STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK

K961820 · Storz Instrument Co. · HQC · Jul 25, 1996 · Ophthalmic

Device Facts

• Record ID: K961820
• Device Name: STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Jul 25, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Storz DP4600 surgical accessory pack contains an Anterior Intraocular Pressure (IOP) Tube Set Assembly. This component is to be used as an accessory to the Storz PREMIERE® (K894278, K921460, and K946227) and Storz DAISY™ (K854508) Microsurgical Systems in the maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures.

Device Story

Accessory pack for ophthalmic microsurgical systems; includes irrigation administration tube set with filtered air line. Connects irrigation bottle to microsurgical system console. System provides controlled positive air pressure to pressurize irrigation bottle; delivers irrigation fluid at user-selected rate. Used in clinical setting by ophthalmic surgeons during anterior segment procedures. Maintains intraocular pressure; facilitates surgical fluid management.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Irrigation administration tube set with filtered air line. Single-patient use. Sterilized via gamma irradiation. Packaged in Tyvek/PET pouch. Operates via positive air pressure to control irrigation reservoir flow.

Indications for Use

Indicated for maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures.

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 DP4600 IOP Control Pack (K894278)
• Storz DP4101 Basic I/A Pack (K953078)

Reference Devices

• Storz PREMIERE Microsurgical System (K894278, K921460, K946227)
• Storz DAISY Microsurgical System (K854508)

Submission Summary (Full Text)

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storz
K961820
JUL 25 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 9, 1996
**Proprietary Name:** Storz DP4600 Anterior Intraocular Pressure Control Pack.
**Common/Usual Name:** Ophthalmic microsurgical system accessory pack for anterior intraocular pressure (IOP) control.
**Classification Name:** System, Phacofragmentation (86 HQC).

**Device Description/Intended Use:** The Storz DP4600 surgical accessory pack contains an Anterior Intraocular Pressure (IOP) Tube Set Assembly. This component is to be used as an accessory to the Storz PREMIERE® (K894278, K921460, and K946227) and Storz DAISY™ (K854508) Microsurgical Systems in the maintenance of intraocular pressure (IOP) during anterior segment ophthalmic surgical procedures. The DP4600 is a standard irrigation administration tube set with an additional line that connects the irrigation bottle to an air port on the microsurgical system console. Controlled positive air pressure from the system pressurizes the irrigation bottle and delivers the irrigation fluid at the user-selected rate.

**Predicate Devices:** The proposed Storz DP4600 Anterior Intraocular Pressure Control Pack is substantially equivalent to the existing Storz DP4600 IOP Control Pack (K894278) and to the Storz DP4101 Basic I/A Pack (K953078).

**Predicate Comparison:** A chart comparing the proposed Storz DP4600 to the predicate devices, demonstrating substantial equivalence, is attached.

**Submitted by:**

Audrey Swearingen
Storz Instrument Company

STORZ
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122-0004
[phone]
FAX [phone]
62

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# DEVICE COMPARISON CHART

## Storz DP4600 Intraocular Pressure Control Pack

| Device | Storz DP4600, modified | Storz DP4600, existing | Storz DP4101 Basic I/A Pack |
| --- | --- | --- | --- |
| Intended Use | Controlled Delivery of Irrigation Solution during Anterior Segment Ophthalmic Surgery | Controlled Delivery of Irrigation Solution during Anterior Segment Ophthalmic Surgery | Controlled Delivery of Irrigation Solution and Removal of Aspirant during Anterior Segment Ophthalmic Surgery |
| Components | IOP Tube Set, with irrigation administration line and filtered air line, and Instruction Sheet | IOP Tube Set, with irrigation administration line and filtered air line, and Instruction Sheet | Irrigation/Aspiration (I/A) Tubing, I/A Test Chamber, Collection Cassette, and Instruction Sheet |
| Manual Adjustment of Flow? | Yes | Yes | Yes |
| Flow Control Variable | Irrigation Reservoir Pressure | Irrigation Reservoir Pressure | Irrigation Reservoir Height |
| Single Patient Use? | Yes | Yes | Yes |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Singly in Tyvek® / PET Pouch, Ten pouches per Box | High-impact Polystyrene Tray with Tyvek® Lid, Six Trays per Box | High-impact Polystyrene Tray with Tyvek® Lid, Six Trays per Box |