AMO PRESTIGE DAY PACK (ALLERGAN, INC.)

K962402 · Allergan, Inc. · HQC · Sep 19, 1996 · Ophthalmic

Device Facts

• Record ID: K962402
• Device Name: AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
• Applicant: Allergan, Inc.
• Product Code: HQC · Ophthalmic
• Decision Date: Sep 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2

Intended Use

The AMO® Prestige® Day Pack supports the irrigation fluid path for replenishing intraocular fluid removed during cataract extraction. The tubing pack also supports the aspiration fluid path for removing fluid and nuclear fragments during cataract surgery.

Device Story

AMO® Prestige® Day Pack is a sterile tubing set used with the AMO® Prestige® Advanced Cataract Extraction™ System. It consists of a disposable cartridge assembly, disposable I/A tubing assembly, and drip spike assembly. The device provides a conduit for irrigation fluid to replenish intraocular fluid and a conduit for aspiration fluid containing nuclear fragments removed during surgery. Used in clinical settings by surgeons and surgical staff during phacoemulsification procedures. The system facilitates fluid management, ensuring chamber maintenance during cataract extraction.

Clinical Evidence

Bench testing only. Performance testing included durability tests, worst-case sterilization validation, aspiration obstruction testing, and chamber maintenance verification. Results demonstrate compatibility with the AMO® Prestige® Advanced Cataract Extraction™ System and substantial equivalence to predicate devices.

Technological Characteristics

Materials: Kynar, Polypropylene, Silicone. Sterilization: Gamma Radiation and EtO. Components: Disposable cartridge, disposable I/A tubing, drip spike assembly. Function: Fluid conduit for irrigation and aspiration in phacoemulsification systems. Reusability: Supports both single-patient use and multiple reuse configurations.

Indications for Use

Indicated for use during cataract extraction surgery to support irrigation and aspiration fluid paths for patients undergoing phacoemulsification.

Regulatory Classification

Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

Predicate Devices

• AMO® Prestige® Pack (OPO-40)
• AMO® Diplomax™ I/A tubing system (One Bottle Reusable Tubing, One Bottle Disposable Tubing, Irrigation Administration Set, T-Fitting)

Submission Summary (Full Text)

{0}

Notification
'Prestige® Day Pack
K962402
Page 11-2
510(k) Summary
AMO® Prestige® Day Pack
SEP 19 1996

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

a. Allergan, Inc.
2525 Dupont Drive
Irvine, California 92715
[phone]

b. Contact Person: Monique M. Heyninck

c. Date Summary Prepared: June 20, 1996

2. Name of device, including trade name and classification name:

a. Name of Device: AMO® Prestige® Day Pack

b. Common Name: Phacofragmentation or I/A Tubing Pack

c. Classification Name: As per 21 CFR 886.4670, the product nomenclature is Phacofragmentation System.

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

a. I/A disposable tubing system for use with the AMO® Prestige® phacoemulsification machine:
AMO® Prestige® Pack (Disposable, Sterile), OPO-40

b. I/A tubing system for use with the AMO® Diplomax™ phacoemulsification machine:
AMO® One Bottle Reusable Tubing (Sterile)
AMO® One Bottle Disposable Tubing (Sterile)
AMO® Irrigation Administration Set (Sterile)
AMO® T-Fitting (Non-Sterile)

ALLERGAN, INC. - CONFIDENTIAL

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Amendment to 510(k) K962402
AMO® Prestige® Day Pack
Page 11-3R

4. A description of the device that is the subject of the 510(k), including an explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties).

The AMO® Prestige® Day Pack has been designed for single patient use or multiple reuse and is used with the AMO® Prestige® Advanced Cataract Extraction™ System. The Day Pack is comprised of the AMO® Prestige® Disposable Cartridge Assembly, the AMO® Prestige® Disposable I/A Tubing Assembly and the AMO® Prestige® Drip Spike Assembly, all of which are provided to the customer in a sterile configuration. The AMO® Prestige® Day Pack provides a conduit for the irrigation fluid used to replenish the intraocular fluid removed during cataract extraction. The tubing pack also provides a conduit for the aspiration fluid that contains the aspirated fluid and nuclear fragments removed during cataract surgery. The design, materials and physical properties of the AMO® Prestige® Day Pack are substantially equivalent to those used in the predicate devices.

5. Statement of intended use:

The AMO® Prestige® Day Pack supports the irrigation fluid path for replenishing intraocular fluid removed during cataract extraction. The tubing pack also supports the aspiration fluid path for removing fluid and nuclear fragments during cataract surgery.

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

| | AMO® Prestige® Day Pack | Predicate Devices* |
| --- | --- | --- |
| Intended Use | The Day Pack supports the irrigation and aspiration fluid paths during the phacoemulsification procedure. | The Predicate Devices support the irrigation and aspiration fluid paths during the phacoemulsification procedure. |
| Tubing Material | Kynar, Polypropylene and Silicone | Kynar, Polypropylene, Silicone, and PVC |
| Sterilization Method | Gamma Radiation and EtO | Gamma Radiation and EtO |
| Reusable Cartridge | No | Yes/No |
| Reusable Tubing | Yes | Yes/No |
| Disposable Tubing | Yes | Yes |
| Reusable Drip Spike Assembly | No | Yes/No |
| Reusable Drain Bag | Yes | Yes/No |

* AMO® Prestige® Pack, OPO-40, and the tubing sets and accessories of the AMO® Diplomax™.

ALLERGAN, INC. - CONFIDENTIAL

{2}

Amendment to 510(k) K962402 AMO® Prestige® Day Pack
Page 11-4R

7. Brief summary of nonclinical tests and results:

The performance testing conducted on the AMO® Prestige® Day Pack included the following:

- Durability Tests
- Worst Case Sterilization
- Aspiration Obstruction
- Chamber Maintenance

The results of these tests indicate that the AMO® Prestige® Day Pack is substantially equivalent to the currently marketed predicate devices and is compatible for use with the AMO® Prestige® Advanced Cataract Extraction™ System.

ALLERGAN, INC. - CONFIDENTIAL