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.

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.

AI/ML Overview

The provided text describes the acceptance criteria and study proving the device meets those criteria. However, it does not pertain to an AI/ML medical device, but rather a sterile container for corneal tissue. Therefore, many of the requested bullet points, such as those regarding AI model performance, training data, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this 510(k) submission.

Here's a breakdown of the relevant information from the provided document, addressing the applicable points:

Device: Independent Corneal Viewing Chamber (IVC-21)
Predicate Device: Independent Corneal Viewing Chamber (IVC-12)

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a single, concise table of acceptance criteria with corresponding performance data in the traditional sense for an AI/ML device. Instead, the performance data is described qualitatively or with specific pass/fail statements regarding various tests related to biocompatibility, sterility, and functional requirements for a container.

However, based on the Implicit acceptance criteria from the "Performance Data" section (VII), we can construct a table for the tests performed:

Test/Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Functional & Simulated Use Testing	Device passes all functional and simulated use tests, with no failures/anomalies. Meets all design input requirements.	"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.""All tests executed for the Functional Verification Testing (Group 1) and Simulated Use Validation (Group 2) passed all requirements. The IVC-21 container passes all functional and simulated use testing with no failures or anomalies noted. Based on the attached results, the IVC-21 meets or exceeds all of the design input requirements."
Biocompatibility (General)	Meets requirements of ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1..." Test results satisfy acceptance criteria as defined by associated ISO 10993-1 standards.	"Biocompatibility assessment for the IVC-21 has been performed in accordance with the requirements of ISO 10993-1 and FDA guidance... Test results satisfied the acceptance criteria as defined by the associated ISO 10993-1 standards."
Sensitization	No evidence of causing delayed dermal contact sensitization. Not considered a sensitizer.	"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."
Ocular Irritation	No significant differences in ocular observations compared to control. Not irritating to intraocular tissues.	"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	No evidence causing cell lysis or toxicity. Grade less than 2 (mild reactivity).	"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, Pyrogenicity	Assessed by chemical characterization and analytical chemistry (implying acceptable results).	"Systemic toxicity, genotoxicity, and material mediated pyrogenicity were assessed by chemical characterization and analytical chemistry." (No explicit "pass" statement, but implied by lack of mention of failure)
Limulus Amebocyte Lysate (LAL) / Endotoxin	Measured EU level lower than 0.2 EU/device. Not likely to result in TASS.	"IVC-21 passed the BET testing. The measured EU level was lower than the acceptance criterion of 0.2 EU/device..." "Based on these test results, IVC-21 is not likely to result in Toxic Anterior Segment Syndrome (TASS)."
Sterility	Maintained after gamma sterilization (implied).	No explicit performance data provided beyond "Gamma" sterilization method and "25 kGy" minimum sterilization dose, but the functional tests were done on gamma-sterilized product, implying success.

The following points are not applicable to this 510(k) submission for a physical medical device (corneal viewing chamber) as it does not involve an AI/ML component.

2. Sample size used for the test set and the data provenance: Not applicable for a non-AI/ML device. Tests were performed on the device itself (e.g., extracts, or the physical container). The numbers relate to test animals (e.g., 10 guinea pigs, 6 rabbits) or in vitro cell cultures, not data for an algorithm. Data provenance (country of origin, retrospective/prospective) is typically for clinical data or imaging datasets, which are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Relates to expert consensus for AI/ML model ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. Relates to reader studies for AI/ML performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Applies to AI/ML algorithm performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. Refers to ground truth for AI/ML model validation. For a physical device, performance is evaluated against defined physical, chemical, and biological standards.
8. The sample size for the training set: Not applicable. Relates to AI/ML model training data.
9. How the ground truth for the training set was established: Not applicable. Relates to AI/ML model training data.

Summary

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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

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(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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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I.	Submitter	Bausch & Lomb Inc.3365 Tree Court Industrial Blvd.St. Louis MO 63122General Telephone: 636-226-3017
	Contact	Heather Christie, (585) 356-5422,heather.christie@bausch.com
	Date Prepared	June 1, 2021. Date revised October 1 2021. Daterevised version S001 October 18, 2021. Daterevised 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

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 IndependentCorneal ViewingChamber (IVC) is asterile container thatmay be used for thetransportation ofcorneal tissuepreserved in OptisolGS storage media.	The IndependentCorneal ViewingChamber (IVC) is asterile container thatmay be used for thetransportation ofcorneal tissuepreserved in storagemedia.	Added specificstorage media nameto IVC-21 IFU

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Sterility	Gamma	Same	No difference
Shelf Life	18 months	12 months	Increased shelf life -Refer Shelf Lifesection for detaileddiscussion
Lid	0.64" high1.96" diameter	0.56" high1.96" diameter	Slight heightdifference
O-ring	Silbione LSR 4360silicone with 3% NusilMed 1-4900-7 (Blue)	60 Durometer SiliconeRed: Siloprene LSR2060	Base materialchanged from a non-medical gradesilicone and colorant(predicate) to amedical gradesilicone and colorant(subject device)
Jar	1.95" wide1.76" high	1.95" wide1.76" high	No difference
Jar pedestalconfiguration	9 pedestal elements incircular configuration	12 pedestal elementsin circularconfiguration	Reduction of pedestalelements in subjectdevice allowing morespacing for betterviewing
Lid viewingdiameter	1.14" diameter	1.06" diameter	Larger viewingdiameter in subjectdevice
SterileBarrierConfiguration	HIPS pre-formedblister tray with Tyveklid stock	Tyvek pouch	Changed from pouchto tray packagingconfiguration
SterileBarrierComponentMaterials	Blister Tray: 0.030thick virgin whiteHIPSTyvek lid stock:Dupont Grade –1073B SpunbondedPolyolefin	Pouch: Tyvek Web =Dupont Grade 1073B;Film Web =Laminated 48PET/200 LDPE	IVC-21 uses a HIPSblister tray which iscommonly used onother Bausch + Lombsurgical productsSame Tyvek DupontGrade 1073B usedbetween IVC-12 andIVC-21
Sterility	Gamma	Same*Note: initial Chiron510k noted EtOsterilization however,Bausch + Lombrecords show this hasalways been gammasterilized	No difference
MinimumSterilizationDose	25 kGy	Same	No difference
PackagingConfiguration	Quantity 1 IVC-21placed in blister trayand sealed with Tyveklid stock	Quantity 1 IVC-12wrapped in cloth wrapwith latex freecohesive tape andsealed in Tyvek pouch	Refer packagingimages below

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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

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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).