(83 days)
K970746, P010019
Not Found
No
The document describes a standard soft contact lens with different designs (spherical, toric, multifocal) and material properties. There is no mention of any computational or algorithmic components, let alone AI/ML. The focus is on the physical characteristics, material composition, and clinical performance of the lens itself.
No.
The contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia, which is a refractive correction and not a therapeutic treatment for disease.
No
Explanation: This device is a soft contact lens for optical correction of refractive ametropia. It is used to correct vision, not to diagnose a disease or condition.
No
The device is a physical contact lens made of a specific material (lotrafilcon B) and has defined physical parameters (diameter, base curve, power, thickness). The description focuses on the material properties, manufacturing, packaging, and clinical performance of the lens itself, not on any software component.
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 optical correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and material of the contact lens, designed for placement on the eye to alter light refraction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status through in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This contact lens does not perform any such function.
N/A
Intended Use / Indications for Use
Focus® Excelens™ (Iotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Focus® Excelens™ Toric (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
Focus® Excelens™ Progressives (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The material used for (lotrafilcon B) soft contact lenses is a modification to the lens material used for (lotrafilcon A) lenses. The lens material is 33% water and 67% lotrafilcon B, a silicone containing hydrogel which is surface treated.
Lotrafilcon B lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
• Diameter Range: 13.0 to 15.0 mm
• Base Curve Range: 8.0 to 9.2 mm
• Power Range: -20.00D to +20.00D
• Center Thickness: varies with power (0.080 mm for -3.00D spherical)
Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.
Lenses have the following properties:
Refractive index: 1.42 (hydrated)
Light transmittance: > 96 %
Water content : 33 % by weight in normal saline
Oxygen permeability: 110 x 10 *1 [(cm2 /sec)(ml O2 /ml+mmHg)] measured at 35°C (intrinisic Dk-Coulometric method)
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marked packaging System has boon domenstare effectively steam sterilized in a validated lens products, and puonagou lensors are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability and product oxpiration dater the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a twenty four (24) (ablity to maint of the for (lotrafilcon B) soft contact lenses in sealed blister pack containers. Shelf-life studies are ongoing to determine extension of expiration dating.
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
eye care professional
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)
A series of non-clinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the (lotrafilcon B) contact lens, and establish substantial equivalence to a currently marketed, predicate (intrastition A) control lens. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket was conducted in accordance for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is non-Conformatible, and has material characteristics comparable to or better than other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the Substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.
Nonclinical Testing:
A series of in vitro and in vivo pre-clinical toxicology and biocompatibility testing was A senes of in viro and in the pro official toxocogy and ontaction (of non-clinical performed to assess the barety and crordance with the GLP regulation (21 CFR Part 58).
The results of the non-clinical testing on the (lotrafilcon B) contact lens demonstrate:
- The lens material and extracts are not toxic and non- irritating.
- Lens physical and material properties are consistent with industry marketed lenses, and similar to lotrafilcon A lenses.
- The lens material remains unaffected, with respect to lens properties, by exposure. The lens material cleaning and disinfection systems, and is compatible with commonly available lens care products.
Clinical Testing:
The (lotrafilcon B) contact lens was investigated in daily wear clinical study. The onemonth clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens.
Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions.
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.
K970746, P010019
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
APR o 9 2002
11 020139
CIBA Vision® Corporation 28-Mar-02, v02 11460 Johns Creek Parkway Duluth, Georgia USA 30097 Page 1 of 4 Lotrafilcon B Soft Contact Lenses 510(k) - K020139 Summary of Safety and Substantial Equivalence 510(k) Summary
1. Submitter Information:
| Company: | CIBA Vision Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 |
|--------------------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Alicia M. Plesnarski, RAC
Senior Specialist, Global Regulatory Affairs |
| Telephone:
FAX:
Date Prepared: | 678-415-3924
678-415-4333
28 March, 2002 |
2. Device Name:
- Soft Contact Lens Common Name: . Focus® Excelens™ (lotrafilcon B) Trade/Proprietary Name: . Daily Wear Soft Contact Lens Classification Name: ●
- Class II [21 CFR 886.5925 (b) (1)] . Device Classification:
3. Predicate Device:
The Focus® Excelens™ (lotrafilcon B) lens is a modification of the predicate device, (lotrafilcon A) soft contact lens. Both are in FDA Group 1 (low water, nonionic polymer). CIBA Vision obtained FDA 510(k) clearance for daily wear on May 9, 1997 (K970746) and FDA PMA marketing approval for extended wear on October 11, 2001 (P010019) for (lotrafilcon A) lenses.
4. Description of Device:
The material used for (lotrafilcon B) soft contact lenses is a modification to the lens material used for (lotrafilcon A) lenses. The lens material is 33% water and 67% lotrafilcon B, a silicone containing hydrogel which is surface treated.
Lotrafilcon B lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
| • Diameter Range: | 13.0 to 15.0 mm |
|---|---|
| • Base Curve Range: | 8.0 to 9.2 mm |
| • Power Range: | -20.00D to +20.00D |
- varies with power (0.080 mm for -3.00D spherical) ● Center Thickness:
Lenses contain the color additive copper phthalocyanine, a light blue handling tint, which makes them easier to see when handling.
1
Image /page/1/Picture/0 description: This image shows a document from CIBA Vision Corporation, located at 11460 Johns Creek Parkway in Duluth, Georgia, USA 30097. The document is dated 28-Mar-02, version v02, and is page 2 of 4. The document is titled "Lotrafilcon B Soft Contact Lenses" and includes the text "510(k) - K020139 Summary of Safety and Substantial Equivalence".
Lenses have the following properties:
- 1.42 (hydrated) Refractive index: .
-
96 % Light transmittance: ●
- 33 % by weight in normal saline Water content : .
- 110 x 10 *1 Oxygen permeability .
[(cm2 /sec)(ml O2 /ml+mmHg)]
measured at 35°C (intrinisic Dk-Coulometric method)
Lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marked packaging System has boon domenstare effectively steam sterilized in a validated lens products, and puonagou lensors are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability and product oxpiration dater the chemical stability of the lens and package integrity (ability to maintain sterility). Stability study data currently supports a twenty four (24) (ablity to maint of the for (lotrafilcon B) soft contact lenses in sealed blister pack containers. Shelf-life studies are ongoing to determine extension of expiration dating.
5. Indications for Use:
Focus® Excelens™ (Iotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic opersons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Focus® Excelens™ Toric (lotrafilcon B) soft contact lenses are indicated for the optical r ouds Exection of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
Focus® Excelens™ Progressives (lotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
2
| CIBA
Vision.
A Novartis Company | CIBA Vision® Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 | 28-Mar-02, v02
Page 3 of 4 |
| ---------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------ | ------------------------------- |
|---|
Lotrafilcon B Soft Contact Lenses# 510(k) - K020139 Summary of Safety and Substantial Equivalence
6. Description of Safety and Substantial Equivalence:
A series of non-clinical tests and clinical studies were performed to demonstrate the safety and effectiveness of the (lotrafilcon B) contact lens, and establish substantial equivalence to a currently marketed, predicate (intrastition A) control lens. All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket was conducted in accordance for Class II Contact Lenses and in conformance to applicable device regulations. Results demonstrate the lens is non-Conformatible, and has material characteristics comparable to or better than other currently marketed soft contact lenses. Clinically, the lens has performed satisfactorily in a daily wear investigation. Results from all tests demonstrate the Substantial equivalence to previously FDA approved, and currently marketed predicate (control) lenses.
Nonclinical Testing:
A series of in vitro and in vivo pre-clinical toxicology and biocompatibility testing was A senes of in viro and in the pro official toxocogy and ontaction (of non-clinical performed to assess the barety and crordance with the GLP regulation (21 CFR Part 58).
The results of the non-clinical testing on the (lotrafilcon B) contact lens demonstrate:
- The lens material and extracts are not toxic and non- irritating. .
- Lens physical and material properties are consistent with industry marketed lenses, . and similar to lotrafilcon A lenses.
- The lens material remains unaffected, with respect to lens properties, by exposure . The lens material cleaning and disinfection systems, and is compatible with commonly available lens care products.
Clinical Testing:
The (lotrafilcon B) contact lens was investigated in daily wear clinical study. The onemonth clinical evaluation was conducted in accordance with current Good Clinical Practices and published regulations (21 CFR Parts 50, 56, 312, 812). The study assessed the safety and effectiveness, and clinical performance as compared to the predicate control lens.
Clinical evaluation of the (lotrafilcon B) lens demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit to compared to concurrent controls when used under daily wear conditions.
3
| CIBA
Vision.
A Novartis Company | CIBA Vision ® Corporation
11460 Johns Creek Parkway
Duluth, Georgia USA 30097 | 28-Mar-02, v02
Page 4 of 4 |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-------------------------------|
| Lotrafilcon B Soft Contact Lenses
510(k) - K020139 Summary of Safety and Substantial Equivalence | | |
Substantial Equivalence:
The (lotrafilcon B) contact lens is similar to other daily wear soft contact lenses in terms of water content (33% water) and ionic characteristics (FDA Group I: low water, or water ochical performance, and indications for use. In addition, the lenses may be disinfected using a chemical, not heat, disinfection regimen.
Any differences which may exist between the (lotrafilcon B) soft contact lens and other Any androinood million plastic contact lenses does not adversely effect the safety and effectiveness of the device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
APR - 9 2002
CIBA Vision Corporation c/o Alicia M. Plesnarski, RAC 11460 Johns Creek Parkway Duluth, GA 30097
Re: K020139
Trade/Device Name: Focus Excelens (lotrafilcon B) Soft Contact Lenses Regulation Number: 21CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: January 15, 2002 Received: January 16, 2002
Dear Ms. Plesnarski:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in 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 I va may , and severy anions 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 rr your avisor 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 Erth 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
Page 2 - Alicia M. Plesnarski, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w your e FDA finding of substantial equivalence of your device to a legally premailed noutreation - 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of 1 Far 3613. Additionally, for questions on the promotion and advertising of Compinatee at (301) 59 + + t the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director · Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
6
Indications for Use Statement, v02, 28-Mar-02, Page 1 of 1 Premarket Notification 510(k): (Iotrafilcon B) Soft Contact Lens for Daily Wear
INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
Focus® Excelens™ (lotrafilcon B) Soft Contact Lenses
Indications For Use:
Focus® Excelens™ (Iotrafilcon B) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes and with approximately 1.50 diopters of astigmatism that does not interfere with visual acuity.
Focus® Excelens™ Toric (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with 6.00 diopters (D) or less of astigmatism.
Focus® Excelens™ Progressives (Iotrafilcon B) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters of astigmatism.
The lenses may be prescribed for daily wear with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, as recommended by the eye care professional.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lancel W.C. Brown, Ph.D.
ion of Ophthalmic Ear. Nose and Throat Devises
K020139 510(k) Number
Prescription Use:
Over the Counter Use
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