(78 days)
The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or byperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters of less where the astigmatism does not interfere with visual acuity.
The OXYLENS (hioxifileon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
The OXYLENS (bioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. 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.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Oxylens:
Based on the provided 510(k) summary, the device (Oxylens soft contact lenses) is seeking substantial equivalence to predicate devices, rather than presenting a standalone study with specific acceptance criteria for device performance in a clinical trial. The "acceptance criteria" here refer to demonstrating that the Oxylens device is functionally and materially equivalent to already-approved devices, meaning it meets the same safety and effectiveness profile.
The document primarily focuses on demonstrating equivalence through comparison of physical properties and manufacturing methods, rather than presenting a clinical study with performance metrics like sensitivity, specificity, or reader improvement.
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the characteristics of the predicate devices. The device "performance" is the Oxylens' material and manufacturing properties matching or being similar to those of the predicate.
| Characteristic | Acceptance Criteria (Predicate Device Property) | Reported Device Performance (OxyLens) |
|---|---|---|
| Production Method | Lathe-Cut | Lathe-Cut |
| Lens Function | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including astigmatism | Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including astigmatism |
| Material | Hydrophilic Polymer | Hydrophilic Polymer |
| Water Content | 48% (for predicate) | 48% |
| Polymer Content | 52% (for predicate) | 52% |
| Polymer | hioxifilcon B | hioxifilcon B |
| Dk Value (Oxygen Permeability) | 15 | 15 X 10-11 (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method), effectively 15 |
| Refractive Index | 1.404 (hydrated) | 1.404 (hydrated) |
| Specific Gravity | 1.136 (hydrated) | 1.136 (hydrated) |
| Light Transmission | greater than 95 % T | greater than 95 % T |
Study that proves the device meets the acceptance criteria:
The "study" proving equivalence is a comparison of the physical, chemical, and manufacturing characteristics of the Oxylens with those of the identified predicate devices ("Alden Classic" series, "Satureyes" and "Satureyes Toric" manufactured by Metro Optics, and "BENZ-G 3X" manufactured by Benz Research and Development). The document explicitly states: "The following matrix illustrates that the production method, lens function and material of the OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathecut from Lens Blank), are substantially equivalent to the predicate device(s). In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."
This is a technical and material comparison, not a clinical efficacy or safety trial in the typical sense. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X (hioxifilcon B), 510(k) #K964528.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable. This submission relies on material and manufacturing equivalency testing and existing data from predicate devices, not on a new clinical test set of patients or images.
- Data Provenance: The data provided relates to the physical and chemical properties of the lens material. The "established safety profile" is linked to a predicate device (BENZ-G 3X) which would have undergone its own review. The provenance of that underlying data is not detailed here. It is not a clinical study with patient data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission does not involve expert review for a "test set ground truth" in the context of an AI or diagnostic device. The ground truth for material properties is established through standard laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no clinical "test set" and thus no adjudication method for establishing ground truth from multiple readers/experts.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC clinical study was done. This device is a contact lens, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is based on standard material science properties and manufacturing characteristics (e.g., water content, Dk value, refractive index) as determined by established laboratory methods, and the functional characteristics of existing, legally marketed contact lenses. This is a technical equivalency, not a medical "ground truth" derived from patient outcomes or pathology.
8. The sample size for the training set
- Not applicable. This submission does not involve machine learning or an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
{0}------------------------------------------------
JUN 2 3 1998
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
98i2j2
Applicant information:
Date Prepared:
April 2, 1998
Name: Address: Alden Optical Laboratories 13295 Broadway Alden, New York 14004
Mr. Charles H. Creighton Contact Person: 800.253.3669 Phone Number:
US Consultant:
Phone Number:
Fax Number:
Mr. Martin Dalsing 623 Glacier Grand Junction, CO 81503 970.243.5490 970 243.5501
Med-Vice Consulting, Inc.
Device Information:
Regulatory Classification: Class II
86 LPL Product Code:
OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Trade Name: Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)
Lenses, Soft Contact, Daily Wear Classification Name:
{1}------------------------------------------------
Equivalent Devices:
The OXYLENS (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include our own "Alden Classic" series (spherical and toric lens) manufactured by Alden Optical Labs, "Satureyes" and "Satureyes Toric" manufactured by Metro Optics and the "BENZ-G 3X" manufactured by Benz Research and Development.
Device Description:
The OXYLENS (bioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. 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.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are.
| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|---|---|
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Color Pigment Name | Phthalocyanine Blue |
| Water Content | 48 % ± 2% |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Oxygen Permeability | 15 X 10-11 (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method) |
Intended Use:
The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
The OXYLENS (hioxifilcon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
{2}------------------------------------------------
Substantial Equivalence:
The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Alden Optical Laboratories. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X (hioxifilcon B), 510(k) #K964528. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.
The following matrix illustrates that the production method, lens function and material of the OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathecut from Lens Blank), are substantially equivalent to the predicate device(s). In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device.
| Characteristic | OXYLENS (bioxifilcon B) | PREDICATEDEVICES | |
|---|---|---|---|
| 1.) | PRODUCTIONMETHOD | Lathe-Cut | SAME |
| 2.) | LENS FUNCTION | Refractive medium that focuses lightrays from near and distant objects onthe retina, while compensating forrefractive error, including(astigmatism) | SAME |
| 3.) | MATERIAL | Hydrophilic Polymer | SAME |
| a. | Water Content | 48% | SAME/SIMILAR |
| b. | Polymer Content | 52% | SAME/SIMILAR |
| c. | Polymer | bioxifilcon B | SAME/SIMILAR |
| d. | DK Value | 15 | SAME/SIMILAR |
| e. | Refractive Index | 1.404 (hydrated) | SAME/SIMILAR |
| f. | Specific Gravity | 1.136 (hydrated) | SAME/SIMILAR |
| g. | Light Transmission | greater than 95 % T | SAME/SIMILAR |
SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix
{3}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 3 1998
Alden Optical Laboratories, Inc. C/O Martin J. Dalsing 623 Glacier Drive Grand Junction, CO 81503
Re: K981252
Trade Name: Oxylens (hioxifilcon B) Soft (Sperical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)
Regulatory Class: II Product Code: 86 LPL Dated: April 2, 1998 Received: April 6, 1998
Dear Mr. Dalsing:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
{4}------------------------------------------------
Page 2 - Mr. Martin J. Dalsing
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
INDICATIONS FOR USE STATEMENT
OXYLENS (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens Device Name: (Clear & Blue Visibility Tint, Lath-cut from Lens Blank)
INDICATIONS FOR USE:
The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or byperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters of less where the astigmatism does not interfere with visual acuity.
The OXYLENS (hioxifileon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use 12 (Per 21 CFR 801.109)
or
Over-The-Counter Use 0
(Optional Format 1-2-96)
Mig-Churen. Shi
(Division Sign-Off) Division of Ophthalmic Devices
510(k) Number
< 78/2.
§ 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.