(53 days)
Not Found
No
The device description and intended use are for standard soft contact lenses and do not mention any AI or ML components or functionalities.
No.
The device is used for the correction of visual acuity, which is a refractive purpose, not a therapeutic one.
No
The device is a contact lens intended for correcting visual acuity, which is a therapeutic function, not a diagnostic one. It does not identify or detect a disease or condition.
No
The device description clearly states it is a physical contact lens made from polymacon, a material that is machined, polished, and hydrated. It is a tangible medical device, not software.
No, 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 (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ALDEN CLASSIC TINTED contact lenses are medical devices designed to be worn on the surface of the eye (in vivo) to correct visual acuity. They do not analyze samples from the body to provide diagnostic information.
- Intended Use: The intended use clearly states correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia and/or astigmatism. This is a therapeutic/corrective function, not a diagnostic one.
- Device Description: The description focuses on the material properties and physical characteristics of the contact lens itself, not on any analytical or testing capabilities.
Therefore, based on the provided information, the ALDEN CLASSIC TINTED contact lens is a medical device, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ALDEN CLASSIC TINTED (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in 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 ALDEN CLASSIC TINTED (polymacon) 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.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, 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. A Blue tint (transparent/enhancing), 7,16-Dichloro-6, 15-dihydro-5, and 9,14,18anthrazinetetrone is added to the lens."
In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) 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 eye. If the lens dries out, it will become hard 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 38% water by weight. The physical properties of the lens are:
Refractive Index: 1.52 (dry) 1.43 (hydrated)
Light Transmission: greater than 70% T
Water Content: 38 %
Specific Gravity: 1.28 (dry) 1.18 (hydrated)
Oxygen Permeability: 9 X 10-11 Fatt Units (cm2/sec)(ml O2/ml x mm Hg @ 35° C), (revised Fatt method)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
K961103 (BENZ-38 (polymacon)), Metro Tint
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
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.
February 9, 1998
13295 Broadway
800.253.3669
623 Glacier
970.243.5490
970.243.5501
APR - 7 1998
The assigned 510(k) number is:
Alden Optical Laboratories
Alden, New York 14004
Mr. Charles H. Creighton
Med-Vice Consulting, Inc.
Grand Junction, CO 81503
Mr. Martin Dalsing
Applicant information:
Date Prepared:
Name: Address
Contact Person: Phone Number:
US Consultant:
Phone Number: Fax Number:
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Trade Name: | ALDEN CLASSIC TINTED (polymacon) Soft (Spherical |
| & Toric) Daily Wear Contact Lens, Tinted | |
| (Transparent/Enhancing) | |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
1
Equivalent Devices:
The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include Metro Tint manufactured by Metro Optics and the BENZ-38 manufactured by Benz Research and Development.
Device Description:
The ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from polymacon, 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. A Blue tint (transparent/enhancing), 7,16-Dichloro-6, 15-dihydro-5, and 9,14,18anthrazinetetrone is added to the lens."
In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (polymacon) 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 eye. If the lens dries out, it will become hard 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 38% water by weight. The physical properties of the lens are:
| Refractive Index | 1.52 (dry) 1.43 (hydrated) |
|---|---|
| Light Transmission: | greater than 70% T |
| Water Content | 38 % |
| Specific Gravity | 1.28 (dry) 1.18 (hydrated) |
| Oxygen Permeability | 9 X 10-11 Fatt Units (cm2/sec)(ml O2/ml x mm Hg @ 35° C), (revised Fatt method) |
Intended Use:
The ALDEN CLASSIC TINTED (polymacon) 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 ALDEN CLASSIC TINTED (polymacon) Toric Soft Contact Lenses for daily waar 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.
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 (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-38 (polymacon), 510(k) #K961103. 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 roise different questions of i safety and effectiveness than the predicate devices identified above.
The following matrix illustrates that the production method, lens function and material of the ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing) are substantially equivalent to the predicate device. 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 | ALDEN CLASSIC TINTED | PREDICATE
DEVICE |
|-----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| 1.) | PRODUCTION
METHOD | Lathe-Cur | SAME |
| 2.) | LENS FUNCTION | Refractive medium that focuses light
rays from near and distant objects on
the retina, while compensating for
refractive error, including
(astigmatism) | SAME |
| 3.) | MATERIAL | Hydrophilic Polymer | SAME |
| a. | Water Content | 38% | SAME |
| b. | Polymer Content | 62% | SAME |
| c. | Polymer | polymacon | SAME |
| d. | DK Value | 9 | SAME |
| e. | Refractive Index | 1.43 (hydrated) | SAME |
| f. | Specific Gravity | 1.180 (hydrated) | SAME |
| g. | Light Transmission | greater than 70% T | SAME |
| h. | Dye Color | Blue (21CDR 73,3119)
CJ # 69825 | SAME |
Substantial Equivalence Matrix
- The Dye Color in the SE predicate device "Benz-38" is that of phthalocyanato (2) (copper) being a blue visibility tint and not the Vat blue 6 CI# 69825.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 7 1998
Alden Optical Laboratories c/o Mr. Martin Dalsing Med-Vice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K980554
Trade Name: Alden Classic Tinted (polymacon) Hydrophilic Contact Lens for Daily Wear (Lathe-cut, enhancement tint) Regulatory Class: II Product Code: 86 LPL Dated: February 9, 1998 Received: February 13, 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 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 at (301) 443-6597.
Sincerely yours,
A. Ralph Rosenthal, MD
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
Device Name: ALDEN CLASSIC TINTED (polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing)
INDICATIONS FOR USE:
The ALDEN CLASSIC TINTED (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in 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 ALDEN CLASSIC TINTED (polymacon) 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.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Ophthalmic Devices | |
| 510(k) Number | K980554 |
| Karen Warbenton | |
| or | |
| (Optional Format 1-2-96) |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
| Over-The-Counter Use | __________ |
|---|---|
| ---------------------- | ------------ |
ALDEN CLASSIC TINTED (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing) ...14