LogoFDA 510(k) Search
K Number
K962402
Device Name
AMO PRESTIGE DAY PACK (ALLERGAN, INC.)
Manufacturer
ALLERGAN, INC.
Date Cleared
1996-09-19

(90 days)

Product Code
HQC
Regulation Number
886.4670
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
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 UA 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.
More Information

OPO-40

Not Found

No
The description focuses on fluid management components and does not mention any AI/ML capabilities or image processing.

No
The device, a tubing pack, supports the fluid paths for irrigation and aspiration during cataract surgery, but it does not directly treat or diagnose a disease.

No

The device is described as providing a fluid path for irrigation and aspiration during cataract surgery, which are therapeutic and supportive functions, not diagnostic.

No

The device description explicitly states it is comprised of physical components (Disposable Cartridge Assembly, Disposable UA Tubing Assembly, Drip Spike Assembly) and provides a conduit for fluids, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use describes the device's role in supporting fluid paths during cataract surgery. It's a surgical accessory used during a medical procedure, not for testing samples in vitro (outside the body) to diagnose a condition.
  • Device Description: The description details the components and function of the tubing pack for irrigation and aspiration during surgery. It doesn't mention any components or processes related to analyzing biological samples.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring specific analytes
    • Providing diagnostic information
    • Using reagents or assays

The device is clearly a surgical instrument/accessory used to facilitate a surgical procedure.

N/A

Intended Use / Indications for Use

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

Product codes

Not Found

Device Description

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 UA 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

intraocular

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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 prodicate devices and is compatible for use with the AMO® Prestige® Advanced Cataract Extraction™ System.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

AMO® Prestige® Pack (Disposable, Sterile), OPO-40, AMO® One Bottle Reusable Tubing (Sterile), AMO® One Bottle Disposable Tubing (Sterile), AMO® Irrigation Administration Set (Sterile), AMO® T-Fitting (Non-Sterile)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 886.4670 Phacofragmentation system.

(a)
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.(b)
Classification. Class II.

0

K96x402

SEP 19 10

510(k) Summary AMO® Prestige® Day Pack

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

  • Allergan, Inc. a. 2525 Dupont Drive Irvine, California 92715 (714) 246-2226
    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:

  • I/A disposable tubing system for use with the AMO® Prestige® a. 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

1

  • A description of the device that is the subject of the 510(k), including 4. 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 UA 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.

ળે Statement of intended use:

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

    1. 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

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 Q
  • . Chamber Maintenance

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

ALLERGAN, INC. - CONFIDENTIAL