(241 days)
No
The device description and intended use clearly define it as a contact lens care solution, and there is no mention of AI, ML, or related concepts in the provided summary.
No
The device is a multi-purpose solution for cleaning and storing contact lenses, not for treating a disease or condition.
No
The device description and intended use clearly state that this is a multi-purpose solution for cleaning, disinfecting, conditioning, and storing contact lenses. It does not perform any diagnostic function.
No
The device is a contact lens care solution, which is a chemical product, not a software-only medical device. The description clearly outlines its chemical composition and physical packaging.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Bausch + Lomb ABT12 multi-purpose solution is a liquid used for cleaning, disinfecting, and storing contact lenses. It is applied to the contact lens itself, not to a sample taken from the human body.
- Lack of Diagnostic Function: The solution's purpose is to maintain the contact lens, not to diagnose any medical condition in the user.
Therefore, this product falls under the category of a medical device for contact lens care, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN
Device Description
Bausch + Lomb ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility: Cytotoxicity, ocular irritation, oral toxicity, sensitization and in-vivo ocular biocompatibility studies were completed for Bausch + Lomb ABT12 multi-purpose solution. Testing was conducted under various conditions including on ABT12 multi-purpose solution itself, the ABT12 solution manufactured with the maximum preservative concentrations, and testing with extracts of eight different lenses (USAN materials) cycled 30 times in ABT12 multi-purpose solution. In relevant studies the predicate device K014202 was used for side by side comparison. The test results demonstrated the biocompatibility of Bausch + Lomb ABT12 multi-purpose solution.
Microbiology: The sponsor conducted a series of studies according to EN ISO 14729:2001 and EN ISO 14730:2014 and demonstrated Bausch + Lomb ABT12 multi-purpose solution exceeds the criteria for disinfection and preservative efficacy.
Lens Compatibility: The results of lens compatibility studies demonstrate Bausch + Lomb ABT12 multi-purpose solution is compatible with soft contact lenses including silicone hydrogel contact lenses.
Cleaning Efficacy: The cleaning efficacy of the solution was evaluated through the determination of the Critical Micelle Concentration (CMC). In-vitro laboratory studies demonstrated the cleaning properties of Bausch + Lomb ABT12 multi-purpose solution with contact lenses artificially deposited with protein.
Clinical Study: A controlled clinical study with soft (hydrophilic) contact lenses, including silicone hydrogel lenses, comparing the safety and effectiveness of Bausch + Lomb ABT12 multi-purpose solution to COMPLETE multi-purpose solution Easy Rub Formula.
- Sample Size: A total of 252 subjects were enrolled in the study. 240 subjects completed the study.
- Study Type: Multicenter, randomized, masked, parallel, bilateral study.
- Key Results - Safety: The ABT12 group demonstrated noninferiority to the COMPLETE group Over All Follow-up Visits for slit lamp findings greater than Grade 2. There were no eyes with serious adverse events, adverse device effects, or significant non-serious adverse events in the ABT12 group, and no eyes were discontinued due to an AE. No corneal infiltrates or changes to pre-existing corneal scars were reported. Visual acuities were similar between both groups. The ABT12 multi-purpose solution is safe for use with soft contact lenses, including silicone hydrogel lenses.
- Key Results - Effectiveness: For each of the three primary effectiveness endpoints (overall comfort, dryness, and optimal {none or light} lens deposits at all follow-up visits), the treatment differences indicated that the ABT12 solution is non-inferior to the COMPLETE solution. There were no notable differences between the two treatment groups with regard to additional effectiveness assessments. The ABT12 multi-purpose solution is effective for use with soft contact lenses, including silicone hydrogel lenses.
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.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 28, 2021
Bausch & Lomb Incorporated Melissa Thomas Director, Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K202932
Trade/Device Name: ABT12 multi-purpose solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN Dated: April 27, 2021 Received: April 28, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling
1
(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202932
Device Name ABT12 multi-purpose solution
Indications for Use (Describe)
Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silicone hydrogel contact lenses, as recommended by your eye care practitioner.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| General Information | |
|---|---|
| Submitter: | Contact Person: |
| Bausch & Lomb Incorporated | Melissa Thomas |
| 1400 North Goodman Street | 1400 North Goodman Street |
| Rochester, NY 14609 | Rochester, NY 14609 |
| General Telephone: 585-338-5800 | 585-338-6045 (phone) |
| 585-338-0702 (fax) | |
| Melissa.Thomas@bausch.com |
Premarket Notification Number: K202932
Preparation Date: May 27, 2021
| 1. Names | |
|---|---|
| Device Name: | Bausch + Lomb ABT12 multi-purpose solution |
| Classification Name: | Accessories, Soft Lens Products |
| Common Name: | Soft (hydrophilic) Contact Lens Care Solution |
| Product Codes: | LPN |
| Device Classification: | Class II (21 CFR §886.5928) |
2. Predicate Devices
K014202 COMPLETE multi-purpose solution Easy Rub Formula cleared on February 20, 2002.
3. Product Description
The subject of this 510(k) submission is for the new product Bausch + Lomb ABT12 multi-purpose solution which is substantially equivalent to the COMPLETE multi-purpose solution Easy Rub Formula which is currently commercialized.
Bausch + Lomb ABT12 multi-purpose solution is a sterile isotonic aqueous solution [containing polyaminopropyl biguanide (0.0005%), polyquaternium (0.00015%), and alexidine (0.00025%)] for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft (hydrophilic) and silicone hydrogel contact lenses. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
4. Indications for Use
Bausch + Lomb ABT12 multi-purpose solution is indicated for use in the daily cleaning, conditioning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses, including silcone hydrogel contact lenses, as recommended by your eye care practitioner.
5. Summary of Technological Characteristics
The technological characteristics of Bausch + Lomb ABT12 multi-purpose solution are substantially equivalent to those of the predicate devices.
4
| Features | Predicate Device
COMPLETE multi-purpose
solution Easy Rub Formula | Subject Device
ABT12 multi-purpose solution |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K014202 | K202932 |
| | Classification | |
| Classification | Class II | Class II |
| Product Code | LPN | LPN |
| | Indication | |
| Indicated for Soft
Contact Lenses | Yes | Yes |
| Indicated for
Silicone Hydrogel
Lenses | No | Yes |
| | Indicated for the care of soft
(hydrophilic) contact lenses. Use
this product, as recommended by
your eye care professional, to: •
Chemically (NOT HEAT) Disinfect
• Clean • Rinse • Store • Remove
Protein | Indicated for use in the daily cleaning,
conditioning, removing protein deposits,
rinsing, chemical (not heat) disinfection, and
storage of soft (hydrophilic) contact lenses,
including silicone hydrogel contact lenses,
as recommended by your eye care
practitioner. |
| Intended Use | | |
| | Formulation / Regimen | |
| Rub Regimen | 3 Or More Drops for 20 seconds | 3 Drops for 20 seconds |
| Optional No-Rub
Regimen | No | No |
| Rinse Required for
Cleaning | Rinse for 5 seconds on each side | Thoroughly rinse for 5 seconds on each side |
| Minimum
Disinfection Time | 6 hours | 4 hours |
| Triple Disinfection
System | No | Yes |
| Preservatives /
Disinfectants | Polyhexamethylene biguanide | Polyaminopropyl Biguanide
Polyquaternium
Alexidine |
| Dural Surfactants | No | Yes |
| Surfactants | Poloxamer 237 | Poloxamer 181
Poloxamine 1107 |
| Lens Storage
Period | 30 Days | 30 Days |
| Discard After
Opening | 90 Days | 90 Days |
| Primary Container | White Plastic Bottle, Multiple
Sizes | Clear Plastic Bottle, Multiple Sizes |
| Tamper Resistant | Yes | Yes, includes a tamper evident seal |
5
6. Safety and Effectiveness Information
The review of the indications for use and technical characteristics provided demonstrates that Bausch + Lomb ABT12 multi-purpose solution is substantially equivalent to the predicate devices.
Performance Data
A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb ABT12 multi-purpose 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:
Biocompatibility
Cytotoxicity, ocular irritation, oral toxicity, sensitization and in-vivo ocular biocompatibility studies were completed for Bausch + Lomb ABT12 multi-purpose solution in accordance with FDA Guidance Premarket Notification (510(K)) Guidance Document for Contact Lens Care Products. Testing was conducted under various conditions including on ABT12 multi-purpose solution itself, the ABT12 solution manufactured with the maximum preservative concentrations, and testing with extracts of eight different lenses (USAN materials) cycled 30 times in ABT12 multi-purpose solution. In relevant studies the predicate device K014202 was used for side by side comparison. ABT12 multi-purpose solution uses identical packaging materials previously cleared under K083757, testing previously conducted on the packaging components was leveraged to support biocompatibility. The test results demonstrated the biocompatibility of Bausch + Lomb ABT12 multi-purpose solution.
Microbiology
The sponsor conducted a series of studies according to EN ISO 14729:2001 Ophthalmic optics – Contact lens care products – Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, including Amendment 1 (2010) and EN ISO 14730:2014 Ophthalmic optics – Contact lens care products – Antimicrobial preservative efficacy testing and guidance on determining discard date and demonstrate Bausch + Lomb ABT12 multi-purpose solution exceeds the criteria for disinfection and preservative efficacy.
Lens Compatibility
The results of lens compatibility studies demonstrate Bausch + Lomb ABT12 multi-purpose solution is compatible with soft contact lenses including silicone hydrogel contact lenses.
Cleaning Efficacy
The cleaning efficacy of the solution was evaluated through the determination of the Critical Micelle Concentration (CMC). The surfactant concentrations are well above the CMC for the individual surfactants. In-vitro laboratory studies demonstrated the cleaning properties of Bausch + Lomb ABT12 multi-purpose solution with contact lenses artificially deposited with protein.
Clinical Study
Bausch + Lomb conducted a controlled clinical study with soft (hydrophilic) contact lenses, including silicone hydrogel lenses, comparing the safety and effectiveness of Bausch + Lomb ABT12 multi-purpose solution to COMPLETE multi-purpose solution Easy Rub Formula. The results of the study support a substantial equivalence determination.
A total of 252 subjects were enrolled in a three-month multicenter, randomized, masked, parallel, bilateral study conducted in the USA. Subjects were randomized to receive Bausch + Lomb investigational
6
K202932
ABT12 multi-purpose solution (Test), or COMPLETE® Multi-Purpose Solution (Control). Eligible subjects were enrolled into one of five lens groups based on their habitual contact lenses. In total, 240 of the 252 subjects enrolled completed the study.
Subject Demographics:
Of the 127 subjects in the ABT12 group, 39 (30.7%) were male and 88 (69.3%) were female, with a mean (SD) age of 34.4 (9.72) years (range: 18 - 67 years). Of the 125 subjects in the COMPLETE group, 34 (27.2%) were male and 91 (72.8%) were female, with a mean (SD) age of 34.1 (9.79) years (range: 18 - 65 years).
With regard to race, in the ABT12 group 101 (80.2%) subjects were White, 13 (10.3%) were Black/African American, 11 (8.7%) were Asian, and 1 (0.8%) was Multiple. In the COMPLETE group 103 (82.4%) subjects were White, 11 (8.8 %) were Black/African American, 10 (8.0%) were Asian, and 1 (0.8 %) was Multiple.
Safety results:
The primary endpoint of interest for slit lamp findings was achieved. The ABT12 group demonstrated noninferiority to the COMPLETE group Over All Follow-up Visits for slit lamp findings greater than Grade 2.
In the test device ABT12 multi-purpose solution there were no eyes with serious adverse events, adverse device effects, or significant non-serious adverse events, and there were no eyes discontinued from the study due to an AE. None of the AEs in either treatment group were considered related to the study solution.
There were no corneal infiltrates reported and no changes to pre-existing corneal scars. There were no notable differences between the ABT12 and COMPLETE groups for any of the lens wear or lens performance parameters at any of the study visits. Visual acuities were similar between eyes of both groups.
In conclusion, graded slit lamp findings; the comparison of AEs; and the comparison of visual acuities indicate that the ABT12 multi-purpose solution is safe for use with soft contact lenses, including silicone hydrogel lenses.
Effectiveness results:
For each of the three primary effectiveness endpoints (overall comfort averaged over all follow-up visits; dryness averaged over all follow-up visits; and optimal [{none or light} lens deposits at all follow-up visits), the treatment differences indicated that the ABT12 solution is non-inferior to the COMPLETE solution. There were no notable differences between the two treatment groups with regard to the additional effectiveness assessments of symptoms/complaints, worn lens characteristics, and dispensed lens characteristics. In conclusion, the three primary effectiveness endpoints indicate that the ABT12 multi-purpose solution is effective for use with soft contact lenses, including silicone hydrogel lenses.
Substantial Equivalence
The cumulative results of laboratory, in-vivo, and clinical testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb ABT12 multi-purpose solution are substantially equivalent to COMPLETE multi-purpose solution Easy Rub Formula for soft contact lenses, including silicone hydrogel contact lenses.