LIOLI IOL DELIVERY SYSTEM

K142056 · Ast Products, Inc. · MSS · Apr 9, 2015 · Ophthalmic

Device Facts

• Record ID: K142056
• Device Name: LIOLI IOL DELIVERY SYSTEM
• Applicant: Ast Products, Inc.
• Product Code: MSS · Ophthalmic
• Decision Date: Apr 9, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

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 Story

The lioli™ IOL Delivery System is a single-use, sterile, manual surgical instrument used by ophthalmologists in hospital or surgery center settings. It consists of a syringe-style injector with a silicone-tipped plunger and a LubriMATRIX™-treated cartridge. The device functions by housing a foldable IOL within the cartridge; the surgeon advances the plunger to push the lens through a tubular pathway and into the patient's capsular bag. The silicone tip ensures smooth contact and delivery. By folding the lens, the system allows for implantation through a smaller surgical incision. The device is used with FDA-approved viscoelastic. It provides a mechanical delivery mechanism that facilitates lens placement, potentially reducing surgical trauma and improving patient outcomes during cataract or lens replacement surgery.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluation included simulated surgical manipulation to deliver hydrophilic IOLs of varying diopters. Endpoints included optical properties, sagitta, surface/bulk homogeneity, and lens opening time, assessed per ISO 11979-2 and ISO 11979-3. Results showed no lens damage or scratches post-delivery and all lenses remained within dimensional specifications. Biocompatibility, sterilization, and shelf-life testing were also performed.

Technological Characteristics

Manual syringe-style injector. Materials: Polycarbonate (144R) injector, ABS plunger, silicone (R 401) tip, polypropylene (HD850MO) cartridge, stainless steel (SS304) spring. Tip diameters: 1.67mm, 2.00mm, 2.25mm. Sterilization: ETO (SAL 10^-6). Standards: ISO 11979-3:2012, ISO 10993-5:2009, ISO 10993-10:2010.

Indications for Use

Indicated for the insertion of one-piece foldable intraocular lenses (IOL) into the human eye during surgical procedures, specifically for IOL models validated for use with this device.

Regulatory Classification

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.

Predicate Devices

• ASICO SofTip Injector System, AS-9300 (K103495)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> ☐ Over-The-Counter Use (21 </span> |

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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: [phone] Fax: [phone]

### 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: [phone] Fax: [phone] Email: [e-mail]

### 4. 510(k) Preparer

Regulatory Doctor™ RCTC, LLC 3955 Riner Road, Box 148 Riner. VA 24149 Tel: [phone] Email: [e-mail]

## 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

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

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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.

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.

#### 9. Intended Use and Indications for Use

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.

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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| Trade<br>Name | Manufacturer | Regulation<br>No. | Product<br>Code | Regulation<br>Description | 510(k) No. | Intended Use &<br>Indications for Use |
|---------------------------------------------------|--------------------|-------------------|-----------------|---------------------------|------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| lioliTM IOL<br>Delivery<br>System | AST Products, Inc. | 886.4300 | MSS | Intraocular<br>Lens Guide | New device | The lioliTM IOL Delivery System is a<br>single-use, sterile device intended to<br>insert a one-piece foldable intraocular<br>lens (IOL) into the human eye through<br>a surgical procedure. The system<br>provides a tubular pathway for lens<br>implantation through an incision. Only<br>for the insertion of IOL models<br>validated for use with this device as<br>indicated in the IOL approved labeling. |
| ASICO<br>SofTip<br>Injector<br>System,<br>AS-9300 | ASICO LLC | 886.4300 | MSS | Intraocular<br>Lens Guide | K103495 | The ASICO SofTip Injector System is<br>a sterile, single use device intended to<br>insert a foldable intraocular lens<br>through a surgical procedure in a<br>human eye. The system provides a<br>tubular pathway through an incision,<br>allowing the delivery of an IOL into the<br>human eye. This is indicated for the<br>insertion only of models of IOL that<br>allow use of this injector in their<br>approved 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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| Trade<br>Name | Design | Operating Principle | Forward<br>Motion<br>Principle | Biocomp. | Sterilization<br>Method | Setting<br>Used | Patient<br>Contact | Recommended<br>for Use With | Human<br>Factors | Performance<br>Criteria Met? |
|---------------------------------------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------|----------|---------------------------------------|--------------------------------|-------------------------------------------------------|------------------------------|-------------------------------|------------------------------|
| lioli™ IOL<br>Delivery<br>System | A sterile, single<br>use disposable<br>device | The cartridge is<br>loaded into the<br>injection system and<br>the IOL is pushed<br>through the cartridge<br>into the eye | Plunger/<br>Syringe<br>type | Yes | ETO sterilization<br>SAL level 1x10-6 | Hospital/<br>Surgery<br>center | Distal end<br>of cartridge<br>to place<br>lens in eye | FDA-approved<br>viscoelastic | For use by<br>doctors<br>only | Yes |
| ASICO<br>SofTip<br>Injector<br>System,<br>AS-9300 | A sterile, single<br>use disposable<br>device | The cartridge is<br>loaded into the<br>injection system and<br>the IOL is pushed<br>through the cartridge<br>into the eye | Plunger/<br>Syringe/<br>Screw<br>type | Yes | ETO sterilization<br>SAL level 1x10-6 | Hospital/<br>Surgery<br>center | Distal end<br>of cartridge<br>to place<br>lens in eye | FDA-approved<br>viscoelastic | For use by<br>doctors<br>only | Yes |

Table 2. Device Comparisons – Technological Characteristics

Table 3. Device Comparisons – Materials

| Trade Name | Device Materials | Standards Met |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| lioli™ IOL<br>Delivery System | Injector - Polycarbonate (144R)<br>Plunger - ABS<br>Silicone Tip - Silicone (R 401)<br>Cartridge - Polypropylene (HD850MO)<br>Spring - Stainless Steel (SS304) | ISO 11979-3:2012<br>ISO10993-5: 2009<br>ISO 10993-10: 2010 |
| ASICO SofTip<br>Injector System,<br>AS-9300 | Injector - Polycarbonate (144R Blue)<br>Plunger - Polycarbonate (144R White)<br>Silicone Tip - Silicone<br>Cartridge - Polypropylene<br>Spring - Stainless Steel (SS304) | ISO 11979-3:2006<br>ISO10993-5: 2009<br>ISO 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.