The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

Device Description

The Easy-Load Lens Delivery System is used for folding and delivering a Bausch + Lomb three-piece silicone IOL into the eye. An IOL is placed into the loading area and the drawer is closed. This compresses the IOL. The plunger is advanced until it stops at a detent position. The distal end is filled with viscoelastic or balanced salt solution and placed through an incision into the eye. The haptic puller is used to place the leading haptic in the correct loading position. Once the tip is in the eye, the plunger is advanced until the lens is fully expressed into the capsular bag.

AI/ML Overview

This document describes the premarket notification for the "Easy-Load Lens Delivery System" (Model EZ-24). It's an intraocular lens guide used for folding and injecting intraocular lenses.

Here's the information regarding the acceptance criteria and study, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Item	TEST	Acceptance Criteria	RESULTS
Function Performance	(Before and after insertion) IOL surface & bulk homogeneity	Free from surface and bulk defects and all edges should appear smooth when viewed at 10X magnification	Pass
	(Before and after insertion) IOL lens power	The diopter power of the lenses shall be within the allowed tolerance	Pass
	(Before and after insertion) IOL image quality	The image quality of the lenses shall meet or exceed the minimum resolution group element of the Air Force target specified in the protocol.	Pass
	(Before and after insertion) IOL dimensions	The lenses must meet the dimensional requirements specified in the protocol.	Pass
	IOL delivery outcome	The IOLs do not flip over upon delivery; The IOL must exit inserter upon completion of delivery; No cosmetic defects to the IOL's haptic from folding and/or delivery	Pass
	Damage to insertion device	No damage to the insertion device due to lens delivery	Pass
	Lubricant transfer study	No detectable transfer	Pass
	Particle study	Comparable to or lower than control	Pass
Sterilization verification	Comparative Resistance Performance Determination	For a given exposure time the average recovery of viable test organisms from biological indicators placed within the barrel of either the EZ-24 or the EZ-28 shall differ by no more than one logarithm of the average of the values determined for both inserters. Alternatively, the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-24 may be less than the average recovery of viable test organisms from biological indicators placed within the barrel of the EZ-28 inserters	Pass
	EO transfer test	$\le$ 0.5μg EO per IOL	Pass
	Endotoxin test	$<$ 0.2 EU/device	Pass
Packaging verification	Plunger push force and cartridge detachment testing	Cartridge detachment force is greater than the force to disengage the plunger from the detents in the injector body.	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample size for each specific test or the data provenance. It mentions "nonclinical tests" and "accepted ISO standards," implying laboratory testing rather than human clinical trials. The data is internal to the manufacturer, Bausch + Lomb.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided. The tests described are primarily objective physical and chemical measurements ("Free from surface and bulk defects," "diopter power," "resolution group element," "dimensional requirements," "IOL delivery outcome," "no damage," "no detectable transfer," "comparable to or lower than control," "recovery of viable test organisms," "$\le$ 0.5μg EO," "$<$ 0.2 EU/device," "force greater than"). Expert judgment for these specific criteria would likely be embedded in the test protocol design and execution, but the document doesn't detail the number or qualifications of individuals involved in setting up or interpreting these nonclinical tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or subjective evaluations by multiple human readers. For the nonclinical tests described in this document, such adjudication methods are not applicable. The results are based on direct measurements and adherence to specified physical/chemical parameters.

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:

No MRMC study was mentioned. This device is an intraocular lens delivery system, not an AI-powered diagnostic tool, so MRMC studies and "human readers improve with AI" are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not an algorithm or AI product, so the concept of standalone performance for an algorithm is not applicable. The tests performed are on the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the nonclinical tests is based on established engineering specifications, accepted ISO standards (ISO 11979-2, ISO 11979-3, and ISO 11135 where applicable), and internal protocols. For example:

IOL surface & bulk homogeneity: "Free from surface and bulk defects and all edges should appear smooth when viewed at 10X magnification." (Direct observation against a visual quality standard)
IOL lens power: "within the allowed tolerance." (Measurement against a quantitative specification)
Sterilization verification: "recovery of viable test organisms... differ by no more than one logarithm..." (Microbiological standard)
EO transfer test: "$\le$ 0.5μg EO per IOL." (Chemical quantitative standard)

8. The sample size for the training set:

There is no mention of a "training set" as this is not an AI/machine learning device. The tests are on the physical product and its components.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for an AI model. For the nonclinical tests conducted, the acceptance criteria (which serve as the "ground truth" for pass/fail) were established based on ISO standards and internal protocols.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2016

Bausch and Lomb, Inc. Dr. Joyce Zhong Regulatory Affairs Specialist 50 Technology Drive Irvine, CA92618

Re: K161012

Trade/Device Name: Easy-load Lens Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: June 3, 2016 Received: June 6, 2016

Dear Dr. Zhong:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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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5 Indications for Use Statement

510(k) Number (if known):

Device Name: Easy-Load Lens Delivery System

Indications for Use:

The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 19

CONFIDENTIAL

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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:

Joyce Zhong, PhD Regulatory Affairs Specialist Bausch + Lomb 50 Technology Drive, Irvine, CA 92618 Phone: 949-398-5594 Fax: 949-398-5764

Date Summary Prepared: April 7, 2016

1. Subject Device:

Trade name:	Easy-Load Lens Delivery System
Common Name:	Intraocular lens Guide
Classification Name:	21 CFR 886.4300

Predicate Device: 2.

Primary Predicate Device	K132481	Easy-Load Lens Delivery System	EZ-28
Secondary Predicate Device	K131958	Bausch + Lomb Injector System	BLIS-X1

3. Device Description:

4. Indications for Use:

The Easy-Load Lens Delivery System is indicated for the folding and injection of Bausch + Lomb intraocular lenses identifying the Easy-Load Lens Delivery System in their approved labeling.

The indications for use of the proposed device are the same as the primary predicate device.

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5. Brief Summary of Nonclinical Test and Results:

Nonclinical tests listed below were completed on the proposed Easy-Load Lens Delivery System (Model EZ-24) and results show the system to be in conformance with the requirements set forth by accepted ISO standards (ISO 11979-2, ISO 11979-3, and ISO 11135) where applicable.

Item	TEST	Acceptance Criteria	RESULTS
FunctionPerformance	(Before and afterinsertion) IOL surface &bulk homogeneity	Free from surface and bulk defects and alledges should appear smooth when viewed at10X magnification	Pass
	(Before and afterinsertion) IOL lens power	The diopter power of the lenses shall bewithin the allowed tolerance	Pass
	(Before and afterinsertion) IOL imagequality	The image quality of the lenses shall meetor exceed the minimum resolution groupelement of the Air Force target specified inthe protocol.	Pass
	(Before and afterinsertion) IOL dimensions	The lenses must meet the dimensionalrequirements specified in the protocol.	Pass
	IOL delivery outcome	The IOLs do not flip over upon delivery;The IOL must exit inserter upon completionof delivery; No cosmetic defects to theIOL's haptic from folding and/or delivery	Pass
	Damage to insertiondevice	No damage to the insertion device due tolens delivery	Pass
	Lubricant transfer study	No detectable transfer	Pass
	Particle study	Comparable to or lower than control	Pass
Sterilizationverification	Comparative ResistancePerformanceDetermination		For a given exposure time the averagerecovery of viable test organisms frombiological indicators placed within thebarrel of either the EZ-24 or the EZ-28 shalldiffer by no more than one logarithm of theaverage of the values determined for bothinserters. Alternatively, the averagerecovery of viable test organisms frombiological indicators placed within thebarrel of the EZ-24 may be less than theaverage recovery of viable test organismsfrom biological indicators placed within thebarrel of the EZ-28 inserters	Pass
	EO transfer test	$\le$ 0.5μg EO per IOL	Pass
	Endotoxin test	$\lt$ 0.2 EU/device	Pass
Packagingverification	Plunger push force andcartridge detachmenttesting	Cartridge detachment force is greater thanthe force to disengage the plunger from thedetents in the injector body.	Pass

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6. Comparative Analysis

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

Characteristic	Primary Predicate DeviceEZ-28 (K132481)	Proposed DeviceEZ-24
Indications for use	The Easy-Load Lens Delivery Systemis indicated for the folding and injectionof Bausch + Lomb intraocular lensesidentifying the Easy-Load LensDelivery System in their approvedlabeling.	The Easy-Load Lens Delivery Systemis indicated for the folding andinjection of Bausch + Lomb intraocularlenses identifying the Easy-Load LensDelivery System in their approvedlabeling.
Contraindications	None	None
Anatomical site	Eye	Eye
Injector configuration	Body, drawer, haptic puller, plunger	Body, cartridge, drawer, haptic puller,plunger, bearing
Materials	Body, drawer, haptic puller, plunger:Polypropylene	Body: drawer, haptic puller, 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. The haptic puller is used to placethe leading haptic in the correct loadingposition. 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 distal end is filled withviscoelastic or balanced salt solutionand placed through an incision into theeye. The haptic puller is used to placethe leading haptic in the correct loadingposition. Once the tip is in the eye, theplunger is advanced until the lens isfully expressed into the capsular bag.
Single use?	Yes	Yes
Is the product sterile?	Sterile	Sterile
How sterilized	Ethylene oxide	Ethylene oxide
Sterility assurancelevel	10-6	10-6

Table 6-1: Comparison of Primary Predicate Device (Model EZ-28) to the Proposed Easy-Load Lens Delivery System (Model EZ-24)

7. Conclusion

The results obtained from nonclinical tests performed on the proposed Easy Load Lens Delivery System have demonstrated that the proposed device is as effective, and performs at least as safely and effectively as the predicate devices, therefore the proposed Easy Load Lens Delivery System is substantially equivalent to the predicate devices.

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.