(55 days)
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No
The device description and performance studies focus on the chemical composition and physical properties of a contact lens solution, with no mention of AI or ML.
No.
This device is a cleaning and soaking solution for contact lenses, not a substance applied to the body to treat a disease or condition.
No
The device is a contact lens wetting and soaking solution indicated for disinfecting and soaking contact lenses. It does not perform any diagnostic function.
No
The device is a sterile conditioning solution for contact lenses, contained in a plastic bottle, and consists of a liquid formulation. This is a physical product, 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 for disinfecting and soaking contact lenses. This is a product used on a medical device (contact lenses) for their maintenance, not a test performed on a biological sample from a human to diagnose a condition.
- Device Description: The description confirms it's a sterile solution for contact lens care.
- 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 patient's health
- Measuring analytes or biomarkers
The performance studies focus on the safety and effectiveness of the solution for contact lens care (cytotoxicity, irritation, disinfection efficacy, lens compatibility, etc.), not on diagnostic performance.
N/A
Intended Use / Indications for Use
BAUSCH & LOMB® Wetting and Soaking Solution is indicated for use in the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.
Product codes (comma separated list FDA assigned to the subject device)
86 LPN
Device Description
BAUSCH & LOMB Wetting and Soaking Solution is a sterile conditioning solution used in the care of rigid gas permeable and hard (PMMA) contact lenses and is indicated for the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses. This product is contained in a plastic bottle, and consists of a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified BAUSCH & LOMB Wetting and Soaking Solution.
Toxicology:
- In-Vitro Cytotoxicity: USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.
- Acute Ocular Irritation: Acute Ocular Irritation test was performed and produced no ocular irritation.
Microbiology:
- Preservative Effectiveness: Product stored up to 36 months at room temperature were tested for Preservative Effectiveness. The results demonstrate that the product meets the relevant preservative efficacy requirements.
- Disinfection Efficacy: Product stored at room temperature for 36 months was tested. The results demonstrate that the product meets the ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements.
- Shelf Life: Expiration dating was established based on 36 months room temperature data.
Solution Compatibility: BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses were subjected to a thirty cycle lens compatibility study with the modified BAUSCH & LOMB Wetting and Soaking Solution and BAUSCH & LOMB Concentrated Cleaner. After thirty repeated cycles, all physical and lens parameters were within ISO specifications, and there was no change in cosmetic appearance.
Wetting Angle: This study investigated retention of the modified BAUSCH & LOMB Wetting and Soaking Solution and the currently marketed BAUSCH & LOMB Wetting and Soaking Solution on three selected RGP lens materials (BOSTON IV, BOSTON ES, BP Flex PMMA). Dynamic contact angle (DCA) analysis was used. The results indicate that the modified and currently marketed solutions are equivalent in their behavior.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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.”
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510(k) Premarket Notification BAUSCH & LOMB Wetting and Soaking Solution
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 1 1 1998
FOR
BAUSCH & LOMB® WETTING AND SOAKING SOLUTION
1. SUBMITTER INFORMATION:
Polymer Technology, a division of Wilmington Partners, L.P. Global Vision Care 1400 N. Goodman Street Rochester, New York 14692-0450
2. CONTACT PERSON:
Address:
Telephone No .: Fax No .: E-mail Address:
Debra Ketchum Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14692 (716) 338-8638 (716) 338-0702 dketchum@bausch.com
3. DEVICE IDENTIFICATION:
Classification Name: Rigid Gas Permeable Contact Lens Solution BAUSCH & LOMB® Wetting and Soaking Solution Proprietary Name: Contact Lens Conditioning Solution Common Name:
4. PREDICATE DEVICE:
BAUSCH & LOMB Wetting and Soaking Solution has been selected as the predicate device for the modified BAUSCH & LOMB Wetting and Soaking Solution.
న్. DESCRIPTION OF THE DEVICE:
BAUSCH & LOMB Wetting and Soaking Solution is a sterile conditioning solution used in the care of rigid gas permeable and hard (PMMA) contact lenses and is indicated for the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate and hard (PMMA) contact lenses. This product is contained in a plastic bottle, and consists of a sterile, buffered solution, preserved with chlorhexidine gluconate and edetate disodium.
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6. INDICATIONS FOR USE:
BAUSCH & LOMB Wetting and Soaking Solution is indicated for use in the disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.
7. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE:
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified BAUSCH & LOMB Wetting and Soaking Solution. A summary of these results from the preclinical studies is presented below.
Toxicology:
In-Vitro Cytotoxicity:
USP Agar Diffusion Cytotoxicity was completed in accordance with USP XXII. The test article meets the requirements of the Agar Diffusion Test.
Acute Ocular Irritation:
Acute Ocular Irritation test was performed and produced no ocular irritation.
The results of all testing demonstrated that the safety and effectiveness of the modified BAUSCH & LOMB Wetting and Soaking Solution is equivalent to the currently marketed BAUSCH & LOMB Wetting and Soaking Solution.
The solution is not toxic and extracts of lenses treated with the solution are not toxic when tested in laboratory animals.
Microbiology:
Preservative Effectiveness:
Product stored up to 36 months at room temperature were tested for Preservative Effectiveness. The results of this test demonstrate that the product meets the relevant preservative efficacy requirements.
Disinfection Efficacy:
Product stored at room temperature for 36 months was tested. The results of this evaluation demonstrate that the product meets the ISO Stand Alone Procedure for Disinfecting Products Primary Acceptance Criteria requirements.
Shelf Life:
Expiration dating was established based on 36 months room temperature data.
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Solution Compatibility:
BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses were subjected to a thirty cycle lens compatibility study with the modified BAUSCH & LOMB Wetting and Soaking Solution and BAUSCH & LOMB Concentrated Cleaner.
After thirty repeated cycles with BAUSCH & LOMB Concentrated Cleaner and the modified BAUSCH & LOMB Wetting and Soaking Solution, all of the physical and lens parameters tested for BOSTON IV, BOSTON ES rigid gas permeable and BP FLEX hard tinted contact lenses were within ISO specifications for rigid corneal and scleral contact lenses. There were no change in the cosmetic appearance.
Wetting Angle:
This study investigated retention of the modified BAUSCH & LOMB Wetting and Soaking Solution and the currently marketed BAUSCH & LOMB Wetting and Soaking Solution on three selected RGP lens materials, BOSTON IV (silicone acrylate), BOSTON ES (fluoro silicone acrylate) tinted rigid gas permeable contact lenses and BP Flex PMMA contact lenses. Dynamic contact angle (DCA) analysis was the method chosen to measure the desorption of solution from the lens material surface. The results of the DCA testing indicate that the modified BAUSCH & LOMB Wetting and Soaking Solution and the currently marketed BAUSCH & LOMB Wetting and Soaking Solution are equivalent in their behavior.
SUBSTANTIAL EQUIVALENCE 8.
The modified BAUSCH & LOMB Wetting and Soaking Solution is substantially equivalent to the currently marketed BAUSCH & LOMB Wetting and Soaking Solution, approved July 11, 1984 under PMA P820070, Supplement 2, in that both products are formulated similarly, with the same indications, usage, and all aspects of manufacturing. The two products differ only in that one of the tonicity agents in the modified BAUSCH & LOMB Wetting and Soaking Solution has a lower concentration than found in the currently marketed product.
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.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 11 1998
Ms. Debra L.B. Ketchum Manager, Regulatory Affairs Polymer Technology 1400 N. Goodman Street Rochester, NY 14692
Re: K980133
Trade Name: BAUSCH & LOMB® Wetting and Soaking Solution Regulatory Class: II Product Code: 86 LPN Dated: January 14, 1998 Received: Tanuary 15, 1998
Dear Ms. Ketchum:
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; throughperiodic (QS) 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.
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Page 2 - Ms. Debra L.B. Ketchum
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 at (301) 443-6597.
Sincerely yours,
A. Robb Rosenthal, MD
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Polymer Technology, a division of Wilmington Partners, L.P. 1400 North Goodman Street Rochester, NY 14692-0450
Indications for Use Statement
K980133 510(k) Number (if known):
Device Name: BAUSCH & LOMB® Wetting and Soaking Solution
Indications for Use:
BAUSCH & LOMB® Wetting and Soaking Solution is indicated for use in disinfecting and soaking after cleaning and rinsing of fluoro silicone acrylate, silicone acrylate rigid gas permeable and hard (PMMA) contact lenses.
(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 /
Heniel W. C. Brown, PH.D.
(Division Sign Off)
sion of Onhthalmic Devic K980133 n/k) Number
APPX1.doc
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