(38 days)
No
The document describes the physical properties and design of rigid gas permeable contact lenses and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a contact lens intended for the correction of visual acuity, which is a vision aid and not a therapeutic intervention for a disease or condition.
No
Explanation: The device is a contact lens indicated for correcting visual acuity, not for diagnosing medical conditions. It acts as a refracting medium to focus light, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states that the device is a physical contact lens fabricated from specific materials, which is a hardware component.
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 intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The description clearly states that the QUASAR contact lenses are "placed on the human cornea" and "act as a refracting medium to focus light rays upon the retina." This describes a device that interacts directly with the human body to correct vision.
- Lack of Specimen Examination: There is no mention of the device being used to examine any biological specimens (blood, tissue, urine, etc.) derived from the human body.
- Purpose: The stated purpose is the "correction of visual acuity," which is a therapeutic or corrective function, not a diagnostic one based on in vitro analysis.
Therefore, the QUASAR contact lenses are medical devices, but they fall under a different classification than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The QUASAR® (hybufocon A, hexafocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
The QUASAR TORIC® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.
The QUASAR PLUS® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only.
Product codes
HQD
Device Description
The QUASAR® - QUASAR PLUS® - QUASAR TORIC® Contact Lenses are fabricated from the hydrophobic contact lens materials (hybufocon A, paflufocon B). When placed on the human cornea, the QUASAR® - QUASAR PLUS® - QUASAR TORIC® rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The QUASAR® and QUASAR TORIC® series of contact lenses are aspheric from center to edge. The QUASAR® and QUASAR TORIC® are designed with the central area consisting of a modified conic profile, which is designed to flatten at a much slower rate than a fixed elliptical curve. This improves centration characteristics and eliminates any significant positive/astigmatic aberration over the central 7mm. This aspheric geometry results in slight apical clearance and close alignment over the mid-peripheral cornea. Edge clearance is achieved by the addition of a second aspheric edge band resulting in the optimal final tear lens profile as shown in the figure below. Constant apical and edge clearance are maintained independent of base curve and the total diameter of the lens.
The QUASAR PLUS® multifocal design cleverly utilizes the eyes' own tears to provide precise vision at distance, intermediate and near. The QUASAR PLUS® is a distance center multifocal with a graduated annulus of near vision where the progressive power is incorporated into the optics back surface of the The aspheric design of the optical zone is based upon the patient's degree of ametropia and the lens. reading addition required. By incorporating the asphericity into the back surface, the profile of the tear film will be altered resulting in a fluorescein pattern different than that of a single vision lens.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970698, K000795, K021977, P870024
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko32256
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:
Applicant information:
Date Prepared: | July 18, 2003 | |
---|---|---|
Name: | ||
Address | No. 7 Contact Lens Laboratory Ltd. | |
Unit 3, Highfields Business Park | ||
Sidney Little Road | ||
Hastings, East Sussex TN38 9UB | ||
England | ||
Contact Person: | Mr. Ashley Pepper | |
Managing Director | ||
Phone Number: | 44 142 4850620 | |
Fax: | 44 142 4850650 | |
Official Correspondent: | ||
Regulatory Consultant: | Med-Vice Consulting, Inc. | |
Mr. Martin Dalsing | ||
623 Glacier Drive | ||
Grand Junction, CO 81503 | ||
Phone Number: | ||
Fax Number: | (970) 243-5490 | |
(970) 243 -5501 | ||
Device Information: | ||
Regulatory Classification: | Class II | |
Product Code: | HQD |
| Trade Name: | QUASAR® - QUASAR PLUS® - QUASAR TORIC®
(hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable
(RGP) Daily Wear Contact Lens. |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Purpose for 510(k) | New Device |
Lenses, Contact (other material), Daily Wear Classification Name:
1
Equivalent Devices:
The QUASAR® - QUASAR PLUS® - QUASAR TORIC® (hybufocon A, paflufocon B, hexafocon A) Rigid Gas Permeable (RGP) Daily Wear Contact Lens is substantially equivalent to the predicate devices identified below.
Predicate device manufacturer: | Device name: |
---|---|
1.) | |
Polymer Technology | |
1400 North Goodman Street | |
Rochester, NY 14603 | Boston Multifocal, Daily Wear |
510(k) #: K970698 | |
2.) | |
Polymer Technology | |
1400 North Goodman Street | |
Rochester, NY 14603 | Boston XO, Daily Wear |
510(k) #: K000795 | |
3.) | |
Contamac LTD. | |
Bearwalden Business Park | |
Saffron Walden | |
Essex CB11 4JX UK | Hybrid FS, Daily Wear |
510(k) #: K021977 | |
4.) | |
Paragon Vision Sciences | |
947 East Impala | |
Mesa, AZ 85204 | Fluoroperm 60/HDS, Flexible Wear |
PMA #: P870024 |
Device Description:
The QUASAR® - QUASAR PLUS® - QUASAR TORIC® Contact Lenses are fabricated from the hydrophobic contact lens materials (hybufocon A, paflufocon B). When placed on the human cornea, the QUASAR® - QUASAR PLUS® - QUASAR TORIC® rigid gas permeable contact lenses act as a refracting medium to focus light rays upon the retina.
The QUASAR® and QUASAR TORIC® series of contact lenses are aspheric from center to edge. The QUASAR® and QUASAR TORIC® are designed with the central area consisting of a modified conic profile, which is designed to flatten at a much slower rate than a fixed elliptical curve. (see figure below). This improves centration characteristics and eliminates any significant positive/astigmatic aberration over the central 7mm. This aspheric geometry results in slight apical clearance and close alignment over the mid-peripheral cornea. Edge clearance is achieved by the addition of a second aspheric edge band resulting in the optimal final tear lens profile as shown in the figure below. Constant apical and edge clearance are maintained independent of base curve and the total diameter of the lens.
2
Image /page/2/Figure/0 description: The image contains two figures. Figure 1 shows a graph of the Quasar curve, with the x-axis labeled as "Primary sag (u) (x coordinates) not drawn to scale" and the y-axis labeled as "Semi-diameter y (mm)". The graph shows three curves: Quasar curve, Elliptical curve, and Spherical curve, with an axial lift at approximately 5. Figure 2 shows the back surface profile of the Quasar lens, with labels indicating the edge radius, axial edge lift, peripheral aspheric "ski-bever" (0.6mm), semi-diameter 4.8mm, spherical curve, and central progressive aspheric zone (8.40mm).
The QUASAR PLUS® multifocal design cleverly utilizes the eyes' own tears to provide precise vision at distance, intermediate and near. The QUASAR PLUS® is a distance center multifocal with a graduated annulus of near vision where the progressive power is incorporated into the optics back surface of the The aspheric design of the optical zone is based upon the patient's degree of ametropia and the lens. reading addition required. By incorporating the asphericity into the back surface, the profile of the tear film will be altered resulting in a fluorescein pattern different than that of a single vision lens.
No 7 Contact Lens Laboratories has been granted referencing rights from the following button material manufacturers. The physical properties of the lenses can be referenced in the corresponding 510(k) and/or PMA
Contamac | Hybrid FS (hybufocon A) | 510(k), K021977 |
---|---|---|
Polymer Technology | Boston XO (hexafocon A) | 510(k), K000795 |
Paragon Vision Sciences | FluoroPerm 60/HDS (paflufocon B) | PMA, P870024 |
Intended Use:
The QUASAR® (hybufocon A, hexafocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with nondiseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.
The QUASAR TORIC® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.
The QUASAR PLUS® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only.
3
Substantial Equivalence:
The new device will be manufactured according to specified process controls and a Quality Management System certified to QSR guidelines. The new device will undergo manufacturing, packaging and other process procedures similar to RGP devices currently marketed and distributed by No 7 Contact Lens Laboratory Ltd. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device was established in the following referenced FDA approvals:
(hybufocon A) | 510(k), K021977 |
---|---|
(hexafocon A) | 510(k), K000795 |
(paflufocon B) | PMA, P870024 |
Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, 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 devices identified above.
The following chart illustrates that the production method, indications for use, polymer material, specific gravity and oxygen permeability of the QUASAR® - QUASAR PLUS® - QUASAR TORIC® (hybufocon A, hexafocon A, patlufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact Lens are substantially equivalent to the predicate device.
4
SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix
| | Characteristic | NEW DEVICE
QUASAR® - QUASAR PLUS®
QUASAR TORIC® | PREDICATE DEVICE
Hybrid FS, Boston XO,
Fluoroperm 60/HDS | PREDICATE DEVICE
Boston Multifocal |
|-----|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INDICATION | Daily wear, Rigid Gas Permeable
(RGP) contact lens | Daily wear, Rigid Gas Permeable
(RGP) contact lens | Daily wear, Rigid Gas Permeable
(RGP) contact lens |
| 2.) | INTENDED
USE | for the correction of refractive
ametropia (myopia, hyperopia,
and astigmatism) in aphakic and
not aphakic persons with non-
diseaased eyes and are presbyopic
(Quasar Plus only) | for the correction of refractive
ametropia (myopia, hyperopia,
and astigmatism) in aphakic and
not aphakic persons with non-
diseaased eyes | for the correction of refractive
ametropia (myopia, hyperopia,
and astigmatism) in aphakic and
not aphakic persons with non-
diseaased eyes and are presbyopic |
| 3.) | PRODUCTION
METHOD | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| 4.) | RGP
MATERIAL
common name | HyBrid FS
Boston XO
Fluoroperm 60/HDS | HyBrid FS
Boston XO
Fluoroperm 60/HDS | Boston ES |
| a. | Water Content | (hybufocon A)