheric
(polymacon) Soft (hydrophilic)
Contact Lens for Daily Wear | Predicate Device (K020927)
BAUSCH & LOMB Soflens MultiFocal
(polymacon) Visibility Tinted Contact
Lens |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Number | 886.5925 | 886.5925 |
| Classification | II | II |
| Intended Use | Eye Secret 38 UV Aspheric
(polymacon) Soft (hydrophilic)
Contact Lens for Daily Wear is
indicated for daily wear for the
correction of refractive ametropia
(myopia) in aphakic and not-aphakic
persons with non-diseased eyes. The
lenses may be worn by person who
exhibit astigmatism of 2.00 diopters
or less that does not interfere with
visual acuity. | BAUSCH & LOMB Soflens MultiFocal
(polymacon) Visibility Tinted Contact
Lens is indicated for daily wear for
the correction of the refractive
ametropia (myopia, hyperopia, and
astigmatism) and presbyopia in
aphakic and/or not-aphakic persons
with non-diseased eyes, exhibiting
astigmatism of 2.00 diopters or less,
that does not interfere with visual
acuity. |
| Prescription
Use | Yes | Yes |
| Material | polymacon | polymacon |
| Manufacturing
Method | Cast Molded | Cast Molded |
| Water Content | 38% | 38% |
| Powers | $-0.50D ~ -12.00 D$ | $\pm 20.00D$ |
| Light
Transmittance | 95% ± 5% | ≥ 96% |
| UV-A |