(54 days)
P800024/S16
No
The device is a saline solution for contact lenses, and the summary focuses on its chemical composition, sterility, and compatibility, with no mention of AI or ML.
No
This device is described as a sterile solution for rinsing contact lenses, falling under general care products for contact lenses rather than a device for treating a disease or condition.
No
The device is a sterile solution for rinsing contact lenses, not for diagnosing any medical condition. Its intended use is contact lens care, and the performance studies focus on microbiological efficacy, biocompatibility, and lens compatibility, not diagnostic accuracy.
No
The device is a sterile, preserved solution for rinsing contact lenses, which is a physical product (liquid) and 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 rinsing contact lenses. This is a direct interaction with a medical device (contact lens) and not a test performed on a biological sample (like blood, urine, or tissue) to diagnose a condition or provide information about a person's health.
- Device Description: The description details a sterile solution for contact lens care. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing biological samples.
- Providing diagnostic information.
- Analyzing biomarkers.
- Using techniques like immunoassays, molecular diagnostics, or clinical chemistry.
- Regulatory Classification: The intended user is listed as "Over-The-Counter Use (21 CFR 801 Subpart C)". While some IVDs can be over-the-counter, the overall context points away from an IVD classification.
- Performance Studies: The performance studies focus on microbiology (preservative efficacy), lens compatibility, and clinical history of the product's safety and efficacy for contact lens care. These are not the types of studies typically conducted for IVDs, which would focus on analytical and clinical performance related to diagnosing or monitoring a condition.
In summary, the Bausch + Lomb Sensitive Eyes Plus Saline Solution is a contact lens care product, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.
Product codes (comma separated list FDA assigned to the subject device)
LPN, MRC
Device Description
Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). 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)
A series of preclinical testing was performed to demonstrate the safety and effectiveness of 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 performed to establish discard dating of 90 days for Sensitive Eves Plus Saline Solution. The test articles were evaluated initially and again following simulated use for the proposed discard date of 90 days. The results demonstrate that Sensitive Eyes Plus Saline Solution meets the requirements of ISO 14730, Annex C Procedure II. Additionally, a modified regimen procedure allowing for a rinse with Sensitive Eves Plus Saline Solution In Place of Tap Water was conducted for both Boston Conditioning Solution and Boston Advance Conditioning Solution. The results demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for reqimen 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 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. The Sensitive Eyes Plus Saline Solution was previously cleared for use and expansion of the indication did not prompt the need for new testing.
Lens Compatibility:
The results of lens compatibility studies per ISO 11981 demonstrate Bausch + Lomb Sensitive Eyes Plus Saline Solution is compatible with rigid gas permeable contact lenses.
Clinical Data:
Clinical studies involving Sensitive Eyes Plus Saline Solution were unnecessary for this application. The Sensitive Eyes Plus Saline Solution has been commercially available in the market for over 25 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.
Bausch + Lomb Sensitive Eyes Plus Saline Solution (P800024/S16)
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.
Menicon Saline Rinse Solution (K151768)
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.”
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Image /page/0/Picture/2 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 image of three human profiles facing to the right, stacked one in front of the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 11, 2017
Bausch & Lomb Incorporated Ms. Melissa Thomas Senior Manager, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609
Re: K170483
Trade/Device Name: Bausch + Lomb Sensitive Eyes Plus Saline Solution Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LPN, MRC Dated: February 14, 2017 Received: February 16, 2017
Dear Ms. 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
1
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 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.
Denise L. Hampton -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
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Indications for Use
510(k) Number (if known)
K170483
Device Name Bausch + Lomb Sensitive Eyes Plus Saline
Indications for Use (Describe)
Bausch + Lomb Sensitive Eyes Plus Salinon is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.
| 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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510(k) SUMMARY K170483
Bausch + Lomb Sensitive Eyes Plus Saline 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: April 2017
2. Device Name
| Trade Name: | Bausch + Lomb Sensitive Eyes Plus Saline Solution |
|---|---|
| Classification: | Accessories, Contact Lens Care Products |
| Device classification: | Class II |
| Regulation Number: | 886.5928 Soft Contact Lens Care Products |
| 886.5918 Rigid Gas Permeable Contact Lens Care Products | |
| Product Code: | LPN, MRC |
3. Predicate Device
Bausch + Lomb Sensitive Eyes Plus Saline Solution (P800024/S16) Menicon Saline Rinse Solution (K151768)
4. Description of the Device
Bausch + Lomb Sensitive Eyes Plus Saline Solution is a sterile, isotonic, buffered solution that contains boric acid, sodium borate, potassium chloride, sodium chloride, preserved with polyaminopropyl biguanide (0.00003%) and edetate disodium (0.025%). 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 Sensitive Eyes Plus Saline Solution is a sterile, preserved solution for rinsing soft (hydrophilic) and gas permeable contact lenses after cleaning and before lens insertion with chemical (not heat) and hydrogen peroxide systems.
6. Description of Safety and Substantial Equivalence
A series of preclinical testing was performed to demonstrate the safety and effectiveness of 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 performed to establish discard dating of 90 days for Sensitive Eves Plus Saline Solution. The test articles were evaluated initially and again following simulated use for the proposed discard date of 90 days.
The results of these evaluations demonstrate that Sensitive Eyes Plus Saline Solution meets the requirements of ISO 14730, Annex C Procedure II. Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard for the designation of a 90 day discard date.
Additionally a modified regimen procedure allowing for a rinse with Sensitive Eves Plus Saline Solution In Place of Tap Water was conducted for both Boston Conditioning Solution and Boston Advance Conditioning Solution. The results of both evaluations demonstrate that modified regimen with Sensitive Eyes Plus Saline Solution meets the FDA performance criteria for reqimen 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. The Sensitive Eyes Plus Saline Solution was previously cleared for use and expansion of the indication did not prompt the need for new testing.
Lens Compatibility
The results of lens compatibility studies per ISO 11981 demonstrate Bausch + Lomb Sensitive Eyes Plus Saline Solution is compatible with rigid gas permeable contact lenses.
Clinical Data
Clinical studies involving Sensitive Eyes Plus Saline Solution were unnecessary for this application. The Sensitive Eyes Plus Saline Solution has been commercially available in the market for over 25 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 Bausch + Lomb Sensitive Eyes Plus Saline Solution when used with gas permeable contact lenses are substantially equivalent to the current product which is indicated for use with soft contact lenses.
| Feature | Menicon Saline Rinse
Solution (K151768) | Sensitive Eyes Plus
Saline Solution
(P800024/S16) | Sensitive Eyes Plus
Saline Solution
(K170483) |
|------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Product Code | LPN, MRC | LPN | LPN, MRC |
| Regulation Number | 21 CFR 886.5918
21 CFR 886.5928 | 21 CFR 886.5928 | 21 CFR 886.5918
21 CFR 886.5928 |
| Indicated for Soft
Lenses | Yes | Yes | Yes |
| Indicated for Rigid
Gas Permeable
Lenses | Yes | No | Yes |
| Rinse Required for
Cleaning | Unknown | Thoroughly Rinse
5 Seconds Each Side | Thoroughly Rinse
5 Seconds Each Side |
| Discard After Opening | Unknown | NA | 90 day Discard Date |
| Primary Container | Plastic resin container
with twist off cap | Plastic Bottle
Multiple Sizes | Plastic Bottle
Multiple Sizes |
| Container Usage | Single Use | Multi Use | Multi Use |
| Preserved | No | Yes | Yes |
| Sterile | Yes | Yes | Yes |
| Technology
Features | Isotonic
Aqueous Solution | Isotonic
Aqueous Solution | Isotonic
Aqueous Solution |
| Materials | Plastic Resin Container
With Twist Off Cap | Plastic Resin Container
With Cap | Plastic Resin Container
With Cap |
| Principles of
Operation | Mechanical Rinsing | Mechanical Rinsing | Mechanical Rinsing |
| Directions for Use | Unknown | Rinse After Cleaning
(5 sec. per side)
Rinse After Disinfection
(20 seconds)
Carton Onsert
Bausch.com | Rinse After Cleaning
(5 sec. per side)
Rinse After Disinfection
(20 seconds)
Carton Onsert
Bausch.com |