(244 days)
Not Found
No
The provided text describes a standard contact lens made of hydrogel material. There is no mention of any computational or analytical capabilities, let alone AI or ML. The "SMART PERFORMER" name appears to be a brand name and not indicative of intelligent technology.
No
Explanation: The device is intended for the correction of refractive myopia, which is a refractive error, not a disease or condition that requires therapeutic intervention.
No.
The device is a contact lens intended for correction of refractive myopia, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made from a hydrogel material, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is a medical device intended for the correction of refractive errors (myopia) by being placed directly on the surface of the eye. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for correcting vision in non-diseased eyes.
- Device Description: The description details the physical composition and manufacturing of a contact lens.
Therefore, this device falls under the category of a medical device, specifically a contact lens, and not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eve.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disanfected and should be discarded after a single use.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available visibility tinted and cosmetic tinted. The visibility tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone, with iron oxides (red) or C.I. Pigment green 7. The cosmetically tinted lens is available in GREEN and RED. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
The Lens designs in the following parameter ranges:
Chord Diameter
13.8 mm to 14.8 mm
Center Thickness
0.060 mm to 0.250 mm (varies with power)
Base Cure
8.2 mm to 9.0 mm
Power
-0.25D to -12.00 D
The Lens designs in the following physical properties:
Refractive Index
1.41
Water Content
55 %
Oxygen Permeability (Dk)*
23 x 10-11 (cm²/sec) (ml O2/ml x mm Hg ) at 35°
(revised Coulometric method)
Light Transmittance
97% (clear)
97% (tinted)
Specific Gravity
1.10 (hydrated)
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
Eyecare practitioners
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Studies:
The following tests were conducted as recommended by the Premarket Notification 510 (k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.
(a). Biocompatibility ( cytotoxicity, ocular irritation, delayed type hypersensitization and acute systemic injection)
(b). Physicochemical Testing
(c). Stability Testing
Clinical Studies:
Ocufilcon D lenses have been used widely. Their safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by two lenses cleared by FDA:
iLens@ (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens, K141280
BIOMEDICS UV Colors (Ocufilcon D) Soft (hydrophilic) Contact Lens, K013377
Clinical studies for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens are not required for premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
Key results: Information submitted in the 510(k) establishes that the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens has comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of cytotoxicity, ocular irritation, delayed type hypersensitization and acute systemic injection showed the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate devices in safety and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 17, 2016
Smart Performer Corp. Ltd. Mr. Jeffersion Shen QA Dept. Manager & Management Representative No.13-1, Wuquan 1st Rd., Xinzhuang Dist. New Taipei City, 242 TW
Re: K152657
Trade/Device Name: Smart Performer 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 8, 2016 Received: April 8, 2016
Dear Mr. Shen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Kesia Alexander
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
SMART PERFORMER 55 (Ocutilcon D) Soft (hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eve.
Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disanfected and should be discarded after a single use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995,
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92.
The assigned 510(k) number is
| Submitter Information | |
|---|---|
| Company | SMART PERFORMER CORP. LTD. |
| No.13-1, Wuquan 1st Rd., Xinzhuang Dist., New Taipei City 242, | |
| Taiwan (R.O.C.) | |
| Contact Person | Jefferson Shen |
| QA Dept. Manager & Management Representative | |
| Telephone | 886-2-22999699 |
| Fax | 886-2-22996866 |
| E mail | jefferson@smartvision.tw |
| Date of Summary | July 8, 2015 |
Device Information
| Name of Device | SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact
Lens |
|-------------------|---------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) contact lens, daily wear |
| Classification | Class II |
| Regulation Number | 886.5925 |
| Product Code | LPL, MVN |
| Review Panel | Ophthalmic Devices |
Predicate Device
- iLens@ (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens, K141280, submitted by SEINOH OPTICAL CO. LTD. .
- BIOMEDICS UV Colors (Ocufilcon D) Soft (hydrophilic) Contact Lens, K013377, submitted by Ocular Sciences Inc.
- ACUVUE 2 COLOURS Brand (etafilcon A) Contact Lens with UV blocker, K010114, submitted by VISTAKON, Division of Johnson & Johnson Vision Care, Inc.
4
Intended Use
SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is intended to use as correction of refractive myopia in aphakic or non-aphakic persons with non-diseased eyes, who may have 1.00D of astigmatism or less. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye. Eyecare practitioners may prescribe the contact lens for single-use disposable daily wear. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lenses are not intended to be disinfected and should be discarded after a single use.
Device Description
The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available as spherical lenses manufactured by cast molded method. The lens is made from a lens material that is approximately 55% water. The hydrogel lens' material is a copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with ethyleneglycol dimethacrylate (EGDMA) via UV photo-polymerization. The SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is available visibility tinted and cosmetic tinted. The visibility tinted blue using Reactive Blue Dye #19 to make the lenses more visible for handling. The cosmetically tinted lens is tinted in an annular pattern, providing a clear optic zone, with iron oxides (red) or C.I. Pigment green 7. The cosmetically tinted lens is available in GREEN and RED. The lens is supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline.
The Lens designs in the following parameter ranges:
| Chord Diameter | 13.8 mm to 14.8 mm |
|---|---|
| Center Thickness | 0.060 mm to 0.250 mm (varies with power) |
| Base Cure | 8.2 mm to 9.0 mm |
| Power | -0.25D to -12.00 D |
| The Lens designs in the following physical properties: | |
| Refractive Index | 1.41 |
| Water Content | 55 % |
| Oxygen Permeability (Dk)* | 23 x 10-11 (cm²/sec) (ml O2/ml x mm Hg ) at 35° |
| (revised Coulometric method) | |
| Light Transmittance | >97% (clear) |
97% (tinted) |
| Specific Gravity | 1.10 (hydrated) |
5
Non-Clinical Studies
The following tests were conducted as recommended by the Premarket Notification 510 (k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.
- (a). Biocompatibility ( cytotoxicity, ocular irritation, delayed type hypersensitization and acute systemic injection)
- (b). Physicochemical Testing
- (c). Stability Testing
Clinical Studies
Ocufilcon D lenses have been used widely. Their safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by two lenses cleared by FDA
- iLens@ (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens, K141280
● BIOMEDICS UV Colors (Ocufilcon D) Soft (hydrophilic) Contact Lens, K013377 Clinical studies for SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens are not required for premarket notification as the USAN name and process are the same as the above mentioned predicate devices.
Substantial Equivalence Summary
Information submitted in the 510(k) establishes that the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens has comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of cytotoxicity, ocular irritation, delayed type hypersensitization and acute systemic injection showed the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate devices in safety and biocompatibility. Therefore, the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate devices.
6
| Substantial Equivalence Comparison | ||||
|---|---|---|---|---|
| Device | SMART | |||
| PERFORMER 55 | ||||
| (Ocufilcon D) Soft | ||||
| (hydrophilic) | ||||
| Contact Lens | iLens@ (ocufilcon | |||
| D) Daily Wear | ||||
| Soft (Hydrophilic) | ||||
| Contact Lens | BIOMEDICS UV | |||
| Colors (Ocufilcon D) | ||||
| Soft (hydrophilic) | ||||
| Contact Lens | ACUVUE 2 | |||
| COLOURS Brand | ||||
| (etafilcon A) Contact | ||||
| Lens with UV blocker | ||||
| Material | ||||
| (USAN name) | Ocufilcon D | Ocufilcon D | Ocufilcon D | Etafilcon A |
| Indication for use | correction of | |||
| refractive ametropia | correction of | |||
| refractive | ||||
| ametropia | correction of | |||
| refractive ametropia | correction of | |||
| refractive ametropia | ||||
| Manufacturing | ||||
| Method | Cast Molded | Cast Molded | Cast Molded | Cast Molded |
| Water Content | 55% | 55% | 55% | 58% |
| Light | ||||
| Transmittance | >97% | >95% | >97 % | > 70% |
| Dk (35 ℃) | $23 x 10^{-11}$ | $20 x 10^{-11}$ | $19.6 x 10^{-11}$ | $21.4 x 10^{-11}$ |
| Refractive Index | 1.41 | 1.405 | 1.41 | 1.40 |
| Toxicity | Non-Toxic | Non-Toxic | Non-Toxic | Non-Toxic |
| Color Additives | ● Iron oxides (red) | |||
| ● | ||||
| C.I. Pigment green 7 | Reactive blue dye #19 | ● Iron oxides | ||
| ● Titanium Dioxide | ||||
| ● Carbazole Violet | ||||
| ● Copper | ||||
| ● Phthalocyanine Blue | ||||
| ● Copper | ||||
| ● Phthalocyanine Green | ● iron oxides | |||
| ● titanium dioxide | ||||
| ● Reactive blue dye 4 | ||||
| ● Vat orange 1 | ||||
| ● Phthalocyanine Green | ||||
| ● Phthalocyaninato(2-) |
7
Conclusion
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the lens do not raise questions of safety and effectiveness. Therefore, the SMART PERFORMER 55 (Ocufilcon D) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate devices.