The Crystalsert Delivery System is intented to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.

Device Description

The Crystalsert Delivery System is a device used for folding and delivering the Crystalens accommodating intraocular lens and other IOLs indicating use of the Crystalsert Delivery System in their approved labeling into the eye. The Crystalsert Delivery System consists of a syringe shaped body and tip with a plunger and drawer. The Crystalsert Delivery System is a sterile, disposable plastic device, with a small tubular pathway in which the lens can be placed into the eye with one continuous motion, designed for single use only.

AI/ML Overview

The provided document is a 510(k) summary for the Bausch & Lomb Crystalsert Lens Delivery System (Model CI-26). It primarily focuses on demonstrating substantial equivalence to a predicate device (Model CI-28) through nonclinical bench and laboratory tests.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly "Pass" for all tests, indicating that the device met the established benchmarks for each test. The document emphasizes that the proposed device demonstrated equivalence to the predicate device.

Item	Test	Acceptance Criteria (Implicit)	Reported Device Performance
Function Performance	(Before and after insertion) IOL surface & bulk homogeneity	Pass	Pass
	(Before and after insertion) IOL lens power	Pass	Pass
	(Before and after insertion) IOL image quality	Pass	Pass
	(Before and after insertion) IOL dimensions	Pass	Pass
	IOL delivery outcome	Pass	Pass
	Damage to insertion device	Pass	Pass
	Coating transfer study	Pass	Pass
	Particle counting study	Pass	Pass
Sterilization Verification	Evaluation and rationale for inclusion in "family grouping" of similar devices per ISO11135:2014 and AAMI TIR 28:2009	Pass	Pass
Packaging Verification	Evaluation and rationale for inclusion in "family grouping" of similar devices.	Pass	Pass
Product Shelf Life	Evaluation and rationale for inclusion in "family grouping" of similar devices for a one-year shelf life.	Pass	Pass
Biocompatibility	Evaluation and rationale was performed per ISO 10993-1:2009 and ISO 10993-18:2005. Components are either the same part or considered to be materially equivalent to parts in the predicate device. As such, no additional biocompatibility testing was warranted or conducted.	Pass	Pass
EO/ECH Residuals Transfer Test	Lab testing per ISO 10993-7:2008 with protocols and acceptance criteria previously reviewed by FDA.	Pass	Pass
Bacterial Endotoxin Validation	Lab testing per EN ISO 13485:2012	Pass	Pass

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Crystalsert Lens Delivery System (Model Cl-26). No animal or clinical testing was required for this submission."

Sample Size: The exact sample sizes for each nonclinical test are not specified in the provided text.
Data Provenance: The data provenance is from nonclinical bench and laboratory testing. The country of origin of the data is not explicitly stated, but the submitter (Bausch + Lomb) is based in St. Louis, Missouri, USA, implying the testing likely occurred within the US or by US-affiliated labs. The nature of the testing is prospective as it was conducted for the purpose of this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this submission relies solely on nonclinical bench and laboratory testing, the concept of "ground truth" established by human experts in the way it applies to diagnostic or prognostic devices is not directly applicable. The "ground truth" for these tests would be defined by the technical specifications, standards (e.g., ISO, AAMI), and predefined acceptance criteria for each test. The individuals performing and evaluating these tests would be laboratory technicians and engineers, whose qualifications are not detailed but are assumed to be appropriate for conducting such tests.

4. Adjudication Method for the Test Set

As the evaluation is based on objective nonclinical tests against predetermined acceptance criteria, there is no human adjudication method in the sense of a 2+1 or 3+1 design. The results are binary (Pass/Fail) based on direct measurement and comparison to specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No animal or clinical testing was required for this submission." This type of study is relevant for diagnostic imaging or AI devices involving human interpretation, which is not the case here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an algorithm or AI device. It's a medical device for delivering intraocular lenses. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The Type of Ground Truth Used

The "ground truth" for the nonclinical tests is based on engineering specifications, established industry standards (ISO, AAMI), and predefined acceptance criteria for each test (e.g., IOL surface homogeneity, lens power, dimensions, sterility, biocompatibility). It is objective and measurable, rather than expert consensus, pathology, or outcomes data, which are typically associated with diagnostic or therapeutic efficacy studies in clinical settings.

8. The Sample Size for the Training Set

Not Applicable. This device is not an AI or machine learning algorithm, so there is no "training set" in the conventional sense. The device itself is manufactured, and its performance is evaluated against engineering and safety standards.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. (See point 8).

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 11, 2017

Bausch & Lomb, Inc Gary Rauvola Regulatory Affairs Manager 3365 Tree Ct. Industrial Blvd. St. Louis, Missouri 63122

Re: K173480

Trade/Device Name: Crystalsert Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: November 2, 2017 Received: November 13, 2017

Dear Gary Rauvola:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(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 (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 medical devices and radiation-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)

Device Name

Crystalsert Lens Delivery System CI-26

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

This summary document has been prepared in accordance with section 21 CFR 807.92(c).

The submitter of the 510(k) is:

Gary Rauvola Regulatory Affairs Manager Bausch + Lomb 3365 Tree Court Industrial Blvd St. Louis, MO. 63122 Phone: 636-226-3402

Date Summary Prepared: November 02, 2017

1. Subject Device:

Trade name:	Crystalsert Lens Delivery System
Common Name:	Intraocular lens Guide
Classification Name:	21 CFR 886.4300

2. Predicate Device:

Primary Predicate Device	K132593	Crystalsert Lens Delivery System	CI-28
--------------------------	---------	----------------------------------	-------

3. Device Description:

4. Indications for Use:

The Crystalsert Delivery System is intended to be used to fold and deliver the Crystalens accommodating intraocular lens and other intraocular lenses identifying the Crystalsert Delivery System in their approved labeling.

The indications for use of the proposed device are identical to the primary predicate device.

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5. Brief Summary of Nonclinical Tests and Results:

Bench tests, laboratory tests, and evaluations were completed on the proposed B+L Crystalsert Lens Delivery System (Model Cl-26). No animal or clinical testing was required for this submission. Please refer to the summary table shown below.

Item	Test	Results
FunctionPerformance	(Before and after insertion) IOL surface & bulkhomogeneity	Pass
	(Before and after insertion) IOL lens power	Pass
	(Before and after insertion) IOL image quality	Pass
	(Before and after insertion) IOL dimensions	Pass
	IOL delivery outcome	Pass
	Damage to insertion device	Pass
	Coating transfer study	Pass
	Particle counting study	Pass
Sterilizationverification	Evaluation and rationale for inclusion in "family grouping" ofsimilar devices per ISO11135:2014 and AAMI TIR 28:2009	Pass
Packaging verification	Evaluation and rationale for inclusion in "family grouping" ofsimilar devices.	Pass
Product shelf life	Evaluation and rationale for inclusion in "family grouping" ofsimilar devices for a one-year shelf life.	Pass
Biocompatibility	Evaluation and rationale was performed per ISO 10993-1:2009 and ISO 10993-18:2005. Components are either thesame part or considered to be materially equivalent to partsin the predicate device. As such, no additionalbiocompatibility testing was warranted or conducted.	Pass
EO/ ECH residualstransfer test	Lab testing per ISO 10993-7:2008 with protocols andacceptance criteria previously reviewed by FDA.	Pass
Bacterial EndotoxinValidation pre- andpost-sterilization	Lab testing per EN ISO 13485:2012	Pass

Device functional performance testing all passed and demonstrates equivalence to predicate device. EO/ ECH residual transfer tests all passed. Endotoxin validation testing passed. Sterilization evaluation, packaging verification, shelf-life evaluation, biocompatibility evaluation all met requirements and demonstrated equivalence to the predicate device. All results support the conclusion that the proposed device (Model Cl-26) is as safe and as effective, and therefore equivalent to the predicate device (Model CI-28).

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6. Comparative Analysis

A table comparing the proposed device to the primary predicate device is provided below.

Table 6-1: Comparison of Crystalsert Lens Delivery System Predicate Device
(Model CI-28) to the Proposed Minor Modification (Model CI-26)
Characteristic	Primary Predicate DeviceCI-28 (K132593)	Proposed DeviceCI-26
Indications for use	The Crystalsert Delivery System isintended to be used to fold and deliverthe Crystalens accommodatingintraocular lens and other intraocularlenses identifying the CrystalsertDelivery System in their approvedlabeling.	The Crystalsert Delivery System isintended to be used to fold and deliverthe Crystalens accommodatingintraocular lens and other intraocularlenses identifying the CrystalsertDelivery System in their approvedlabeling.
Contraindications	None	None
Anatomical site	Eye	Eye
Injector configuration	Body, drawer, plunger, bearing	Body, cartridge, drawer, plunger,bearing, haptic guide
Materials	Body, drawer, plunger, bearing:Polypropylene	Body: drawer, plunger, bearing:PolypropyleneCartridge: Polyimide
How is the deviceused	An IOL is placed into the loading areaand the drawer is closed. Thiscompresses the IOL. The plunger isadvanced until it stops at a detentposition. The distal end is filled withviscoelastic or balanced salt solutionand placed through an incision into theeye. Once the tip is in the eye, theplunger is advanced until the lens isfully expressed into the capsular bag.	An IOL is placed into the loading areaand the drawer is closed. Thiscompresses the IOL. The plunger isadvanced until it stops at a detentposition. The haptic guide is removedand distal end is filled with viscoelasticor balanced salt solution and placedthrough an incision into the eye. Oncethe tip is in the eye, the plunger isadvanced until the lens is fullyexpressed into the capsular bag.
Single use?	Yes	Yes
Is the product sterile?	Sterile	Sterile
How sterilized/SAL	Ethylene oxide/ 10-6	Ethylene oxide/ 10-6
Shelf life	12 months	12 months

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7. Conclusion

The proposed Crystalsert Lens Delivery System CI-26 is substantially equivalent to the CI-28 predicate device.

Regulation Number and Section

§ 886.4300 Intraocular lens guide.

(a)
Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.(b)
Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.