(56 days)
Aveo (omafilcon A) 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.
Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the 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 between 0.50D and 2.50D or less that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent Planned Replacement Wear
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
Disposable Wear
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are daily wear soft contact lenses 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 are 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. Reactive ultraviolet absorber RUVA-93 is used to block UV radiation.
The device is a corneal contact lens having a total diameter less than the visible iris diameter and is designed to be worn in its entirety on the cornea.
Aveo (Omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
Aveo (Omafilcon A) Toric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve for the sphere power and multi-radius base curve for the cylinder power (internal curve).
The contact lenses are hydrophilic, soft and it is supplied in sterile state.
The provided document is a 510(k) summary for a medical device, specifically contact lenses. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity (as would be typical for an AI/ML medical device submission).
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics (like those for an AI/ML diagnostic) is not directly applicable to this document. This submission primarily relies on showing the new device is fundamentally similar to an already approved one.
However, I can extract the information relevant to the substantial equivalence claim, which acts as the "proof" for this type of device.
Here's an interpretation based on the document's content:
1. Table of "Acceptance Criteria" (for Substantial Equivalence) and Reported Device Performance:
For a 510(k) of a contact lens, the "acceptance criteria" are essentially demonstrating similarity to a predicate device across various characteristics, and the "performance" is the subject device exhibiting these similar characteristics.
| Characteristic | Predicate Device (Proclear Asphere) | Subject Device (Aveo) | "Acceptance Criteria" (Similarity) | Reported Device Performance (Aveo) |
|---|---|---|---|---|
| Intended Use | Similar scope | Similar scope | Met | Daily wear for vision correction in non-aphakic, non-diseased eyes with myopia/hyperopia and limited astigmatism. |
| Material Name | Omafilcon A | Omafilcon A | Met | Omafilcon A |
| FDA Group (Material) | Group II (Non-ionic, High water) | Group II (Non-ionic, High water) | Met | Group II (Non-ionic, High water) |
| Modality | Daily Wear | Daily Wear | Met | Daily Wear |
| Lens Design | Aspherical | Aspherical | Met | Aspherical |
| Manufacturing Method | Finished Inside Polymerization System II | Cast Molded | Minor difference, justified. | Cast Molded |
| Curing | Thermal Cure | Thermal Cure | Met | Thermal Cure |
| Sterilization | Moist Heat (Steam) | Moist Heat (Steam) | Met | Moist Heat (Steam) |
| Packaging | Blister Pack | Blister Pack | Met | Blister Pack |
| Visibility Tint | VAT Blue 6 | Reactive Blue Dye 246 | Minor difference, justified. | Reactive Blue Dye 246 |
| Water Content | 59% ± 2% | 59% ± 2% | Met | 59% ± 2% |
| Package Saline | Phosphate Buffers, PEG200, Tween 80 | Phosphate Buffered Saline | Minor difference, justified. | Phosphate Buffered Saline |
| Refractive Index | 1.395 ± 0.005 | 1.4002 | Within range/similar. | 1.4002 |
| Oxygen Permeability (Dk) | 21.05 | 25.68 | Higher Dk is generally an improvement, not a concern for safety. | 25.68 |
| Light Transmission | >90% | 98% | Met/Exceeded | 98% |
| Base Curve | 8.0mm to 9.3mm | 8.4mm to 8.8mm | Overlapping range. | 8.4mm to 8.8mm |
| Diameter Øт | 13.6mm to 15.2mm | 14.0mm to 14.7mm | Overlapping range. | 14.0mm to 14.7mm |
| Power | -20.00 to +20.00 | -10.00 to +6.00 | Within a clinically accepted range for specified indications. | -10.00 to +6.00 |
Note: The "acceptance criteria" for a 510(k) submission are not rigid pass/fail thresholds like for a performance study, but rather demonstrating that the new device is as safe and effective as a legally marketed predicate device. Differences are acceptable if they do not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Non-Clinical Performance Data): The document refers to "Physiochemical Studies" and "Toxicology Studies."
- Physiochemical Studies: Conducted according to ISO 18369-4:2006 and ISO 18369-3:2006. The sample sizes are not explicitly stated but would adhere to the standards' requirements (e.g., number of lenses tested for Dk, water content, etc.).
- Toxicology Studies:
- Cytotoxicity Test: Sample size not specified, typically in-vitro (cell cultures).
- Ocular Irritation Study: "New Zealand White Rabbit" - not specified, but typically a small number of animals (e.g., 3-6).
- Skin Sensitization Study: "Guinea Pigs" - not specified, typically a small number of animals (e.g., 10-20).
- Acute Systemic Toxicity Study: "Swiss Albino Mice" - not specified, typically a small number of animals (e.g., 5-10 per group).
- Data Provenance: Not explicitly stated (e.g., country of origin for the non-clinical tests). These are prospective tests conducted specifically for the device submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable in the context of this 510(k) submission. Ground truth for an AI/ML device (e.g., presence/absence of disease based on expert consensus) is not relevant here. The "ground truth" for contact lens substantial equivalence relies on established international standards (ISO) for physical and chemical properties, and standard toxicology testing protocols.
4. Adjudication Method for the Test Set:
- Not applicable. This isn't a human-reader or AI performance study requiring adjudication. The results of the physiochemical and toxicology tests are directly measured/observed by the testing facility.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study (comparing human readers with and without AI assistance) is not conducted for contact lens submissions. The submission states, "no clinical studies were required to demonstrate the safety or effectiveness of the subject device" due to its substantial equivalence to the predicate.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This submission is for a physical medical device (contact lenses), not an algorithm or AI.
7. Type of Ground Truth Used:
- Standardized Test Results and Predicate Device Characteristics. The "ground truth" for this 510(k) relies on:
- Results from physiochemical tests (e.g., water content, Dk, refractive index) measured according to ISO standards.
- Results from toxicology tests (cytotoxicity, irritation, sensitization, systemic toxicity) measured according to ISO 10993 standards.
- The established characteristics and safety profile of the legally marketed predicate device (Proclear, K112302, and also Aveo K162223 as another similar device).
8. Sample Size for the Training Set:
- Not applicable. Contact lenses are physical medical devices, not AI/ML algorithms that require training sets. Their manufacturing process is well-defined, and their properties are measured after production.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As there's no training set for an AI/ML algorithm, this question doesn't apply.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and white. The text is arranged in three lines, with "FDA" on the top line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
June 8, 2018
Supervision Optimax SDN BHD Yap Peak Geeh Regulatory Affairs Manager Lot 38. Putra Industrial Park. Bukit Rahman Putra 40160 Sungai Buloh, Selangor Dural Ehsan, Malaysia
Re: K180985
Trade/Device Name: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 30, 2018 Received: April 13, 2018
Dear Yap Peak 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.
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
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(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.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
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) K180985
Device Name
Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
Indications for Use (Describe)
Aveo (omafilcon A) 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 and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.
Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of between 0.50D and 2.50D or less that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent Planned Replacement Wear
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
Disposable Wear When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
| 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 K180985
Preparation Date: 05th June 2018
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) Soft (Hydrophilic) Contact Lenses Common Name : Soft (Hydrophilic) Contact Lenses Classification Name: Lenses, Soft Contact, Daily Wear (21 CFR 886.5925, Product Code LPL) Lenses, Soft Contact, (Disposable) (21 CFR 886.5925, Product Code MVN) Classification : Class II
3.0 Identification Of The Legally Marketed Devices that equivalency is claimed:
| Predicate Device | ||
|---|---|---|
| Manufacturer | CooperVision, Inc | Supervision Optimax Sdn Bhd |
| Device Name | Proclear (omafilcon A) Soft Contact Lenses | Aveo (omafilcon A) 1-day Aspheric Soft (Hydrophilic) Contact Lens |
| 510(k) Number | K112302 | K162223 |
| 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 |
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4.0 Description of the Device:
The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are daily wear soft contact lenses 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 are 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. Reactive ultraviolet absorber RUVA-93 is used to block UV radiation.
The device is a corneal contact lens having a total diameter less than the visible iris diameter and is designed to be worn in its entirety on the cornea.
Aveo (Omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).
Aveo (Omafilcon A) Toric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve for the sphere power and multi-radius base curve for the cylinder power (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) 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.
Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the 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 between 0.50D and 2.50D or less that does not interfere with visual acuity.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.
Frequent Planned Replacement Wear
When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.
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Disposable Wear
When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.
6.0 Summary of the Technological Characteristics of the Device:
Below is the summary of the technological characteristics of the Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses as compared to the predicate device.
| Technological Characteristics | |||
|---|---|---|---|
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Product Name | Aveo | Proclear Asphere | Aveo |
| Manufacturer | Supervision Optimax SdnBhd | CooperVision, Inc. | Supervision OptimaxSdn Bhd |
| 510(K) Number | K180985 | K112302 | K162223 |
| Intended Use | Aveo (omafilcon A)Aspheric Soft (Hydrophilic)Contact Lenses areindicated for daily wear forthe correction of visualacuity in not aphakicpersons with non-diseasedeyes that are myopic orhyperopic and exhibitastigmatism of 1.00D or lessthat does not interfere withvisual acuity.Aveo (omafilcon A) ToricSoft (Hydrophilic) ContactLenses are indicated thedaily wear for thecorrection of visual acuity innot aphakic persons withnon-diseased eyes that aremyopic or hyperopic andexhibit astigmatism ofbetween 0.50D and 2.50Dor less that does notinterfere with visual acuity. | Proclear Asphere(omafilcon A) SoftContact Lenses areindicated for daily wearfor the correction ofvisual acuity in non-aphakic persons withnon-diseased eyes thatare myopic or hyperopicand exhibit astigmatismof 2.00D or less thatdoes not interfere withvisual acuity.Proclear Toric(omafilcon A) SoftContact Lenses areindicated for daily wearfor the correction ofvisual acuity in non-aphakic persons withnon-diseased eyes thatare myopia or hyperopic.The lens may be worn bypersons who haveastigmatism of 5.00D orless . | Aveo (omafilcon A)1-Day Aspheric Soft(Hydrophilic) ContactLenses are indicatedfor daily wear for thecorrection of visualacuity in not aphakicpersons with non-diseased eyes thatare myopic orhyperopic and exhibitastigmatism of 1.00Dor less that does notinterfere with visualacuity. The contactlenses are intendedfor daily wear, singleuse and are to bediscarded at the endof the day. |
| Modality | Daily Wear | Daily Wear | Daily Wear |
| Lens Design | Aspherical | Aspherical | Aspherical |
| Material | Omafilcon A | Omafilcon A | Omafilcon A |
| Name | |||
| FDA(Group) | Group IINon-ionic, High water | Group IINon-ionic, High water | Group IINon-ionic, High water |
| ManufacturingMethod | Cast Molded | Finished InsidePolymerization System II | Cast Molded |
| Curing | Thermal Cure | Thermal Cure | Thermal Cure |
| Sterilization | Moist Heat (Steam) inValidated Autoclave | Moist Heat (Steam) inValidated Autoclave | Moist Heat (Steam) inValidated Autoclave |
| Packaging | Blister Pack | Blister Pack | Blister Pack |
| Visibility Tint | Reactive Blue Dye 246 | VAT Blue 6 | Reactive Blue Dye 246 |
| Water Content | 59% ± 2% | 59% ± 2% | 59% ± 2% |
| Package Saline | Phosphate Buffered Saline | Phosphate BuffersPEG200 and Tween 80 | Phosphate Buffered Saline |
| Refractive Index | 1.4002 | $1.395 \pm 0.005$ | 1.4002 |
| OxygenPermeability (Dk) x10-11 | 25.68 | 21.05 | 25.68 |
| Light Transmission | 98% | >90% | 98% |
| Base Curve | 8.4mm to 8.8mm | 8.0mm to 9.3mm | 8.4mm to 8.8mm |
| Diameter Øт | 14.0mm to 14.7mm | 13.6mm to 15.2mm | 14.0mm to 14.4mm |
| Power | -10.00 to +6.00 | -20.00 to +20.00 | -10.00 to +6.00 |
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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.
Toxicology Studies
Toxicology (in-vivo and in-vitro) studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.
{7}------------------------------------------------
| 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, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.
9.0 Conclusion
The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are substantially equivalent to the predicate device as they are produced from the same material (Omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical.
§ 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.