(147 days)
Not Found
No
The device description and performance studies focus on the chemical composition and cleaning/disinfection efficacy of a contact lens solution, with no mention of AI or ML technologies.
No.
This device is a contact lens care solution, which is intended for cleaning, disinfecting, and storing contact lenses, not for treating a disease or condition. While it ensures the lenses are safe for wear, it does not directly act on the body therapeutically.
No
This device is a multi-purpose solution for contact lens care (cleaning, disinfection, storage), not a device used to diagnose a medical condition.
No
The device is a contact lens care solution, which is a chemical product, not a software-only medical device. The description details its chemical composition and physical form (sterile solution in a plastic bottle).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the care and maintenance of contact lenses (cleaning, disinfecting, storing, etc.). This is a product used on a medical device (contact lenses) to ensure their safe and effective use, not a product used to diagnose a condition or analyze a biological sample.
- Device Description: The description details the chemical composition of a solution for contact lens care. It does not describe a device designed 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 patient's health
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry
The information provided clearly describes a contact lens care product, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Bausch + Lomb® NNR06 Multi-Purpose Solution is indicated for use in the daily conditioning, cleaning, removal of 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 NNR06 Multi-Purpose Solution is a sterile, isotonic solution containing a triple disinfection system (polyaminopropyl biguanide 0.00005%, polyquaternium 0.00015% and alexidine 0.0002%), dual surfactants, poloxamine, poloxamer 181, and a novel buffering system consisting of edetate disodium, sodium citrate, and diglycine. The formulation also contains boric acid, sodium borate, sodium chloride and purified water. 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)
Preclinical and clinical testing was performed to demonstrate the safety and effectiveness.
Biocompatibility studies (Cytotoxicity, ocular irritation, oral toxicity, sensitization and in vivio ocular biocompatibility studies) demonstrated biocompatibility.
Microbiology studies showed the solution exceeds criteria for disinfection and preservative efficacy. Sterilization methods were also assessed.
Lens compatibility studies confirmed compatibility with soft contact lenses including silicone hydrogel contact lenses.
Cleaning efficacy was evaluated through Critical Micelle Concentration and in vitro laboratory studies showing cleaning properties.
Clinical Study: A three-month, active control, parallel group, masked randomized study of habitual contact lens wearers compared the safety and effectiveness of Bausch + Lomb NNR06 Multi-Purpose Solution to Complete Multi-Purpose Solution Easy Rub Formula.
Safety: Primary endpoint for slit lamp findings was achieved with no reported adverse events. Visual acuities were similar. Slit lamp findings, symptoms requiring medical treatment, and absence of adverse events indicated safety.
Effectiveness: Comfort-related symptoms/complaints, Investigator-assessed lens wettability, and Investigator-assessed lens deposits indicated effectiveness.
Key results: The study demonstrated similar safety and effectiveness profiles supporting substantial equivalence.
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
§ 886.5928 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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a symbol often associated with healthcare.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2016
Bausch & Lomb Incorporated Glenn Davies, O.D. Senior Director Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K161819
Trade/Device Name: NNR06 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: October 19, 2016 Received: October 20, 2016
Dear Dr. Davies:
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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Glenn Davies, O. D.
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
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Indications for Use
510(k) Number (if known)
K161819
Device Name NNR06 Multi-Purpose Solution
Indications for Use (Describe)
Bausch + Lomb® NNR06 Multi-Purpose Solution is indicated for use in the daily conditioning, cleaning, removal of 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) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K161819
510(k) SUMMARY
1. Submitter Information
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609
Contact Person Glenn A. Davies, O.D. Senior Director Requlatory Affairs
Telephone Number
(585) 338-8215
Summary Prepared: November 2016
2. Device Name
| Common Name: | Soft (hydrophilic) Contact Lens Care Solution |
|---|---|
| Trade Name: | NNR06 Multi-Purpose Solution |
| Classification: | Accessories, Soft Lens Products |
| Device classification: | Class II (21 CFR §886.5928) |
| Product Code: | LPN |
3. Predicate Device
COMPLETE Multi-Purpose Solution Easy Rub Formula (K030092)
4. Description of the Device
Bausch + Lomb NNR06 Multi-Purpose Solution is a sterile, isotonic solution containing a triple disinfection system (polyaminopropyl biguanide 0.00005%, polyquaternium 0.00015% and alexidine 0.0002%), dual surfactants, poloxamine, poloxamer 181, and a novel buffering system consisting of edetate disodium, sodium citrate, and diglycine. The formulation also contains boric acid, sodium borate, sodium chloride and purified water. The sterile solution is packaged in a plastic bottle with a tamper evident seal and labeled with a lot number and expiration date.
4
5. Intended Use
Bausch + Lomb NNR06 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.
6. Description of Safety and Substantial Equivalence
A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb NNR06 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 vivio ocular biocompatibility studies were completed for Bausch + Lomb NNR06 Multi-Purpose Solution. The test results demonstrated the biocompatibility of NNR06 Multi-Purpose Solution.
Testing was conducted according to Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and ISO Standard 10993-1 Biological evaluation of medical devices and related biocompatibility standards (ISO 9394. ISO 10993-5. ISO 10993-10. ISO 10993-11).
Microbiology
The sponsor conducted a series of studies according to EN ISO 14729:2001 Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, including Amendment 1 (2010), and EN ISO 14730:2014 Antimicrobial preservative efficacy testing and guidance on determining discard date, ISO18259 Method to assess contact lens care products with contact lens care products with contact lenses in a lens case, and ISO 19045 Method for evaluating Acanthamoeba encystment by contact lens care products and demonstrate Bausch + Lomb NNR06 Multi-Purpose Solution exceeds the criteria for disinfection and preservative efficacy.
In addition, ISO 17665-1 Sterilization of Health Care Products - Moist Heat and ISO 11137 Sterilization of Health Care Products - Radiation were used to assess the sterilization method for production.
Lens Compatibility
The results of lens compatibility studies demonstrate Bausch + Lomb NNR06 Multi-Purpose Solution is compatible with soft contact lenses including silicone hydrogel contact lenses.
Testing was conducted according to Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and ISO Standard 11981
5
Determination of physical compatibility of contact lens care products with contact lenses, ISO 11986 Determination of preservative uptake and release.
Cleaning Efficacy
The cleaning efficacy of the solution was evaluated through the determination of the Critical Micelle Concentration. The surfactant concentrations are well above the CMC for the individual surfactants. In vitro laboratory studies demonstrated the cleaning properties of NNR06 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 NNR06 Multi-Purpose Solution to Complete Multi-Purpose Solution Easy Rub Formula. The study was a three-month, active control, parallel group, masked randomized study of habitual contact lens wearers.
Testing was conducted according to Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997 and ISO Standard 11980 Guidance for clinical investigations.
Safety
The primary endpoint of interest for slit lamp findings was achieved. There were no reported adverse events in either treatment group during the study. Visual acuities were similar between eyes of both groups.
Graded slit lamp findings; the incidence and type of slit lamp findings and symptoms requiring medical treatment; the comparison of visual acuities; and the absence of adverse events indicate that the NNR06 Solution is safe for use with soft contact lenses, including silicone hydrogel lenses.
Effectiveness
Comfort-related symptoms/complaints, Investigator-assessed lens wettability, and Investigator-assessed lens deposits indicate that the NNR06 Multi-Purpose Solution is effective for use with soft contact lenses including silicone hydrogel lenses.
The results of the study demonstrated similar safety and effectiveness profiles and support a substantial equivalence determination.
7. Substantial Equivalence
Bausch + Lomb NNR06 Multi-Purpose Solution has the same technological characteristics, sterile, isotonic, aqueous chemical disinfecting solution, as the predicate device. Bausch + Lomb NNR06 Multi-Purpose Solution does not raise new questions of safety and effectiveness.
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The cumulative results of laboratory, in vivo, and clinical testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb NNR06 Multi-Purpose Solution are substantially equivalent to AMO Complete Multi-Purpose Solution Easy Rub Formula for soft contact lenses, including silicone hydrogel contact lenses.
The similarities and differences between Bausch + Lomb NNR06 Multi-Purpose Solution and the predicate device, AMO Complete Multi-Purpose Solution Easy Rub Formula, are described in the following table.
| Feature | Bausch + Lomb
NNR06 Multi-Purpose
Solution | AMO
Complete Multi-
Purpose Solution
Easy Rub Formula |
|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indicated for Soft Lenses | Yes | Yes |
| Indicated for Silicone
Hydrogel Lenses | Yes | No |
| Indicated for use in
conditioning, cleaning,
removal of protein rinsing,
disinfection and storage of
contact lenses | Yes | Yes
Except Conditioning |
| Rub Regimen | 3 Drops
20 Seconds | 3 Or More Drops
20 Seconds |
| Optional No-Rub Regimen | No | No |
| Rinse Required for
Cleaning | Thoroughly Rinse
5 Seconds Each Side | Rinse
5 Seconds Each Side |
| Minimum Disinfection Time | 4 hours | 6 hours |
| Triple Disinfection System | Yes | No |
| Preservatives /
Disinfectants | Polyaminopropyl Biguanide
0.5ppm
Polyquaternium
1.5ppm
Alexidine
2.0ppm | Polyhexamethylene Biguanide
1ppm |
SUBSTANTIAL EQUIVALENCE SUMMARY TABLE
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SUBSTANTIAL EQUIVALENCE SUMMARY TABLE (CONTINUED)
| Feature | Bausch + Lomb
NNR06 Multi-Purpose
Solution | AMO
Complete Multi-
Purpose Solution
Easy Rub Formula |
|-----------------------|--------------------------------------------------|----------------------------------------------------------------|
| Dual Surfactants | Yes | No |
| Surfactants | Poloxamer 181
Poloxamine | Poloxamer 237 |
| Lens Storage Period | 30 Days | 30 Days |
| Discard After Opening | 90 Days | No
Use Before Expiration Date |
| Primary Container | Clear Plastic Bottle
Multiple Sizes | White Plastic Bottle
Multiple Sizes |