(35 days)
No
The document describes contact lenses and their intended use and performance studies, none of which mention or imply the use of AI or ML.
No
The device is indicated for correcting refractive ametropia and presbyopia, and for cosmetic purposes (altering eye color), not for treating or rehabilitating a disease or injury. While it "helps protect against transmission of harmful UV radiation," this is a protective function and not a therapeutic one as defined for medical devices.
No
The ACUVUE® 2 COLOURS Contact Lenses are indicated for "daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia)" and other vision correction purposes. This means they are a therapeutic/corrective device rather than a diagnostic one.
No
The device is a contact lens, which is a physical medical device, not software. The description focuses on the material and physical properties of the lens.
Based on the provided information, the ACUVUE® 2 COLOURS Contact Lenses are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ACUVUE 2 COLOURS Function: The intended use and device description clearly state that these contact lenses are for:
- Enhancing or altering the apparent color of the eye.
- Correcting refractive errors (myopia, hyperopia, astigmatism).
- Correcting distance and near vision in presbyopia.
- Providing UV protection.
- No Specimen Examination: The device does not involve the examination of any biological specimens from the patient. It is a medical device that is placed directly on the eye to alter vision and appearance.
Therefore, the ACUVUE® 2 COLOURS Contact Lenses fall under the category of a medical device, specifically a contact lens, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. 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 frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
Product codes
LPL, MVN
Device Description
The device description is identical to that cleared under K010114.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners / Daily wear
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)
Non-Clinical Studies: The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994 and are included in PMA N18-033/S038.
• Toxicology Testing
• Cytotoxicity
• USP Ocular Irritation
• USP Systemic Injection
• Leachable Monomer and Additive
• Physical/Chemical Testing
• Stability Testing
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
JAN 2 2 2003
510(k) Summary
| Name and
Address of
Submitter | VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, Florida 32256
Contact: James W. Parziale
Phone: (904) 443-1808
Date Prepared: December 12, 2002 |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of
Device | Trade Name: ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker Common or Usual Name: Soft (hydrophilic) Contact Lens (daily wear) Classification: Class II under 21 CFR 886.5925 |
| Predicate
Devices | The predicate devices is the:
ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker cleared under K010114 on April 11, 2001. |
| Device
Description | The device description is identical to that cleared under K010114. |
| Intended Use | The intended use is identical to that cleared under K010114. |
| Technological
Characteristics | The technological characteristics are identical to that cleared under K010114. |
| | Continued on next page |
1
510(k) Summary, Continued
| Non-Clinical
Studies | The following tests were conducted as recommended by the Premarket
Notification 510(k) Guidance Document for Daily Wear Contact Lenses,
revised May 1994 and are included in PMA N18-033/S038.
• Toxicology Testing
• Cytotoxicity
• USP Ocular Irritation
• USP Systemic Injection
• Leachable Monomer and Additive
• Physical/Chemical Testing
• Stability Testing |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Studies | Clinical data is not required for this submission. |
| Conclusions | The ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic)
contact lenses with UV blocker, which is the subject of this 510(k), is
substantially equivalent to the ACUVUE® 2 COLOURS™ Brand (etafilcon
A) soft (hydrophilic) contact lenses with UV blocker, cleared under 510(k)
K010114 on April 11, 2001. |
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a profile view.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 2 2003
Mr. James W. Parziale Project Leader, Regulatory and Clinical Affairs VISTAKON, Division of Johnson-Johnson Vision Care, Inc. 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K024177
Trade/Device Name: ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft (hydrophilic) Contact Lenses with UV Blocker Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: December 17, 2002 Received: December 18, 2002
Dear Mr. Parziale:
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. Iisting 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
3
Page 2 - Mr. James W. Parziale
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. 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 Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information 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
Enclosure
4
Indications Statement
510(k) Number (if known):
Device Name:
ACUVUE® 2 COLOURS™ Brand (etafilcon A) soft (hydrophilic) contact lenses with UV blocker
Indications for Use:
The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with nondiseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
ACUVUE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. 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 frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over the Counter |
|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ------------------ |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K024177 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL