(426 days)
Not Found
No
The document describes a standard contact lens with various configurations (spherical, multifocal, toric, toric-multifocal) and material properties. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The clinical study described is a standard safety and efficacy trial for a medical device, not a performance evaluation of an AI/ML algorithm.
No.
The device is indicated for the correction of refractive errors like myopia, hyperopia, presbyopia, and astigmatism, which are visual impairments, not diseases or conditions that require therapy.
No
Explanation: This device is a contact lens intended for correcting vision, not for diagnosing medical conditions. The "Intended Use" section explicitly states its purpose for correcting myopia, hyperopia, and astigmatism, which are refractive errors, not diseases that require diagnosis by the lens itself.
No
The device is a physical contact lens made of a specific material, 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a contact lens. Contact lenses are medical devices placed directly on the eye to correct vision. They do not analyze biological specimens.
- Intended Use: The intended use is for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one based on in vitro analysis.
The text describes a medical device used for vision correction, not an IVD.
N/A
Intended Use / Indications for Use
The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.
The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.
The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.
The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.
The lenses may be disinfected using chemical (not heat) disinfecting systems.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration.
The lens material, (mangofilcon A), is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A (N.N-dimethyl acrylamide (NNDMA) polymer with 3-methacryloxy propyltris(trimethylsilyl)siloxane (TRIS)), trifluoroethyl methacrylate (TFEM), 2- hydroxyethyl methacrylate (HEMA), N-vinyl-2-pyrrolidone (NVP), cross-linked with ethyleneglycol dimethacrylate (EGDMA), and 49% water by weight.
Mangofilcon A is available in clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). The UV absorber is 2-(5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)-4- ethenyl phenol (UVAM).
Mangofilcon A is available in Blue or Aqua visibility tints to assist with handling, and both colors are available with or without UV absorber. The Blue lenses are tinted using 1,4-Bis[4-(2-methacryloxyethy]) phenylamino]anthraquinone (21 CFR 73.3106), and the Aqua lenses are tinted using Phthalocyanine Green (21 CFR 73.312).
The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions.
Diameter(s):
Sphere: 10.0 mm to 16.0 mm
Multifocal: 14.0 mm to 16.0 mm
Toric: (Not listed, but implies range given in other specs)
Toric-Multifocal: 14.0 mm to 16.0 mm
Center Thickness (Low Minus Lens): 0.07 mm dry
Center Thickness (Plus Lens): Up to 0.50 mm
Base Curve(s): 6.5 mm - 9.7 mm
Powers:
Sphere: -20.00 D to +12.00 D
Multifocal: -20.00 D to +12.00 D
Toric: -20.00 D to +12.00 D
Toric-Multifocal: -20.00 D to +12.00 D
Cylinder Powers:
Sphere: Not Applicable (N/A)
Multifocal: (Not specified, assumed N/A for Sphere/Multifocal as per table structure)
Toric: -0.50 D to 2.50 D in steps of 0.25 D
Toric-Multifocal: (Not specified, assumed as cylindrical for toric-multifocal as per table structure)
Axes:
Sphere: Not Applicable (N/A)
Multifocal: (Not specified, assumed N/A for Sphere/Multifocal as per table structure)
Toric: 0° to 180°
Toric-Multifocal: (Not specified, assumed as axes for toric-multifocal as per table structure)
Add Powers:
Sphere: N/A
Multifocal: +1.00 D to +3.25 D in steps of 0.25 D
Toric: N/A
Toric-Multifocal: +1.00 D to +3.25 D in steps of 0.25 D
Physical/optical properties:
Oxygen Permeability (Dk) (35°C, Fatt Units): 49
Refractive Index: Dry - 1.470, Hydrated - 1.413
Specific Gravity: Dry - 1.112, Hydrated - 1.109
Linear Expansion Ratio: 1.26
Water Content: 49%
Visible Light Transmittance: 96%T
Plasma Treatment Required: Yes
Shore D Hardness (in blank form): ≥83
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)
Non Clinical Data: In support of the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens a series of non clinical testing was conducted. Tests included physical/chemical analysis, shelf life stability testing and toxicology (cytotoxicity, systemic injection and ocular irritation).
Clinical Data: A three month clinical study was conducted to establish the safety and efficacy of the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for daily wear. Seventy-five (75) patients were enrolled in the study (56 test/19 control). The data from the clinical trial demonstrates that the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is safe and effective for its intended use. The risks and benefits of the subject device for patients are the same as for other silicone hydrogel contact lenses.
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
MAY 1 3 2013
LSH (mangofilcon A) Soft (hydrophilic) Contact Lens 510(k) Summary
1. Applicant Information
Lagado Corporation Contact Person: Mark Allen Telephone No .: (303) 789-0933 Fax No.: (303) 789-4506 E-mail: mark@lagadocorp.co Date Prepared: May 1, 2013
2. Device Information
Classification name: Soft hydrophilic contact lens Device classification: Class II Regulation number: 21 CFR 886.5925 Product code: LPL Proprietary name:
LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens
3. Predicate Devices
Lagado Corporation claims substantial equivalence to Benz- 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens as cleared for marketing in the United States in K964528 on March 10, 1997.
1
4. Description of Device
The LSH (mangofilcon A) is available as a spherical, multifocal, toric, and toric-All LSH lenses are plasma treated in the dry state prior to initial multifocal lens. hydration.
The lens material, (mangofilcon A), is a non-ionic hydrophilic copolymer that consists of 51% mangofilcon A (N.N-dimethyl acrylamide (NNDMA) polymer with 3-methacryloxy propyltris(trimethylsilyl)siloxane (TRIS)), trifluoroethyl methacrylate (TFEM), 2- hydroxyethyl methacrylate (HEMA), N-vinyl-2-pyrrolidone (NVP), cross-linked with ethyleneglycol dimethacrylate (EGDMA), and 49% water by weight.
Mangofilcon A is available in clear (no tint) with or without a UV absorber to block a significant amount of the UV radiation occurring between 200 and 400 nm (UVA and UVB). The UV absorber is 2-(5-chloro-2H-benzotriazole-2-yl)-6-(1,1-dimethylethyl)-4- ethenyl phenol (UVAM).
Mangofilcon A is available in Blue or Aqua visibility tints to assist with handling, and both colors are available with or without UV absorber. The Blue lenses are tinted using 1,4-Bis[4-(2-methacryloxyethy]) phenylamino]anthraquinone (21 CFR 73.3106), and the Aqua lenses are tinted using Phthalocyanine Green (21 CFR 73.312).
2
.
The LSH (mangofilcon A) Sphere, Multifocal, Toric, and Toric-Multifocal Soft (hydrophilic) Lenses for Daily Wear are hemispheric flexible shells of the following dimensions.
| LSH (mangofilcon A) | ||||
|---|---|---|---|---|
| Sphere | Multifocal | Toric | Toric- | |
| Multifocal | ||||
| Diameter(s) | 10.0 mm to | |||
| 16.0 mm | 14.0 mm to 16.0 mm | 14.0 mm to 16.0 mm | ||
| Center Thickness | ||||
| (Low Minus Lens) | 0.07 mm dry | |||
| Center Thickness | ||||
| (Plus Lens) | Up to 0.50 mm | |||
| Base Curve(s) | 6.5 mm - 9.7 mm | |||
| Powers | -20.00 D | |||
| to +12.00 D | -20.00 D | |||
| to +12.00 D | -20.00 D to +12.00 D | -20.00 D to +12.00 D | ||
| Cylinder Powers | Not Applicable (N/A) | -0.50 D to 2.50 D | ||
| in steps of 0.25 D | ||||
| Axes | Not Applicable (N/A) | 0° to | ||
| 180° | ||||
| Add Powers | N/A | +1.00 D to | ||
| +3.25 D | ||||
| in steps of | ||||
| 0.25 D | N/A | +1.00 D to | ||
| +3.25 D | ||||
| in steps of | ||||
| 0.25 D |
3
| Property . | LSH Latheable
Silicone
Hydrogel |
|---------------------------------------------------|---------------------------------------|
| Oxygen Permeability
(Dk)
(35°C, Fatt Units) | 49 |
| Refractive Index | Dry - 1.470
Hydrated - 1.413 |
| Specific Gravity | Dry - 1.112
Hydrated - 1.109 |
| Linear Expansion Ratio | 1.26 |
| Water Content | 49% |
| Visible Light Transmittance | 96%T |
| Plasma Treatment Required | Yes |
| Shore D Hardness
(in blank form) | ≥83 |
The physical/optical properties of the lenses are:
5. Indications for Use
The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia and hyperopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.
The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.
The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or non-aphakic persons with non diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.
4
The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic or non-aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.
The lenses may be disinfected using chemical (not heat) disinfecting systems.
6. Performance Data
Non Clinical Data
In support of the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens a series of non clinical testing was conducted. Tests included physical/chemical analysis, shelf life stability testing and toxicology (cytotoxicity, systemic injection and ocular irritation).
Clinical Data
A three month clinical study was conducted to establish the safety and efficacy of the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for daily wear. Seventy-five (75) patients were enrolled in the study (56 test/19 control). The data from the clinical trial demonstrates that the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is safe and effective for its intended use. The risks and benefits of the subject device for patients are the same as for other silicone hydrogel contact lenses.
Conclusion
Based upon the test data presented, the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is as safe, as effective and performs as well as the predicate device. A comparison of the new device and the predicate device is presented in Table 1.
5
・・
7. Substantial Equivalence
Lagado Corporation claims that the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate device, Benz- 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens (K964528).
Based upon clinical and non clinical product testing presented in this application, the LSH (mangofilcon A) Soft (hydrophilic) Contact Lens for daily wear is as safe and effective as the predicate device when used for the requested indications and in accordance with the directions for use.
| LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
| Comparison Table | ||
|---|---|---|
| PROPERTY | LSH Latheable Silicone Hydrogel (mangofilcon A) | Predicate Device BENZ 3GX (hioxifilcon B ) |
| OXYGEN PERMEABILITY | ||
| (Dk) (35°C, Fatt Units) | 49 | 15 |
| REFRACTIVE INDEX | Dry - 1.470 | Dry - 1.507 |
| Hydrated - 1.413 | Hydrated - 1.425 | |
| SPECIFIC GRAVITY | Dry - 1.112 | Dry - 1.308 |
| Hydrated - 1.109 | Hydrated - 1.136 | |
| LINEAR EXPANSION RATIO | 1.26 | 1.3 |
| WATER CONTENT | 49% | 49% |
| TENSILE STRENGTH | 3.07 M Pa | 25g/mm2 |
| % ELONGATION AT BREAK | 470 | 186 |
| VISIBLE LIGHT | ||
| TRANSMITTANCE | 96 % T | 95 % T |
| PLASMA TREATMENT | ||
| REQUIRED | Yes | No |
| Shore D HARDNESS | ||
| (in Blank form) | ≥ 83 | ≥ 90 |
Table 1 Comparison to Predicate Device:
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
May 13, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Lagado Corporation % Ms. Ellen M. Beucler Vice President Foresight Regulatory Strategies, Inc. 187 Ballardvale Street. Suite 180 Wilmington, MA 01887
Re: K120756
Trade/Device Name: LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft hydrophilic contact lens Regulatory Class: Class II Product Code: LPL Dated: May 1, 2013 Received: May 3, 2013
Dear Ms. Beucler:
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 (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. 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.
7
Page 2 - Ms. E.M. Beucler
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
DeborahDMEalls-S
for Malvina B. Eydelman, M.D. Director. Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number: K120756
Device Name: LSH (mangofilcon A) Soft (hydrophilic) Contact Lens
Indications for Use:
The LSH (mangofilcon A) Sphere Soft (hydrophilic) Contact Lens is indicated for the correction of myopia in aphakic or non-aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of assignatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters.
The LSH (mangofilcon A) Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic and hyperopic eyes in aphakic patients with non-diseased eyes who exhibit no more than 2.00 Diopters of astigmatism and can obtain satisfactory visual acuity in a power range of +12.00 to -20.00 Diopters and have near add requirements up to 3.25 Diopters.
The LSH (mangofilcon A) Toric Soft (hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic persons with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters and a cylinder power range of -0.50 to 2.50 Diopters.
The LSH (mangofilcon A) Toric-Multifocal Soft (hydrophilic) Contact Lens is indicated for the correction of presbyopia in myopic, hyperopic and astigmatic aphakic patients with non-diseased eyes in a spherical power range of +12.00 to -20.00 Diopters, a cylinder power range of -0.50 to 2.50 Diopters and an add requirement up to 3.25 Diopters.
The lenses may be disinfected using chemical (not heat) disinfecting systems.
Prescription Use _________________XX (part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leonid Livshitz-S
2013.05.10 19:19:25 -04'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number: K120756
page 1 of 1