The Hydron ActiToric(ocufilcon A) Soft (Hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.

Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.

Device Description

The ActiToric soft contact lens is a hemispherical shell manufactured of polymerised material of HEMA and other monomeric incredients crosslinked with EGDMA and other components which yield the appearance of a lens which is designed to fit over the corneal surface of the eve. This lens is designed with varying base curves which conform to the shape of the radius of the cornea and centre over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (near-sightedness), hyperopia (farsightedness) and astigmatism (multiple foci). The lens provides corrective power which is to correspond to the refractive power of the eve to which it is being treated. The lens has an aspheric base curve that is formed in the free surface during the spinning process. Secondary and tertiary curves as well as bevelled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mould to provide consistent optics. Onentation marks are moulded into the front surface as part of the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort. Axis stabilisation is action of the action of the lids on the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hydron ActiToric contact lens:

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a de novo study with novel acceptance criteria and extensive clinical trials. Therefore, many of the requested elements for a study proving device meeting acceptance criteria (like sample size for test sets, expert qualifications, effect size with AI assistance, MRMC studies, etc.) are not applicable (N/A) in this context, as the primary method of demonstrating safety and effectiveness is through comparison to the predicate device.

The "acceptance criteria" here are largely implicit in the comparison to the predicate device, meaning the new device must perform comparably to the predicate across various properties.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (ActiToric)
Material: USAN	ocufilcon A
Material: Group	3 (ionic)
Material: Monomers	2-HEMA, MA, EGDMA
Manufacturing: Process	Spun-cast
Manufacturing: Diameter (mm)	14.5
Manufacturing: Center Thickness (mm)	0.15
Manufacturing: Base curve (mm)	8.95 (equivalent to 8.90 of predicate)
Physical Properties: Refractive Index	1.43 ± 0.001
Physical Properties: Water content %	45 ± 0.00
Physical Properties: Oxygen Permeability	$11.9 \pm 1.85 \times 10^{-11}$ (cm² x ml O₂)/(sec x ml x mmHg)
Physical Properties: Light Transmittance %	98 ± 0.4
Mechanical Properties: Modulus (N/mm²)	0.32 ± 0.045
Mechanical Properties: Tensile strength (N/mm²)	0.32 ± 0.116
Mechanical Properties: Elongation at break (%)	208 ± 94
Toxicology: Within normal limits	All necessary toxicology studies were undertaken and results were within normal limits.
Microbiology: Relevant test procedures	Relevant test procedures have been undertaken and are included.
Compatibility: (No specific requirement if similar material and approved care products)	Compatibility testing not required as recommended lens care products have been approved for the same lens material (ocufilcon A).
Lens Stability: (Determined lifespan without adverse effect)	Indicates storage for up to 8 years with no adverse effect.
Clinical Safety: (Comparability to predicate)	Not required due to same USAN and manufacturing method as predicate device.

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" for a clinical trial. The comparison is based on product specifications and laboratory testing of the ActiToric lens, which are then compared to the specifications of the predicate device.
- Data Provenance: The manufacturing process, material, and testing would originate from Hydron Limited, United Kingdom. The document implies these are measurements from their own product and comparisons to established data for the predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in this context is established by objective laboratory measurements of physical, chemical, and mechanical properties, not expert consensus on interpretations.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are relevant for subjective assessments or when discrepancies arise in expert interpretations, which is not the primary method of demonstration here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is a contact lens and does not involve "readers" or "AI assistance."
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device does not involve an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Laboratory Measurements / Objective Product Specifications. The ground truth for equivalency is derived from direct measurements of the lens's physical, optical, and mechanical properties, toxicology results, microbiology tests, and stability data.
The sample size for the training set:
- N/A. No "training set" in the machine learning sense is relevant for this type of device submission. The device is characterized through laboratory measurements of its properties.
How the ground truth for the training set was established:
- N/A. No training set for an algorithm is involved. The ground truth for the device's properties is established through standard manufacturing quality control and laboratory testing methodologies.

Summary of the Study:

The "study" presented here is a substantial equivalence demonstration for a 510(k) premarket notification. It primarily relies on a side-by-side comparison of the physical, optical, and mechanical properties, material composition, manufacturing processes, and established safety tests (toxicology, microbiology, lens stability) of the new device (ActiToric) against a legally marketed predicate device (Specialty UltraVision Specialty T).

The acceptance criteria are effectively met if the new device exhibits equivalent properties and performance characteristics to the predicate device, as detailed in Table 2.1. Clinical safety data was not required because the device used the same USAN (ocufilcon A) and method of manufacture as the predicate, which implies that their clinical safety profiles are expected to be similar.

Summary

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Image /page/0/Picture/1 description: The image shows a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2005

Hydron Limited c/o Mr. J.B. Holloway Head of Quality and Regulatory Affairs Hawley Lane Farnborough Hampshire GU14 8EQ United Kingdom

Re: K983160

Trade/Device Name: ActiToric (ocufilcon A) Hydrophilic Toric Contact Lens for Daily Wear Regulation Number: 886.5925 Regulation Name: Lenses, Soft Contact, Daily Wear Regulatory Class: II Product Code: LPL Dated: January 8, 1999 Received: January 11, 1999

Dear Mr. Holloway:

This letter corrects the product code in our substantially equivalent letter of February 18. 1999.

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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In

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Page 2 - Mr. J.B. Holloway

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 (240) 276-0115. 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,

David M. Whipple

David M. Whipple Acting 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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510(k) Number (if known): K 983160

Device Name: Hydron ActiToric(ocufflicon A) Soft (Hydrophlic) Tonc Contact Lens for Daily Wear .

Indications For Use:

The Hydron ActiToric(ocufilcon A) Soft (Hydrophilic) Toric Contact Lors is indicated for daily wear for the correction of reactive ametmpia (myopia, hyperopia and astigmatism) In aphakic and non-aphakicpersons with non-diseased eyes that may exhibit refractive and/or comeal astigmatism up to 2.50 diopters.

Eyecare practitioners may prescribe the lens for planned frequent replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfortion system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kaisa Ulaishr
(Division Sign-Off)

Division of Ophthalmic Devices
510(k) Number K983160

(Optional Format 3-10-98)

Prescription Use-(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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2/18/99

510(k) SUMMARY FOR ACTITORIC SOFT (HYDROPHILIC) TORIC CONTACT LENS

K NUMBER: 983160

APPLICANT INFORMATION:

Date Prepared:	January 1999
Company Name:	Hydron Limited
Company Address:	Hawley LaneFarnboroughHantsGU14 8EQUnited Kingdom
Contact Person:	Julian HollowayHead of Quality Assurance and Regulatory Affairs
Phone No:Fax No:	011 44 1252 554500011 44 1252 544040

DEVICE INFORMATION:

Regulatory Classification:	Class II – Ophthalmic devices
Trade Name:	ActiToric (ocufilcon A)
Classification Name:	Soft (Hydrophilic) Toric Contact Lens for Daily Wear

EQUIVALENT DEVICE:

Hydron ActiToric (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is equivalent to Specialty UltraVision Specialty T (ocufficon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear approved by the FDA under 510(k) application K963764, Jan. 1997.

ActiToric (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is substantially equivalent to the indication for use of the Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear marketed for use in the US. This lens is in Group 3 ionic, low water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, and chemical properties of the ActiToric (ocufilcon A) Soft (Hydrophilic) Toric contact Lens for Daily Wear are equivalent to those of the Specialty T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear. The subject device utilises the same formulation, manufacturing and sterilisation processes, packaging, Quality Control/Quality Assurance Procedures and established shelf life as the predicate device, the Specialty UltraVision Specialty T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear.

A side by side comparison of the physical, optical and mechanical properties establishes the equivalency of these two contact lens products (see Table 2.1).

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Property	ActiToric	Specialty T
Material:
USAN	ocufilcon A	ocufilcon A
Group	3 (ionic)	3 (ionic)
Monomers	2-HEMA, MA, EGDMA	2-HEMA, MA, EGDMA
Manufacturing;
Process	Spun-cast	Spun-cast
Diameter (mm)	14.5	14.5
Center Thickness (mm)	0.15	0.15
Base curve (mm)	8.95	8.90
	(equivalent)	(equivalent)
Physical Properties:
Refractive Index	1.43 ± 0.001	1.43 ± 0.001
Water content %	45 ± 0.00	45 ± 0.00
Oxygen Permeability*	$11.9 \pm 1.85 \times 10^{-11}$	$12.2 \pm 1.41 \times 10^{-11}$
Light Transmittance %	98 ± 0.4	99 ± 0.4
Mechanical Properties:
Modulus (N/mm²)	0.32 ± 0.045	0.33 ± 0.056
Tensile strength (N/mm²)	0.32 ± 0.116	0.30 ±0.010
Elongation at break (%)	208 ± 94	186 ± 89

Table 2.1. Summary of Properties of ActiToric and the Predicate Device, Specialty T.

measured on single lenses Units: (cm² x ml O₂)/(sec x ml x mmHg)

a production of the contribution of the comments of the comments of the comments of the comments of

the state of the state of the states

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DESCRIPTION OF THE DEVICE:

INDICATIONS FOR USE:

Device Name: Hydron ActiToric (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear.

The Hydron ActiToric (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.50 diopters.

TECHNICAL SUMMARY:

1. Toxicology
  All necessary toxicology studies were undertaken and results were within normal limits.
1. Microbiology
  Relevant test procedures have been undertaken and are included with this 510(k) notification.
1. Compatibility
  Compatibility testing is not required as recommended lens care products have been approved for the same lens material (ocufilcon A).

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Lens Stability 4.

Lens stability testing indicates that the ActiToric lenses can be stored for a time period of up to 8 years with no adverse effect on the lenses.

5. Clinical

Clinical safety data is not required as the device has the same USAN and method of manufacture as the predicate device.

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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.