(24 days)
Not Found
No
The 510(k) summary describes a standard contact lens made from a specific material and manufactured using lathing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are standard tests for contact lens safety and physical properties.
No.
The device is intended for the correction of visual acuity, which is a functional improvement rather than a therapeutic treatment for a disease or condition.
No
The device is described as a contact lens intended for correcting visual acuity (refractive error), not for diagnosing conditions. It acts as a refracting medium to focus light, which is a therapeutic function, not a diagnostic one.
No
The device is a physical contact lens made from a specific material, not a software program.
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 description clearly states that this device is a contact lens intended for the correction of visual acuity by acting as a refracting medium on the cornea. It is a physical device placed on the eye, not a test performed on a biological sample.
- Intended Use: The intended use is for correcting vision in aphakic and non-aphakic persons with non-diseased eyes. This is a therapeutic/corrective function, not a diagnostic one.
- Device Description: The description focuses on the material composition, manufacturing process (lathing), and how it functions as a lens. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a medical device, specifically a contact lens, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.
The lenses may be disinfected using chemical disinfection systems.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.
This non-ionic material is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate, plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution.
When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
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)
A. PRE-CLINICAL TESTING
The following pre-clinical tests were run by a recognized independent testing facility:
i. Primary Ocular Irritation ii. Systemic Injection iii. Agar Diffusion
All results obtained were within normal limits hence this material All results obtainsd were within his for Class II contact lenses.
B. PHYSICAL TESTING
The following tests were run to demonstrate the physical properties of the lens material are within normal limits:
i. Burst Test
This test was performed by an independent laboratory and inis test was performed by an entires of the material is within normal limits.
- ii. 12 Lens Parameter Test 2 Lens Farameter 200lenses made from BENZ methafilcon A optical blanks. The fenses made from being accidentes when measured were within normal limits.
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
980418
510(k) Notification BENZ Methafilcon A
January 30, 1998
SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS FEB 2 7 1998
Soft (hydrophilic) contact lenses for Daily Wear manufactured from methafilcon A material are generally recognized as safe and effective. Such lenses have been successfully marketed in the U.S. since the early 1980's by several manufacturers of both optical blanks and finished lenses. To date, there are more than twelve approved methafilcon A products (PMA's & 510(k)'s) on the U.S. market.
To demonstrate the methafilcon A material manufactured by BENZ R&D and the finished lenses manufactured from BENZ methafilcon A is safe and effective for its intended use, we offer the following statements :
1. PURPOSE OF THIS NOTIFICATION
BENZ's primary interest is in the distribution of optical blanks. They will manufacture and test a limited number of finished lenses for Quality Assurance and customer support purposes. The methafilcon A blanks will only be sold to finishing laboratories with the appropriate regulatory approvals for the distribution of methafilcon A contact lenses.
2. DEVICE DESCRIPTION
The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.
This non-ionic material is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid crosslinked with Ethylene Glycole Dimethacrylate, plus an initiator. The co-polymer consists of 45% methafilcon A and 55% water by weight when immersed in normal buffered saline solution.
When the lens is hydrated and placed on the cornea it acts as a refracting medium to focus light rays on the retina.
1
510(k) Notification BENZ Methafilcon A
January 30, 1998
SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS (continued)
3. ALTERNATIVE PRACTICES AND PROCEDURES
Alternative practices and procedures for the same indications are in use and generally consist of other prescription products such In use and generally Combines made from other materials, or spectacles.
4. TECHNICAL SUMMARY
A. PRE-CLINICAL TESTING
The following pre-clinical tests were run by a recognized independent testing facility:
i. Primary Ocular Irritation ii. Systemic Injection iii. Agar Diffusion
All results obtained were within normal limits hence this material All results obtainsd were within his for Class II contact lenses.
B. PHYSICAL TESTING
The following tests were run to demonstrate the physical properties of the lens material are within normal limits:
i. Burst Test
This test was performed by an independent laboratory and inis test was performed by an entires of the material is within normal limits.
- ii. 12 Lens Parameter Test 2 Lens Farameter 200lenses made from BENZ methafilcon A optical blanks. The fenses made from being accidentes when measured were within normal limits.
C. FINISHED LENS TESTING
All lenses to be produced form BENZ methafilcon A will be manufactured in accordance with the methods, equipments, and mandlactard in anted in the referenced 510(k) Notification K950294 Flexlens 55 (methafilcon A) Soft Contact Lenses.
2
January 30, 1998 510(k) Notification BENZ Methafilcon A
SUMMARY STATEMENT OF SAFETY & EFFECTIVENESS (continued)
Please refer to K950294 for the following information for all BENZ methafilcon A lenses:
i. Microbiology ii. Solutions Compatibility iii. Shelf Life/Stability iv. Preservative Uptake/Release
12000
A letter of authorization to reference this 510(k) is included with this Notification.
Flexlens last FDA inspection was March 7, 1996 and there are no outstanding GMP deficiencies.
- CONCLUDING STATEMENTS
Any adverse effects to the patient would not be any more likely or any more severe with lenses made from BENZ methafilcon A than with lenses made from any other methafilcon A or any other soft contact lens material.
From the above referenced test data, it can be deduced that the BENZ methafilcon A material is safe and effective for its intended purpose as a daily wear contact lens.
t
3
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael A. Clark Consultant to BENZ c/o South East Regulatory Associates, Inc. 1070 Thornwood Lane Dacula, GA 30019
FEB 2 7 1998
K980418 Re:
Trade Name: BENZ methafilcon A Spherical and Toric Soft (hydrophilic) contact lenses (clear, lathe cut) for Daily Wear
Regulatory Class: II Product Code: 86 LPL Dated: January 30, 1998 Received: February 3, 1998
Dear Mr. Clark:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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.
Image /page/3/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The symbol is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
4
Page 2 - Mr. Michael A. Clark
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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
The BENZ methafilcon A soft (hydrophilic) spherical and toric contact lenses will be made from clear methafilcon A optical blanks and indicated for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes to be worn in daily wear regimens.
The spherical lenses are available from +20.00 to -20.00 diopters and will mask up to 1.50 diopters of astigmatism where it does not interfere with visual acuity.
The toric lenses are available from +20.00 to -20.00 diopters and with up to 4.50 diopters of astigmatic correction.
The BENZ methafilcon A optical blanks are lathed into a soft (hydrophilic) spherical or toric hemispherical shell. The spherical lenses have a spherical base curve and the toric lenses have a non-spherical base curve.
The lenses may be disinfected using chemical disinfection systems.
****************************************************************************************************************************************************************************** (Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W.C. Brown, Ph.D.
Division Sign-Off
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K980418
OR
Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)