AMO PHACOFLEX II INTERSECTION SYSTEM

K961242 · Allergan, Inc. · KYB · Jun 17, 1996 · Ophthalmic

Device Facts

• Record ID: K961242
• Device Name: AMO PHACOFLEX II INTERSECTION SYSTEM
• Applicant: Allergan, Inc.
• Product Code: KYB · Ophthalmic
• Decision Date: Jun 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4300
• Device Class: Class 1

Intended Use

The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.

Device Story

Bartell-type injector system for folding and inserting silicone intraocular lenses (IOLs) during cataract surgery. Components include reusable titanium handpiece, single-use lubricated polypropylene cartridge, single-use silicone soft tip, and acrylic tip holder. Surgeon loads IOL into cartridge; handpiece pushes IOL through cartridge into eye. System facilitates controlled IOL delivery through small incision. Benefits include reliable IOL delivery without compromising optical performance, lens dimensions, or cosmetic appearance. Reusable handpiece sterilized via steam autoclaving; single-use components provided sterile via EtO.

Clinical Evidence

Bench testing only. Evaluated IOL dioptric power, resolution, diameter, haptic angle, decentration, tilt, compression force, haptic pull strength, advancement force, release characteristics, and cosmetic integrity. Biocompatibility testing included cytotoxicity (ISO Agarose Overlay, Elution, USP Agar Diffusion), ICG inhibition, ocular irritation, and delayed contact sensitization. Results demonstrate non-toxic, non-irritating, and non-sensitizing properties, with performance equivalent to predicates.

Technological Characteristics

Handpiece: titanium (reusable). Cartridge: lubricated polypropylene (single-use). Soft tip: medical-grade silicone (single-use). Tip holder: acrylic resin (single-use). Operating principle: mechanical push-rod injector. Sterilization: steam autoclave (handpiece), EtO (cartridge, soft tip, applicator).

Indications for Use

Indicated for patients undergoing cataract extraction requiring the insertion of AMO®PhacoFlex® II (SLM-2/UV) silicone intraocular lenses (specifically SI-30NB and SI-40NB models).

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

• AMO®PhacoFlex® Inserter Disposable Cartridge (K941603)
• AMO®PhacoFlex® Inserter (K930320)

Submission Summary (Full Text)

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K961242
510(k) Notification
AMO®PhacoFlex® II Insertion System
JUN 17 1996
Page 170

# 510(k) Summary

In accordance with 21 CFR 807.92, Allergan is providing this 510(k) summary.

1. Submitter's name, address, and telephone number, a contact person, and the date the summary was prepared:

Allergan, Inc.
2525 Dupont Drive
Irvine, California 92713-9534
[phone]

Contact person: Maureen Weiner
Regulatory Affairs Analyst

Date summary prepared: March 29, 1996

2. Name of the device, including trade or proprietary name, common or usual name, and classification name:

Trade/proprietary name: AMO®PhacoFlex® II Insertion System

Common/usual name: lens insertion guide

Classification name: intraocular lens guide

3. Identification of the predicate device or legally marketed device to which substantial equivalence is claimed:

510(k) K941603, cleared on 7/6/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter Disposable Cartridge

510(k) K930320, cleared on 4/7/94, filed by Allergan Medical Optics, AMO®PhacoFlex® Inserter

Allergan, Inc. - Strictly Private

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510(k) Notification
AMO®PhacoFlex® II Insertion System

4. Description of the device that is the subject of the premarket notification submission, including an explanation of how the device functions, the scientific concepts that form the basis for the device, and the significant physical and performance characteristics of the device such as device design, material used, and physical properties:

The AMO®PhacoFlex® II Insertion System is used to fold and assist in the insertion of an AMO®PhacoFlex® II (SLM-2/UV) silicone intraocular lens (IOL) into the eye following cataract extraction. The materials used in the AMO®PhacoFlex® II Insertion System are similar to the materials used in predicate devices.

The AMO®PhacoFlex® II Insertion System is a Bartell-type injector system comprised of the following components:

**AMO®PhacoSert™ Handpiece (Model #PSH-ST)**

All handpiece components are composed of titanium, a material commonly used for reusable surgical instruments. The handpiece rod is designed to accept a single-use silicone rubber soft tip. This handpiece is reusable and is designed to withstand conventional in-office steam autoclaving. The titanium handpiece is provided to the customer in a plastic box in a non-sterile state.

**AMO®PhacoSert™ Soft Tip**

The soft tip is a single-use component composed of medical grade silicone which contains blue pigment to enhance its visibility during tip application and IOL implantation. The tip is provided sterile in the single-use soft tip holder.

**Single-use soft tip holder**

This component is composed of an optically clear version of acrylic resin. The tip holder facilitates application of the soft tip to the handpiece rod and eliminates direct handling of the soft tip during application. The tip holder is discarded following application of the soft tip to the titanium rod and does not directly contact either the IOL or the patient. The tip holder is provided sterile.

**AMO®PhacoSert™ Cartridge (Model #PSC-ST)**

The cartridge is a single-use component composed of lubricated polypropylene and is provided sterile.

5. Statement of intended use:

The AMO®PhacoFlex® II Insertion System is used to fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.

Allergan, Inc. - Strictly Private

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510(k) Notification
AMO®PhacoFlex® II Insertion System

6. Statement of how the technological characteristics (i.e., design, material, chemical composition, energy source) compare to the predicate device:

| Technological Characteristic | AMO®PhacoFlex® II Insertion System | Predicate Devices* |
| --- | --- | --- |
| Intended Use | To fold and assist in inserting the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye | To fold and insert a foldable IOL (AMO®PhacoFlex® II) into the eye during normal small incision cataract surgery |
| Operating Principle | IOL is loaded into the cartridge and the IOL is pushed through the cartridge and delivered into the eye | same operating principle |
| Materials: | | |
| handpiece | titanium | titanium or medical-grade stainless steel |
| cartridge | lubricated polypropylene | lubricated polypropylene |
| soft tip | silicone | N/A |
| soft tip holder | acrylic | N/A |
| Design: | | |
| handpiece | reusable | reusable |
| cartridge | 1 piece (insertion chamber) disposable, single use only | 1 piece (insertion chamber) disposable, single use only |
| soft tip | disposable, single use only | N/A |
| soft tip holder | disposable, single use only | N/A |
| Sterilization Method | handpiece is provided non-sterile cartridge, soft tip, and soft tip applicator are EtO sterilized | handpiece is provided non-sterile cartridge is EtO sterilized |
| Portion of Device that Contacts the Eye | tip of cartridge and soft tip | tip of cartridge |

*AMO®PhacoFlex® Inserter and the AMO®PhacoFlex® Inserter Disposable Cartridge

Allergan, Inc. - Strictly Private

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510(k) Notification
AMO®PhacoFlex® II Insertion System

7. Brief summary of nonclinical tests and results:

The in vitro performance testing conducted on the AMO®PhacoFlex® II Insertion System evaluated the following variables:
- Impact on IOL dioptric power
- IOL resolution return/fold recovery
- Overall lens diameter and haptic angle
- IOL decentration, tilt and compression force testing
- IOL haptic pull strength
- Force required to advance the IOL
- IOL release characteristics
- Streaks on IOL
- IOL optic body marks/damage

All test results indicate that like the predicate device, the AMO®PhacoFlex® II Insertion System reliably delivers SI-30NB and SI-40NB intraocular lenses without significantly impacting lens optical performance, lens dimensions, or cosmetic appearance.

The following biocompatibility testing has been conducted by a qualified independent testing laboratory on the AMO®PhacoFlex® II Insertion System:
- Cytotoxicity Test--ISO Agarose Overlay Method (soft tip)
- Cytotoxicity Test--ISO Elution Method (soft tip)
- In Vitro Inhibition of Cell Growth (ICG, One-Point Assay) (soft tip)
- Ocular Irritation Study (soft tip)
- Delayed Contact Sensitization Study (soft tip)
- Cytotoxicity Test--USP Agar Diffusion (soft tip holder)
- Cytotoxicity Test--ISO Elution Method (soft tip holder)

The test results indicate that the materials are non-toxic, non-irritating, non-inhibitory, and non-sensitizing. Please note that biocompatibility for the cartridge was established in the predicate device 510(k) #K941603. No new materials have been added to the cartridge since this 510(k) was cleared.

Based on the performance and biocompatibility testing, we conclude that this system is a safe and effective device for delivering the AMO®PhacoFlex® II (SLM-2/UV) family of intraocular lenses, specifically the SI-30NB and SI-40NB, into the eye.

Allergan, Inc. - Strictly Private