(91 days)
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 to -20.00 diopters. The MAXSIGHT (polymacon) Sport-Tinted contact lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye.
Replacement schedules may vary from patient to patient, and should be decided by eye care professionals in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care professionals. The lens may be disinfected using a chemical disinfection system.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is a hemispherical flexible shell which may cover a portion of the cornea and a portion of the adjacent sclera. It consists of a polymer of Hydroxyethyl Methacrylate (HEMA) and Ethylene Glycol Dimethacrylate (EGDMA), and is 38% water by weight when immersed in a sterile saline solution. This lens is tinted in the monomer with Phthalocyanine Blue Dye 246 (1, 4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone), which conforms to 21 CFR Part 73.3106. Finished lenses are subsequently tinted to achieve different colors using color additives that conform to 21 CFR Part 73.3121.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is designed to aid visual performance in athletic settings. MAXSIGHT (polymacon) Sport-Tinted Contact lenses enhance contrast in a wide range of outdoor light conditions. This allows athletes to see created objects with greater clarity than with the naked eye.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is manufactured with the following dimensions:
Diameter: 13.5 to 15.5 mm
Center Thickness: 0.06 to 0.175mm
Base Curve: 8.4-9.0mm
Powers (Spherical): +20.00D to -20.00D
The physical / optical properties of the lens are:
Specific Gravity: 1.13
Refractive Index: 1.43
Light Transmittance: ≥30%
UV Absorption: >95%
UVA absorption: >95%
UVB absorption: >95%
Water Content: 38.6%
Oxygen Permeability (Dk): 8.4x10-11[cm³O2 (STP) x cm]/(sec x cm x cm² x mmHg)@35°C (Polargraphic Method)
Each MAXSIGHT (polymacon) Sport-Tinted Contact Lens is supplied in a plastic blister container with sterile saline solution. The lid of the container is marked with the lens power, diameter, manufacturing lot number, and expiration date.
The provided text describes a 510(k) premarket notification for the MAXSIGHT™ (polymacon) Sport-Tinted Contact Lens, which seeks substantial equivalence to a predicate device. This type of submission focuses on demonstrating safety and effectiveness through equivalence to an existing legally marketed device, rather than through a comprehensive clinical trial with specific performance acceptance criteria and a detailed study design as might be seen for a novel device.
The document does not contain explicit acceptance criteria for device performance in a clinical study or a study proving that such criteria were met. Instead, it focuses on non-clinical laboratory testing to demonstrate safety and physicochemical equivalence to a predicate device.
Therefore, many of the requested details about acceptance criteria, clinical study sample sizes, expert involvement, and ground truth are not applicable or not provided in this type of submission.
Here's a breakdown of the information that can be extracted or deduced from the provided text, and where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly stated as "acceptance criteria" for a primary performance study. The document reports physicochemical properties and their equivalence to a predicate device and the untinted base lens, as well as toxicology and biocompatibility test results demonstrating safety.
| Property/Test | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Physicochemical Properties | Equivalent to Bausch & Lomb NaturalTint® (polymacon) Contact Lens | MAXSIGHT (polymacon) Sport-Tinted Contact Lens physicochemical properties are equivalent to the predicate device. |
| Equivalent to base lens prior to tinting | MAXSIGHT (polymacon) Sport-Tinted Contact Lens physicochemical properties are equivalent to the base lens prior to tinting. | |
| Specific Gravity | (Not explicitly stated as criterion, but a property) | 1.13 |
| Refractive Index | (Not explicitly stated as criterion, but a property) | 1.43 |
| Light Transmittance | (Not explicitly stated as criterion, but a property) | ≥30% |
| UV Absorption (UVA, UVB) | (Not explicitly stated as criterion, but a property) | >95% (for both UVA and UVB) |
| Water Content | (Not explicitly stated as criterion, but a property) | 38.6% |
| Oxygen Permeability (Dk) | (Not explicitly stated as criterion, but a property) | 8.4x10⁻¹¹ [cm³O₂(STP) x cm]/(sec x cm x cm² x mmHg)@35°C (Polargraphic Method) |
| Toxicology & Biocompatibility | No detectable monomer components, cross-linker, initiator, or diluent in extracts; dye extracts < 10 ppm; no cytotoxicity or irritation. | Extracts show no detectable quantities of monomer components, cross-linker, initiator, or diluent. Levels of dye extracts are less than 10 ppm. No toxicity or irritation demonstrated in cytotoxicity testing. |
| Material Classification | FDA Group I | Falls into FDA material classification Group I. |
| USAN Name | polymacon | USAN name is polymacon. |
| Manufacturing Process | Spin-cast/Lathe cut with in-monomer visibility tinting | Manufactured by the same visibility tinted lens manufacturing process. |
| Lens Color Tinting Process | Involves tinting a fully cured soft contact lens | Involves tinting a fully cured soft contact lens. |
| Compatibility with Disinfection Systems | Compatible with several different chemical disinfection systems | Compatible with several different chemical disinfection systems. |
2. Sample Size and Data Provenance for Test Set
Not applicable/Not provided. This submission primarily relies on laboratory testing and demonstrates substantial equivalence based on material properties and manufacturing processes, rather than a clinical human use "test set" with a specific sample size. The non-clinical laboratory tests "were performed to demonstrate the safety and effectiveness" but the details of sample size for these specific tests (e.g., number of lenses tested for Dk, number of samples for extractables, or animals for in vivo tests) are not provided in this summary.
3. Number and Qualifications of Experts for Ground Truth (Test Set)
Not applicable/Not provided. No explicit "ground truth" was established by experts for a clinical test set as part of this 510(k) submission. The safety and effectiveness are established through non-clinical laboratory tests and comparison to a predicate device.
4. Adjudication Method for Test Set
Not applicable/Not provided. No adjudication method is mentioned as there was no clinical test set requiring expert interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC comparative effectiveness study was not done. The submission is for a medical device (contact lens) and focuses on safety and physicochemical equivalence, not on an algorithm's impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
For the non-clinical laboratory tests, the "ground truth" is based on standardized test methodologies and accepted scientific principles for assessing physicochemical properties, toxicology, and biocompatibility, as outlined in FDA guidance (e.g., "Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994"). The ultimate "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device.
8. Sample Size for Training Set
Not applicable/Not provided. This is not an AI/algorithm-based device requiring a training set. The manufacturing process of a contact lens does not involve a "training set" in the context of machine learning.
9. How Ground Truth for Training Set was Established
Not applicable/Not provided. As there is no training set mentioned in the context of an algorithm or AI, there is no ground truth establishment for such a set.
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SUMMARY OF SAFETY AND EFFECTIVENESS
FOR MAXSIGHT™ (polymacon) Sport-Tinted Contact Lens
1. Submitter Information:
Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609
Contact Person:Lisa Graney Manager, Global Regulatory Affairs (585) 338-6612 Telephone No.: (585) 338-0702 Fax No.:
2. Device Name:
Soft (hydrophilic) contact lens Classification Name: MAXSIGHT (polymacon) Sport-Tinted Contact Lens Proprietary Name:
Predicate Device: 3.
NaturalTint® (polymacon) Contact Lens
N16-895
DESCRIPTION OF DEVICE 4.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is a hemispherical The MPONSTY (polymaton), Spersea and may cover a portion of the adjacent fiexible Sholl Which of a polymer of Hydroxyethyl Methacrylate (HEMA) and sciera. It consists of a polymor Dimethacrylate (EGDMA), and is 38% water by weight when immersed in a sterile saline solution. This lens is tinted in weight which immorou nlue Dye 246 (1, 4-Bis[4-(2-methacryloxyethyl) monomer with Productione), which conforms to 21 CFR Part 73.3106. Finished lenses are subsequently tinted to achieve different colors using r linished lenood are olor additives that conform to 21 CFR Part 73.3121.
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is designed to aid The MAXSIGHT (polymaten), Spitings. MAXSIGHT (polymacon) Sport-Tinted Visual penonmance in athlette set in a wide range of outdoor light conditions. Contact lenses chhanos contract in a created objects with greater clarity than with the naked eye.
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The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is manufactured with the following dimensions:
| Diameter: | 13.5 to 15.5 mm |
|---|---|
| Center Thickness: | 0.06 to 0.175mm |
| Base Curve: | 8.4-9.0mm |
| Powers (Spherical): | +20.00D to -20.00D |
| The physical / optical properties of the lens are: | |
| Specific Gravity: | 1.13 |
| Refractive Index: | 1.43 |
| Light Transmittance: | ≥30% |
| UV Absorption: | >95% |
| UVA absorption: | >95% |
| UVB absorption: | >95% |
| Water Content: | 38.6% |
| Oxygen Permeability (Dk): | 8.4x10-11[cm³O2 (STP) x cm]/(sec x cm x cm² x mmHg)@35°C(Polargraphic Method) |
Each MAXSIGHT (polymacon) Sport-Tinted Contact Lens is supplied in a plastic Each M. Roler . (por saline solution. The lid of the container is marked with blieter oonlainer wower, diameter, manufacturing lot number, and expiration date.
5. INDICATIONS FOR USE
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in notwear for the sonovith non-diseased eyes exhibiting astigmatism of 2.00 diopters aphartis por done not interfere with visual acuity. The lens may be prescribed in or loos, than wers ranging from +20.00 to -20.00 diopters. The MAXSIGHT (polymacon) Sport-Tinted contact lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye.
Replacement schedules may vary from patient to patient, and should be decided replacement ochouals in consultation with their patients. The lens is to be by eye care professionals in ochsalt time it is removed from the patient's eye cleaned, finded and theinfoccour ended wearing period prescribed by the eye and ulscarded after the roommonded working a chemical disinfection system.
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6. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE
A series of non-clinical laboratory tests was performed to demonstrate the safety and effectiveness of the MAXSIGHT (polymacon) Sport-Tinted Contact Lens. A summary of results of these tests are provided below.
Safety: Non-Clinical Laboratory Testing
A series of in vitro and in vivo toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guidance Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP regulation.
The results of the testing of the MAXSIGHT (polymacon) Sport-Tinted Contact Lenses demonstrate that:
- The physicochemical properties of the MAXSIGHT (polymacon) Sport-. Tinted Contact Lens are equivalent to the predicate device, Bausch & Lomb NaturalTint (polymacon) Contact Lens.
- The physicochemical properties of the MAXSIGHT (polymacon) Sport-. Tinted Contact Lens are equivalent to the base lens prior to tinting.
- The extracts of the MAXSIGHT (polymacon) Sport-Tinted Contact Lens do . not show any detectable quantities of monomer components, cross-linker, initiator, or diluent. The levels of extracts of the dye are less than 10 ppm, and cytotoxicity testing results of the MAXSIGHT (polymacon) Sport-Tinted Contact Lens demonstrated no toxicity or irritation.
- The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is compatible with . several different chemical disinfection systems.
Substantial Equivalence
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is similar to the Bausch & Lomb NaturalTint (polymacon) Contact Lens, in that both:
- Fall into the same FDA material classification group (Group I), .
- Have the same USAN name (polymacon) .
- Are manufactured by the same visibility tinted lens manufacturing . process (Spin-cast/Lathe cut with in monomer visibility tinting)
- Have equivalent lens color tinting processes; both processes involve . tinting a fully cured soft contact lens.
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Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Public Health Service
Food and Drug Administration Rockville MD 20857
APR 2 6 2005
Ms. Lisa C. Graney Manager, Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609
Re: K050157
Trade/Device Name: MAXSIGHT™ (polymacon) Sport-Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: March 31, 2005 Received: April 1, 2005
Dear Ms. Graney
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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); 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.
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Page 2 - Ms. Lisa C. Graney
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
:
... ..
David M. Whipple
Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image shows the logo and address of Bausch & Lomb. The address is 1400 North Goodman Street, Rochester, NY 14609. The logo is a stylized version of the company name.
Indications for Use Statement " "
510(k) Number (if known):_K ο δύ | 57
Device Name: MAXSIGHT™ (polymacon) Sport-Tinted Contact Lens
Indications for Use:
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in notaphakic persons with non-diseased eyes exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 to -20.00 diopters. The MAXSIGHT (polymacon) Sport-Tinted contact lens helps protect against the transmission of harmful UV radiation to the cornea and into the eve.
Replacement schedules may vary from patient to patient, and should be decided by eye care professionals in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care professionals. The lens may be disinfected using a chemical disinfection system.
Prescription Use (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)
Ni-Chun Shu
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K050157 |
|---|---|
| --------------- | --------- |
§ 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.