(84 days)
Not Found
No
The device description and performance studies focus on the chemical composition and clinical efficacy of a lubricating eye drop solution, with no mention of AI or ML technologies.
No
The device is described as Contact Lens Comfort Drops, which lubricate and rewet contact lenses and relieve dryness and irritation, indicating it is an ophthalmic solution for comfort and maintenance rather than a therapeutic device for treating a disease or condition.
No
The device is a contact lens comfort drop used to lubricate and rewet contact lenses and relieve dryness and irritation. It does not diagnose any condition.
No
The device description clearly indicates it is a liquid solution containing various chemical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to lubricate and rewet contact lenses and relieve associated discomfort. This is a direct interaction with a medical device (contact lenses) and the user's eye, not a test performed in vitro (outside the body) on a biological sample to diagnose a condition.
- Device Description: The description details the chemical composition of a lubricating solution. It does not describe a test kit, reagent, or instrument used to analyze a biological sample.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a disease or condition
The device is clearly intended for the comfort and maintenance of contact lenses and the user's eyes, which falls under the category of a medical device, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
TheraTears Contact Lens Comfort Drops is indicated
- to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact lenses.
- to help relieve dryness, discomfort and irritation that may be associated with lens wear and,
- to cushion lenses and ease insertion.
- RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.
Product codes (comma separated list FDA assigned to the subject device)
LPN; MRC
Device Description
TheraTears® brand Contact Lens Comfort Drops contains carmellose sodium in purified water as a lubricant. It is a sterile, hypotonic, borate buffered solution containing the following essential electrolytes found in natural tears: sodium chloride, potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, and sodium phosphate. The gentle patented preservative system consists of sodium perborate stabilized with phosphonic acid. This solution contains no chlorhexidine, no thimerosal and no other mercury-containing ingredients, and it contains no detergents.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical Testing: The applicant performed stability, compatibility, toxicology and microbiology testing based the requirements of the May 1, 1997 Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. The results support the claim of substantial equivalence.
Clinical Testing: A one month clinical study was conducted to evaluate the safety and efficacy of TheraTears Contact Lens Comfort Drops. The results of the study demonstrate that TheraTears Contact Lens Comfort Drops is equivalent in performance, safety and efficacy to the Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops. This conclusion is based upon and supported by:
- The relative frequency and severity of positive slit lamp findings.
- The stability of the contact lens visual acuities as well as the stability of the best spectacle-corrected visual acuities
- The relative incidence and severity of symptoms, problems and complaints.
- The lack of solution-associated complications
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.
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
§ 886.5928 Soft (hydrophilic) contact lens care products.
(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
NOV = 4 2003
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K 032481", followed by the text "Page 1 of 2". The characters are written in a simple, clear font, and the text is smaller and positioned below the string of characters. The image appears to be a scan or photograph of a document.
510(k) Summary of Safety and Effectiveness
| Applicant's Name and Address: | Advanced Vision Research, Inc.
12 Alfred Street, Suite 200
Woburn, MA 01801 |
|-------------------------------|-----------------------------------------------------------------------------------|
| Contact Person: | Jeffrey R. Gilbard, M.D. |
| Contact Person: | Jeffrey P. Gilbard, M.D. |
| | Phone (781) 932-8327 |
| | Fax (781) 935-5075 |
October, 2003 Summary Prepared
Trade Name:
TheraTears Contact Lens Comfort Drops
Classification Name:
Soft (hydrophilic) contact lens care products (886.5928) Rigid gas permeable contact lens care products (886.5918)
Predicate Device:
Allergan Refresh Contacts™ (K992928) AQuify lens Comfort Drops (K013204)
Device Description:
TheraTears® brand Contact Lens Comfort Drops contains carmellose sodium in purified water as a lubricant. It is a sterile, hypotonic, borate buffered solution containing the following essential electrolytes found in natural tears: sodium chloride, potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride, and sodium phosphate. The gentle patented preservative system consists of sodium perborate stabilized with phosphonic acid. This solution contains no chlorhexidine, no thimerosal and no other mercury-containing ingredients, and it contains no detergents.
1
Indication for Use:
TheraTears Contact Lens Comfort Drops is indicated
- to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) contact . lenses.
- to help relieve dryness, discomfort and irritation that may be associated with lens . wear and,
- to cushion lenses and ease insertion. .
- RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.
Safety, Performance and Substantial Equivalence
Non-clinical Testing
The applicant performed stability, compatibility, toxicology and microbiology testing based the requirements of the May 1, 1997 Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products. The results support the claim of substantial equivalence.
Clinical Testing
A one month clinical study was conducted to evaluate the safety and efficacy of TheraTears Contact Lens Comfort Drops. The results of the study demonstrate that TheraTears Contact Lens Comfort Drops is equivalent in performance, safety and efficacy to the Bausch & Lomb ReNu MultiPlus® Lubricating and Wetting Drops.
This conclusion is based upon and supported by:
- The relative frequency and severity of positive slit lamp findings .
- The stability of the contact lens visual acuities as well as the stability of the . best spectacle-corrected visual acuities
- The relative incidence and severity of symptoms, problems and complaints .
- . The lack of solution-associated complications
The claim of substantial equivalence to Allergan Refresh Contacts and AQuify lens Comfort Drops is based on the indication for use as a lubricating and rewetting solution for soft (hydrophilic) and RGP contact lenses. TheraTears Contact Lens Comfort Drops contains the same active ingredient as Allergan Refresh Contacts and the same preservative system as AQuify lens Comfort Drops.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is a stylized symbol resembling three abstract shapes that could be interpreted as human figures or abstract forms. The logo is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV = 4 2003
Advanced Vision Research, Inc. c/o Beverley D. Venuti, Ph.D. R.A.C. Foresight Regulatory Strategies 269A Ballardvale Street Wilmington, MA 01887
Re: K032481
Trade/Device Name: TheraTears Contact Lens Comfort Drops Regulation Number: 21 CFR 886.5928; 21 CFR 886.5918 Regulation Name: Soft (hydrophilic) contact lens care products; Rigid gas permeable contact lens care products Regulatory Class: Class II Product Code: LPN; MRC Dated: August 11, 2003 Received: August 12, 2003
Dear Dr. Venuti:
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.
3
Page 2 - Beverley D. Venuti, Ph.D. R.A.C.
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. 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 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/cdrl/dsma/dsmamain.html
Sincerely vours,
A. Karyi korenthal.
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 for Use
510(k) Number (if known):
Device Name: TheraTears Contact Lens Comfort Drops
Indications for Use:
TheraTears Contact Lens Comfort Drops is indicated
- to lubricate and rewet soft (hydrophilic) and RGP* (rigid gas permeable) . contact lenses,
- to help relieve dryness, discomfort and irritation that may be associated with . lens wear and,
- . to cushion lenses and ease insertion.
- RGP lenses include silicone acrylate and fluoro silicone acrylate rigid gas permeable lenses. Consult with your eye care practitioner to identify your RGP material.
(Please do not write below this line. Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W. C. Brown Ph.D.
Ophthalmic Ear, roat Devises
510(k) Number K032481
OR Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use (Per 21 CFR 80.109)