STORZ D4600 AIR EXCHANGE LINE PACK

K962131 · Storz Instrument Co. · HQC · Aug 23, 1996 · Ophthalmic

Device Facts

• Record ID: K962131
• Device Name: STORZ D4600 AIR EXCHANGE LINE PACK
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2

Intended Use

The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

Device Story

Accessory tubing pack for ophthalmic microsurgical systems; routes air from system to posterior chamber of eye during surgery. Single-patient use; sterile; gamma-irradiated. Used by ophthalmic surgeons in clinical settings to facilitate air/fluid exchange. Device provides physical pathway for air delivery; no active electronic or software components.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Tubing set for air delivery; sterile; gamma irradiation sterilization; packaging includes Tyvek® and PET/PE pouch. No electronic components, software, or active sensing.

Indications for Use

Indicated for use in posterior segment ophthalmic surgical procedures requiring air and fluid exchange.

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 D4600 Air Exchange Line Pack (K894278)
• Intek International, Inc. TR-9006-11 Air Delivery Tubing System (K832761)

Reference Devices

• Storz PREMIERE® Microsurgical System (K894278, K921460, K946227)
• Storz DAISY® Microsurgical System (K854508)
• Escalon™ CFAE-40 Air/Fluid Exchange Pump

Submission Summary (Full Text)

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K962131

storz®

AUG 23 1996

Premarket Notification
Storz Instrument Company

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

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

Contact Person: Regulatory Affairs Associate

Date Prepared: May 31, 1996

Proprietary Name: Storz D4600 Air Exchange Line Pack.

Common/Usual Name: Ophthalmic surgical system accessory pack for posterior segment procedures.

Classification Name: System, Phacofragmentation (86 HQC).

Device Description/Intended Use: The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye.

Predicate Device: The proposed Storz D4600 Air Exchange Line Pack is substantially equivalent to the existing Storz D4600 Air Exchange Line Pack (K894278), and to the Intek International, Inc. TR-9006-11 Air Delivery Tubing System (K832761).

Predicate Comparison: A chart comparing the Storz D4600 to the predicate devices, 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

STORZ

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# DEVICE COMPARISON CHART

## Storz D4600 Air Exchange Line Pack

| Device | Storz D4600, modified | Storz D4600, existing | Intek International TR9006-11 |
| --- | --- | --- | --- |
| Intended Use | To deliver air to the eye during posterior ophthalmic surgical procedures | To deliver air to the eye during posterior ophthalmic surgical procedures | To deliver air to the eye during ophthalmic surgical procedures |
| Recommended System | Storz PREMIERE® or Storz Daisy™ Microsurgical Systems | Storz PREMIERE® or Storz Daisy™ Microsurgical Systems | Escalon™ CFAE-40 Air/Fluid Exchange Pump |
| Instructions For Use Included? | Yes | No | Unknown |
| Single Patient Use? | Yes | Yes | Yes |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Unknown |
| Packaging | Singly in Tyvek® and PET/PE Pouch, Ten pouches per Box | Singly in Tyvek® and PET/PE Pouch, Ten pouches per Box | Unknown package type, Ten units per Box |