The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

Device Description

The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. The plunger is advanced by applying a direct forward motion.

AI/ML Overview

The provided document describes the lioli™ IOL Delivery System and its substantial equivalence to a predicate device, but it does not contain detailed acceptance criteria or a comprehensive study report that directly proves the device meets specific performance metric acceptance criteria in a structured format.

The document discusses performance data in a general sense, focusing on non-clinical tests to demonstrate the device's functionality and safety by showing that the delivered IOLs were undamaged and within specifications.

Here's an attempt to extract and synthesize the requested information based on the provided text, noting where specific details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied/Deduced)	Reported Device Performance
IOL Integrity Post-Delivery:
No damages or scratches	All delivered lenses showed no damages or scratches.
Within dimensional specifications	All delivered lenses were within dimensional specifications.
Functionality not affected	Lens functionality was not affected.
Cartridge Integrity Post-Delivery:
No damages	All cartridges showed no damages after lens delivery.
Biocompatibility:
Safe for human contact (all contact materials)	Performance testing for all contact materials has been tested for biocompatibility and was found to be safe.
Sterilization:
SAL level 1x10^-6 achieved (ETO)	Achieved with ETO sterilization.
Shelf-Life:
Maintained throughout shelf life	Testing was performed; results not explicitly detailed but stated as part of the conclusion for SE.

Explanation of "Implied/Deduced" Criteria: The document describes the results of the tests ("all delivered lenses showed no damages"), from which we can infer the unstated acceptance criteria (e.g., "no damages or scratches on IOLs post-delivery").

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

Sample Size: Not explicitly stated. The document mentions "All lenses were delivered..." and "Each lioli™ IOL Delivery System were also evaluated...", which implies a sample was used but the exact number for IOLs or delivery systems is not provided.
Data Provenance: Retrospective, as these are pre-market notification tests conducted by the manufacturer for regulatory submission. The country of origin of the data is not specified, but the manufacturer is AST Products, Inc., located in Billerica, MA, USA.

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

Experts: Not applicable. The "ground truth" for the performance tests (e.g., integrity checks, dimensional specifications, optical properties) was established through objective measurements and standardized test methods (ISO standards), not through expert consensus or interpretation of subjective data.
Qualifications: Not applicable for establishing ground truth in this context.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The tests performed are objective measurements and observations (e.g., microscope inspection for damage, dimensional checks), rather than subjective assessments requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What War the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

MRMC Study: No, an MRMC study was not done.
Effect Size: Not applicable. This device is an IOL delivery system, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance in interpretation.

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

Standalone Performance: Not applicable. This device is a mechanical delivery system for IOLs, not an algorithm. Its "performance" is its ability to successfully deliver an IOL without damage, which was assessed in non-clinical tests.

7. The Type of Ground Truth Used

Ground Truth: Objective measurements against predefined specifications and visual inspection. For example:
- IOL optical properties: Measured in accordance with ISO 11979-2.
- IOL mechanical properties (including sagitta): Measured in accordance with ISO 11979-3.
- Damages/scratches: Visually inspected using a microscope.
- Biocompatibility: Tested against known safety standards for materials.
- Dimensional specifications: Compared against manufacturing specifications.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This device is a mechanical medical device, not a machine learning model, and therefore did not require a "training set."

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

Ground Truth Establishment: Not applicable, as there was no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract symbol of a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

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

April 9, 2015

AST Products, Inc. % David Lim, Ph.D. Regulatory Consultant 3955 Riner Road, Box 148 Riner, VA 24149

Re: K142056

Trade/Device Name: lioli™ IOL Delivery System Regulation Number: 21 CFR 886.4300 Regulation Name: Intraocular Lens Guide Regulatory Class: Class I Product Code: MSS Dated: March 4, 2015 Received: March 6, 2015

Dear Dr. Lim:

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.

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Page 2 - David Lim, Ph.D.

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 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.

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 Y. Alexander -A

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142056

Device Name lioli™ IOL Delivery System

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

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1. 510(k) Summary

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.92, 510(k) summary is provided.

2. Submitter

AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778

3. Official Correspondence/Contact Person

William Lee, Ph.D. Director, R&D and Regulatory Affairs AST Products, Inc. 9 Linnell Circle Billerica, MA 01821 USA Tel: (978) 667-4500 Fax: (978) 667-9778 Email: wlee@astp.com

4. 510(k) Preparer

Regulatory Doctor™ RCTC, LLC 3955 Riner Road, Box 148 Riner. VA 24149 Tel: (800) 321-8567 Email: info@regulatorydoctor.com

5. Product Name

Trade Name: lioli™ IOL Delivery System Common Name: Folders and Injectors, Intraocular Lens (IOL)

6. Device Classification

Classification Name: Class I (21 CFR § 886.4300 Intraocular lens quide) Classification Panel: Ophthalmic (86) Product Code: MSS

7. Leqally Marketed Predicate

K103495: ASICO SofTip Injector System, AS-9300

8. Device Description

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an incision. Only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling.

The set consists of a single- use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge.

9. Intended Use and Indications for Use

The lioli™ IOL Delivery System shares the same intended use and indications for use for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application. Refer to Table 1.

Note: One of the statutory requirements for demonstrating substantial equivalence (SE) is to show that a new device has the same intended use, which is broader than indications.

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TradeName	Manufacturer	RegulationNo.	ProductCode	RegulationDescription	510(k) No.	Intended Use &Indications for Use
lioliTM IOLDeliverySystem	AST Products, Inc.	886.4300	MSS	IntraocularLens Guide	New device	The lioliTM IOL Delivery System is asingle-use, sterile device intended toinsert a one-piece foldable intraocularlens (IOL) into the human eye througha surgical procedure. The systemprovides a tubular pathway for lensimplantation through an incision. Onlyfor the insertion of IOL modelsvalidated for use with this device asindicated in the IOL approved labeling.
ASICOSofTipInjectorSystem,AS-9300	ASICO LLC	886.4300	MSS	IntraocularLens Guide	K103495	The ASICO SofTip Injector System isa sterile, single use device intended toinsert a foldable intraocular lensthrough a surgical procedure in ahuman eye. The system provides atubular pathway through an incision,allowing the delivery of an IOL into thehuman eye. This is indicated for theinsertion only of models of IOL thatallow use of this injector in theirapproved labeling.

Table 1. Device Comparisons – Intended Use and Indications for Use

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10. Technological Characteristics

The lioli™ IOL Delivery System is an intraocular lens delivery system used for progressive folding and delivering intraocular lenses into the eye for replacement of the human crystalline lens. The device consists of:

(1) a cartridge that holds the intraocular lens in position in preparation for loading

(2) and a single-use injector that houses a silicone-tipped plunger used to advance the lens into the capsular bag.

An intraocular lens folded into the cartridge reduces the surgical incision size. Injector tip outer diameter measurements vary in size (1.67mm, 2.00mm and 2.25mm, respectively).

Model LIOLI-18 is with an injector tip outer diameter of 1.67mm
Model LIOLI-22 is with an injector tip outer diameter of 2.00mm
Model LIOLI-24 is with an injector tip outer diameter of 2.25mm

The lioli™ IOL Delivery System shares many similar technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application.

Differences in design/materials between lioli™ IOL Delivery System and the predicate device are not critical and do not affect its safety and effectiveness when used as labeled as patient contact during lens placement for the listed device is only intended to occur between the human eye and materials in which the both devices share - a single-use, sterile polypropylene cartridge and silicone tip. Refer to Tables 2 and 3.

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TradeName	Design	Operating Principle	ForwardMotionPrinciple	Biocomp.	SterilizationMethod	SettingUsed	PatientContact	Recommendedfor Use With	HumanFactors	PerformanceCriteria Met?
lioli™ IOLDeliverySystem	A sterile, singleuse disposabledevice	The cartridge isloaded into theinjection system andthe IOL is pushedthrough the cartridgeinto the eye	Plunger/Syringetype	Yes	ETO sterilizationSAL level 1x10-6	Hospital/Surgerycenter	Distal endof cartridgeto placelens in eye	FDA-approvedviscoelastic	For use bydoctorsonly	Yes
ASICOSofTipInjectorSystem,AS-9300	A sterile, singleuse disposabledevice	The cartridge isloaded into theinjection system andthe IOL is pushedthrough the cartridgeinto the eye	Plunger/Syringe/Screwtype	Yes	ETO sterilizationSAL level 1x10-6	Hospital/Surgerycenter	Distal endof cartridgeto placelens in eye	FDA-approvedviscoelastic	For use bydoctorsonly	Yes

Table 2. Device Comparisons – Technological Characteristics

Table 3. Device Comparisons – Materials

Trade Name	Device Materials	Standards Met
lioli™ IOLDelivery System	Injector - Polycarbonate (144R)Plunger - ABSSilicone Tip - Silicone (R 401)Cartridge - Polypropylene (HD850MO)Spring - Stainless Steel (SS304)	ISO 11979-3:2012ISO10993-5: 2009ISO 10993-10: 2010
ASICO SofTipInjector System,AS-9300	Injector - Polycarbonate (144R Blue)Plunger - Polycarbonate (144R White)Silicone Tip - SiliconeCartridge - PolypropyleneSpring - Stainless Steel (SS304)	ISO 11979-3:2006ISO10993-5: 2009ISO 10993-10: 2002

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Performance Data (Nonclinical and/or Clinical) 11.

Non-clinical Tests:
All lenses were delivered through the lioli™ according to the loading and delivery procedure in the Indications for Use (IFU).

The IOLs were evaluated for the optical properties, sagitta, and overall surface and bulk homogeneity before and after being surgically manipulated using each of the 3 models of lioli™ IOL Delivery System, as well as lens opening time after folding. Each lioli™ IOL Delivery System were also evaluated for its cartridge performance, such as overall cartridge surface and bulk homogeneity.

IOL optical properties and overall surface and bulk homogeneity inspection were conducted in accordance with ISO 11979-2. Ophthalmic implants -Intraocular lenses – Part 2: Optical properties and test methods and ISO 11979-3, Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods.

After delivery, all lenses were observed for possible damages or scratches using a microscope. All delivered lenses showed no damages or scratches. and were within dimensional specifications. Also, all cartridges showed no damages after lens delivery.

The resulting data from simulated surgical manipulation of lioli™ IOL Delivery System to deliver hydrophilic intraocular lenses ((OL) showed that lioli™ IOL Delivery System models LIOLI-18, LIOLI-22 and LIOLI-24, can successfully deliver Lenstec's Softec 1 IOL of low to high diopters without affecting the functionality of the lens.

To evaluate the safety of the proposed new device, performance testing for all contact materials has been tested for biocompatibility and was found to be safe.

Clinical Tests: Not required for this device. I

Conclusion 12.

The lioli™ IOL Delivery System shares the same intended use and indications for use, and technological characteristics for lens insertion into the eye with the predicate device referenced in this 510(k) premarket notification application.

Differences in design/materials between lioli™ IOL Delivery System and the predicate device are not critical and do not affect its safety and effectiveness when used as labeled as patient contact during lens placement for the listed device is only intended to occur between the human eye and materials in which both devices share - a single-use, sterile polypropylene cartridge and silicone tip.

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The resulting data from simulated surgical manipulation of lioli™ IOL Delivery System to deliver intraocular lenses (IOL) showed that lioli™ IOL Delivery System models LIOLI-18, LIOLI-22 and LIOLI-24 can successfully deliver hydrophilic IOLs of low to high diopters without affecting the functionality of the lens.

Based on the assessment of these findings, along with the results of Biocompatibility, Sterilization and Shelf-Life testing, the lioli™ IOL Delivery System is substantially equivalent to the referenced legally marketed predicate device provided in this 510(k) premarket notification submission.

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.