(149 days)
Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.
The Aveo (omafilcon A) 1-DaY Aspheric Soft (Hydrophilic) Contact Lenses are single use daily disposable soft contact lens produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) where molecules are found naturally in human cell membranes that improves the lens biocompatibility. The contact lenses contain 58% water by weight and is sold in the blister package immersed in phosphate buffered packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens. The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve). The contact lenses are hydrophilic, soft and it is supplied in sterile state.
This document describes a 510(k) premarket notification for the "Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses." The submission claims substantial equivalence to two predicate devices: "Proclear Asphere (omafilcon A) Soft Contact Lenses" (K112302) and "Proclear XC (omafilcon A) and Proclear 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear" (K061948), both from CooperVision, Inc.
The document indicates that no clinical studies were required to demonstrate the safety or effectiveness of the subject device. Instead, the submission relies on the technological characteristics, formulation, manufacturing, and sterilization processes being the same as the predicate devices, along with physiochemical and toxicology studies. Therefore, a complete description of acceptance criteria for a clinical study and the study proving it cannot be provided from this document.
However, based on the provided "Toxicology Studies" section, we can infer some acceptance criteria for the pre-clinical performance data:
- A table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria (Inferred from "Result") | Reported Device Performance (as "Performance of Subject Device") | Result |
|---|---|---|---|
| Cytotoxicity Test (ISO 10993-5: 2009(E)) | Non-cytotoxic | Non-cytotoxic. | Pass |
| Ocular Irritation Study in New Zealand White Rabbit (ISO 10993-10: 2010(E)) | Non-irritant to eyes of rabbits | Non-irritant to eyes of rabbits. | Pass |
| Skin Sensitization Study in Guinea Pigs (ISO 10993-10: 2010(E)) | Non-sensitizer | Non-sensitizer | Pass |
| Acute Systemic Toxicity Study in Swiss Albino Mice (ISO 10993-11: 2006(E)) | No systemic toxicity | Animals treated with the extract of the subject device did not show any systemic toxicity. | Pass |
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify the sample sizes for the toxicology studies directly. It mentions "rabbits," "guinea pigs," and "Swiss Albino Mice." Specific numbers are not provided.
- The provenance is not explicitly stated as country of origin, nor is it classified as retrospective or prospective. These are lab-based pre-clinical studies.
-
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 information is not applicable and not provided. Toxicology studies typically rely on established protocols and observations by trained laboratory personnel or toxicologists, rather than a consensus of experts in the way clinical diagnostic image interpretation might.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable and not provided. Laboratory toxicology studies follow standard operating procedures for assessment and reporting of results, rather than an adjudication process by multiple readers.
-
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 MRMC comparative effectiveness study was done. 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, as this is a contact lens and not an algorithm.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the toxicology studies, the "ground truth" is based on established biological responses observed in the animal models according to the specified ISO standards (e.g., absence of cell death, absence of irritation, absence of sensitization, absence of systemic toxic effects). This is determined by macroscopic and microscopic observations and established toxicological endpoints.
-
The sample size for the training set:
- Not applicable. There is no "training set" in the context of these pre-clinical toxicology studies for a contact lens.
-
How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of evaluation.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2017
Supervision Optimax Sdn Bhd Ms. Yap Peak Geeh Regulatory Affairs Manager Lot 38, Putra Industrial Park, Bukit Rahman Putra 40160 Sungai Buloh Selangor Darul Ehsan, Malaysia
Re: K162223
Trade/Device Name: Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: November 25, 2016 Received: November 28, 2016
Dear Ms. Geeh:
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.
{1}------------------------------------------------
Page 2 - Ms. Yap Geeh
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 devicerelated 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.
Denise L. Hampton -S
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K162223
Device Name Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses
Indications for Use (Describe)
Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Preparation Date: 4th January 2017
1.0 Submitter:
| Name | : Supervision Optimax Sdn Bhd |
|---|---|
| Address | : Lot 38, Putra Industrial Park,Bukit Rahman Putra,40160 Sungai Buloh, Selangor, Malaysia |
| Phone No. | : 603-6145 2328 |
| Fax No. | : 603-6156 2191 |
| Contact Person | : Yap Peak Geeh |
| Email Address | : pg.yap@supervision.com.my |
2.0 Device Identification:
| Proprietary Name | : Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) ContactLens |
|---|---|
| Common Name | : Soft (Hydrophilic) Contact Lens |
| Classification Name | : Soft (Hydrophilic) Contact Lens(21 CFR 886.5925, Product Code LPL) |
| Classification | : Class II |
3.0 Identification Of The Legally Marketed Devices that equivalency is claimed:
| Predicate Device | ||
|---|---|---|
| Manufacturer | CooperVision, Inc | CooperVision, Inc |
| Device Name | Proclear (omafilcon A)Soft Contact Lenses | Proclear XC (omafilcon A) and Proclear 1 day(omafilcon A) HydrophilicContact Lenses for DailyWear |
| 510(k) Number | K112302 | K061948 |
| Regulation Number | 21 CFR 886.5925 | 21CFR 886.5925 |
| Regulatory Name | Soft (hydrophilic) contactlens | Soft (hydrophilic) contactlens |
| Regulatory Class | II | II |
| Product Code | LPL and MVN | LPL and MVN |
4.0 Description of the Device:
The Aveo (omafilcon A) 1-DaY Aspheric Soft (Hydrophilic) Contact Lenses are single use daily disposable soft contact lens produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)
{4}------------------------------------------------
where molecules are found naturally in human cell membranes that improves the lens biocompatibility.
The contact lenses contain 58% water by weight and is sold in the blister package immersed in phosphate buffered packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens.
The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
The contact lenses are hydrophilic, soft and it is supplied in sterile state.
5.0 Intended Use of the Device:
Aveo (omafilcon A)1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with nondiseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.
6.0 Summary of the Technological Characteristics of the Device:
Below is the summary of the technological characteristics of the Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses as compared to the predicate device.
| Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Product Name | Aveo (omafilcon A)1-DayAspheric Soft (Hydrophilic)Contact Lenses | Proclear Asphere | Proclear 1 day |
| Manufacturer | Supervision Optimax SdnBhd | CooperVision, Inc. | CooperVision, Inc. |
| 510(K) Number | This submission | K112302 | K061948 |
| Intended Use | Aveo (omafilcon A) 1-DayAspheric Soft (Hydrophilic)Contact Lenses areindicated for daily wear forthe correction of visualacuity in not aphakicpersons with non-diseasedeyes that are myopic or | Proclear Asphere(omafilcon A) SoftContact lenses areindicated for daily wearfor the correction ofvisual acuity in non-aphakic persons withnon-diseased eyes that | Sphere and aspheric(omafilcon A) Soft(hydrophilic) contactlenses are indicatedfor daily wear for thecorrection of visualacuity in not aphakicpersons with non- |
{5}------------------------------------------------
| hyperopic and exhibitastigmatism of 1.00D or lessthat does not interfere withvisual acuity. The contactlenses are intended fordaily wear, single use andare to be discarded at theend of the day. | are myopic or hyperopicand exhibit astigmatismof 2.00D or less thatdoes not interfere withvisual acuity. | diseased eyes thatare myopic orhyperopic and exhibitastigmatism of 2.00Dor less that does notinterfere with visualacuity. | |
|---|---|---|---|
| Modality | Daily Wear | Daily Wear | Daily Wear |
| Lens Design | Aspherical | Aspherical | Aspheric |
| USANMaterialName | omafilcon A | omafilcon A | omafilcon A |
| FDACategory | Group II | Group II | Group II |
| (Group) | Non-ionic, High water | Non-ionic, High water | Non-ionic, High water |
| Manufacturing | Cast Molded | Finished InsidePolymerization System II | Cast Molded |
| Method | |||
| Curing | Thermal Cure | Thermal Cure | Thermal Cure |
| Sterilization | Moist Heat (Steam) inValidated Autoclave | Moist Heat (Steam) inValidated Autoclave | Steam: ValidatedAutoclave |
| Packaging | Blister Pack | Blister Pack | Blister Pack |
| Visibility Tint | Reactive Blue Dye 246 | VAT Blue 6 | Vat Blue 6 |
| Water Content | 59% ± 2% | 59% ± 2% | 60% ± 2% |
| Package Saline | Phosphate Buffered Saline | Phosphate BuffersPEG200 and Tween 80 | Not Stated |
| Refractive Index | 1.4002 | 1.395 ± 0.005 | 1.40 |
| OxygenPermeability (Dk) x$10-11$ | 25.68 | 21.05 | 21 |
| Light Transmission | 98% | >90% | >90% |
| Base Curve | 8.4mm to 8.8mm | 8.0mm to 9.3mm | 8.00mm to 9.50mm |
| Diameter ⌀T | 14.0mm to 14.4mm | 13.6mm to 15.2mm | 13.0mm to 15.5mm |
| Power | -10.00 to +6.00 | -20.00 to +20.00 | -20.00 to +20.00 |
7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data
Physiochemical Studies
The physiochemical studies were conducted according to ISO 18369-4:2006 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2006 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses.
{6}------------------------------------------------
Toxicology Studies
Toxicology (in-vivo and in-vitro) studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.
| Test | Performance of SubjectDevice | Result |
|---|---|---|
| Cytotoxicity TestISO 10993-5: 2009(E): BiologicalEvaluation of Medical Devices-Part 5:Tests for in vitro Cytotoxicity. | Non-cytotoxic. | Pass |
| Ocular Irritation Study in New ZealandWhite RabbitISO 10993-10: 2010(E): BiologicalEvaluation of Medical Devices-Part 10:Tests for Irritation and Skin Sensitization. | Non-irritant to eyes ofrabbits. | Pass |
| Skin Sensitization Study in Guinea PigsISO 10993-10: 2010(E): BiologicalEvaluation of Medical Devices-Part 10:Tests for Irritation and Skin Sensitization. | Non-sensitizer | Pass |
| Acute Systemic Toxicity Study in SwissAlbino MiceISO 10993-11: 2006(E): BiologicalEvaluation of Medical Devices-Part 11:Tests for in Systemic Toxicity. | Animals treated with theextract of the subjectdevice did not show anysystemic toxicity. | Pass |
8.0 Clinical Test
The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, Proclear Asphere (K112302) and Proclear 1 day (K061948). Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.
9.0 Conclusion
The Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are substantially equivalent to the predicate device, Proclear Asphere (K112302) and Proclear 1 day (K061948) in term of optical property, Physiochemical and pre-clinical toxicology. They are produced from the same material (omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.
§ 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.