The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in not-aphakic persons with non-diseased eyes. The lens may be worn by persons who may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The lens may be disinfected using either heat (thermal) or chemical (not heat) disinfection systems.

Device Description

The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is available as a lens with an aspheric front surface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The lens is constructed to provide optimum edge thickness and contour, with the central area providing the reading power in the equivalent of a 2.00 diopter near addition. The aspheric front curve undergoes a progressive power change, resulting in intermediate and distance power outward from the center. The lens is a flexible transparent shell of the following dimensions:
Chord diameter: Baber: steps)
The lens material, hioxifilcon B, is a hydrophilic co-polymer of glycerol methacrylate (GMA) and 2-hydroxyethyl methacrylate (2-Hema), crosslinked with ethylene glycol dimethacrylate. The lens is swollen to equilibrium state in sterile buffered saline solution, and contains 48% water by weight when fully

AI/ML Overview

Acceptance Criteria and Reported Device Performance:

There are no specific quantifiable acceptance criteria or reported device performance metrics presented in the provided document regarding efficacy or safety directly related to the ESSTECH® MULTI Aspheric (multifocal) contact lens. The approval is based on a determination of substantial equivalence to previously cleared devices.

The document states: "Ten (10) ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lenses were manufactured according to prescription, and shown to be within acceptable standards by the ordering clinician." This implies an implicit standard of clinical acceptability but doesn't specify measurable criteria or a performance table.

Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: 10 lenses.
Data Provenance: The document does not explicitly state the country of origin for the "ordering clinician" who evaluated the 10 lenses. The study appears to be prospective, as lenses were "manufactured according to prescription" and then evaluated.

Number of Experts Used to Establish Ground Truth and Their Qualifications:

Number of Experts: One ("the ordering clinician").
Qualifications: "Ordering clinician." No specific qualifications like "radiologist with 10 years of experience" are provided.

Adjudication Method for the Test Set:

Adjudication Method: None. A single "ordering clinician" evaluated the 10 lenses.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document does not describe any study involving human readers or AI assistance to measure improvement in performance.

Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical medical device (contact lens), not an algorithm or AI. Therefore, no standalone algorithm performance study was conducted.

Type of Ground Truth Used:

Ground Truth: "Acceptable standards by the ordering clinician." This is a form of expert consensus or clinical judgment from a single expert, demonstrating that the manufactured lenses met the prescription and were clinically acceptable.

Sample Size for the Training Set:

The document does not describe a separate "training set" in the context of an algorithmic or AI device. The submission refers to a small manufacturing run of 10 lenses that were evaluated. The basis for approval is primarily substantial equivalence to previously cleared devices and materials.

How the Ground Truth for the Training Set Was Established:

Not applicable as there is no training set described in the context of AI or algorithmic development. The "acceptable standards" for the 10 manufactured lenses were established by a single "ordering clinician."

Summary

{0}------------------------------------------------

SEP 1 1998

K 982904

SUMMARY
ESSTECH® MULTI Aspheric (multifocal)
(hioxifilcon B) Soft (hydrophilic) Contact Lens
1. Submitted by:	Les Laboratoires BlanchardLentilles De Contact1552, rue King ouest, suite 200Sherbrooke, QC J1J 2C3Canada
Contact:Official agent	John M. Szabocsik, Ph.D.Szabocsik and Associates203 N. Wabash, Ste 1200Chicago, IL 60601(312) 553-0828
2. Date prepared:	August 3, 1998
3. Device:Common Name	ESSTECH® MULTI Aspheric (multifocal)(hioxifilcon B) Soft (hydrophilic)Contact Lens
Trade Name	ESSTECH® MULTI Aspheric (multifocal)(hioxifilcon B) Soft (hydrophilic)Contact Lens
4. Classification	Class II (Performance Standards)21 CFR 886.5925, 86LPLLenses, Soft Contact, Daily Wear
5. Substantialequivalence	This lens is made in hioxifilcon B, thesame material as cited in K964528 (Mar10, 1997) and is identical in design tothe ESSTECH® PS Aspheric (polymacon)Soft (hydrophilic) Contact Lens,P910029/S1 (June 29, 1993).
6. Devicedescription	The ESSTECH® MULTI Aspheric (multifocal)(hioxifilcon B) Soft (hydrophilic)Contact Lens is available as a lens withan aspheric front surface for thecorrection of visual acuity inpresbyopic persons who are myopic orhyperopic. The lens is constructed toprovide optimum edge thickness andcontour, with the central area providingthe reading power in the equivalent of a2.00 diopter near addition. Theaspheric front curve undergoes aprogressive power change, resulting inintermediate and distance power outwardfrom the center. The lens is a flexibletransparent shell of the following dimensions:

dimensions :

{1}------------------------------------------------

K982904, Esstech® Multi

Chord diameter: Baber: steps)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Comments of the comments of the comments of the country of the country of the first of the first of the first of the first of the first of the first of the first of the first

The lens material, hioxifilcon B, is a hydrophilic co-polymer of glycerol methacrylate (GMA) and 2-hydroxyethyl methacrylate (2-Hema), crosslinked with ethylene glycol dimethacrylate. The lens is swollen to equilibrium state in sterile buffered saline solution, and contains 48% water by weight when fully ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications for Use

The lens may be disinfected using either heat (thermal) or chemical (not heat) disinfection systems.

Comparison to predicate device: see following table SUBSTANTIAL EQUIVALENCE

Material	BENZ-G 3X Sphere &Toric (K964528)hioxifilcon B	Esstech® MultiAsphere (K982904)hioxifilcon B
Refractive index	1.404, hydrated	1.404, hydrated
Lighttransmittance	>95% clear>95% blue tint	>95% clear>95% blue tint
Surfacecharacteristics	hydrophilic,hemisphericalshell; toric lenshas a toric basecurve	hydrophilic,spherical backcurve, asphericfront curve
Water content	48% by weight innormal bufferedsaline	48% by weight innormal bufferedsaline
Oxygenpermeability	15 (cm²/sec) (ml O₂/ml x mmHg@35°C)(revised Fattmethod)	15 (cm²/sec) (ml O₂/ml x mmHg@35°C)(revised Fattmethod)

{2}------------------------------------------------

K982904, Esstech® Multi

9. Chemistry and Manufacturing

This lens is made in hioxifilcon B, the same material as cited in K964528 (Mar 10, 1997) and is identical in design to the ESSTECH® PS Aspheric (polymacon) Soft (hydrophilic) Contact Lens, P910029/S1 (June 29, 1993). Contained in this submission are references to K964528 and MAF-816 for the manufacture of the lens material, to P910029/S1 for the manufacture, packaging and sterilization of the lens, a report of the manufacture of 10 lenses to prescription, and draft labeling.

Ten (10) ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lenses were manufactured according to prescription, and shown to be within acceptable standards by the ordering clinician. The report is attached.

10. Toxicology

All toxicology is contained in K964528.

1. Microbiology
  Lens manufacturing, packaging and sterilization are identical to the manufacturing, packaging and sterilization described for the ESSTECH® PS Aspheric approved in PMA P910029,S1, therefore sterilization validation is not required.

Clinical Studies

All clinical information is contained in K964528.

1. Shelf-Life
l year, as established in K964528.

(一

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1998

Les Laboratories Blachard c/o John M. Szabocsik, Ph.D. SZABOCSIK AND ASSOCIATES 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

Re: K982904

Trade Name: ESSTECH ® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens (clear and blue visibility tint, lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: August 14, 1998 Received: August 18, 1998

Dear Dr. Szabocsik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

{4}------------------------------------------------

Page 2 - Dr. John M. Szabocsik, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Roerl. lorentthal

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

Enclosure

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

Esstech® MultiRev, Pg 5

August 26, 1998

510 (k) NUMBER (IF KNOWN)

11982904

Page 1 of 1

ESSTECH® MULTI Aspheric (multifocal) DEVICE NAME (hioxifilcon B) Soft (hydrophilic) Contact Lens

INDICATIONS FOR USE

The ESSTECH® MULTI Aspheric (multifocal) (hioxifilcon B) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and/or presbyopia) in not-aphakic persons with non-diseased The lens may be worn by persons who may exhibit eyes. astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The lens may be disinfected using either heat (thermal) or chemical (not heat) disinfection systems.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A Prescription Üse (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

$\xi\ \xi\ \theta$

(Division Sign-Off)
Division of Ophthalmic Devices

510(k) Number_K 982904

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.