STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX

K955901 · Storz Instrument Co. · HQC · Mar 28, 1996 · Ophthalmic

Device Facts

• Record ID: K955901
• Device Name: STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Mar 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of I/A test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé® (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.

Device Story

Accessory pack for phacoemulsification systems; includes drapes, irrigation/aspiration tubing, collection cassette, test chambers, infusion sleeves, and tools. Used in clinical settings by surgeons during cataract procedures. Facilitates ultrasonic lens emulsification, anterior chamber irrigation, and aspiration of lens material via Storz microsurgical systems. Single-patient use; provided sterile. Enhances surgical workflow by providing necessary fluidics and protection components for phacoemulsification handpieces.

Clinical Evidence

Bench testing only.

Technological Characteristics

Components include medical grade silicone tubing/sleeves, PETG tray, and Tyvek lid. Sterile, single-patient use. Designed for integration with Storz microsurgical systems for fluid management and surgical site protection during phacoemulsification.

Indications for Use

Indicated for irrigation/aspiration and phacoemulsification procedures in patients undergoing cataract surgery.

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

• Storz Universal I/A and Phacoemulsification Pack (K882240)

Reference Devices

• Auxiliary drape (K934445)
• Collection cassette (K953078)
• STORZ Protegé® (K921758, K950114)
• PREMIERE® (K894278, K921460, K946227)
• DAISY® (K854508)
• Storz Phacoemulsification Handpieces (K935926)

Submission Summary (Full Text)

{0}

K955901

storz®

MAR 28 1995

Premarket Notification
Storz Instrument Company

# 510(k) SUMMARY OF SAFETY AND EFFICACY

The following information is submitted in accordance with the requirements of 21 CFR 807.92:

Contact Person: Audrey Swearingen, Regulatory Affairs Associate

Date Prepared: December 28, 1995

Proprietary Name: STORZ DP4310 Deluxe Phaco Pack Without Reflux.

Common/Usual Name: Ophthalmic surgical system accessory pack for phacoemulsification.

Classification Name: System, Phacofragmentation (86 HQC).

Device Description/Intended Use: The STORZ DP4310 surgical accessory pack contains an auxiliary drape (K934445), a Mayo arm drape, an irrigation administration tube assembly, a collection cassette (K953078), and an irrigation/aspiration (I/A) tube assembly. Other components included are a pair of I/A test chambers, a pair of infusion sleeves, a tube stopper, a male Luer cap, and a needle wrench. These components are to be used in conjunction with the STORZ Protegé® (K921758 and K950114), PREMIERE® (K894278, K921460, and K946227) or DAISY® (K854508) Microsurgical Systems in the performance of phacoemulsification.

Phacoemulsification involves the ultrasonic disintegration of the opacified crystalline lens (cataract) from the eye. This process is accomplished by means of an electronically driven ultrasonic handpiece which 1) emulsifies the lens; 2) facilitates the irrigation of the anterior chamber; and 3) facilitates the aspiration of the emulsified lens material and irrigant from the eye. The Storz DP4310 Pack provides the accessories necessary to enable use of the Storz Phacoemulsification Handpieces (K935926) with the above Storz microsurgical systems.

Predicate Device: The Storz DP4310 is substantially equivalent to the Storz Universal I/A and Phacoemulsification Pack (K882240).

Predicate Comparison: A chart comparing the Storz DP4310 Deluxe Phaco Pack

STORZ
1985 Treo Court Industrial Blvd.
St. Louis, MO 63122-0694
[phone]
Fax (01-8) STORZ STI
FAX [phone]

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Without Reflux to the predicate device, demonstrating substantial equivalence, is attached.

Submitted by:

Audrey Swearingen
Storz Instrument Company
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122
Ph. 314/225-5051

95

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K955901

# DEVICE COMPARISON CHART

| DEVICE CHARACTERISTIC | STORZ DP4310 | STORZ UNIVERSAL I/A PACK |
| --- | --- | --- |
| Pack Contents | Aux drape, Arm Drape, Collection Cassette, I/A Tubing, Test Chambers, Infusion Sleeves, Stopper, Cap, Wrench | Collection Cassette, I/A Tubing, Test Chamber |
| Indication for Use | Irrigation/Aspiration and Phacoemulsification | Irrigation/Aspiration and Phacoemulsification |
| Applicable Ophthalmic Microsurgical System | Storz DAISY®, PREMIERE®, and Protegé® Systems | Storz DAISY®, PREMIERE® and Protegé® Systems |
| Patient Contact Material | Medical Grade Silicone | None |
| Instructions for Use Included in Each Pack? | YES | YES |
| Labeled Per 21CFR §801.109? | YES | YES |
| Labeled For Single Patient Use? | YES | NO |
| Provided Sterile? | YES | NO |
| Packaging | PETG Tray with TYVEK Lid | Polybag |