(149 days)
Not Found
No
The summary describes a physical contact lens and its material properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is indicated for the corrective ametropia (myopia, hyperopia, and astigmatism) in otherwise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas, which is a corrective rather than therapeutic function.
No
The device is a contact lens intended for the correction of ametropia in non-diseased eyes following surgical alterations, not for diagnosing medical conditions.
No
The device description clearly describes a physical contact lens made of Hioxifilcon B, detailing its material properties, physical characteristics, and how it functions as a physical object placed on the eye. There is no mention of software as the primary or sole component of the device.
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 Function: The description clearly states that the RevitalEyes contact lens is a device that is placed on the eye to correct vision after surgery. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for the "corrective ametropia" and "management of surgically altered corneas," which are direct therapeutic and corrective actions, not diagnostic testing.
The device description focuses on the physical properties and function of the contact lens itself, not on any diagnostic capabilities.
N/A
Intended Use / Indications for Use
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The RevitalEyes, Post-Surgical (Hioxifilcon B) Soft Contact Lenses for daily wear may be prescribed in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Product codes
LPL
Device Description
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilis contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appar somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
(Hioxifilcon B)
Refractive Index 1.51 (dry) 1.42 (hydrated)
Light Transmission greater than 94%
Surface Character hydrophilic
Water Content 49 %
Specific Gravity 1.137 (hydrated)
Oxygen Permeability 16.40 X 10-11 (cm^2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes, corneas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
JUL 2 3 2008 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
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.
The assigned 510(k) number is:
K080Sız
Applicant information:
い
子
| Date Prepared: | June 9, 2008 |
|---|---|
| Name: | Metro Optics of Austin, Inc. |
| Address | 15802 Vision Drive |
| Pflugerville, TX 78660 | |
| Contact Person: | Steve Webb |
| Phone number: | (512) 251-2382 |
| President | |
| Consultant: | Martin Dalsing |
| Medvice Consulting, Inc. | |
| 806 Kimball Avenue | |
| Grand Junction, CO 81501 | |
| Phone number | (970) 243-5490 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens |
| (Hioxifilcon B) clear and blue visibility tint. |
1
Equivalent Devices:
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint are substantially equivalent to the following predicate devices in terms of contact lens material, intended use and design.
Predicate devices include:
| Metro-G 3X, manufactured by Metro Optics of Austin, | K964902 |
|---|---|
| FlexLens Post Refractive Surgery, manufactured by FlexLens, | K961943 |
Device Description:
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials allows the lens to become soft and pliable when immersed in an aqueous solution.
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon B) soft hydrophilis contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appar somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:
(Hioxifilcon B)
| Refractive Index | 1.51 (dry) 1.42 (hydrated) |
|---|---|
| Light Transmission | greater than 94% |
| Surface Character | hydrophilic |
| Water Content | 49 % |
| Specific Gravity | 1.137 (hydrated) |
| Oxygen Permeability | $16.40 X 10^{-11} (cm^2/sec) (ml O_2/ml x hPa @ 35°C), (revised Fatt method)$ |
2
Intended Use:
The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Substantial Equivalence:
The device will be manufactured according to specified process controls and a quality assurance program. The established safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry of the device is equivalent to the BENZ-G 3X. Being similar with respect to indications for use, materials, plysical construction and safety & effectiveness to the predicate devices, this meets the requirements per six(r) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness, than the predicate devices identified above.
The following matrix illustrates the production method, lens function and material characteristics of the RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, as well as the predicate devices.
3
Substantial Equivalence Matrix
| | RevitalEyes
New Device | Flexlens Post Refractive
Surgery (hefilcon A)
predicate device | METRO-G
(hioxifilcon B)
predicate device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear and may be
prescribed in other wise non-diseased
eyes that require a soft contact lens for
the management of surgically altered
corneas following LASIK, PRK or RK
surgery. | Indicated for daily wear and may be
prescribed in other wise non-diseased
eyes that require a soft contact lens for
the management of surgically altered
corneas following refractive surgery. | Indicated for daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia. |
| Functionality | same as
predicate device | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light rays
from near and distant objects on the
retina. | After machining from the optical
blank, the contact lenses act as a
refractive medium that focus light rays
from near and distant objects on the
retina. |
| Indications | same as
predicate device | Daily wear, Soft (hydrophilic) contact
lens | Daily wear, Soft (hydrophilic) contact
lens |
| Production
Method | same as
predicate device | Lathe-cut | Lathe-cut |
| FDA Group # | same as
predicate device | Group # 1 Trade/Device Name: RevitalEyes Post-Surgical Soft Daily Wear Contact Lens (hioxifilcon B) clear and blue visibility tint Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: June 9, 2008 Received: June 18, 2008
Dear Mr. Dalsing:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.
5
This letter will allow you to begin 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egerthans, m.d.
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
6
METRO OPTICS of Austin
510(K) Premarket Notification
INDICATIONS FOR USE STATEMENT
Device Name: RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint.
INDICATIONS FOR USE:
The RevitalEyes, Post-Surgical (Hioxifilcon B) Soft Contact Lenses for daily wear may be prescribed in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH Office of Device Evaluation (ODE) | |||
|---|---|---|---|
| Division Sign-Off | |||
| Division of Ophthalmic Ear, | |||
| Nose and Throat Devices | |||
| Prescription Use (Per 21 CFR 801.109) | X | ||
| 510(k) Number | K080512 or | Over-The-Counter Use | |
| (Optional Format 1-2-96) |