(221 days)
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No
The summary describes a standard soft contact lens made of a specific material. There is no mention of any computational or analytical features that would suggest the use of AI or ML.
No.
The device is indicated for the correction of visual acuity, which is a compensatory function rather than a therapeutic one. It does not treat or cure a disease but rather corrects a vision defect.
No
Explanation: The device is a soft contact lens intended for the correction of visual acuity. Its purpose is to treat or correct a condition (myopia, hyperopia, astigmatism), not to diagnose a disease or condition.
No
The device description clearly describes a physical contact lens made of specific materials, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The LM-70 contact lens is a device that is placed on the eye to correct vision. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states its purpose is for "correction of visual acuity."
Therefore, the LM-70 contact lens falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LM-70 (Udofilcon A) Spherical Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.
The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The LM-70 Spherical and Toric Soft Contact Lens is fabricated from lidofilcon A, 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 (lidofilcon A) 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 and appear somewhat warned however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The non-ionic lens material, (lidofilcon A) is a terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA). It consists of 30% lidofilcon A and 70% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight. The physical properties of the lens are:
Refractive Index: 1.52 (dry) 1.41 (hydrated)
Light Transmission: greater than 95%
Water Content: 70% ±2%
Specific Gravity: 1.061 (hydrated)
Oxygen Permeability: 38.5 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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.
Not Found
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.
The assigned 510(k) number is: K991015
Applicant information:
| Date Prepared: | March 24, 1999 |
|---|---|
| ---------------- | ---------------- |
| Name:
Address | Lamda Polytech Limited
1 Lincoln Park Borough Road
Brackley Northants
England NN13 7BE |
|----------------------------------|-------------------------------------------------------------------------------------------------|
| Contact Person:
Phone number: | Ian Atkins
44-1280 705500 |
| USA Consultant: | Med-Vice Consulting Inc. |
| USA Consultant. | Med-vice Consulting, inc. |
|---|---|
| Phone number | (970) 243-5490 |
| Fax number | (970) 243-5501 |
| Martin Dalsing |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens |
| for Daily Wear (clear, lathe-cut) |
1
Equivalent Devices:
The LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens is substantially equivalent to the following predicate device in terms of intended use and design. Predicate device: "LL-70" manufactured/distributed by Lombart Lenses, LTD.
Device Description:
The LM-70 Spherical and Toric Soft Contact Lens is fabricated from lidofilcon A, 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 (lidofilcon A) 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 and appear somewhat warned however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The non-ionic lens material, (lidofilcon A) is a terpolymer of N-vinyl-2-pyrrolidone (NVP) and methyl methacrylate (MMA), cross-linked with ethylene glycol dimethacrylate (EGDMA) and Allyl methacrylate (AMA). It consists of 30% lidofilcon A and 70% water by weight when immersed in normal saline solution buffered with sodium bicarbonate.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 70% water by weight. The physical properties of the lens are:
| Refractive Index | 1.52 (dry) 1.41 (hydrated) |
|---|---|
| Light Transmission | greater than 95% |
| Water Content | 70% ±2% |
| Specific Gravity | 1.061 (hydrated) |
| Oxygen Permeability | 38.5 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method). |
Intended Use:
The LM-70 (Udofilcon A) Spherical Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.
The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.
2
Substantial Equivalence:
The LM-70 Soft Contact Lens will be manufactured according to specified process controls and an ISO 9001/9002 and CGMP quality assurance program currently in place. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the LM-70 material is equivalent to the predicate device identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, 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 device identified above.
The following matrix illustrates the production method, lens function and material characteristics of the LM-70 Spherical and Toric Soft Contact Lens, as well as the predicate device.
| | General S.E. Areas | Lamda Polytech
LM-70 (lidofilcon A) | Predicate Device
LL-70 (lidofilcon A) |
|-----|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | Intended Use | Visual correction in Not-aphakic
persons with non-diseased eyes
that myopic or hyperopic | Visual correction in Not-aphakic
persons with non-diseased eyes
that myopic or hyperopic |
| 2.) | Functionality | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. |
| 3.) | Indications | Daily wear, Soft (hydrophilic)
contact lens | Daily wear, Soft (hydrophilic)
contact lens |
| 4.) | Production Method | Lathe-cut | Lathe-cut |
| 5.) | FDA Group # | Group # 2 >50% Water, Nonionic
Polymers | Group # 2 >50% Water, Nonionic
Polymers |
| 6.) | Water Content | 70% ± 2 % | 70% ± 2 % |
| 7.) | Oxygen Permeability | 38.5 X 10-11 (cm2/sec)
(ml 02/ml x mm Hg @ 35 degrees
C), (revised Fatt method). | 34.7 X 10-11 (cm2/sec)
(ml 02/ml x mm Hg @ 35 degrees
C), (revised Fatt method). |
| 8.) | Specific Gravity | 1.061 | 1.073 |
Substantial Equivalence Matrix
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 2 1999
Lamda Polytech Limited c/o Mr. Martin Dalsing Offical Representative and Consultant for Lamda Polytech Limited MedVice Consulting, Inc. 623 Glacier Drive Grand Junction, Co 81503
Re: K991015
Trade Name: LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens for Daily Wear (clear, lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: October 5, 1999 Received: October 8, 1999
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
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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Roerl 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
LM-70 (lidofilcon A) Spherical and Toric Soft Contact Lens for Daily Wear Device Name: (clear, lathe-cut)
INDICATIONS FOR USE:
The LM-70 (lidofilcon A) Spherical Soft Contact Lens for daily wear aisre indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lens may be disinfected using either a chemical or heat disinfecting system.
The LM-70 (lidofilcon A) Toric Soft Contact Lens for daily wear is indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes that are myopic or hyperopic and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected using either a chemical or heat disinfecting system.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Orus
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_k 9905
Image /page/5/Picture/11 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a line through the text, indicating that it is not applicable. The text is likely related to the regulatory requirements for prescription drug labeling.
or
Over-The-Counter Use
(Optional Format 1-2-96)