(88 days)
Not Found
No
The summary describes a contact lens and its physical properties and performance testing, with no mention of AI or ML.
No
Justification: The device is indicated for the correction of refractive ametropia (myopia and hyperopia), which is a visual defect, not a disease or injury that requires therapy.
No
Explanation: The device is a contact lens indicated for the correction of refractive ametropia. It is used to correct vision, not to diagnose a medical condition.
No
The device description clearly indicates it is a physical contact lens made of specific materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Bausch + Lomb Naturelle Daily Disposable Contact Lens is a medical device intended for the correction of refractive ametropia (vision correction) by being placed directly on the eye. It does not analyze samples taken from the body.
- Intended Use: The stated intended use is for correcting vision, not for diagnosing a disease or condition based on in vitro analysis.
- Device Description: The description focuses on the physical properties and materials of the contact lens itself, not on reagents or components used for in vitro testing.
- Performance Studies: The performance studies listed are related to the safety and effectiveness of the contact lens as a medical device for vision correction (toxicology, biocompatibility, physical properties), not to the accuracy or performance of an in vitro diagnostic test.
Therefore, this device falls under the category of a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Product codes
MVN
Device Description
The Bausch + Lomb Naturelle Cosmetically Tinted daily disposable (hilafilcon B) Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The printed ink pattern consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and the lens is 59% water by weight when immersed in a sterile saline solution. The lens monomer may be tinted blue with Reactive Blue Dye 246 (1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone, CFR Part 73.3106).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
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)
As recommended in the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the following tests were conducted:
- Toxicology / Biocompatibility
- o ISO Ocular Irritation Study
- ISO Systemic Toxicity o
- o In-Vitro Cytotoxicity
- Chemistry / Leachables ●
- Physical and Mechanical Properties o
- o Leachable Monomer and Additives
The testing performed on the Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens demonstrated that the device continues to function in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user.
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
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
K112192 OCT 2 5 2011
510(k) SUMMARY
Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens
:
1.0 Submitter Information:
| Bausch & Lomb |
|---|
| 1400 N. Goodman Street |
| Rochester, NY 14609 |
| Contact: Tricia Garrett |
| Senior Specialist, Global Regulatory Affairs |
| 1400 North Goodman Street |
| Rochester, NY 14609 |
| (585) 338-6706 (office) |
| (585) 338-0702 (fax) |
| Tricia.m.garrett@bausch.com |
2.0 Device Name:
| Trade Name: | Bausch & Lomb Naturelle Daily Disposable
(hilafilcon B) Cosmetically Tinted Contact Lens |
|------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | soft (hydrophilic) contact lens |
| Device Classification: | Class II (21 CFR 886.5925 (b) (1)) |
3.0 Predicate Device
The predicate device is Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in K061157 on June 22, 2006.
4.0 Device Description
The Bausch + Lomb Naturelle Cosmetically Tinted daily disposable (hilafilcon B) Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The printed ink pattern consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and the lens is 59% water by weight when immersed in a sterile saline solution. The lens monomer may be tinted blue with Reactive Blue Dye 246 (1,4-Bis[4-(2methacryloxyethyl) phenylamino] anthraquinone, CFR Part 73.3106).
1
5.0 Intended Use
The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
The intended use is identical to that cleared under K061157.
Technological Characteristics (comparison to Predicate Device) 6.0
The table below shows a side-by-side comparison of the predicate device to the modified device:
| Property | Bausch & Lomb SofLens® Daily
Disposable (hilafilcon B)
Visibility Tinted Contact Lens | Naturelle Daily Disposable
(hilafilcon B) Cosmetically
Tinted Contact Lens |
|-------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Water Content %: | 59% | Same |
| Refractive Index: | 1.4036 | |
| Oxygen
Permeability (Dk): | 22 x 10-11[cm³O₂(STP) x
cm]/(sec x cm² x mmHg)@35°C
(polarographic method) | |
| Light
Transmittance: | C.I.E. Y value - approximately
95% | |
| Specific Gravity: | 1.119 | |
| Diameter mm: | 13.5 to 15.0 mm | |
| Base Curve mm: | 7.8 mm to 9.5 mm | |
| Spherical Power,
Diopters: | +20.00 D to -20.00 D | |
| Center Thickness
mm: | 0.05 mm to 0.75 mm | |
| Print Pattern: | NA | Cosmetically Tinted Print
area 8.2 to 13.0 mm |
2
7.0 Summary of Non-Clinical Testing
As recommended in the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994, the following tests were conducted:
- Toxicology / Biocompatibility
- o ISO Ocular Irritation Study
- ISO Systemic Toxicity o
- o In-Vitro Cytotoxicity
- Chemistry / Leachables ●
- Physical and Mechanical Properties o
- o Leachable Monomer and Additives
The testing performed on the Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens demonstrated that the device continues to function in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user.
8.0 Clinical Testing
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 Substantial Equivalence
The Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens that is the subject of this Special 510(k) submission maintains the identical intended use, technological and functional characteristics as the predicate device. Where cosmetic differences exist between the two devices, appropriate testing has been conducted to demonstrate that the differences do not impact the safety or efficacy of the device. Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is substantially equivalent to the previously cleared Bausch & Lomb SofLens® Daily Disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in K061157 on June 22, 2006.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces right and is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" which are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bausch & Lomb C/O Tricia Garrett Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
MAY 31 2012
Re: K112192
Trade/Device Name: Bausch & Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: MVN Dated: September 23, 2011 Received: September 26, 2011
Dear Ms. Garrett:
This letter corrects our substantially equivalent letter of October 25, 2011.
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 (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 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
4
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
KI12192 510(k) Number (if known):
Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Device Name: Tinted Contact Lens
Indications for Use:
The Bausch + Lomb Naturelle Daily Disposable (hilafilcon B) Cosmetically Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Over-The-Counter Use Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K112192