← Product Code [LRX](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX) · K173365 # Bausch + Lomb Boston Scleral Lens Case (K173365) _Bausch & Lomb, Incorporated · LRX · Nov 17, 2017 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K173365 ## Device Facts - **Applicant:** Bausch & Lomb, Incorporated - **Product Code:** [LRX](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX.md) - **Decision Date:** Nov 17, 2017 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5928 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for 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. ## Device Story Device is a contact lens storage case consisting of a polypropylene cap and body. Used by patients for the storage of gas permeable contact lenses, including large diameter (scleral) lenses, during chemical disinfection. The case features color-coded caps to differentiate between right and left wells to assist the user in lens management. The device provides a 6.5mL fill volume to ensure complete lens immersion. It is a passive storage accessory; no electronic or mechanical processing occurs. The device benefits the patient by providing a biocompatible environment for lens disinfection, reducing the risk of microbial contamination when used according to labeling instructions. ## Clinical Evidence No clinical data. Safety and effectiveness were established through bench testing, including biocompatibility studies (ISO 10993-5, ISO 10993-10, ISO 10993-11) and performance testing to ensure adequate lens immersion volume. ## Technological Characteristics Materials: Polypropylene cap and body. Dimensions: 6.5mL fill volume. Biocompatibility: Compliant with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and ISO 10993-11 (systemic toxicity). Design: Manual storage case with color-coded caps for well differentiation. ## Regulatory 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. ## Special Controls *Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Predicate Devices - CyberCases™ by Bausch & Lomb® ([K013232](/device/K013232.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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. {4}------------------------------------------------ ### 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). {5}------------------------------------------------ | 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. | | {6}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K173365](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K173365) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com