The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Description

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are manufactured from machine latheable rigid gas permeable materials composed of siloxanyl fluoromethacrylate copolymers that are tinted for visibility and available with or without an ultraviolet (UV) light absorber.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:

Parameter	Range	Tolerance
Base Curve	4.00mm to 11.50mm	± 0.05 mm
Center Thickness	0.08mm to 0.75mm	± 0.02 mm
Diameter	7.0mm to 21.0mm	± 0.10mm
Spherical Power	-20.00D to +20.00D	± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D)
Cylindrical Power	Up to 9.00D	± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D)
Multifocal Power	+1.00D to 4.00D	± 0.25D
Surface Appearance		Lenses should be clear with no surfacedefect

The following table depicts the physical properties of the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses:

	Fluoroxyfocon A Rigid Gas Permeable Contact Lens
Refractive Index	1.430
Modulus (MPa)	1194
Hardness (Shore D)	78
Specific Gravity	1.18
Oxygen Permeability(Dk)	200 x 10 to the power of -11 (cm squared/sec) (ml O2/ml x mm Hg @ 35 degrees C)
Color Additives	Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are supplied dry (without storage solution) and non-sterile in a screw top case and must be cleaned and conditioned prior to use.

AI/ML Overview

This is an FDA 510(k) summary for a rigid gas permeable contact lens. The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving performance against predefined acceptance criteria for a novel device through clinical trials. Therefore, much of the information you requested regarding acceptance criteria and study details (like sample size for test sets, expert ground truth, MRMC studies, training set details) is not applicable to this type of submission.

Here's a breakdown of what is available in the document related to acceptance criteria and performance, and why other elements are absent:

Context: This 510(k) submission is for the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses. The manufacturer is not introducing a new type of device or technology but is demonstrating that their product is "substantially equivalent" to existing, legally marketed predicate devices. For this type of submission, extensive clinical studies and a complex acceptance criteria framework (as would be seen for a novel AI device, for example) are generally not required. The focus is on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate devices.

Acceptance Criteria and Device Performance (as evident from the document):

The acceptance criteria are implicitly based on demonstrating that the device's physical properties and manufacturing quality fall within acceptable ranges and meet the standards set by the predicate devices and relevant industry standards (like ANSI Z80.20 for lens specifications).

Acceptance Criteria (Implicit from Testing)	Reported Device Performance (as stated or implied)
Bench Testing: Manufacturing Verification	The manufacturer demonstrated the ability to produce lenses from fluoroxyfocon A blanks to a variety of prescribed parameters. All manufactured lenses met established finished product specifications within the ANSI Z80.20 tolerance.
Bioburden Testing: Colony Forming Units (CFU) per lens	The acceptance criterion was less than 100 CFU per lens. The testing demonstrated that the product met this established acceptance criterion.
Biocompatibility Testing:1. In-Vitro Cytotoxicity2. Systemic Toxicity3. Acute Ocular Irritation	1. In-Vitro Cytotoxicity: Per ISO 10993-5, results indicated that the finished lenses are not cytotoxic. 2. Systemic Toxicity: Per ISO 10993-11, the finished lenses met the requirements of the systemic injection test, and extracts did not induce acute systemic toxicity. 3. Acute Ocular Irritation: Per ISO 10993-23, extracts did not induce ocular irritation.
Physical Properties (Matching Predicate and Industry Standards)	Specific values are listed, demonstrating they are within typical ranges for such lenses and comparable to predicate devices: - Refractive Index: 1.430- Modulus (MPa): 1194- Hardness (Shore D): 78- Specific Gravity: 1.18- Oxygen Permeability (Dk): 200 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)- Water Content: <1%- UV Absorber Available: YesThese are implicitly "accepted" if they are equivalent to the predicate and meet established safety/performance profiles for RGP lenses.

Regarding the specific questions you asked:

A table of acceptance criteria and the reported device performance: See the table above. The "acceptance criteria" for a 510(k) are often implied by compliance with recognized standards and substantial equivalence to predicates, rather than a strict, numerical performance target for a novel feature.
Sample size used for the test set and the data provenance:
- The document does not specify exact sample sizes for bench testing (manufacturing verification, bioburden) or biocompatibility tests. It mentions "finished lenses" and "a variety of prescribed parameters."
- Data Provenance: The manufacturing facility is Tianjin MasterVision Technology Co., Ltd. in Tianjin, P.R. China. The testing was conducted "at the Tianjin MasterVision Technology Co., Ltd. facility" for bioburden and biocompatibility, or implied to be internal for bench testing. The data is non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For a contact lens 510(k), ground truth isn't established by expert consensus on, for example, diagnostic image interpretations. Performance is measured against physical and biological compatibility standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is typically used in clinical studies involving subjective assessments or interpretation by multiple readers/experts.
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: Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" here is compliance with established physical standards (e.g., ANSI Z80.20 tolerances for lens parameters), and recognized international standards for biocompatibility (ISO 10993 series). For bioburden, it's a quantitative microbiological test.
The sample size for the training set: Not applicable. This describes the manufacturing of physical medical devices, not the development of an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary of Study Type:

The studies conducted were non-clinical bench testing and biocompatibility testing. The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices based on:

Identical or similar intended use and indications for use.
Highly similar technological characteristics (material, production method, physical properties).
Demonstrating safety and performance through standard bench and biocompatibility testing, showing the device meets established manufacturing and biological compatibility standards for its class and material.

The FDA explicitly states: "Based on recommendations in the FDA guidance titled Class II Daily Wear Contact Lenses - Premarket Notification [510(k)] Guidance Document, clinical studies are not required for this 510(k) premarket notification." This clarifies why the document lacks the detailed clinical study information often associated with AI/diagnostic device approvals.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 22, 2024

Tianjin MasterVision Technology Co., Ltd. % Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K241398

Trade/Device Name: SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: May 3, 2024 Received: September 20, 2024

Dear Bret 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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents titled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

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Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J Angelo Green -S

J.Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K241398

Device Name

SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

Indications for Use (Describe)

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

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

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.

K241398 The assigned 510(k) number is:

I. SUBMITTER

Date Prepared:	October 17, 2024
Name:Address:	Tianjin MasterVision Technology Co., Ltd.1st Floor No.15 Building. No. 89 Heyuan Road, Jing-jin TechnologyValley, Wuqing District, Tianjin. P.R. China
Contact Person:	Delia KeManaging Director
Phone number:	+86 18920270903
Consultant:	Bret AndreAndre Vision and Device Research6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	SDJMASTERVISION (fluoroxyfocon A) Rigid Gas PermeableContact Lenses
-------------	-------------------------------------------------------------------------

CommonName:	Rigid gas permeable contact lens
ClassificationName:	Rigid gas permeable contact lens. (21 CFR 886.5916)
RegulatoryClass:	Class II
Product Code:	HQD

Reason for Submission New Device

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III. PREDICATE DEVICE

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are substantially equivalent to the following predicate devices:

"Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with . Tangible® Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid Gas Permeable Contact Lenses" By Acuity Polymers, Inc. 510(k) number; K240618 Product Code: HQD
I "Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number; K201194 Product Code: HQD
I "Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers, Inc. 510(k) number: K203571 Product Code: HQD

IV. DEVICE DESCRIPTION

Parameter	Range	Tolerance
Base Curve	4.00mm to 11.50mm	± 0.05 mm
Center Thickness	0.08mm to 0.75mm	± 0.02 mm
Diameter	7.0mm to 21.0mm	± 0.10mm
Spherical Power	-20.00D to +20.00D	± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D)
Cylindrical Power	Up to 9.00D	± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D)
Multifocal Power	+1.00D to 4.00D	± 0.25D
Surface Appearance		Lenses should be clear with no surfacedefect

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The following table depicts the physical properties of the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses:

	Fluoroxyfocon A Rigid Gas Permeable Contact Lens
Refractive Index	1.430
Modulus (MPa)	1194
Hardness (Shore D)	78
Specific Gravity	1.18
Oxygen Permeability(Dk)	$200 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$
Color Additives	Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17

V. INDICATIONS FOR USE

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are also indicated for therapeutic use in eves with ocular surface disease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir and protection against an adverse environment. When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens may concurrently provide correction of refractive error.

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens care system.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K240618) in terms of the following:

I Intended use - daily wear contact lenses
I Indications for use
I Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
트 FDA material group - group # 3 fluoro silicone acrylate
트 USAN material (fluoroxyfocon A)
I Production method - lathe cut

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K201194) in terms of the following:

트 Intended use - daily wear contact lenses
I Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
FDA material group group # 3 fluoro silicone acrylate l
I USAN material (fluoroxyfocon A)
I Production method - lathe cut

The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are substantially equivalent to the predicate device (cleared under K203571) in terms of the following:

트 Intended use - daily wear contact lenses
I Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
I FDA material group - group # 3 fluoro silicone acrylate
트 USAN material (fluoroxyfocon A)
I Production method - lathe cut

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The following matrix illustrates the production method, lens function and material characteristics of the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses, as well as the predicate devices.

	SDJMASTERVISIONRigid Gas PermeableContact Lenses	Acuity 200™ Acuity100™ Rigid GasPermeable Contact Lens	Acuity 200™ Rigid GasPermeable Contact Lens	Acuity 200™ Rigid GasPermeable Contact Lens		Indications for Use
	Subject Device	Predicate Device(K240618)	Predicate Device(K201194)	Predicate Device(K203571)	SDJMASTERVISIONRigid Gas PermeableContact Lenses(subject device)	The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicatedfor daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/orastigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may beprescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for themanagement of irregular corneal conditions such as keratoconus, pellucid marginal degeneration,or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
Classification	Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916	Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916	Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916	Class IILenses, Rigid GasPermeable, Daily Wear21 CFR 886.5916		The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are alsoindicated for therapeutic use in eyes with ocular surface disease (e.g. ocular Graft-versus-Hostdisease, Sjögren's syndrome, dry eye syndrome and Filamentary Keratitis), limbal stem celldeficiency (e.g. Stevens-Johnson syndrome, chemical radiation and thermal burns), disorders ofthe skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes simplex, Herpeszoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that might benefitfrom the presence of an expanded tear reservoir and protection against an adverse environment.When prescribed for therapeutic use for a distorted cornea or ocular surface disease, the lens mayconcurrently provide correction of refractive error.
Product Code	HQD	HQD	HQD	HQD		The SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses may becleaned and disinfected using a chemical (not heat) lens care system.
FDA Group #	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Group # 3 Fluoro SiliconeAcrylate	Acuity 200™ Acuity100™ Rigid GasPermeable ContactLens (K240618)	The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible®Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid GasPermeable Contact Lenses are indicated for daily wear for the correction of refractive error(myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise non-diseased eyes thatrequire a rigid contact lens for the management of irregular corneal conditions such askeratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive(e.g., LASIK) surgery.The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible®Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid GasPermeable Contact Lenses are also indicated for therapeutic use in eyes with ocular surfacedisease (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye syndrome andFilamentary Keratitis), limbal stem cell deficiency (e.g. Stevens-Johnson syndrome, chemicalradiation and thermal burns), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophickeratitis (e.g. Herpes simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g.anatomic, paralytic) that might benefit from the presence of an expanded tear reservoir andprotection against an adverse environment. When prescribed for therapeutic use for a distortedcornea or ocular surface disease, the lens may concurrently provide correction of refractive error.The Acuity 200™ (fluoroxyfocon A), Acuity 100™ (hexafocon A), Acuity 200™ with Tangible®Hydra-PEG® (fluoroxyfocon A), and Acuity 100™ with Tangible® Hydra-PEG® Rigid GasPermeable Contact Lenses may be cleaned and disinfected using a chemical (not heat) lens caresystem.
Material (USAN)	fluoroxyfocon A	hexafocon A,fluoroxyfocon A	fluoroxyfocon A	fluoroxyfocon A	Acuity 200™(fluoroxyfocon A)Rigid Gas PermeableContact Lens(K201194)	The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for dailywear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) inaphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in sphericaland aspheric powers ranging from -20.00 D to +20.00 D for daily wear.
Production Method	Lathe-Cut	Lathe-Cut	Lathe-Cut	Lathe-Cut	Acuity 200™(fluoroxyfocon A)Rigid Gas PermeableContact Lens(K203571)	The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for dailywear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) inaphakic and non-aphakic persons with non-diseased eyes. The lenses may be prescribed for dailywear in otherwise non-diseased eyes that require a rigid contact lens for the management ofirregular corneal conditions such as keratoconus, pellucid marginal degeneration, or followingpenetrating keratoplasty or refractive (e.g., LASIK) surgery.
Intended Use	Daily Wear	Daily Wear	Daily Wear	Daily Wear		The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned anddisinfected using a chemical (not heat) lens care system.
Water Content (%)	<1%	<1%	<1%	<1%
UV Absorber Available	Yes	Yes	Yes	Yes

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VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

The following testing was performed on finished SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses:

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Tianjin MasterVision Technology Co., Ltd. to manufacture lenses, on a repeatable basis, from fluoroxyfocon A supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Bioburden Testing-bioburden testing conducted on fluoroxyfocon A rigid gas permeable lenses manufactured at Tianjin MasterVision Technology Co., Ltd. demonstrated that the colony forming units (CFU) per lens was within the established acceptance criteria of less than 100 CFU per lens.

Biocompatibility Testing-biocompatibility studies were conducted on finished fluoroxyfocon A gas permeable contact lenses produced at the Tianjin MasterVision Technology Co., Ltd. facility. The following biocompatibility/toxicology tests were conducted in accordance with Good Laboratory Practice (GLP):

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses are not cytotoxic.
· Systemic Toxicity: The finished lenses meet the requirements of the systemic injection test in accordance with ISO 10993-11, and the extracts from finished lenses did not induce acute systemic toxicity.
· Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23, and the extracts from finished lenses did not induce ocular irritation.

~ Clinical Studies ~

Finished contact lenses manufactured from fluoroxyfocon A, which is a contact lens material adopted by United States Adopted Name (USAN) council, were previously cleared by the United States Food and Drug Administration (FDA). Based on recommendations in the FDA guidance titled Class II Daily Wear Contact Lenses -Premarket Notification [510(k)] Guidance Document, clinical studies are not required for this 510(k) premarket notification.

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VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted biocompatibility studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this premarket notification establishes that the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses for daily wear are as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the proposed indications.

Risks and Benefits

The risks of the SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.

Regulation Number and Section

§ 886.5916 Rigid gas permeable contact lens.

(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract 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.