The CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (nyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

The CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The CONTAFLEX 54 Spherical Soft (hydrophilic) Contact Lenses are fabricated from hioxifilcon D, 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.

The non-ionic lens material, (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2.3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint, [phthalocyaninato (2-)] copper. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back 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 and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index 1.5193 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 54 % ± 2%
Specific Gravity (wet) 1.120
Oxygen Permeability 20.96 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

The CONTAFLEX 49 Spherical Soft (hydrophilic)Contact Lenses are fabricated from hioxifilcon B, 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.

The non-ionic lens material, (hioxifilcon B) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 51% hioxifilcon B and 49% water by weight when immersed in normal buffered saline solution. The lens is available in clear and with a blue visibility-handling tint. [phthalocvaninato (2-)] copper. The hioxifilcon B name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back 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 and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

Refractive Index 1.5164 (hydrated)
Light Transmission (clear) greater than 96%
Light Transmission (tinted) greater than 96%
Water Content 49% ± 2%
Specific Gravity (wet) 1.140
Oxygen Permeability 16.09 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

AI/ML Overview

This prompt is asking for a structured summary of acceptance criteria and device performance based on the provided FDA 510(k) submission document for Contaflex contact lenses. However, the document provided is a 510(k) Summary and Determination Letter, not a study report. As such, it does not contain the detailed information required to answer all parts of your request, particularly regarding specific study designs, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case (MRMC) studies.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of physical properties and toxicology, rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way you've outlined for an AI/diagnostic device.

Here's an attempt to extract the information that is available and explain what is missing:

1. A table of acceptance criteria and the reported device performance

For medical devices, especially contact lenses in a 510(k) submission, "acceptance criteria" are often tied to demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness. The performance is demonstrated by comparing the new device's characteristics to those of the predicate.

Below is a table constructed from the "Substantial Equivalence Matrix" (Page 8), showing the comparison of the subject devices (Contaflex 54 and 49) with their respective predicate devices (BENZ-G 4X and BENZ-G 3X). The acceptance criteria, implicitly, are that the subject devices' properties are comparable to or fall within an acceptable range of the predicate devices.

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Contaflex 54 - Subject Device)	Reported Device Performance (Contaflex 49 - Subject Device)
Intended Use	Correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear.	Matches predicate (correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear).	Matches predicate (correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia for daily wear).
Functionality	Refractive medium focusing light rays from near and distant objects on the retina.	Matches predicate (refractive medium focusing light rays from near and distant objects on the retina).	Matches predicate (refractive medium focusing light rays from near and distant objects on the retina).
Indications	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)	Matches predicate (Soft (hydrophilic) Contact Lens (21 CFR 886.5925)).	Matches predicate (Soft (hydrophilic) Contact Lens (21 CFR 886.5925)).
Production Method	Lathe cut	Lathe cut	Lathe cut
USAN Name	hioxifilcon D (for BENZ-G 4X) / hioxifilcon B (for BENZ-G 3X)	hioxifilcon D	hioxifilcon B
Water Content (%)	54 ± 2% (for BENZ-G 4X) / 49 ± 2% (for BENZ-G 3X)	54 ± 2%	49 ± 2%
Oxygen Permeability	$20.09 \times 10^{-11} (cm^2/sec)(mlO_2)/(ml \times mmHg @ 35°C)$ (for BENZ-G 4X) / $15.71 \times 10^{-11}$ (for BENZ-G 3X)	$20.96 \times 10^{-11} (cm^2/sec)(mlO_2)/(ml \times mmHg @ 35°C)$	$16.09 \times 10^{-11} (cm^2/sec)(mlO_2)/(ml \times mmHg @ 35°C)$
FDA Group	FDA Group 2 (>50% H2O, non-ionic polymer) (for BENZ-G 4X) / FDA Group 1 (<50% H2O, non-ionic polymer) (for BENZ-G 3X)	FDA Group 2 (>50% H2O, non-ionic polymer)	FDA Group 1 (<50% H2O, non-ionic polymer)
Specific Gravity	1.10 (hydrated) (for BENZ-G 4X) / 1.15 (hydrated) (for BENZ-G 3X)	1.12 (hydrated)	1.14 (hydrated)

Note: The "acceptance criteria" here are based on the comparative values of the predicate devices. The study demonstrates that the subject devices' properties are either identical or very similar (e.g., oxygen permeability) to their respective predicates, supporting substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in this 510(k) summary. The document mentions "a series of preclinical testing were performed" (Page 6) but does not provide details on the number of lenses or test subjects used for each specific test (e.g., cytotoxicity, systemic toxicity, ocular irritation).
Data Provenance: Not explicitly stated. The applicant is based in England (Contamac Ltd., Saffron Walden, Essex, England, CB11 4JX - Page 3), which might suggest where the testing was conducted or data originated, but it's not confirmed for the studies themselves. The document describes pre-clinical testing, which are typically laboratory-based rather than patient-based cohort studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable or available in this submission. This document describes a medical device (contact lenses) for which ground truth is established through laboratory material characterization and toxicology testing, not through expert clinical interpretation of images or patient data in the way an AI diagnostic device would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. Adjudication methods are typically used in clinical studies where multiple human readers assess cases, especially when establishing ground truth for AI algorithms. For contact lens material testing, laboratory standards and protocols are followed, not expert adjudication panels.

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

No. An MRMC comparative effectiveness study is not applicable here. This is a 510(k) submission for conventional contact lenses, not an AI-powered diagnostic device. The document does not describe any human reader studies or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not applicable as the device is a physical medical device (contact lens), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" is established by:

Physical material properties: Measured values (e.g., water content, oxygen permeability, refractive index, specific gravity) obtained through standardized laboratory testing methods.
Chemical composition analysis: To confirm the copolymer (hioxifilcon D/B).
Preclinical toxicology testing: In-vitro cytotoxicity, systemic toxicity, and acute ocular irritation tests are performed according to recognized standards (e.g., ISO 10993-5 mentioned for cytotoxicity), with results establishing the safety profile.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context you're asking. The data presented are for device characterization and safety validation for the final product, not for training a model.

9. How the ground truth for the training set was established

Not applicable. As there is no training set for an AI algorithm, this question is not relevant to the provided document. The "ground truth" for the device's material properties and safety is established through the methods mentioned in point 7.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 10, 2015

Contamac Ltd. % Mr. Bret Andre Official Correspondent EyeReg Consulting, Inc. 474 NE 618t PL Hillsboro, Oregon 97124

Re: K150590

Trade/Device Name: Contaflex 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear Contaflex 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: June 4, 2015 Received: June 8, 2015

Dear Mr. Andre:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150590

Device Name

CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lens for Daily Wear (clear and tinted, lathe-cut); CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lens for Daily Wear (clear and tinted, lathe-cut)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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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:	K150590
Applicant information:
Date Prepared:	March 3rd, 2015
Name:Address	CONTAMAC Ltd.Bearwalden Business ParkSaffron WaldenEssex England CB11 4JX
Contact Person:Phone number:	Robert McGregor44-1799 542 000
US Agent:Phone numberFax number	EyeReg Consulting, Inc.Bret Andre(503) 372-5226(503) 419-4475

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	CONTAFLEX 54 (hioxifilcon D) Spherical Soft(hydrophilic) Contact Lens for Daily Wear (clearand tinted, lathe-cut)
	CONTAFLEX 49 (hioxifilcon B) Spherical Soft(hydrophilic) Contact Lens for Daily Wear (clearand tinted, lathe-cut)

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Equivalent Devices:

The CONTAFLEX 54 (hioxifilcon D) & CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic)Contact Lenses are substantially equivalent to the following predicate device(s):

Predicate device:	"BENZ-G 4X hioxifilcon D"Manufactured/distributed by Benz Research and Development.510(k) number; K062854
	"BENZ-G 3X hioxifilcon B"Manufactured/distributed by Benz Research and Development.510(k) number; K964528

CONTAFLEX 54 (hioxifilcon D) Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index Light Transmission (clear) Light Transmission (tinted) Water Content Specific Gravity (wet) Oxygen Permeability

1.5193 (hydrated)
greater than 96%
greater than 96%
54 % ± 2%
1.120
20.96 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃),
(revised Fatt method).

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CONTAFLEX 49 (hioxifilcon B) Device Description:

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back 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 and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

Refractive Index Light Transmission (clear) Light Transmission (tinted) Water Content Specific Gravity (wet) Oxygen Permeability

1.5164 (hydrated) greater than 96% greater than 96% 49% ± 2% 1.140 16.09 X 10-11 (cm /sec) (ml O./ml x mm Hg @ 35℃), (revised Fatt method).

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Intended Use:

The CONTAFLEX 54 (hioxifilcon D) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

The CONTAFLEX 49 (hioxifilcon B) Spherical Soft (hydrophilic) Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected using a chemical disinfecting system.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Description of Safety:

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the CONTAFLEX 54 & CONTAFLEX 49 Soft (hydrophilic) Contact Lens materials. The results of all testing demonstrated that the safety and effectiveness of the CONTAFLEX 54 & CONTAFLEX 49 Soft (hydrophilic) Contact Lenses are equivalent to the currently marketed Benz hioxifilcon D (K062854) & hioxifilcon B (K964528) contact lens materials. A summary of these results from the preclinical studies is presented below.

Toxicology:

In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.

Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.

Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.

Shelf Life

The data presented supports substantial equivalence of this CONTAFLEX 54 & CONTAFLEX 49 Soft (hydrophilic) Contact Lens material to the already marketed Benz hioxifilcon D (K062854) & hioxifilcon B (K964528).

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Substantial Equivalence:

The CONTAFLEX 54 & CONTAFLEX 49 Soft (hydrophilic) Contact Lenses are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously.

The following table depicts the pre-clinical characteristics of the CONTAFLEX 54 & CONTAFLEX 49 materials, as well as the predicate devices.

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Substantial Equivalence Matrix

	Contamac ltd.CONTAFLEX 54(Subject Device)	Contamac ltd.CONTAFLEX 49(Subject Device)	Benz Research andDevelopmentBENZ-G 4X(Predicate Device)	Benz Research andDevelopmentBENZ-G 3X(Predicate Device)
Intended Use	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia orhyperopia.	Indicated for dailywear for the correctionof visual acuity inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.	Indicated for dailywear for thecorrection of visualacuity in aphakicand not aphakicpersons with non-diseased eyes withmyopia orhyperopia.	Indicated for dailywear for thecorrection of visualacuity in aphakicand not aphakicpersons with non-diseased eyes withmyopia orhyperopia.
Functionality	After machining fromthe optical blank, thecontact lenses act as arefractive medium thatfocus light rays fromnear and distant objectson the retina.	After machining fromthe optical blank, thecontact lenses act as arefractive medium thatfocus light rays fromnear and distantobjects on the retina.	After machiningfrom the opticalblank, the contactlenses act as arefractive mediumthat focus light raysfrom near anddistant objects onthe retina.	After machiningfrom the opticalblank, the contactlenses act as arefractive mediumthat focus light raysfrom near anddistant objects onthe retina.
Indications	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)
Production Method	Lathe cut	Lathe cut	Lathe cut	Lathe cut
USAN name	hioxifilcon D	hioxifilcon B	hioxifilcon D	hioxifilcon B
Water Content (%)	54±2%	49±2%	54±2%	49±2%
OxygenPermeability	$20.96 x 10^{-11} (cm^2/sec)(mlO_2)/(ml x mmHg @ 35°C)) (revised Fatt method)$	$16.09 x 10^{-11} (cm^2/sec)(mlO_2)/(ml x mmHg @ 35°C)) (revised Fatt method)$	$20.09 x 10^{-11} (cm^2/sec)(mlO_2)/(ml x mmHg @ 35°C)) (revised Fatt method)$	$15.71 x 10^{-11} (cm^2/sec)(mlO_2)/(ml x mmHg @ 35°C)) (revised Fatt method)$
FDA Group	FDA Group 2(>50% H2O, non-ionicpolymer)	FDA Group 1(<50% H2O, non-ionicpolymer)	FDA Group 2(>50% H2O, non-ionic polymer)	FDA Group 1(<50% H2O, non-ionic polymer)
Specific Gravity	1.12 (hydrated)	1.14 (hydrated)	1.10 (hydrated)	1.15 (hydrated)

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.