(265 days)
Not Found
No
The summary describes a standard contact lens made of polymacon, focusing on its material properties, physical characteristics, and performance testing related to safety and effectiveness as a vision correction device. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is indicated for the correction of visual acuity in individuals with myopia, which is a medical condition. It also acts as a refracting media to focus light rays on the retina, which is a therapeutic function.
No
This device is a contact lens used for vision correction (a treatment) and not for diagnosing a condition.
No
The device description clearly indicates it is a physical contact lens made of polymacon, a hydrophilic polymer. The performance studies also detail physical, optical, and biocompatibility testing of the lens material and packaging, not software.
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 visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia, and for cosmetic purposes (enhancing or altering eye color). This is a direct interaction with the eye for vision correction and cosmetic appearance.
- Device Description: The device is a contact lens that conforms to the curvature of the eye and acts as a refracting media to focus light.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or aid in the diagnosis of any disease or condition by examining specimens derived from the human body.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the body to provide information for diagnosis, monitoring, or treatment decisions. This contact lens does not perform such a function.
N/A
Intended Use / Indications for Use
HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Frequent / Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a spherical lens. It is fabricated from polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives:
Reactive black 5
Titanium dioxide
Iron oxides
Solvent Yellow 18
Carbazole violet
Pigment Blue 36
Phthalocyanine green
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens contains only the amount of color additives to accomplish the intended coloring effect. The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon). As part of the manufacturing process, the color lenses are thoroughly washed to remove the unbound reactive color additives. Because of the 'sandwich' structure, the color additives will not be removed by lens handling and cleaning procedures.
In the hydrated state, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution compatible with the eye.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties:
Back vertex power: -10.00D to 0.00D, step: 0.25D
Base curve: 8.40 mm to 8.70 mm, step: 0.10 mm
Total diameter: 13.80 mm to 14.50 mm, step:0.10 mm
The physical properties of the proposed lens are:
Specific gravity: 1.124
Refractive index: 1.437
Light Transmission: 93% +/- 5%
Surface character: Hydrophilic
Water content: 38%
Oxygen permeability: 8.99x10^-11 (cm²/s) [ml O₂/(ml·mmHg)] at 35°C
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing the borate buffer solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye / Cornea
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 tests were conducted in accordance with the FDA guidance - Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses" issued on June 27, 1994. The non-clinical performance tests had demonstrated the safety and effectiveness of HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens and the substantial equivalence to the predicate device.
Performance Testing:
The physical, optical, physicochemical performance tests were performed in accordance with ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017 and ASTM D882-18, and the test results showed that the proposed device meets the requirements.
- Appearance
- Physical parameters (Total diameter, Base curve, Center thickness)
- Optical parameter (Back vertex power)
- Spectral transmission
- Refractive index
- Water content
- Specific gravity
- Extractables
- Oxygen permeability
- Mechanical properties
- pH and Osmolality of the storage solution
In addition, the compatibility test of the lens with the lens care regimen has been conducted as per ISO 11981:2017, and the results demonstrate the proposed device is compatible with the marketed lens care regimens. The leachability of the color additives has also been conducted, and the results also demonstrate that the color additives contained in the proposed device are stable.
Biocompatibility Testing:
The following biocompatibility tests were performed respectively on the contact lens and primary packaging according to FDA guidance - Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses" issued on June 27, 1994, and the test results demonstrated that the contact lens and primary packaging have no cytotoxicity, no ocular irritation, no skin sensitization and no acute systemic toxicity.
- Cytotoxicity (ISO 10993-5:2009)
- Ocular Irritation (ISO 10993-23:2021)
- Skin Sensitization (ISO 10993-10:2021)
- Acute System Toxicity (ISO 10993-11:2017)
In addition, the following biocompatibility tests were performed on the storage solution, and the test results demonstrated that the storage solution had no cytotoxicity, no ocular irritation and no skin sensitization. - Cytotoxicity (ISO 10993-5:2009)
- Ocular Irritation (ISO 10993-23:2021)
- Skin Sensitization (ISO 10993-10:2021)
In conclusion, the results of the above biocompatibility tests showed that the proposed device has no biocompatibility issues.
Sterilization:
A Sterility Assurance Level (SAL) of 10^-6 has been validated in accordance with the requirements of ISO 17665-1:2006.
Shelf Life:
Accelerated aging testing has been performed to assure the shelf-life of 5 years in accordance with ISO 11987:2012.
Simulated Transportation Testing:
The simulated transportation testing has been conducted according to ASTM D4169-22.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the first line and "ADMINISTRATION" on the second line.
March 20, 2025
Hunan Haipuming Technology Co., Ltd. % Grace Liu Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518000 China
Re: K241884
Trade/Device Name: HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 13, 2025 Received: February 13, 2025
Dear Grace Liu:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-deviceadvice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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 (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J Angelo Green -S
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38)
Indications for Use (Describe)
HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by evecare practitioners in consultation with their patients.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Frequent / Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
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."
4
510(k) Summary - K241884
1. Contact Details
1.1 Applicant information
| Applicant Name | Hunan Haipuming Technology Co., Ltd. |
|---|---|
| Address | The Intersection of Chuangye Avenue and Lvting Avenue, Dahetang |
| Sub-district Office, Shaodong City, Shaoyang City, Hunan Province, | |
| China | |
| Contact person | Zhang Mingxuan |
| Phone No. | +86-739-2712889 |
| +86-18107399879 | |
| 164059332@qq.com | |
| Date Prepared | 2025.03.14 |
1.2 Submission Correspondent
| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd. |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District, | |
| Shenzhen, Guangdong Province, China | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu |
| Contact person's e-mail | grace@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38 |
|---|---|
| Common name | Soft (Hydrophilic) Contact Lens |
| Classification | II |
| Classification name | Lenses, Soft Contact, Daily Wear |
| Product code | LPL, MVN |
| Regulation No. | 21 CFR 886.5925 |
3. Legally Marketed Predicate Device
| Trade Name | Neo Cosmo (polymacon) Soft (hydrophilic) Contact Lens |
|---|---|
| 510(k) Number | K142275 |
| Product Code | LPL |
| Manufacturer | Neo Vision Co., Ltd. |
The predicate device has not been subject to a design-related recall.
4. Device Description
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a spherical lens. It is fabricated from
5
polymacon which has been adopted by the United Stated Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The lens material, polymacon, is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) cross-linked with ethylene glycol dimethacrylate (EGDMA), initiated by 2, 2'-azobisisobutyronitrile (AIBN). The lens consists of 62% polymacon and 38% water by weight when immersed in standard saline solution.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available cosmetic tinted to enhance or alter the apparent color of the eye. It is tinted in an annular pattern, providing a clear optic zone, using a combination of one or more of the following 'listed' color additives:
| Color additive | Listing No. |
|---|---|
| Reactive black 5 | 21 CFR 73.3121 |
| Titanium dioxide | 21 CFR 73.3126 |
| Iron oxides | 21 CFR 73.3125 |
| Solvent Yellow 18 | 21 CFR 73.3122 |
| Carbazole violet | 21 CFR 73.3107 |
| Pigment Blue 36 | 21 CFR 73.3110a |
| Phthalocyanine green | 21 CFR 73.3124 |
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens contains only the amount of color additives to accomplish the intended coloring effect. The proposed color lenses are manufactured by sandwiching the pattern layer containing color additives between two layers of lens materials (polymacon). As part of the manufacturing process, the color lenses are thoroughly washed to remove the unbound reactive color additives. Because of the 'sandwich' structure, the color additives will not be removed by lens handling and cleaning procedures.
In the hydrated state, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus, and it acts as a refracting media to focus light rays on the retina. If the lens dries out, it will become hard and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution compatible with the eye.
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in the spherical configuration with the following features and properties:
| Back vertex power | -10.00D to 0.00D, step: 0.25D |
|---|---|
| Base curve | 8.40 mm to 8.70 mm, step: 0.10 mm |
| Total diameter | 13.80 mm to 14.50 mm, step:0.10 mm |
The physical properties of the proposed lens are:
| Specific gravity | 1.124 |
|---|---|
| Refractive index | 1.437 |
6
| Light Transmission | 93% ± 5% |
|---|---|
| Surface character | Hydrophilic |
| Water content | 38% |
| Oxygen permeability | $8.99\times10^{-11}$ (cm²/s) [ml O₂/(ml·mmHg)] at 35°C |
HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens is supplied sterile in the foil blister pack containing the borate buffer solution.
5. Intended Use/Indication for Use
HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available tinted and used to enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When prescribed for Daily Disposable Wear, the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.
Frequent / Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent / planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.
| Comparison
item | Proposed Device
(K241884) | Predicate Device
(K142275) | Comment |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Manufacturer | Hunan Haipuming Technology Co.,
Ltd. | Neo Vision Co., Ltd. | / |
| Product Name | HPM38 (polymacon) Daily Wear Soft
(hydrophilic) Contact Lens | Neo Cosmo (polymacon) Soft
(hydrophilic) Contact Lens | / |
| Regulation
Number | 21 CFR 886.5925 | 21 CFR 886.5925 | Same |
| Classification | Class II | Class II | Same |
| Prescription
Use | Yes | Yes | Same |
| Intended Use /
Indications for
Use | HPM38 (polymacon) Daily Wear Soft
(Hydrophilic) Contact Lens is
indicated for the correction of visual | The Neo Cosmo (Polymacon) Soft
(hydrophilic) Contact Lens is
indicated for daily wear for the | Equivalent |
| | | | |
| | acuity in aphakic and not-aphakic
persons with non-diseased eyes with | correction of visual acuity in aphakic
and non-aphakic persons with | |
| | myopia. The lens may be worn by | non-diseased eyes with myopia or | |
| | persons who exhibit refractive | hyperopia. The lens may be worn by | |
| | astigmatism of 0.50 diopters or less | persons who exhibit refractive | |
| | where the astigmatism does not | stigmatism of 0.50 diopters or less | |
| | interfere with visual acuity. The lens is | where the astigmatism does not | |
| | available tinted and used to enhance | interfere with visual acuity. The lens is | |
| | or alter the apparent color of the eye. | available clear or colored and may be | |
| | Daily wear replacement schedules
may vary from patient to patient and | used to enhance or alter the apparent
color of the eye. | |
| | should be decided by eyecare | Eye care practitioners may prescribe | |
| | practitioners in consultation with their | the lens frequent replacement wear | |
| | patients. | with cleaning, disinfecting and | |
| | Disposable Wear:
Eyecare practitioners may prescribe | schedule replacement. The lens may
be disinfected using a chemical (not
heat) lens care system only. | |
| | any of the above lenses for Daily | | |
| | Disposable Wear. When prescribed | | |
| | for Daily Disposable Wear, the lenses | | |
| | are not to be used with disinfecting | | |
| | systems as they are to be discarded | | |
| | after a single use. | | |
| | Frequent/Planned
Replacement
Wear: | | |
| | Eyecare practitioners may prescribe | | |
| | any of the above lenses for frequent / | | |
| | planned replacement wear, with | | |
| | cleaning, disinfection and scheduled | | |
| | replacement. When prescribed for | | |
| | frequent/planned replacement wear, | | |
| | the lens may be disinfected using a | | |
| | chemical disinfecting system. | | |
| Functionality | The contact lenses act as a refractive
medium that focus light rays from
near and distant objects on the retina. | The contact lenses act as a refractive
medium that focus light rays from
near and distant objects on the retina. | Same |
| Lens Design | Spherical | Spherical, Toric | Equivalent |
| Manufacturing
Process | Lathe-cut
(semi-molded) | Lathe-cut
(semi-molded) | Same |
| Lens Material | Polymacon | Polymacon | Same |
| Material
Classification | Group I
Low water content (90% | Same |
| Refraction Index | 1.437 | 1.428 | Same |
| Oxygen Permeability | 8.99×10-11 (cm²/s) [ml O₂/(ml·mmHg)]
at 35°C | 9.77×10-11 (cm²/s) [ml O₂/(ml·mmHg)]
at 35°C | Different |
| Modulus | 0.61 MPa | 0.350 MPa | Different |
| Tensile Strength | 0.62 MPa | 0.425 MPa | Different |
| Elongation at break | 279% | 127% | Different |
| Sterilization | Moist Heat Sterilization | Moist Heat Sterilization | Same |
| Biocompatibility | Biocompatible | Biocompatible | Same |
| | | | |
6. Substantial Equivalence Comparison
7
8
HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens has the similar indication for use as the predicate device as well as similar technical characteristics, and the differences don't raise any additional questions for safety and effectiveness, therefore, the proposed device is substantially equivalent to the predicate device.
7. Summary of Non-clinical Testing
9
Non-clinical tests were conducted in accordance with the FDA guidance - Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses" issued on June 27, 1994. The non-clinical performance tests had demonstrated the safety and effectiveness of HPM38 (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens and the substantial equivalence to the predicate device.
> Performance Testing
The physical, optical, physicochemical performance tests were performed in accordance with ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017 and ASTM D882-18, and the test results showed that the proposed device meets the requirements.
- Appearance
- । Physical parameters (Total diameter, Base curve, Center thickness)
- Optical parameter (Back vertex power) ।
- Spectral transmission ।
- । Refractive index
- Water content ।
- -Specific gravity
- i Extractables
- i Oxygen permeability
- Mechanical properties i
- pH and Osmolality of the storage solution ।
In addition, the compatibility test of the lens with the lens care regimen has been conducted as per ISO 11981:2017, and the results demonstrate the proposed device is compatible with the marketed lens care regimens. The leachability of the color additives has also been conducted, and the results also demonstrate that the color additives contained in the proposed device are stable.
> Biocompatibility Testing
The following biocompatibility tests were performed respectively on the contact lens and primary packaging according to FDA guidance - Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses" issued on June 27, 1994, and the test results demonstrated that the contact lens and primary packaging have no cytotoxicity, no ocular irritation, no skin sensitization and no acute systemic toxicity.
- Cytotoxicity (ISO 10993-5:2009) ।
- i Ocular Irritation (ISO 10993-23:2021)
- i Skin Sensitization (ISO 10993-10:2021)
- Acute System Toxicity (ISO 10993-11:2017) ।
In addition, the following biocompatibility tests were performed on the storage solution, and the test
10
results demonstrated that the storage solution had no cytotoxicity, no ocular irritation and no skin sensitization.
- Cytotoxicity (ISO 10993-5:2009) ।
- Ocular Irritation (ISO 10993-23:2021) i
- Skin Sensitization (ISO 10993-10:2021)
In conclusion, the results of the above biocompatibility tests showed that the proposed device has no biocompatibility issues.
A Sterilization
A Sterility Assurance Level (SAL) of 10° has been validated in accordance with the requirements of ISO 17665-1:2006.
A Shelf Life
Accelerated aging testing has been performed to assure the shelf-life of 5 years in accordance with ISO 11987:2012.
A Simulated Transportation Testing
The simulated transportation testing has been conducted according to ASTM D4169-22.
8. Clinical Testing
This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.
9. Conclusions
The results of comparing the design specifications and non-clinical testing between the proposed device and the legally marketed predicate device (K142275) show that they are Substantially Equivalent (SE).