(160 days)
No
The document describes a standard contact lens with UV blocking properties and an extended depth-of-focus design. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device corrects vision, which is a functional improvement, but it does not treat or cure a disease or medical condition.
No
The device is a contact lens intended for correcting vision in presbyopic individuals and protecting their eyes from UV radiation. It is a therapy device, not a diagnostic one, as it does not diagnose or detect any medical condition.
No
The device is a physical contact lens made of etafilcon A, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of vision in presbyopic individuals. This is a therapeutic and corrective function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details the material and design of a contact lens, which is a medical device used in vivo (within the body) to correct vision.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health by examining specimens from the human body.
IVD devices are used to perform tests on samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This contact lens does not perform such a function.
N/A
Intended Use / Indications for Use
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of distance, intermediate and near vision in presbyopic, phakic or pseudo-phakic persons with non-diseased eyes who can have up to approximately 1.50 diopters (D) of astigmatism.
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye care practitioners may prescribe the lenses either for single use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for single-use disposable wear (see "Wearing Schedule") the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Therefore no cleaning or disinfection is required. When prescribed for frequent/planned replacement wear the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed, and disinfected each time the lens is removed. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens contact lens is to be discarded after the recommended wearing period as prescribed by the eye care practitioner. When prescribed for frequent/planned replacement wear, the lenses should be disinfected using a chemical disinfection system only (i.e., not heat).
Product codes
LPL, MVN
Device Description
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is an extended depth-of-focus (EDOF) contact lens for the daily wear correction of distance, intermediate and near vision in presbyopic persons.
The lens material, etafilcon A. is a random co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were cross-linked with ethylene qlycol dimethacrylate (EGDMA) and 1,1,1 -trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using color additive Reactive Blue No. 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UVB range of 280-315 nm and less than 30% in the UVA range of 315-380 nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea and into the eye
Indicated Patient Age Range
Presbyopic persons
Intended User / Care Setting
Eye care 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)
The technological characteristics, formulation, manufacturing and sterilization processes are substantially equivalent to the predicate devices, therefore no clinical data is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Brien Holden Vision Pty Ltd. Mr. Randall May Vice President, Regulatory and Ouality Affairs ABN 85 138 617 062 Level 3 North Wing, Rupert Myers Building Gate 14 Barker Street, UNSW Sydney NSW 2052, Australia
Re: K143280
Trade/Device Name: BHV VIVID (etafilcon A) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: March 23, 2015 Received: March 27, 2015
Dear Mr. May:
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.
1
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 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.
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,
Deborah L. Falls -S
for Malvina B. Eydelman, MD Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143280
Device Name
BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens
Indications for Use (Describe)
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of distance, intermediate and near vision in presbyopic, phakic or pseudo-phakic persons with non-diseased eyes who can have up to approximately 1.50 diopters (D) of astigmatism.
The BHV VIVID (etafficon A) Soft (Hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye care practitioners may prescribe the lenses either for single use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for single-use disposable wear (see "Wearing Schedule") the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Therefore no cleaning or disinfection is required. When prescribed for frequent/planned replacement wear the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed, and disinfected each time the lens is removed. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens contact lens is to be discarded after the recommended wearing period as prescribed by the eye care practitioner. When prescribed for frequent/planned replacement wear, the lenses should be disinfected using a chemical disinfection system only (i.e., not heat).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the logo for Brien Holden Vision. The logo consists of a blue gemstone on the left, followed by the letters "BHV" in a bold, sans-serif font. Below the letters, the words "brien holden vision" are written in a smaller, lighter font. The gemstone is a multifaceted, round shape with varying shades of blue.
510(k) Summary
- l. Submitter
ll.
| Manufacturer Name: | Brien Holden Vision Pty Ltd. |
|---|---|
| Address: | Level 3, North Wing, Rupert Myers Building |
| Gate 14 Barker Street | |
| University of New South Wales | |
| Sydney, NSW 2052 Australia | |
| Phone: | +61 2 9385 7410 |
| Fax: | +61 2 9385 7401 |
| Contact Person | Randall May |
| Date Prepared: | 11 November 2014 |
| Device | |
| Trade Name: | BHV VIVID (etafilcon A) Soft (Hydrophilic) |
| Contact Lens | |
| Common Name: | Daily Wear Soft (Hydrophilic) Contact Lens |
| Device Class | Class II; Ophthalmic therapeutic device |
| Classification: | 21 CFR 886.5925 |
| Product Codes: | LPL, MVN |
III. Predicate Device
Primary Predicate
VISTAKON® (etafilcon A) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (K062614)
This predicate has not been subject to a design-related recall.
Reference Device
PEGAVISION CORPORATION Aquamax (Etafilcon A) Bi-Weekly and Daily Disposable Soft (Hydrophilic) Contact Lenses (K120028)
This reference device has not been subject to a design-related recall.
Brien Holden Vision Pty Ltd ABN 85 138 617 062 Level 3 North Wing, Rupert Myers Building Gate 14 Barker Street, UNSW
Sydney NSW 2052 Australia Tel +61 2 9385 7410 www.brienholdenvision.com
Image /page/3/Picture/13 description: The image contains a logo with the word "vision" in a large, bold, blue font. Below "vision" is the phrase "for everyone...everywhere" in a smaller, gray font. The word "everywhere" is in blue, and there is a trademark symbol to the right of the word.
4
Image /page/4/Picture/0 description: The image is a logo for Brien Holden Vision. The logo features a blue gemstone on the left, followed by the letters "BHV" in a bold, sans-serif font, also in blue. Below the letters, the words "brien holden vision" are written in a smaller, lighter blue font.
Device Description IV.
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is an extended depth-of-focus (EDOF) contact lens for the daily wear correction of distance, intermediate and near vision in presbyopic persons.
The lens material, etafilcon A. is a random co-polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which were cross-linked with ethylene qlycol dimethacrylate (EGDMA) and 1,1,1 -trimethylolpropane trimethacrylate (TMPTMA) via photo-polymerization. These lenses are tinted blue using color additive Reactive Blue No. 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UVB range of 280-315 nm and less than 30% in the UVA range of 315-380 nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.
V. Indications for Use
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of distance, intermediate and near vision in presbyopic, phakic or pseudo-phakic persons with non-diseased eyes who can have up to approximately 1.50 diopters (D) of astigmatism.
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye.
Eve care practitioners may prescribe the lenses either for single use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for single-use disposable wear (see "Wearing Schedule") the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Therefore no cleaning or disinfection is required.
When prescribed for frequent/planned replacement wear the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed, and disinfected each time the lens is removed. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens contact lens is to be discarded after the recommended wearing period as prescribed by the eye care practitioner. When prescribed for frequent/planned replacement wear, the lenses should be disinfected using a chemical disinfection system only (i.e., not heat).
Image /page/4/Picture/10 description: The image shows the word "vision" in a large, bold, blue font. Below the word "vision" is the phrase "for everyone...everywhere" in a smaller, gray font. The phrase is spread out horizontally, taking up about the same width as the word "vision" above it. The overall design is simple and modern.
Brien Holden Vision Pty Ltd _evel 3 North Wing. Rupert Myers Buildin Sydney NSW 2052 Australia Tel +61 2 9385 7410 ww.brienholdenvision.co
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Image /page/5/Picture/0 description: The image is a logo for Brien Holden Vision. The logo consists of a blue diamond on the left, followed by the letters "BHV" in blue. Below the letters is the text "brien holden vision" in a smaller blue font. The logo is clean and modern, and the use of blue gives it a sense of trust and professionalism.
VI. Predicate Device Comparison
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lenses have similar intended use indications and technological characteristics of the primary predicate device and reference device listed above.
Table 8.1 Subject and Primary Predicate Device Comparison
| Characteristic | BHV VIVID (etafilcon A)
Soft (Hydrophilic)
Contact Lenses | VISTAKON® (etafilcon
A) Soft (hydrophilic)
Contact Lens, Clear and
Tinted (Visibility and/or
Cosmetically) with UV
Blocker for Daily Wear
[Primary Predicate] |
|---------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject Device | K062614 |
| FDA Group | Group IV > 50% water,
ionic polymer | Group IV > 50% water,
ionic polymer |
| USAN Name | etafilcon A | etafilcon A |
| Production Method | Cast Molding | Cast Molding |
| Water Content | 58% | 58% |
| Refractive Index | 1.402 | 1.40 |
| Power (Diopter) | +20.00D to -20.00D | +20.00D to -20.00D |
| Base Curve Radius
(mm) | 7.85 to 10.0 | 7.85 to 10.0 |
| Diameter (mm) | 12.0 to 15.0 | 12.0 to 15.0 |
| Centre Thickness
(mm) | Varies with power: 0.060
to 0.500 mm | Varies with power: 0.060
to 1.00 mm |
The subject device complies with the following recognised consensus standards:
- . ISO 18369-1 First edition 2006-08-15 Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labeling specifications [Including: Amendment 1 (2009)]
- ISO 18369-2 Second edition 2012-12-01 Ophthalmic optics -- Contact lenses -- Part 2: Tolerances
- ISO 18369-3 First edition 2006-08-15 Ophthalmic optics Contact lenses ● - Part 3: Measurement Methods
Image /page/5/Picture/11 description: The image contains a logo for "vision for everyone...everywhere". The word "vision" is in a large, bold, blue font. Below it, the phrase "for everyone...everywhere" is in a smaller, gray font. The TM symbol is in the upper right corner of the word "everywhere".
6
Image /page/6/Picture/0 description: The image shows the logo for Brien Holden Vision. The logo consists of a blue gemstone on the left, followed by the letters "BHV" in blue. Below the letters is the text "brien holden vision" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and a visual representation of clarity and precision through the gemstone.
- ISO 18369-4 First edition 2006-08-15 Ophthalmic optics contact lenses - Part 4: Physicochemical properties of contact lens materials
- ASTM F1980 07 (Reapproved 2011) Standard Guide for Accelerated . Aging of Sterile Barrier Systems for Medical Devices
- . ISO 10993-1:2009 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- . ISO 11607-1:2006 Packaging for terminally sterilized medical devices -Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2:2006 Packaging for terminally sterilized medical devices -Part 2: Validation requirements for forming, sealing and assembly processes
- . ISO 11737-2:2009 Sterilization of medical devices - Microbiological methods - Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process
- . ISO 17665-1:2006 Sterilization of health care products - Moist heat -Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Summary of Non-clinical Testing VII.
All tests were conducted in accordance with the FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact lenses, May 12, 1984:
- Bench Testing
- . Biocompatibility
- . Microbiology
- Bacteriostatic Validation
- Leachables
VIII. Clinical Testing
The technological characteristics, formulation, manufacturing and sterilization processes are substantially equivalent to the predicate devices, therefore no clinical data is required.
IX. Conclusions
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is substantially equivalent to the predicate devices for the labeled indications for use. Successful results from chemical/physical, stability, and toxicology tests further confirmed the lenses are within established finished product specifications, remain stable, and are non-toxic and biocompatible with the ocular environment.
Image /page/6/Picture/23 description: The image contains the word "vision" in a large, bold, blue font. Below the word "vision" is the phrase "for everyone...everywhere" in a smaller, gray and blue font. The word "for everyone" is in gray, while the word "everywhere" is in blue. There is a trademark symbol next to the word "everywhere".