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.

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.

AI/ML Overview

The provided text does not describe a study involving acceptance criteria for a device's performance, nor does it detail a study that proves the device meets such criteria in the context of an AI/human comparative effectiveness or standalone algorithm performance.

Instead, the document is a 510(k) Premarket Notification for contact lenses, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The tables provided present characteristics of the new device (QUASAR® - QUASAR PLUS® - QUASAR TORIC® contact lenses) and compare them to predicate devices, but these are material and manufacturing specifications, not performance metrics based on a clinical trial.

Therefore, I cannot provide the requested information from the given input. The categories below are not applicable to the provided document.

1. Table of acceptance criteria and the reported device performance:
N/A - The document describes substantial equivalence based on material properties and intended use, not performance metrics from a clinical study with acceptance criteria.

2. Sample size used for the test set and the data provenance:
N/A - No test set or clinical data is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A - No ground truth establishment is described.

4. Adjudication method for the test set:
N/A - No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
N/A - This document is for contact lenses and does not involve AI or human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
N/A - This document is for contact lenses and does not involve an algorithm.

7. The type of ground truth used:
N/A - No ground truth is described.

8. The sample size for the training set:
N/A - No training set is described.

9. How the ground truth for the training set was established:
N/A - No ground truth for a training set is described.

Summary

{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 ParkSidney Little RoadHastings, East Sussex TN38 9UBEngland
	Contact Person:	Mr. Ashley PepperManaging Director
	Phone Number:	44 142 4850620
	Fax:	44 142 4850650
	Official Correspondent:Regulatory Consultant:	Med-Vice Consulting, Inc.Mr. Martin Dalsing623 Glacier DriveGrand 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 Technology1400 North Goodman StreetRochester, NY 14603	Boston Multifocal, Daily Wear510(k) #: K970698
2.)Polymer Technology1400 North Goodman StreetRochester, NY 14603	Boston XO, Daily Wear510(k) #: K000795
3.)Contamac LTD.Bearwalden Business ParkSaffron WaldenEssex CB11 4JX UK	Hybrid FS, Daily Wear510(k) #: K021977
4.)Paragon Vision Sciences947 East ImpalaMesa, AZ 85204	Fluoroperm 60/HDS, Flexible WearPMA #: P870024

Device Description:

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).

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:

{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 DEVICEQUASAR® - QUASAR PLUS®QUASAR TORIC®	PREDICATE DEVICEHybrid FS, Boston XO,Fluoroperm 60/HDS	PREDICATE DEVICEBoston 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.)	INTENDEDUSE	for the correction of refractiveametropia (myopia, hyperopia,and astigmatism) in aphakic andnot aphakic persons with non-diseaased eyes and are presbyopic(Quasar Plus only)	for the correction of refractiveametropia (myopia, hyperopia,and astigmatism) in aphakic andnot aphakic persons with non-diseaased eyes	for the correction of refractiveametropia (myopia, hyperopia,and astigmatism) in aphakic andnot aphakic persons with non-diseaased eyes and are presbyopic
3.)	PRODUCTIONMETHOD	Lathe-Cut	Lathe-Cut	Lathe-Cut
4.)	RGPMATERIALcommon name	HyBrid FSBoston XOFluoroperm 60/HDS	HyBrid FSBoston XOFluoroperm 60/HDS	Boston ES
a.	Water Content	(hybufocon A) <1%(hexafocon A) < 1%(paflufocon B) < 1%	(hybufocon A) <1%(hexafocon A) < 1%(paflufocon B) < 1%	(enflufocon A) < 1%
b.	Polymer/USAN	Hybrid FS (hybufocon A)Boston XO (hexafocon A)Fluoroperm (paflufocon B)	Hybrid FS (hybufocon A)Boston XO (hexafocon A)Fluoroperm (paflufocon B)	Boston ES (enflufocon A)
c.	Specific Gravity	(hybufocon A) 1.183(hexafocon A) 1.270(paflufocon B) 1.160	(hybufocon A) 1.183(hexafocon A) 1.270(paflufocon B) 1.160	(enflufocon A) 1.220
d.	OxygenPermeability(revised Fatt method)	(hybufocon A) = 31(hexafocon A) = 100(paflufocon B) = 60	(hybufocon A) = 31(hexafocon A) = 100(paflufocon B) = 60	(enflufocon A) = 18

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows a black and white logo. The logo is circular and contains the words "U.S. Department of Health & Human Services" around the perimeter of the circle. Inside the circle is a symbol that resembles three stylized bird wings or swooshes stacked on top of each other.

Public Health Service

AUG 2 9 2003

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20050

No. 7 Contact Lens Laboratory Ltd. c/o Mr. Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction. CO 81503

Re: K032256

Trade/Device Name: OUASAR® - OUASAR PLUS® - OUASAR TORIC® (hybufocon A, hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact Lens (clear and tinted) Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: July 18, 2003 Received: July 24, 2003

Dear Mr. Dalsing:

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.

{6}------------------------------------------------

Page 2 - Mr. Martin Dalsing

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) 594-4613. 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/dsma/dsmamain.html

Sincerely yours,

A. Paezi kiremtkal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

INDICATIONS FOR USE STATEMENT

The QUASAR® - QUASAR PLUS® - QUASAR TORIC® (hybufocon A. Device Name: hexafocon A, paflufocon B) Rigid Gas Permeable (RGP) Daily Wear Contact Lens.

INDICATIONS FOR USE:

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Eric

(Division Sign-Off) Division of Ophthalmic Devices

510(k) Number

Regulation Number and Section

§ 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.