The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty.

The Flexlens (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

The lens may be disinfected with a chemical (not heat) disinfection system.

Device Description

The Flexlens and Harrison Post Refractive Surgery (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) is fabricated from one of the above materials which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eve covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

The provided text describes a 510(k) submission for new contact lens materials, not a study proving device performance against acceptance criteria in the typical sense of a clinical or AI performance study. The submission focuses on demonstrating substantial equivalence to predicate devices. Therefore, many of the requested categories are not applicable to this type of regulatory submission.

Here's a breakdown of the relevant and non-applicable information based on the provided text:

Acceptance Criteria and Device Performance

The "acceptance criteria" in this context are the characteristics and performance values that demonstrate substantial equivalence to legally marketed predicate contact lenses. The device performance is assessed by comparing these characteristics of the new materials to those of the predicate materials.

Characteristic	Acceptance Criteria (Predicate Device Range)	Reported Device Performance (New Materials: hioxifilcon A, B; acofilcon A, B)
INDICATION	Daily wear, Soft Contact Lens	Daily wear, Soft Contact Lens
INTENDED USE	Correction of refractive ametropia and specialized use for daily wear.	Correction of refractive ametropia and specialized use (e.g., aphakia, irregular astigmatism due to keratoconus, trauma, post keratoplasty; and following corneal refractive surgery) for daily wear. (Matches predicate for both Flexlens and Harrison PRS)
PRODUCTION METHOD	Lathe-Cut	Lathe-Cut
HYDROPHILLIC MATERIAL/USAN	(methafilcon A), (hefilcon A)	(hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B)
Water Content	(methafilcon A) - 55%(hefilcon A) - 45%	(hioxifilcon A) - 59%(hioxifilcon B) - 48%(acofilcon A) - 58%(acofilcon B) - 49%
Specific Gravity	(methafilcon A) - 1.090(hefilcon A) - 0.979	(hioxifilcon A) - 1.18 (hydrated)(hioxifilcon B) - 1.136 (hydrated)(acofilcon A) - 1.103 (hydrated)(acofilcon B) - 1.142 (hydrated)
Oxygen Permeability*	(methafilcon A) - 18.8(hefilcon A) - 16.0	(hioxifilcon A) - 18.0(hioxifilcon B) - 15.0(acofilcon A) - 25.5(acofilcon B) - 15.8
Light Transmittance	(methafilcon A) - >95%(hefilcon A) - >95%	(hioxifilcon A) - >95%(hioxifilcon B) - >95%(acofilcon A) - >93%(acofilcon B) - >96%
Refractive Index	(methafilcon A) - 1.40 (hydrated)(hefilcon A) - 1.43 (hydrated)	(hioxifilcon A) - 1.40 (hydrated)(hioxifilcon B) - 1.40 (hydrated)(acofilcon A) - 1.40 (hydrated)(acofilcon B) - 1.42 (hydrated)

*Note: Oxygen Permeability units are (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

Study Details Table

This submission is a 510(k) Pre-Market Notification for substantial equivalence for new materials for an existing device, not a performance study (e.g., clinical trial) in the traditional sense that would generate new patient-specific data for acceptance criteria. The "study" here is primarily a comparison of material properties and intended uses to predicate devices.

Question	Information from Text
2. Sample size used for the test set and the data provenance	Not applicable. This is not a study with a "test set" of patient data. The "test" is a comparison of physical properties of the new materials to the established properties of predicate materials. The "data provenance" for the pre-clinical performance data (cytotoxicity, systemic injection, ocular eye irritation) for the new materials is by reference to previous 510(k) submissions from the material manufacturers (Benz Research and Development for hioxifilcon A and B; Contamac Ltd. for acofilcon A and B). These previous submissions would contain data from their respective studies.
3. Number of experts used to establish the ground truth for the test set and their qualifications	Not applicable. There is no "test set" requiring ground truth established by experts. The properties presented (e.g., water content, oxygen permeability) are measured physical properties of the materials themselves, likely determined by standardized laboratory methods, not subjective expert assessment of clinical data.
4. Adjudication method for the test set	Not applicable. No "test set" requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improve with AI vs without AI assistance	Not applicable. This is not an AI device, nor a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done	Not applicable. This is not an AI algorithm.
7. The type of ground truth used	Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the material properties are the experimentally measured physical and chemical characteristics of the materials, which are then compared to the established properties of the predicate devices for demonstrating substantial equivalence. For pre-clinical safety data, the "ground truth" refers to the results of standard biocompatibility tests (cytotoxicity, systemic injection, ocular irritation) referenced from prior 510(k)s.
8. The sample size for the training set	Not applicable. This is not a machine learning/AI device, so there is no training set.
9. How the ground truth for the training set was established	Not applicable. There is no training set.

Summary

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

510 (k) 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:	K030593
Applicant information:
Date Prepared:	February 19, 2002
Name:Address	X-cel Contacts / Flexlens Products2775 Premier Pkwy., Suite 600Duluth, GA 30097
Contact Person:Phone number:	Robert Chambers(770) 622-9235
USA Consultant:	Martin DalsingMedvice Consulting, Inc.623 Glacier DriveGrand Junction, CO 81503
Phone number	(970) 243-5490Fax (970) 243-5501Email: mdalsing@fdapproval.com
Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	Flexlens and Harrison Post Refractive Surgery (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut)

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

Purpose of 510(k) submission:

ADDITION of MATERIALS ~

The purpose of this 510(k) submission is for X-cel Contacts / Flexlens Products to receive clearance to manufacture their Flexlens Soft Contact Lens for Daily Wear and Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear out of four (4) additional FDA cleared hydrophilic contact lens materials. The additional materials are (hioxifilcon A), (hioxifilcon B), (acofilcon A) and (acofilcon B).

X-cel Contacts / Flexlens Products, proposes to manufacture the Flexlens and Harrison Post Refractive Surgery (hioxifilcon B), (hioxifilcon B), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut). Data supporting substantial equivalency to the predicate devices, performance, and safety and efficacy of the Flexlens and Harrison Post Refractive Surgery (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) is contained in this submission.

Equivalent Device:

The Flexlens and Harrison Post Refractive Surgery (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) is substantially equivalent to the following predicate devices.

Flexlens (methafilcon A) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear . manufactured by X-cel / Flexlens Products (K950294)
Flexlens (hefilcon A) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear ● manufactured by X-cel / Flexlens Products (K961943)
Flexlens 55 Soft (Hydrophilic) manufactured by X-cel Contacts / Flexlens Products (K950295) .

Device Description:

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

The non-ionic lens material, hioxifilcon A, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 41% hioxifileon A and 59% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper),

The physical properties of the hioxifilcon A lens are:

Refractive Index	1.404 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	59%
Specific Gravity	1.18 (hydrated)
Oxygen Permeability	18 X 10 -11 (cm 2 /sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

The non-ionic lens material, hioxifilcon B, is a copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydrosypropyl Methacrylate (Glycerol Methacrylate, GMA). It consists of 52% hioxifileon B and 48% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, phthalocyanato (2) - (copper).

The physical properties of the hioxifilcon B lens are:

Refractive Index	1.404 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	48 %
Specific Gravity	1.136 (hydrated)
Oxygen Permeability	$15 X 10^{-11}$ (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fattmethod)

The non-ionic lens material, acofilcon A, is a terpolymer based on high purity Glycerol Methacrylate2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethy) methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 42% acofilcon A and 58% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'..

The physical properties of the acofilcon A lens are:

Refractive Index	1.40 (hydrated)
Light Transmission (clear)	greater than 93% T
Light Transmission (tinted)	greater than 93% T
Water Content	58 %
Specific Gravity	1.103 (hydrated)
Oxygen Permeability	25.50 X 10-11 (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

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

The non-ionic lens material, acofilcon B, is a terpolymer based on high purity Glycerol Methacrylate2,3-Dihydroxypropyl Methacrylate (GMA), with N-vinyl-2 pyrrolidone (NVP), methyl methacrylate (MMA), and 2-hydroxyethyl methacrylate (2-HEMA) and crossed-linked with Diallyl Maleate (DAM). It consists of 51% acofilcon B and 49% water by weight when immersed in normal saline solution buffered with sodium bicarbonate. The lenses are available in clear and with a blue visibility-handling tint, Color additive 'Reactive Blue 4'.

The physical properties of the acofilcon B lens are:

Refractive Index	1.42 (hydrated)
Light Transmission (clear)	greater than 96% T
Light Transmission (tinted)	greater than 96% T
Water Content	49 %
Specific Gravity	1.142 (hydrated)
Oxygen Permeability	15.8 X 10-11 (cm2/sec) (ml O 2/ml x mm Hg @ 35°C), (revised Fattmethod).

Pre-Clinical Performance Data:

(Reference Permission to Reference letters appendix D)

hioxifilcon A

Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test for can be referenced for the hioxifilcon A in Benz Research and Development's 510(k) K983773.

hioxifilcon B

Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eve irritation test for can be referenced for the hioxifilcon B in Benz Research and Development's 510(k) K964528.

acofilcon A

Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test for can be referenced for the acofilcon A in Contamac Ltd.'s 510(k) K023349.

acofilcon B

Pre-clinical performance data addressing the cytotoxicity test, systemic injection test, and ocular eye irritation test for can be referenced for the acofilcon B in Contamac Ltd.'s 510(k) K024045.

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

Substantial Equivalence:

The device will be manufactured according to specified process controls and a quality assurance program already in place at X-cel Contacts / Flexlens Products. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by X-cel Contacts / Flexlens Products.

The device is similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate device, 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 table illustrates that the production method, lens function and indications for use of the Flexlens and Harrison Post Refractive Surgery (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) substantially equivalent to the predicate devices.

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

Substantial Equivalence Table

		New Device	Predicate Device
	CHARACTERISTICS	Flexlens and Harrison Post RefractiveSurgery (hioxifilcon A), (hioxifilconB), (acofilcon A), (acofilcon B) SoftContact Lens for Daily Wear (lathe-cut)	Flexlens and Harrison Post RefractiveSurgery (methafilcon A) (hefilcon A)Soft Contact Lens for Daily Wear(lathe-cut) K962000, K961943 &N17976
1.)		INDICATION	Daily wear, Soft Contact Lens
2.)		INTENDED USE	The Flexlens (hioxifilcon A), (hioxifilcon B),(acofilcon A), (acofilcon B) Soft Contact Lens forDaily Wear (lathe-cut) are indicated for daily wearuse for the correction of refractive ametropia andspecialized use such as atypical ametropia. Examplesinclude, but are not limited to: adult and pediatricaphakia, and irregular astigmatism created bykeratoconus, trauma, or post keratoplasty.The Flexlens (hioxifilcon A), (hioxifilcon B),(acofilcon A), (acofilcon B) Harrison Post RefractiveSurgery Soft Contact Lens for Daily Wear (lathe-cut)are indicated for daily wear use for the correction ofrefractive ametropia and specialized use such asatypical ametropia following corneal refractivesurgery.
3.)		PRODUCTIONMETHOD	Lathe-Cut
4.)		HYDROPHILLICMATERIAL/USAN	(hioxifilcon A)(hioxifilcon B)(acofilcon A)(acofilcon B)
a.	Water Content	(hioxifilcon A) - 59%(hioxifilcon B) - 48%(acofilcon A) - 58%(acofilcon B) - 49%	(methafilcon A) - 55%(hefilcon A) - 45%
b.	Specific Gravity	(hioxifilcon A) - 1.18 (hydrated)(hioxifilcon B) - 1.136 (hydrated)(acofilcon A) - 1.103 (hydrated)(acofilcon B) - 1.142 (hydrated)	(methafilcon A) - 1.090(hefilcon A) - 0.979
C.	Oxygen Permeability* Revised FATT method	(hioxifilcon A) - 18.0(hioxifilcon B) - 15.0(acofilcon A) - 25.5(acofilcon B) - 15.8	(methafilcon A) - 18.8(hefilcon A) - 16.0
d.	Light Transmittance	(hioxifilcon A) - >95%(hioxifilcon B) - >95%(acofilcon A) - >93%(acofilcon B) - >96%	(methafilcon A) - >95%(hefilcon A) - >95%
e.	Refractive Index	(hioxifilcon A) - 1.40 (hydrated)(hioxifilcon B) - 1.40 (hydrated)(acofilcon A) - 1.40 (hydrated)(acofilcon B) - 1.42 (hydrated)	(methafilcon A) - 1.40 (hydrated)(hefilcon A) - 1.43 (hydrated)

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

Image /page/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

X-cel Contacts/FlexIens Products c/o Mr. Martin Dalsing Medvice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K030593

Trade/Device Name: Flexlens and Harrison Post Refractive Surgery (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut)

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 05, 2002 Received: May 08, 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.

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

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. haleri Rosenthal

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

{8}------------------------------------------------

INDICATIONS FOR USE STATEMENT

Device Name: Flexlens and Harrison Post Refractive Surgery (hioxifilcon A), (hioxifilcon B), (acofilcon A), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut)

INDICATIONS FOR USE:

The Flexlens (hioxifilcon A), (acofilcon B), (acofilcon B) Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia. Examples include, but are not limited to: adult and pediatric aphakia, and irregular astigmatism created by keratoconus, trauma, or post keratoplasty.

The Flexiens (hioxifilcon A), (acofilcon B), (acofilcon B) Harrison Post Refractive Surgery Soft Contact Lens for Daily Wear (lathe-cut) are indicated for daily wear use for the correction of refractive ametropia and specialized use such as atypical ametropia following corneal refractive surgery.

The lens may be disinfected with a chemical (not heat) disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number	K030593

Prescription Use (Per 21 CFR 801.109)	or	Over-The-Counter Use ______
------------------------------------------------------------------------------------	----	-----------------------------

(Optional Format 1-2-96)

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.