Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a sterile container for transporting corneal tissue and the summary focuses on material properties, sterilization, and biocompatibility testing. There is no mention of any computational or analytical functions that would utilize AI/ML.

Therapeutic

No.
The device is a sterile container for transporting corneal tissue, which is a supportive function unrelated to treating a disease or condition.

Diagnostic

No.
The device is described as a sterile container for the transportation of corneal tissue, which is a storage and transport function, not a diagnostic one. No part of its use or function involves identifying, analyzing, or determining a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a sterile container consisting of a jar, lid, and o-ring, which are physical hardware components. The performance studies also focus on the functional and biological properties of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is for the "transportation of corneal tissue preserved in Optisol GS storage media." This describes a container for biological material, not a device used to perform a test on a sample in vitro to diagnose a condition or provide information about a physiological state.
Device Description: The description reinforces that it is a "sterile container" for transportation.
Lack of Diagnostic Function: There is no mention of any testing, analysis, or measurement being performed by the device itself on the corneal tissue or the storage media.
Performance Studies: The performance studies focus on the container's functionality, sterility, biocompatibility, and safety for transporting the tissue, not on any diagnostic accuracy or analytical performance.

IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is solely to transport the tissue, not to analyze it for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Independent Viewing Chamber (IVC-21) is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.

Product codes (comma separated list FDA assigned to the subject device)

LYX

Device Description

The Independent Corneal Viewing Chamber (IVC) is a sterile container (consisting of a jar, lid, and o-ring) that may be used for transportation of corneal tissue preserved in Optisol GS storage media.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

corneal tissue

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)

The IVC-21 container passes all functional and simulated use testing with no failures or anomalies noted. Based on the attached results of the container as designed, passes all of the design input requirements.
Biocompatibility assessment for the IVC-21 has been performed in accordance with the requirements of ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Test results satisfied the acceptance criteria as defined by the associated ISO 10993-1 standards.
The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.
There were no significant differences in ocular observations between eyes treated with the test article extract and those treated with the control vehicle. The test article extract was not irritating to intraocular tissues.
The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity).
Systemic toxicity, genotoxicity, and material mediated pyrogenicity were assessed by chemical characterization and analytical chemistry.
Per the Nelson Laboratories test report, IVC-21 passed the BET testing. The measured EU level was lower than the acceptance criterion of 0.2 EU/device prescribed in "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices, Guidance for Industry and Food and Drug Administration Staff," August 17, 2015. Based on these test results, IVC-21 is not likely to result in Toxic Anterior Segment Syndrome (TASS).
Functional verification testing and simulated use validation testing was successfully performed. The IVC-21 container used for testing was production equivalent. The product was gamma sterilized prior to the functional testing.
All tests executed for the Functional Verification Testing (Group 1) and Simulated Use Validation (Group 2) passed all requirements.

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.

K921729

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

Regulation Number and Section

N/A

Summary

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 & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 3, 2021

Bausch + Lomb, Incorporated Heather Christie Sr. Specialist, Regulatory Affairs 3365 Tree Court Industrial Boulevard St. Louis, MO 63122

Re: K211786

Trade/Device Name: Independent Corneal Viewing Chamber (IVC-21) Regulatory Class: Unclassified Product Code: LYX Dated: October 5, 2021 Received: October 8, 2021

Dear Heather Christie:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

(21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Tieuvi Nguyen, Ph.D. Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K211786

Device Name Independent Viewing Chamber (IVC-21)

Indications for Use (Describe)

The Independent Viewing Chamber (IVC-21) is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

| I. | Submitter | Bausch & Lomb Inc.
3365 Tree Court Industrial Blvd.
St. Louis MO 63122
General Telephone: 636-226-3017 |
|------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | Contact | Heather Christie, (585) 356-5422,
heather.christie@bausch.com |
| | Date Prepared | June 1, 2021. Date revised October 1 2021. Date
revised version S001 October 18, 2021. Date
revised version November 29, 2021 |
| II. | Device | |
| | Name of Device | Independent Viewing Chamber (IVC-21) –
K211786 |
| | Common Name | Media, Corneal Storage |
| | Classification Name | None |
| | Regulatory Class | Unclassified |
| | Product Code | LYX |
| | Regulation Number | None |
| III. | Predicate Device | Independent Viewing Chamber (IVC-12) –
K921729 |

K211786 510(k) Summary: Independent Viewing Chamber (IVC-21)

IV. Device Description

The Independent Corneal Viewing Chamber (IVC) is a sterile container (consisting of a jar, lid, and o-ring) that may be used for transportation of corneal tissue preserved in Optisol GS storage media.

V. Indications for Use

The IVC is a sterile container that may be used for the transportation of corneal tissue preserved in Optisol GS storage media.

VI. Comparison of Technological Characteristics with the Predicate

The Independent Viewing Chamber (IVC-21) subject of the premarket notification is a larger version of the currently cleared IVC-12 predicate device (cleared via K921729 under Chiron which was later acquired by Bausch + Lomb). The IVC-21 contains a lid, jar, and o-ring.

	IVC-21 (subject device)	IVC-12 (K921729)	Comment
Indications for Use	The Independent
Corneal Viewing
Chamber (IVC) is a
sterile container that
may be used for the
transportation of
corneal tissue
preserved in Optisol
GS storage media.	The Independent
Corneal Viewing
Chamber (IVC) is a
sterile container that
may be used for the
transportation of
corneal tissue
preserved in storage
media.	Added specific
storage media name
to IVC-21 IFU

4

Sterility	Gamma	Same	No difference
Shelf Life	18 months	12 months	Increased shelf life -
Refer Shelf Life
section for detailed
discussion
Lid	0.64" high
1.96" diameter	0.56" high
1.96" diameter	Slight height
difference
O-ring	Silbione LSR 4360
silicone with 3% Nusil
Med 1-4900-7 (Blue)	60 Durometer Silicone
Red: Siloprene LSR
2060	Base material
changed from a non-
medical grade
silicone and colorant
(predicate) to a
medical grade
silicone and colorant
(subject device)
Jar	1.95" wide
1.76" high	1.95" wide
1.76" high	No difference
Jar pedestal
configuration	9 pedestal elements in
circular configuration	12 pedestal elements
in circular
configuration	Reduction of pedestal
elements in subject
device allowing more
spacing for better
viewing
Lid viewing
diameter	1.14" diameter	1.06" diameter	Larger viewing
diameter in subject
device
Sterile
Barrier
Configuration	HIPS pre-formed
blister tray with Tyvek
lid stock	Tyvek pouch	Changed from pouch
to tray packaging
configuration
Sterile
Barrier
Component
Materials	Blister Tray: 0.030
thick virgin white
HIPS

Tyvek lid stock:
Dupont Grade –
1073B Spunbonded
Polyolefin | Pouch: Tyvek Web =
Dupont Grade 1073B;
Film Web =
Laminated 48
PET/200 LDPE | IVC-21 uses a HIPS
blister tray which is
commonly used on
other Bausch + Lomb
surgical products

5

VII.

Performance Data

The IVC-21 container passes all functional and simulated use testing with no failures or anomalies noted. Based on the attached results of the container as designed, passes all of the design input requirements.

Biocompatibility assessment

The device is an external communicating device with prolonged contact with tissue. Biocompatibility assessment for the IVC-21 has been performed in accordance with the requirements of ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Test results satisfied the acceptance criteria as defined by the associated ISO 10993-1 standards. The jar component of the device was determined to be substantial equivalent to the jar component of the predicate device based on material characterization, suppliers, and manufacturing processes.

The lid and O-ring were tested jointly for sensitization, ocular irritation, and cytotoxicity. Sensitization summary:

The test article, IVC-21 Independent Viewing Chamber (gamma sterilized), was evaluated for the potential to cause delayed dermal contact sensitization in a guinea pig maximization test. This study was conducted based on the requirements of ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. The test article was extracted in 0.9% sodium chloride USP and sesame oil, NF. Each extract was intradermally injected and occlusively patched to ten test guinea pigs (per extract). The extraction vehicle was similarly injected and occlusively patched to five control guinea pigs (per vehicle). Following a recovery period, the test and control animals received a challenge patch of the appropriate test article extract and the vehicle control. All sites were scored for dermal reactions at 24 and 48 hours after patch removal. The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test.

Irritation summary:

The test article, IVC-21 Independent Viewing Chamber (gamma sterilized), was extracted in balanced salt solution and evaluated for the potential to cause intraocular irritation or toxicity following an intracameral (anterior chamber) injection in rabbits. In one eye of each of six animals, 0.15 mL of aqueous fluid was evacuated from the anterior chamber and replaced with 0.15 mL of the test article extract. The opposite eye of each animal received a similar injection of balanced salt solution and served as the control. The eves were evaluated for irritation by slit-lamp examination daily for three days. There were no significant differences in ocular observations between eyes treated with the test article extract and those treated with the control vehicle. The test article extract was not irritating to intraocular tissues.

Cytotoxicity summary:

The test article, IVC-21 Independent Viewing Chamber (gamma sterilized), was evaluated for potential cytotoxic effects using an in vitro mammalian cell culture test. This study was

6

conducted following the guidelines of ISO 10993-5. Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity. A single preparation of the test article was extracted in single strength Minimum Essential Medium (1X MEM) at 37°C for 24 hours. The negative control, reagent control, and positive control were similarly extracted. Triplicate monolayers of L-929 mouse fibroblast cells were dosed with each extract and incubated at 37 C in the presence of 5% CO2 for 48 hours. Following incubation, the monolayers were examined microscopically for abnormal cell morphology and cellular degeneration. The test article extract showed no evidence of causing cell lysis or toxicity. The test article extract met the requirements of the test since the grade was less than a grade 2 (mild reactivity).

Systemic toxicity, genotoxicity, and material mediated pyrogenicity were assessed by chemical characterization and analytical chemistry.

Limulus Amebocyte Lysate (LAL) testing [Endotoxin]

Per the Nelson Laboratories test report, IVC-21 passed the BET testing. The measured EU level was lower than the acceptance criterion of 0.2 EU/device prescribed in "Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices, Guidance for Industry and Food and Drug Administration Staff," August 17, 2015. Based on these test results, IVC-21 is not likely to result in Toxic Anterior Segment Syndrome (TASS).