(241 days)
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.
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.
Based on the provided text, the device in question is a multi-purpose contact lens solution (ABT12 multi-purpose solution), not an AI-powered medical device for image analysis. Therefore, many of the typical acceptance criteria and study details related to AI performance (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of product and approval process.
The document describes the regulatory approval of a contact lens solution (Bausch + Lomb ABT12 multi-purpose solution) for which the primary claims are related to its safety and effectiveness in cleaning, disinfecting, and storing contact lenses. The "acceptance criteria" here are based on demonstrating substantial equivalence to a predicate device (COMPLETE multi-purpose solution Easy Rub Formula) through a combination of preclinical (biocompatibility, microbiology, lens compatibility, cleaning efficacy) and clinical studies.
Here's a breakdown of the requested information, adapted to the context of this non-AI medical device:
Acceptance Criteria and Study for Bausch + Lomb ABT12 Multi-Purpose Solution
As the device is a contact lens solution, not an AI-powered diagnostic tool, the typical "acceptance criteria" table for AI performance metrics (e.g., sensitivity, specificity, AUC) is not applicable. Instead, the acceptance criteria are based on demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a contact lens solution primarily revolve around meeting established safety and effectiveness standards, often demonstrated through non-inferiority to a legally marketed predicate device.
| Criteria Category | Specific Acceptance Criteria (Demonstrated via Non-Inferiority to Predicate) | Reported Device Performance (ABT12 Multi-Purpose Solution) |
|---|---|---|
| Clinical Safety | Non-inferiority in ophthalmological findings (e.g., slit lamp findings) compared to predicate. Absence of serious adverse events (SAEs) or device-related adverse events (AEs). No significant changes to corneal health. | The ABT12 group demonstrated non-inferiority to the COMPLETE group Over All Follow-up Visits for slit lamp findings greater than Grade 2. No serious adverse events, adverse device effects, or significant non-serious adverse events were reported in the ABT12 multi-purpose solution group. No eyes were discontinued due to an AE. None of the AEs were considered related to the study solution. No corneal infiltrates were reported, and no changes to pre-existing corneal scars. Visual acuities were similar between groups. Conclusion: Safe for use. |
| Clinical Effectiveness | Non-inferiority in user-reported comfort and dryness. Non-inferiority in lens deposit prevention/removal. | For 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. No notable differences were found regarding symptoms/complaints, worn lens characteristics, and dispensed lens characteristics. Conclusion: Effective for use. |
| Biocompatibility | No significant cytotoxicity, ocular irritation, oral toxicity, or sensitization. Compatibility with various lens materials. | Studies demonstrated the biocompatibility of ABT12 multi-purpose solution, including tests on the solution itself, with maximum preservative concentrations, and with extracts from different lens materials. Leveraged existing clearance for packaging components. Predicate K014202 was used for side-by-side comparison in relevant studies. |
| Microbiological Efficacy | Meets or exceeds criteria for disinfection and preservative efficacy against relevant microorganisms (e.g., as per EN ISO 14729:2001 and EN ISO 14730:2014). | The solution exceeds the criteria for disinfection and preservative efficacy. |
| Lens Compatibility | Compatible with soft contact lenses, including silicone hydrogel contact lenses. | Studies demonstrated compatibility with soft contact lenses, including silicone hydrogel contact lenses. |
| Cleaning Efficacy | Demonstrates effective cleaning properties (e.g., protein removal). | In-vitro laboratory studies demonstrated cleaning properties with artificially protein-deposited contact lenses. Surfactant concentrations are well above the Critical Micelle Concentration (CMC). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study - Test Set): A total of 252 subjects were enrolled. 240 subjects completed the study. These subjects were randomized into two groups:
- ABT12 multi-purpose solution (Test): 127 subjects
- COMPLETE multi-purpose solution (Control/Predicate): 125 subjects
- Data Provenance: The clinical study was a multicenter study conducted in the USA.
- Retrospective or Prospective: This was a prospective, randomized, masked, parallel, bilateral clinical study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable in the context of this device. The "ground truth" for a contact lens solution's performance is established through direct clinical observations (e.g., slit lamp findings by ophthalmologists/optometrists) and patient-reported outcomes, as well as laboratory testing results, rather than expert consensus on image interpretation. The study was masked, implying that the clinicians assessing outcomes were blinded to the treatment assignment.
4. Adjudication Method for the Test Set
This concept (adjudication of interpretations) is not applicable to this type of study. Clinical outcomes were measured directly by investigators in a masked fashion and patient-reported outcomes were collected.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. MRMC studies are typically used to evaluate the impact of a diagnostic tool (like AI) on physician performance in interpreting medical images. This study focused on the safety and effectiveness of a physical product (contact lens solution) in a clinical trial setting.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm for this device. The "standalone performance" of the contact lens solution is demonstrated through the preclinical studies (biocompatibility, microbiology, cleaning efficacy, lens compatibility) which evaluate the product's intrinsic properties irrespective of human handling errors (though proper usage instructions are provided).
7. The Type of Ground Truth Used
The ground truth was established through a combination of:
- Clinical Measurements: Objective clinical assessments by masked investigators (e.g., slit lamp findings, visual acuities).
- Patient-Reported Outcomes: Subjective data gathered directly from subjects regarding comfort, dryness, and other symptoms.
- Laboratory Testing: In-vitro and ex-vivo studies to assess intrinsic properties like microbiological efficacy, cleaning efficacy, and biocompatibility.
- Comparison to Predicate: The "truth" of effectiveness and safety was established by demonstrating non-inferiority to a known, legally marketed predicate device.
8. The Sample Size for the Training Set
This question is not applicable as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as this is not an AI/machine learning device.
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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
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(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
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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)
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| 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.
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| Features | Predicate DeviceCOMPLETE multi-purposesolution Easy Rub Formula | Subject DeviceABT12 multi-purpose solution |
|---|---|---|
| 510(k) Number | K014202 | K202932 |
| Classification | ||
| Classification | Class II | Class II |
| Product Code | LPN | LPN |
| Indication | ||
| Indicated for SoftContact Lenses | Yes | Yes |
| Indicated forSilicone HydrogelLenses | No | Yes |
| Indicated for the care of soft(hydrophilic) contact lenses. Usethis product, as recommended byyour eye care professional, to: •Chemically (NOT HEAT) Disinfect• Clean • Rinse • Store • RemoveProtein | Indicated for use in the daily cleaning,conditioning, removing protein deposits,rinsing, chemical (not heat) disinfection, andstorage of soft (hydrophilic) contact lenses,including silicone hydrogel contact lenses,as recommended by your eye carepractitioner. | |
| Intended Use | ||
| Formulation / Regimen | ||
| Rub Regimen | 3 Or More Drops for 20 seconds | 3 Drops for 20 seconds |
| Optional No-RubRegimen | No | No |
| Rinse Required forCleaning | Rinse for 5 seconds on each side | Thoroughly rinse for 5 seconds on each side |
| MinimumDisinfection Time | 6 hours | 4 hours |
| Triple DisinfectionSystem | No | Yes |
| Preservatives /Disinfectants | Polyhexamethylene biguanide | Polyaminopropyl BiguanidePolyquaterniumAlexidine |
| Dural Surfactants | No | Yes |
| Surfactants | Poloxamer 237 | Poloxamer 181Poloxamine 1107 |
| Lens StoragePeriod | 30 Days | 30 Days |
| Discard AfterOpening | 90 Days | 90 Days |
| Primary Container | White Plastic Bottle, MultipleSizes | Clear Plastic Bottle, Multiple Sizes |
| Tamper Resistant | Yes | Yes, includes a tamper evident seal |
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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
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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.
§ 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.”