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K Number
K954124
Device Name
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
Manufacturer
OPTICAL POLYMER RESEARCH, INC.
Date Cleared
1996-03-19

(200 days)

Product Code
HQD
Regulation Number
886.5916
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity. RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.
Device Description
O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye act as a refracting medium to focus light rays on the retina.
More Information

There are no Predicate Device(s) K/DEN numbers listed in the text. The section for "Predicate Device(s)" explicitly states "Not Found".

Not Found

No
The summary describes a standard RGP contact lens made from a specific polymer. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on the physical properties and clinical outcomes related to visual acuity and safety, not on any analytical or predictive capabilities.

No
This device is for visual acuity correction in non-diseased eyes, not for treating any specific disease or condition.

No

Explanation: The device is a contact lens indicated for visual acuity (to correct vision), not for diagnosing a condition.

No

The device description clearly states it is a physical contact lens made from a polymer, which is a hardware component.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens from the human body. The intended use of these contact lenses is to be placed directly on the eye to correct vision. They do not analyze blood, urine, tissue, or any other bodily fluid or substance.
  • IVDs are used to provide information about a physiological state, health, or disease. These contact lenses are used to improve visual acuity in patients with non-diseased eyes. They are a corrective device, not a diagnostic tool.

The description clearly indicates that these are medical devices intended for vision correction, not for in vitro diagnostic testing.

N/A

Intended Use / Indications for Use

RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity.

RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.

Product codes

Not Found

Device Description

O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye act 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

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

This study was run with the help of Salvatori Ophthalmics Manufacturing Inc. of Sarasota, Florida. The clinical study started after obtaining IRB approval.
Study Period: The study period was defined as three (3) months continuous wear. The patients were seen by the Investigators at 7 days, 14 days, 1 month, 2 months and 3 months following the initial dispense date.
Study Population: The study population was to consist of randomly selected patients, approximately fifteen (15) per investigator with a random distribution of 2:1 in the trial lens : control lens.
Safety: The safety of the O->PERM 30 A polymer (sterafocon A) is demonstrated by the study to be well within normal limits for a contact lens of this class. There were no lens related Adverse Reactions reported in the study. All Slit Lamp Findings were typical of that which is generally expected from patients wearing contact lenses in this class. No slit lamp findings required treatment.
Effectiveness: The effectiveness of the O->PERM 30 A (sterafocon A) is demonstrated by the study to be well within Normal Limits for a contact lens in this class.
Visual Acuity: The majority of the patients completing the study period exhibited a final VA of 20/30 or better: 68 eyes out of 72 (94.4%) for the trial lens and 30 eyes out of 34 (88.2%) for the control lens.
Wearing Time: The average wearing time for all patients participating in the Study was typical of daily wear patients generally: 10 to 14 hours per day.
Discontinued Patients: Patient discontinuations were normal for contact lens patients in general with 6 out of 36 (16.7%) in the trial cell, and 3 out of 17 (17.6%) in the control cell.
Symptoms Problems and Complaints: There were no unanticipated observations in this category and none of the observations noted required treatment or gave any cause for a determination of a problem directly attributable to the wearing of the trial lenses.
Replacements: Lens replacements during the study were mostly for fitting related reasons, or other normal contact lens wearing related reasons (such as loss).

Key Metrics

Final VA of 20/30 or better: 68 eyes out of 72 (94.4%) for the trial lens and 30 eyes out of 34 (88.2%) for the control lens.
Average wearing time: 10 to 14 hours per day.
Discontinuation rate: 16.7% for trial cell, 17.6% for control cell.

Predicate Device(s)

Not Found

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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) Notification for O->PERM 30A (sterafocon A) Feb. 15, 1996

MAR 1 9 Janes SECTION 11 SUMMARY of SAFETY AND EFFECTIVENESS

  • I . General Information:
    :

  • A. Generic (USAN) Name: sterafocon A

  • B. Device Trade Name: O->PERM 30A

  • C. Sponsor's Name and Address : Dr. Paul Schuman Optical Polymer Research, Inc. 5921 N.E. 38th Street Gainesville, FL 32609 (904) 378-1027

  • D. 510(k) Number: K954124

  • E. Date Notice of approval sent to Sponsor:

  • F. First OPR Approved Alternate Site Manufacturer and Distributor of Lenses made from the 0->PERM 30 A (sterafocon A) optical blanks (Pending FDA approval):

Salvatori Ophthalmics Mfg. Inc. 6416 Parkland Drive Sarasota, FL 34243 (813) 751-0383

II. Indications

RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity.

RGP Toric contact lenses made from 0->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.

IJI. Device Description

O->PERM 30A (sterafocon A) is a RGP silicone-acrylate polymer which can be lathed into spherical or toric contact lenses. These hemispherical shells when placed on the eye

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act as a refracting medium to focus light rays on the retina.

  • IV. Alternative Practices or Procedures
    Alternative practices or procedures are the use of other available previously approved RGP silicone-acrylate contact lenses or soft (hydrophilic) contact lenses or prescription spectacles as deemed best by the patient's eye care practitioner.

  • V. Technical Summaries

    • A. Nonclinical
        1. Toxicology

Optical Polymer Research, Inc. had all the pre-clinical testing studies necessary for IRB review for Class II daily wear RGP contact lenses. The South West Independent TRB granted their approval to OPR's protocol to start a clinical study on O->PERM 30 A (steratocon A) for daily wear on June 6, 1994.

Conclusion: Approved by IRB

    1. Microbiology
      To assure that a low bioburden level is maintained by alternate site lens manufacturers, a yearly bioburden test will be done using a validated bioburden test method. A PERM 30A (sterafocon A) and has submitted a protocol for the acceptance of alternate site finishing labs. All labs will be subject to testing

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and, if they pass, acceptance.

The equipment manufacturers of lathes and polishing equipment may be different between the various contact lens labs but the finished product will be equivalent in all instances. The recommended manufacturing materials, manufacturing methods, and quality control methods employed by the companies are specified by OPR.

Optical Polymer Research, Inc. was last FDA inspected on August 15/17, 1995

  • C. Patient Selection:
    Fach patient was be selected according to the following criteria:

    1. They must fill in and sign an informed consent form (as approved by the IRB) before any trial lens is There are to be no exceptions. dispensed.
    1. Have no excessive corneal astigmatism that would interfere with the correction of visual acuity.
    1. The patients eyes should be correctable to at least 20/30 for distance as a minimum standard.
    1. They must have non-diseased eyes which are normal or which have a preexisting ocular condition which would not be expected to interfere with the patient's ability to wear contact lenses successfully. A normal eye is defined as one having all the following characteristics:
    • a. No evidence of lid infection.
    • b. No structural lid abnormality
    • c. No conjunctival abnormality or infection
    • d. A cornea which is clear with no edema, staining, vascularization or abnormal opacities, all as observed by slit lamp examination.
    • e. No iritis.
    • f. No other active disease that would contraindicate the wearing of contact lenses or has caused the patient to terminate contact lenses at some previous time.
    1. Use no ocular medication.
    1. Have no known sensitivity to solutions currently used by the investigator for lens care.
    1. Have binocular correction with contact lenses.

The Food and Drug Administration is aware that certain patient characteristics such as mild edema or staining or other minor physical conditions may not necessarily preclude the patient from participating in the study: however, these conditions should be well documented in the preliminary or initial visit and followed during the study.

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D. Study Period

The study period was defined as three (3) months continuous wear. The patients were seen by the Investigators at 7 days, 14 days, 1 month, 2 months and 3 months following the initial dispense date.

  • F. Study Population
    The study population was to consist of randomly selected patients, approximately fifteen (15) per investigator with a random distribution of 2:1 in the trial lens : control lens .

    1. Safety appears to be well within Normal Limits
      The safety of the O->PERM 30 A polymer (sterafocon A) is demonstrated by the study to be well within normal limits for a contact lens of this class.

  • a. Adverse Reactions
    There were no lens related Adverse Reactions reported in the study.

  • b. Slit Lamp Findings
    All Slit Lamp Findings were typical of that which is generally expected from patients wearing No slit lamp contact lenses in this class. findings required treatment.

    1. Effectiveness
      The effectiveness of the O->PERM 30 A (sterafocon A) is demonstrated by the study to be well within Normal Limits for a contact lens in this class.

  • a. Visual Acuity
    The majority of the patients completing the study period exhibited a final VA of 20/30 or better: 68 eyes out of 72 (94.4%) for the trial lens and 30 eyes out of 34 (88.2%) for the control lens.

  • b. Wearing Time
    The average wearing time for all patients participating in the Study was typical of daily wear patients generally: 10 to 14 hours per day.

  • c. Discontinued Patients
    Patient discontinuations were normal for contact lens patients in general with 6 out of 36 (16.78)

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in the trial cell, and 3 out of 17 (17.6%) in the control cell.

  • d. Symptoms Problems and Complaints
    There were no unanticipated observations in this category and none of the observations noted required treatment or gave any cause for a determination of a problem directly attributable to the wearing of the trial lenses.

  • e. Replacements
    Lens replacements during the study were mostly for fitting related reasons, or other normal contact lens wearing related reasons (such as loss).

  • I . Potential Adverse Effects of the Device on Health
    None known

  • II. Conclusion drawn from Study
    It can be concluded from the clinical study results that the O->PERM 30 A (sterafocon A) polymer is Safe and Effective for daily wear use in patients with non diseased eyes.

  • III. FDA Recommendation
    Tt is recommended that the FDA approve the O->PERM 30 A (sterafocon A) for Daily wear use.