(54 days)
Not Found
No
The device is a chemical solution and a lens case for cleaning contact lenses. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is a cleaning and disinfecting solution for contact lenses, not a therapeutic agent for medical conditions.
No
The device is a cleaning and disinfecting solution for contact lenses. Its intended use is to maintain contact lens hygiene, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a sterile, buffered solution containing chemical components and is packaged in physical bottles with a special lens case. This indicates 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 cleaning, disinfecting, and storing contact lenses. This is a direct interaction with a medical device (contact lenses) and not a test performed on a biological sample to provide information about a person's health.
- Device Description: The device is a cleaning and disinfecting solution and a special lens case. It acts on the contact lenses themselves.
- Lack of Biological Sample Testing: There is no mention of the device being used to test or analyze any biological samples (blood, urine, tissue, etc.) from a patient.
- Performance Studies: The performance studies mentioned are microbiological tests related to the efficacy of the solution in cleaning and disinfecting contact lenses, not diagnostic tests on biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is intended for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including sillcone hydrogel) and rigid gas permeable contact lenses, as recommended by your eve care practitioner.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
Device Description
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (referred to as PeroxiClear) is a sterile, buffered solution containing 3% hydrogen peroxide (which contains a phosphonic acid stabilizer), potassium chloride, propylene glycol, carbamide (urea), a citrate/phosphate buffer system, and a poloxamer (P-181) surfactant. The sterile solution is aseptically filled and packaged in ethylene oxide (EtO) sterilized plastic bottles with a tamper-evident seal and labeled with a lot number and expiration date. A special lens case, containing a platinum-coated neutralizing disc, is provided with each bottle of PeroxiClear. This is the same lens case as provided with the previously cleared device.
The solution and lens case combined are considered a lens care system. As with the previously cleared device, the solution requires the use of the provided lens case specifically designed for neutralization of the peroxide and cannot be used in combination with any other lens case. The system is designed to clean and disinfect contact lenses by filling solution into the provided lens case and allowing the lenses to soak for a minimum of four hours. During the soaking period, the hydrogen peroxide is neutralized by a platinum-coated disc, thereby allowing the lenses to be safely inserted in the eye.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
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)
In addition to stability studies, a series of studies were conducted according to EN ISO 14729:2001/AMD.1:2010(E) Ophthalmic optics - Contact lens care products -Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 147302000(E) Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.
The results of the non-clinical and stability testing demonstrate that the safety and effectiveness of Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is substantially equivalent to the previously cleared device.
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
K132216
510(k) Summary
1
· � ା
SEP 0 9 2013
Submitter Information:
| Date Prepared: | July 16, 2013 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street |
| Rochester, NY 14609 | |
| Contact Person: | Heather Michaels |
| Senior Specialist, Global Regulatory Affairs | |
| Phone Number: | (585) 338-8493 |
| (585) 338-0702 (fax) | |
| Email: | Heather.michaels@bausch.com |
Device Information:
| Trade Name: | Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide
Cleaning & Disinfecting Solution |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Contact Lens Disinfection Solution |
| Device
Classification: | Class II |
| Classification
Name: | Soft (hydrophilic) Contact Lens Care Products
(21 CFR 886.5928)
Rigid Gas Permeable Contact Lens Care Products
(21 CFR 886.5918) |
| Product Codes: | LPN, MRC |
Predicate Device:
The predicate device is Bausch + Lomb OCD04 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K112909).
.
1
Device Description:
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (referred to as PeroxiClear) is a sterile, buffered solution containing 3% hydrogen peroxide (which contains a phosphonic acid stabilizer), potassium chloride, propylene glycol, carbamide (urea), a citrate/phosphate buffer system, and a poloxamer (P-181) surfactant. The sterile solution is aseptically filled and packaged in ethylene oxide (EtO) sterilized plastic bottles with a tamper-evident seal and labeled with a lot number and expiration date. A special lens case, containing a platinum-coated neutralizing disc, is provided with each bottle of PeroxiClear. This is the same lens case as provided with the previously cleared device.
The solution and lens case combined are considered a lens care system. As with the previously cleared device, the solution requires the use of the provided lens case specifically designed for neutralization of the peroxide and cannot be used in combination with any other lens case. The system is designed to clean and disinfect contact lenses by filling solution into the provided lens case and allowing the lenses to soak for a minimum of four hours. During the soaking period, the hydrogen peroxide is neutralized by a platinum-coated disc, thereby allowing the lenses to be safely inserted in the eye.
Intended Use:
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is intended for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including sillcone hydrogel) and rigid gas permeable contact lenses, as recommended by your eve care practitioner.
The intended use above is identical to what was cleared in the original 510(k) (K112909).
2
2
Technological Characteristics:
The table below shows a side-by-side comparison of the technological characteristics of the modified device to the previously cleared device. Differences were evaluated during the design and development of the modified device and testing was completed to demonstrate the modified device and predicate device are substantially equivalent and the differences do not negatively impact the safety and efficacy of the device.
| Feature | Bausch + Lomb OCD04 3%
Hydrogen Peroxide Cleaning and
Disinfecting Solution
(predicate device) | Bausch + Lomb PeroxiClear™
3% Hydrogen Peroxide Cleaning
& Disinfecting Solution
(modified device) |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K112909 | K132216 |
| Device Class | Class II | Identical |
| Regulation | Soft (hydrophilic) Contact Lens
Care Products (21 CFR 886.5928) Rigid Gas Permeable Contact Lens
Care Products (21 CFR 886.5918) | Identical |
| Product Codes | LPN, MRC | Identical |
| Indications for Use | Indicated for the daily cleaning,
removal of protein deposits,
disinfection, and storage of soft
(hydrophilic) contact lenses (including
silicone hydrogel) and rigid gas
permeable contact lenses, as
recommended by your eye care
practitioner. | Identical |
| Rub Regimen | Yes, only for Rigid Gas Permeable
Lenses | Identical |
| No-Rub Regimen | 5 second rinse | Identical |
| Platinum-Coated
Neutralization Disc | Yes | Yes |
| Lens Case | Designed for System | Identical |
| Minimum Disinfection
Time | 4 hours | Identical |
| Post Disinfection Saline
Rinse Prior to Wear | Optional | Identical |
| Hydrogen Peroxide
Content | 3% | Identical |
| Buffer System | Phosphate / Citrate Buffers | Identical |
| Stabilizer | Phosphonic Acid | Identical |
| Lens Storage Period | 7 days | Identical |
| Discard After Opening | 90 days or 35 uses | Identical |
| Primary Container
(Material and Size) | HDPE Plastic
(120 ml, 360 ml) | Identical |
Table 1. Comparison of Technological Characteristics
3
Summary of Non-Clinical Testing:
In addition to stability studies, a series of studies were conducted according to EN ISO 14729:2001/AMD.1:2010(E) Ophthalmic optics - Contact lens care products -Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses and EN ISO 147302000(E) Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date.
Substantial Equivalence Conclusion:
The results of the non-clinical and stability testing demonstrate that the safety and effectiveness of Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution is substantially equivalent to the previously cleared device.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping shapes, resembling a person embracing another person.
Public Health Service
ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
September 9, 2013
Bausch & Lomb Incorporated Ms. Heather Michaels Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
K132216 Re:
RT52210
Trade/Device Name: Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) Contact lens Care Products Regulatory Class: Class II Product Code: LPN Dated: August 16, 2013 Received: August 19, 2013
Dear Ms. Michaels:
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 for use stated in the encreation to togally to the Medical Device Amendments, or to Commerce prior to May 20, 1970, and encordance 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 r ou may, mercesse, market 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), If your device is classified (000 above). Existing major regulations affecting your device can be It may of subject to additions, 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 ulat I DA has made a Geted regulations administered by other Federal agencies. You must of any I collars and regending, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Crk Fall 607), ademig (21 CFR 803); good manufacturing practice requirements as set
5
Page 2 - Ms. Heather Michaels
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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Kesia Y. Alexander -S
for Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K132216
Device Name:
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning & Disinfecting Solution
Indications for Use:
Bausch + Lomb PeroxiClear™ 3% Hydrogen Peroxide Cleaning and Disinfecting Solution is indicated for the daily cleaning, removal of protein deposits, disinfection, and storage of soft (hydrophilic) contact lenses (including silicone hydrogel) and rigid gas permeable contact lenses, as recommended by your eye care practitioner.
Prescription Use (part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Leonid Livshitz ... - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - . 2013.09.06 '00'04- 10:25:37
(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:
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