(51 days)
Not Found
No
The document describes a standard soft contact lens and its intended use, material composition, and clinical study results. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is indicated for the optical correction of refractive ametropia, not for the treatment of a disease or condition.
No
Explanation: The device is a soft contact lens indicated for the optical correction of refractive ametropia. Its purpose is to correct vision, not to diagnose a medical condition.
No
The device is a physical contact lens made of 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 clearly states that the Menicon ASRB contact lenses are for the "optical correction of refractive ametropia" and "presbyopia". This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and material composition of the contact lens, which is consistent with a medical device for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Clinical Study Focus: The clinical study described evaluates the safety and efficacy of the lens for vision correction, not its ability to diagnose.
In Vitro Diagnostics are devices used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Menicon ASRB contact lens does not fit this definition.
N/A
Intended Use / Indications for Use
The Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a hydrophilic contact lens which is available as a spherical/aspherical, toric, multifocal and multifocal toric lens. This soft contact lens is indicated for daily wear frequent replacement.
The non-ionic lens material (asmofilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 60% asmofilcon A and 40% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint, C.I. Reactive Blue 246.
The hydrophilic material characteristics allow aqueous solutions to enter the lens. In its fully hydrated state, the lens is approximately 40% water by weight.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioner
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)
A series of in-vitro and in-vivo preclinical tests were performed to assess the safety and effectiveness of the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.
The results of the biocompatibility testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions, and the material properties are consistent with the predicate lens.
A three-month clinical study was completed to evaluate the safety and efficacy of the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens for daily wear, frequent replacement use.
The study evaluated ninety (90) male and female subjects who were randomized and dispensed lenses in a 2:1 ratio with 60 subjects dispensed into the Test lenses and 30 Subjects dispensed into the Control lenses. The primary outcome measures were biomicroscopy and adverse event rates along with lens visual acuity comparisons between the Test and the Control contact lenses. Secondary Outcome measures included average lens wearing times and subjective lens comfort assessed by frequency or symptoms.
The Test contact lens was found to be substantially equivalent to the Control contact lens for safety and efficacy.
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
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 22, 2018
Menicon Co., Ltd. % Ellen M. Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street, Suite A250 Wilmington, MA 01887
Re: K180004
Trade/Device Name: Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: January 2, 2018 Received: January 3, 2018
Dear Ellen Beucler:
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. Iisting 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.
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Scott E. Steffen -S
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
510(k) Number (if known) K180004
Device Name
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
Indications for Use (Describe)
The Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.
| 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) |
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Image /page/3/Picture/0 description: The image shows the text "Menicon Co., Ltd." The text is in a simple, sans-serif font and is horizontally aligned. The text is likely a company name.
510(k) Summary
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
1. Applicant Contact Information
| Menicon Co., Ltd.. | |
|---|---|
| 21-19, Aoi 3, | |
| Naka-ku, Nagoya, Aichi 460-0006 | |
| JAPAN | |
| Contact Person: | Kenichi Tanaka |
| Telephone No.: | +81-52-935-1676 |
| Fax No.: | +81-52-935-1633 |
| E-mail: | kenichi-tanakai@menicon.co.jp |
| Date Prepared: | February 15, 2018 |
2. Device Information
| Classification name: | Soft (hydrophilic) Contact Lens |
|---|---|
| Device classification: | Class II |
| Regulation number: | 21 CFR 886.5925 |
| Product code: | LPL |
| Proprietary name: | Menicon ASRB (asmofilcon A) Silicone Hydrogel |
| Soft Contact Lens |
3. Predicate Device
Menicon claims substantial equivalence to K073459 Alcon Air Optix Aqua (lotrafilcon B) Soft Contact Lens.
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4. Description of Device
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a hydrophilic contact lens which is available as a spherical/aspherical, toric, multifocal and multifocal toric lens. This soft contact lens is indicated for daily wear frequent replacement.
The non-ionic lens material (asmofilcon A) is a random co-polymer containing polydimethyl siloxane macromonomer. It consists of 60% asmofilcon A and 40% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibility handling tint, C.I. Reactive Blue 246.
The hydrophilic material characteristics allow aqueous solutions to enter the lens. In its fully hydrated state, the lens is approximately 40% water by weight.
5. Indications for Use
The Menicon ASRB (asmofilcon A) SPHERICAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes with 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and nonaphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have 1.50 D or less of astigmatism.
The Menicon ASRB (asmofilcon A) MULTIFOCAL TORIC Silicone Hydrogel Soft Contact Lens is indicated for daily wear frequent replacement for the optical correction of refractive ametropia (myopia and hyperopia with astigmatism) and presbyopia in aphakic and
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Image /page/5/Picture/0 description: The image shows a logo with a red circle on top and a green circle on the bottom. A white line runs through the middle of the circles, creating a wave-like pattern. The logo is simple and modern, with a focus on color and shape.
non-aphakic persons with non-diseased eyes who may require a reading addition of +3.00 D or less and who may have up to approximately 3.00 D or less of refractive astigmatism.
The Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a frequent replacement lens. The lenses are intended to be worn on a daily wear basis with removal for cleaning and chemical disinfection (not heat) prior to reinsertion, as recommended by the eye care practitioner.
6. Performance Data
Non-Clinical Data
A series of in-vitro and in-vivo preclinical tests were performed to assess the safety and effectiveness of the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols.
The results of the biocompatibility testing and evaluation demonstrate that the lens material/extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions, and the material properties are consistent with the predicate lens.
Clinical Data
A three-month clinical study was completed to evaluate the safety and efficacy of the Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens for daily wear, frequent replacement use.
The study evaluated ninety (90) male and female subjects who were randomized and dispensed lenses in a 2:1 ratio with 60 subjects dispensed into the Test lenses and 30 Subjects dispensed into the Control lenses. The primary outcome measures were biomicroscopy and adverse event rates along with lens visual acuity comparisons between the Test and the Control contact lenses. Secondary Outcome measures included average lens wearing times and subjective lens comfort assessed by frequency or symptoms.
The Test contact lens was found to be substantially equivalent to the Control contact lens for safety and efficacy.
6
Image /page/6/Picture/0 description: The image shows a logo with a red semi-circle on top and a green semi-circle on the bottom. A white, stylized wave-like shape runs horizontally across the center of the logo, dividing the red and green sections. The logo is simple and modern, using contrasting colors to create a visually appealing design.
Conclusion
Based upon the data presented, the Menicon ASRB (asmofilcon A) Soft Contact lens is as safe, as effective and performs as well as the predicate devices.
7. Substantial equivalence
The claim of substantial equivalence to the previously cleared devices is supported by the following Comparison of Characteristics in Table 1.
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| Menicon ASRB | Air Optix Aqua | |
|---|---|---|
| 510(k) | To be assigned | K073459 |
| USAN | asmofilcon A | lotrafilcon B |
| Product Code | LPL | LPL |
| Modality | Daily wear, Frequent replacement | Daily wear, Frequent replacement |
| FDA Lens Group | SiHy Class V | SiHy Class V |
| Device Classification | II | II |
| Manufacturing Method | Cast Molded | Cast Molded |
| Sterilization | Moist Heat | Moist Heat |
| Packaging | Blister Pack | Blister Pack |
| Packaging Solution | Phosphate Buffered Saline | Phosphate Buffered Saline |
| Visibility Tint | C.I. Reactive Blue #246 | Phathalocyanine Blue |
| Light Transmittance | > 93 % | > 94 % |
| Water Content | 40% | 33% |
| Refractive Index | 1.423 | 1.4217 |
| DK | ||
| x 10-11 [(cm²/sec) × (mL O₂)/(mL × mm Hg)] | 129 | 110 |
| Powers | -13.00 to +6.00 D | -20.00 to +20.00 D |
| Diameter | 13.0 to 18.0 mm | 13.0 to 15.0 mm |
| Base Curve | 8.0 to 9.0 mm | 8.0 to 9.2 mm |
| Optical Design | Spherical, Aspherical, Toric, | |
| Multifocal, Multifocal Toric | Spherical, Aspherical, Toric, | |
| Multifocal, Multifocal Toric |