(22 days)
Not Found
No
The device description and performance studies focus on the material and function of a contact lens case for storage and disinfection, with no mention of AI or ML capabilities.
No
The device is a lens case used for storage and chemical disinfection of contact lenses, not for direct therapeutic treatment of a condition.
No
Explanation: The device is a lens case used for storage and chemical disinfection of contact lenses. Its intended use is not to diagnose any condition.
No
The device description explicitly states it consists of a polypropylene cap and body, indicating it is a physical hardware device for storing contact lenses.
Based on the provided information, the Bausch + Lomb Boston® Scleral Lens Case is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the storage of contact lenses during chemical disinfection. This is a physical storage and disinfection aid, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical container (cap and body) for storing contact lenses.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility and microbiology related to the case itself and its interaction with contact lenses and disinfection solutions, not on diagnostic accuracy or performance related to analyzing biological samples.
Therefore, the Bausch + Lomb Boston® Scleral Lens Case falls under the category of a medical device for contact lens care, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro scrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
Product codes
LRX
Device Description
Bausch + Lomb Boston® Scleral Lens Case consists of a polypropylene cap and polypropylene body for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
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
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Summary of Performance Studies
A series of preclinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb Boston® Scleral Lens Case as described in Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, May 1, 1997.
Microbiology issues pertaining to contact lens cases are covered by the warning included in the labelling which states:
Contact lens cases can be a significant source of microbial contamination. To help prevent eye infections, contact lens cases should be cleaned, rinsed and air dried every day, and replaced at least every three months.
Systemic toxicity, cytotoxicity, and ocular irritation studies were completed for Bausch + Lomb Boston® Scleral Lens Case The test results demonstrated the biocompatibility of the Bausch + Lomb Boston® Scleral Lens Case.
Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application. The Bausch + Lomb Boston® Scleral Lens Case is similar in design, materials and intended use to the predicate device, which has been commercially available in the market for over 15 years with well demonstrated safety and efficacy.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
November 17, 2017
Bausch & Lomb Incorporated Nancy Fehrman Senior Manager Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K173365
Trade/Device Name: Bausch + Lomb Boston® Scleral Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LRX Dated: October 25, 2017 Received: October 26, 2017
Dear Nancy Fehrman:
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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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) K173365
Device Name
Bausch + Lomb Boston® Scleral Lens Case
Indications for Use (Describe)
Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro scrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
| 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
Bausch + Lomb Boston® Scleral Lens Case
1. Submitter Information
| Primary | Alternate |
|---|---|
| Nancy Fehrman | 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) 338-5310 | Tel. (585) 338-8215 |
| Fax (585) 338-0702 | Email: Glenn.Davies@bausch.com |
| Email: Nancy.Fehrman@bausch.com |
Summary Prepared: October 25, 2017
2. Device Name
| Common Name: | Contact Lens Case |
|---|---|
| Trade Name: | Bausch + Lomb Boston® Scleral Lens Case |
| Classification: | Case, Contact Lens |
| Device classification: | Class II (21 CFR §886.5928) |
| Product Code: | LRX |
3. Predicate Device
CyberCases™ by Bausch & Lomb® (K013232)
4. Description of the Device
Bausch + Lomb Boston® Scleral Lens Case consists of a polypropylene cap and polypropylene body for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
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5. Intended Use
Bausch + Lomb Boston® Scleral Lens Case is indicated for storage of gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, including large diameter (scleral) lenses, during chemical disinfection.
6. Description of Safety and Substantial Equivalence
A series of preclinical testing was performed to demonstrate the safety and effectiveness of Bausch + Lomb Boston® Scleral Lens Case 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
Microbiology issues pertaining to contact lens cases are covered by the warning included in the labelling which states:
Contact lens cases can be a significant source of microbial contamination. To help prevent eye infections, contact lens cases should be cleaned, rinsed and air dried every day, and replaced at least every three months.
Toxicology
Systemic toxicity, cytotoxicity, and ocular irritation studies were completed for Bausch + Lomb Boston® Scleral Lens Case The test results demonstrated the biocompatibility of the Bausch + Lomb Boston® Scleral Lens Case.
Clinical Data
Clinical studies involving the Bausch + Lomb Boston® Scleral Lens Case were unnecessary for this application. The Bausch + Lomb Boston® Scleral Lens Case is similar in design, materials and intended use to the predicate device, which has been commercially available in the market for over 15 years with well demonstrated safety and efficacy.
7. Substantial Equivalence
The cumulative results of laboratory testing sponsored by Bausch + Lomb demonstrate that the safety, effectiveness and performance of Bausch + Lomb Boston® Scleral Lens Case are substantially equivalent to the CyberCases™ by Bausch & Lomb® (K013232).
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| Feature | CyberCases™ by
Bausch & Lomb®
(K013232) | Bausch + Lomb
Boston® Scleral Lens
Case
(Subject of this 510(k)) |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LRX | LRX |
| Regulation Number | 21 CFR 886.5928 | 21 CFR 886.5928 |
| Indications For Use | Indicated for use in the
storage of hard, rigid
gas permeable (fluoro
silicone acrylate and
silicone acrylate) and
soft (hydrophilic) contact
lenses during chemical
disinfection | Indicated for use in the
storage of gas
permeable (fluoro
silicone acrylate and
silicone acrylate)
contact lenses during
chemical disinfection |
| Technology
Features | Differentiate between
the right and left wells
for lens storage using
right lens cap colors | Differentiate between
the right and left wells
for lens storage using
right lens cap colors |
| Materials | Polypropylene cap and
body | Polypropylene cap and
body |
| Colorants | Orange, 2%
Magenta (pink), 1%
Teal, 1%
Green, 2%
Purple, 1% | Orange, up to 3%
Magenta, up to 3%
Teal, up to 3%
Green, up to 4%
Purple, up to 6%
White, up to 3%
Blue, up to 4%
Bright Green, up to 3%
Lime Green, up to 3% |
| Volume | 3.3mL fill volume
Sufficient volume to
assure that the lens
remains completely
immersed under
conditions of use | 6.5mL fill volume
Sufficient volume to
assure that the lens
remains completely
immersed under
conditions of use |
| Right cap
embossment | "R" | None |
| Left cap embossment | "L" | "L" |
| Biocompatibility | Met the Requirements
for:
ISO 10993-5 Biological
evaluation of medical
devices, Part 5: Tests
for in vitro cytotoxicity;
ISO 10993-10 Biological
evaluation of medical
devices, Part 10: Tests
for irritation and skin
sensitization | Met the Requirements
for:
ISO 10993-5 Biological
evaluation of medical
devices, Part 5: Tests
for in vitro cytotoxicity;
ISO 10993-10 Biological
evaluation of medical
devices, Part 10: Tests
for irritation and skin
sensitization |
| ISO 10993-11 Biological
evaluation of medical
devices, Part 11: Tests
for systemic toxicity. | ISO 10993-11 Biological
evaluation of medical
devices, Part 11: Tests
for systemic toxicity. | |
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