(88 days)
K 973921
K 973921
No
The device description and intended use clearly describe a chemical solution for contact lens care. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies refer to clinical and preclinical testing of the solution's efficacy, not the performance of an AI/ML model.
No
This device is a multi-purpose solution for contact lenses, primarily for cleaning, rinsing, disinfection, and storage. It is not intended to treat or prevent a disease, but rather to maintain the cleanliness and safety of contact lenses for healthy eyes.
No
The device is a multi-purpose solution for contact lens care (cleaning, rinsing, disinfecting, storage) and does not diagnose any condition or disease.
No
The device is a multi-purpose solution for contact lenses, which is a chemical substance and not software.
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 care of soft contact lenses (cleaning, rinsing, disinfection, storage, and dissolving enzymatic tablets). This is a direct interaction with a medical device (contact lenses) and not a diagnostic test performed on a sample from the human body.
- Device Description: The description details a solution for contact lens care, not a reagent or instrument used to analyze biological samples.
- 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.)
- Providing diagnostic information about a disease or condition
- Measuring analytes or biomarkers
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry
The device is clearly intended for the maintenance and care of contact lenses, which are medical devices themselves, but the solution itself is not an IVD.
N/A
Intended Use / Indications for Use
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider. It is also indicated for use in dissolving enzymatic cleaning tablets.
Product codes
86 LPN
Device Description
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is a multi-purpose solution used in the care of soft (hydrophilic) contact lenses and is indicated for the cleaning, rinsing, disinfection and storage of soft (hydrophilic) contact lenses. It may also be used as a diluent for enzymatic cleaning tablets which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablets. The solution is contained in a plastic bottle and consists of a sterile isotonic solution that contains boric acid, edetate disodium, poloxamine. sodium borate and sodium chloride; it is preserved with alexidine dihydrochloride 4 ppm.
Each plastic bottle is supplied sterile and is labeled with a lot number and expiration date.
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
A series clinical and preclinical, testing was performed to demonstrate the safety and efficacy of Sensitive Eyes Multi-Purpose Solution; all studies had previously been submitted under K 973921 which cleared January 12, 1998. A summary of that testing has been previously provided.
To support a claim of 10 minute disinfection cycle time, a series of microbiological testing has been completed at time period ranging from 10 minutes to 240 minutes. All results were satisfactory.
Key Metrics
Not Found
Predicate Device(s)
K 973921
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510 (k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH AND LOMB ReNu [TBD] MULTI-PURPOSE SOLUTION
Submitter Information 1.
Bausch & Lomb Incorporated Global Vision Care 1400 N. Goodman Street Rochester, New York 14692-0450
| Contact Person: | Paul G. Stapleton |
|---|---|
| Director, Global Regulatory Affairs |
716-338-8172 Telephone Number:
2. Device Name
Classification Name: Soft (hydrophilic) Contact Lens Solution
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution Proprietary Name:
Predicate Device 3.
Bausch & Lomb Sensitive Eyes Multi-Purpose Solution cleared under K 973921 has been selected as the predicate device for Bausch & Lomb ReNu [TBD] Multi-Purpose Solution with the new indication of 10 minute disinfection cycle.
Description of the Device 4.
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is a multi-purpose solution used in the care of soft (hydrophilic) contact lenses and is indicated for the cleaning, rinsing, disinfection and storage of soft (hydrophilic) contact lenses. It may also be used as a diluent for enzymatic cleaning tablets which are to be used in conformance to the established labeling directions of the enzymatic cleaning tablets. The solution is contained in a plastic bottle and consists of a sterile isotonic solution that contains boric acid, edetate disodium, poloxamine. sodium borate and sodium chloride; it is preserved with alexidine dihydrochloride 4 ppm.
1
Each plastic bottle is supplied sterile and is labeled with a lot number and expiration date.
11 11:11 11 11
Indications for Use 5.
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider. It is also indicated for use in dissolving enzymatic cleaning tablets.
Description of Safety and Substantial Equivalence 6.
A series clinical and preclinical, testing was performed to demonstrate the safety and efficacy of Sensitive Eyes Multi-Purpose Solution; all studies had previously been submitted under K 973921 which cleared January 12, 1998. A summary of that testing has been previously provided.
To support a claim of 10 minute disinfection cycle time, a series of microbiological testing has been completed at time period ranging from 10 minutes to 240 minutes. All results were satisfactory.
Substantial Equivalence
BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution is substantially equivalent to the predicate device. BAUSCH & LOMB ReNu [TBD] Multi-Purpose Solution in a 10 minutes disinfection cycle time is microbiologically equivalent to a 4 hour disinfection cycle time.
This product will be sold in plastic bottles as a sterile solution; each bottle will be marked STERILE and will be identified with a lot number and expiration date.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1998 NOV
Mr. Paul G. Stapleton Director, Global Regulatory Affairs Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14603-0450
Re: K982775
Trade Name: BAUSCH & LOMB® Renu® [TBD™] Multi Purpose Solution Regulatory Class: II Product Code: 86 LPN Dated: August 5, 1998 Received: August 7, 1998
Dear Mr. Stapleton:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Paul G. Stapleton
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450
Indications for Use Statement
510(k) Number (if known): __
Device Name: BAUSCH & LOMB ReNu [TM TBD] Multi-Purpose Solution
Indications for Use:
BAUSCH & LOMB ReNu [TM TBD] Multi-Purpose Solution is indicated for use in the daily cleaning, rinsing, chemical (not heat) disinfection and storage of soft (hydrophilic) contact lenses as recommended by your eye care provider. It is also indicated for use in dissolving enzymatic cleaning tablets.
(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-Use
r.
P
Myra Smith
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K982775