(50 days)
P920055, K974466
No
The device description and performance studies focus on chemical formulations and their efficacy in cleaning and disinfecting contact lenses. There is no mention of AI or ML in the provided text.
No.
These devices are contact lens care products, indicated for cleaning, disinfecting, and conditioning contact lenses, not for treating a diseased condition in the human body.
No
Explanation: The device, Boston ADVANCE Cleaner and Conditioning Solution, is intended for cleaning, wetting, disinfecting, and soaking contact lenses. Its purpose is to maintain contact lenses, not to diagnose a medical condition.
No
The device description clearly indicates that the device is a sterile, concentrated, homogeneous surfactant solution and a sterile, aqueous, buffered, slightly hypertonic solution, which are physical substances, 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 clean, wet, disinfect, and soak contact lenses. This is a direct interaction with a medical device (contact lenses) for maintenance and hygiene, not for diagnosing a condition or examining a specimen from the human body.
- Device Description: The description details the chemical composition of cleaning and conditioning solutions for contact lenses. These are topical solutions applied to the lenses, not reagents or instruments used to test biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
The device is clearly a contact lens care product, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
Product codes (comma separated list FDA assigned to the subject device)
MRC
Device Description
Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.
Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).
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)
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified regimen which replaces the water rinse with Bausch + Lomb Sensitive Eyes Plus Saline Solution as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997.
Microbiology:
Studies were previously performed to establish discard dating for both Boston ADVANCE Cleaner and Boston ADVANCE Conditioning Solution. The test articles were evaluated initially and again following simulated use for the proposed 90 discard dates.
The results of these evaluations demonstrate that both solutions meet the requirements of ISO 14730, Annex C, Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.
Additionally a modified regimen procedure allowing for a rinse with Sensitive Eyes Plus Saline Solution in place of tap water was conducted. The results demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products when used in a 10 second rub, 5 second rinse (per lens side) regimen. The products used in this regimen also meet the performance criteria established in ISO Standard 14729: 2001/Amd. 1:2010: (E) for regimen testing.
Biocompatibility: Biocompatibility tests were unnecessary for this application. Previous data submitted is still applicable, please reference P920055 for Boston ADVANCE Conditioning Solution, and K974466 for Boston ADVANCE Cleaner.
Lens Compatibility: The results of lens compatibility studies per ISO 11981 demonstrate that replacing water with Bausch + Lomb Sensitive Eyes Plus Saline Solution as part of the regimen is compatible with gas permeable contact lenses.
Clinical Data: Clinical studies involving the modified regimen for Boston ADVANCE Cleaner and Conditioning Solution were unnecessary for this application. This Cleaner -Conditioning System has been commercially available in the market for almost 20 years with well demonstrated safety and efficacy.
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
§ 886.5918 Rigid gas permeable contact lens care products.
(a)
Identification. A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
March 27, 2018
Bausch and Lomb Incorporated Melissa Thomas Senior Manager Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K180319
Trade/Device Name: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC Dated: February 1, 2018 Received: February 5, 2018
Dear Melissa Thomas:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180319
Device Name
Bausch + Lomb Boston ADVANCE Cleaner Bausch + Lomb Boston ADVANCE Conditioning Solution
Indications for Use (Describe)
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Research Use (Part 21 CFR 201. Subject to Change) | In-Vitro Diagnostic Use (21 CFR 801. Subject to Change) |
|---|---|
| ---------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------ |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
Bausch + Lomb Boston ADVANCE Cleaner & Conditioning Solution
1. Submitter Information
| Primary | Alternate |
|---|---|
| Melissa Thomas | Glenn Davies, O.D. |
| Senior Manager, Regulatory Affairs | Sr. Director Regulatory Affairs, |
| 1400 North Goodman Street | 1400 North Goodman Street |
| Rochester, NY 14609 | Rochester, NY 14609 |
| Tel. (585) 338-6045 | Tel. (585) 338-8215 |
| Fax (585) 338-0702 | Email: Glenn.Davies@bausch.com |
| Email: Melissa.Thomas@bausch.com |
Summary Prepared: February 1, 2018
2. Device Name
| Trade Name: | Boston ADVANCE Cleaner & Conditioning Solution |
|---|---|
| Classification: | Accessories, Contact Lens Care Products |
| Device classification: | Class II |
| Regulation Number: | 886.5918 Rigid Gas Permeable Contact Lens Care Products |
| Product Code: | MRC |
3. Predicate Device
Bausch + Lomb Boston ADVANCE Cleaner (K974466) Bausch + Lomb Boston ADVANCE Conditioning Solution (P920055) Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483)
4. Description of the Device
Boston ADVANCE Cleaner is a sterile, concentrated, homogeneous surfactant solution containing alkyl ether sulfate, ethoxylated alkyl phenol, tri-quaternary cocoa-based phospholipid and silica gel as cleaning agents; with titanium dioxide.
Boston ADVANCE Conditioning Solution is a sterile, aqueous, buffered, slightly hypertonic solution containing a cationic cellulose derivative polymer, a cellulosic viscosifier, polyvinyl alcohol and a derivatized polyethylene glycol as wetting and cushioning agents; preserved with chlorhexidine gluconate (0.003%), polyaminopropyl biguanide (0.0005%) and edetate disodium (0.05%).
4
5. Intended Use
Boston ADVANCE Cleaner is indicated for use to clean fluoro silicone acrylate and silicone acrylate gas permeable contact lenses after each removal and before conditioning (wetting, soaking, disinfecting).
Boston ADVANCE Conditioning Solution is indicated for wetting, disinfecting and soaking (after cleaning and rinsing) fluoro silicone acrylate and silicone acrylate gas permeable contact lenses.
6. Description of Safety and Substantial Equivalence
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the modified regimen which replaces the water rinse with Bausch + Lomb Sensitive Eyes Plus Saline Solution as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997. A brief summary of the test results is provided below:
Microbiology
Studies were previously performed to establish discard dating for both Boston ADVANCE Cleaner and Boston ADVANCE Conditioning Solution. The test articles were evaluated initially and again following simulated use for the proposed 90 discard dates.
The results of these evaluations demonstrate that both solutions meet the requirements of ISO 14730, Annex C, Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.
Additionally a modified regimen procedure allowing for a rinse with Sensitive Eyes Plus Saline Solution in place of tap water was conducted. The results demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for regimen evaluation as described in the May 1, 1997 Guidance for Industry, Pre-market Notification (510(k)) Guidance Document for Contact Lens Care Products when used in a 10 second rub, 5 second rinse (per lens side) regimen. The products used in this regimen also meet the performance criteria established in ISO Standard 14729: 2001/Amd. 1:2010: (E) for regimen testing.
Biocompatibility
Biocompatibility tests were unnecessary for this application. Previous data submitted is still applicable, please reference P920055 for Boston ADVANCE Conditioning Solution, and K974466 for Boston ADVANCE Cleaner.
Lens Compatibility
The results of lens compatibility studies per ISO 11981 demonstrate that replacing water with Bausch + Lomb Sensitive Eyes Plus Saline Solution as part of the regimen is compatible with gas permeable contact lenses.
Clinical Data
Clinical studies involving the modified regimen for Boston ADVANCE Cleaner and Conditioning Solution were unnecessary for this application. This Cleaner -Conditioning System has been commercially available in the market for almost 20 years with well demonstrated safety and efficacy.
5
7. Substantial Equivalence
The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of the modified regimen for Boston ADVANCE Cleaner and Conditioning Solution to include Bausch + Lomb Sensitive Eyes Plus Saline Solution when used with gas permeable contact lenses are substantially equivalent to the current regimen with a water rinse.