(149 days)
Not Found
No
The summary describes a standard soft contact lens with no mention of AI or ML technology in its design, function, or testing.
No
The device is indicated for the correction of visual acuity; it does not treat or cure any disease.
No
Explanation: The device is a contact lens intended for correcting visual acuity, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made from a HEMA-MPC copolymer material, containing water and pigment. It is a tangible, physical medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Aveo contact lenses are placed on the cornea for vision correction. They do not perform any tests on bodily samples.
- Intended Use: The intended use is for correcting visual acuity, not for diagnosing or monitoring a medical condition through analysis of bodily fluids or tissues.
Therefore, the Aveo contact lens is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes, cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Physiochemical Studies: Conducted according to ISO 18369-4:2006 and ISO 18369-3:2006. Physical, optical and chemical properties were within established specifications.
Toxicology Studies: In-vivo and in-vitro studies showed that the lenses are non-toxic and biocompatible with the ocular environment.
- Cytotoxicity Test (ISO 10993-5: 2009(E)): Non-cytotoxic. Result: Pass
- Ocular Irritation Study in New Zealand White Rabbit (ISO 10993-10: 2010(E)): Non-irritant to eyes of rabbits. Result: Pass
- Skin Sensitization Study in Guinea Pigs (ISO 10993-10: 2010(E)): Non-sensitizer. Result: Pass
- Acute Systemic Toxicity Study in Swiss Albino Mice (ISO 10993-11: 2006(E)): Animals treated with the extract of the subject device did not show any systemic toxicity. Result: Pass
Clinical Test: No clinical studies were required due to identical technological characteristics, formulation, manufacturing, and sterilization processes as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
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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) Contact
Lens |
|---------------------|--------------------------------------------------------------------------|
| 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) Hydrophilic | ||
| Contact Lenses for Daily | ||
| Wear | ||
| 510(k) Number | K112302 | K061948 |
| Regulation Number | 21 CFR 886.5925 | 21CFR 886.5925 |
| Regulatory Name | Soft (hydrophilic) contact | |
| lens | Soft (hydrophilic) contact | |
| lens | ||
| 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-Day | ||
| Aspheric Soft (Hydrophilic) | |||
| Contact Lenses | Proclear Asphere | Proclear 1 day | |
| Manufacturer | Supervision Optimax Sdn | ||
| Bhd | CooperVision, Inc. | CooperVision, Inc. | |
| 510(K) Number | This submission | K112302 | K061948 |
| Intended Use | 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 | Proclear Asphere | ||
| (omafilcon A) Soft | |||
| Contact lenses are | |||
| indicated for daily wear | |||
| for the correction of | |||
| visual acuity in non- | |||
| aphakic persons with | |||
| non-diseased eyes that | Sphere and aspheric | ||
| (omafilcon A) Soft | |||
| (hydrophilic) contact | |||
| lenses are indicated | |||
| for daily wear for the | |||
| correction of visual | |||
| acuity in not aphakic | |||
| persons with non- |
5
| | 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. | are myopic or hyperopic
and exhibit astigmatism
of 2.00D or less that
does not interfere with
visual acuity. | diseased eyes that
are myopic or
hyperopic and exhibit
astigmatism of 2.00D
or less that does not
interfere with visual
acuity. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Modality | Daily Wear | Daily Wear | Daily Wear |
| Lens Design | Aspherical | Aspherical | Aspheric |
| USAN
Material
Name | omafilcon A | omafilcon A | omafilcon A |
| FDA
Category | Group II | Group II | Group II |
| (Group) | Non-ionic, High water | Non-ionic, High water | Non-ionic, High water |
| Manufacturing | Cast Molded | Finished Inside
Polymerization System II | Cast Molded |
| Method | | | |
| Curing | Thermal Cure | Thermal Cure | Thermal Cure |
| Sterilization | Moist Heat (Steam) in
Validated Autoclave | Moist Heat (Steam) in
Validated Autoclave | Steam: Validated
Autoclave |
| 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 Buffers
PEG200 and Tween 80 | Not Stated |
| Refractive Index | 1.4002 | 1.395 ± 0.005 | 1.40 |
| Oxygen
Permeability (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 Subject
Device | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity Test
ISO 10993-5: 2009(E): Biological
Evaluation of Medical Devices-Part 5:
Tests for in vitro Cytotoxicity. | Non-cytotoxic. | Pass |
| Ocular Irritation Study in New Zealand
White Rabbit
ISO 10993-10: 2010(E): Biological
Evaluation of Medical Devices-Part 10:
Tests for Irritation and Skin Sensitization. | Non-irritant to eyes of
rabbits. | Pass |
| Skin Sensitization Study in Guinea Pigs
ISO 10993-10: 2010(E): Biological
Evaluation of Medical Devices-Part 10:
Tests for Irritation and Skin Sensitization. | Non-sensitizer | Pass |
| Acute Systemic Toxicity Study in Swiss
Albino Mice
ISO 10993-11: 2006(E): Biological
Evaluation of Medical Devices-Part 11:
Tests for in Systemic Toxicity. | Animals treated with the
extract of the subject
device did not show any
systemic 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.