STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK

K961874 · Storz Instrument Co. · HQC · Aug 6, 1996 · Ophthalmic

Device Facts

• Record ID: K961874
• Device Name: STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2

Intended Use

The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.

Device Story

Single-use collection cassette; accessory to Storz DAISY, Protegé, and PREMIERE ophthalmic microsurgical systems. Functions as reservoir for aspirated fluid/tissue during anterior segment surgery. Used in clinical/surgical settings by ophthalmic surgeons. Device collects surgical waste; facilitates fluid management during phacofragmentation procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Anterior collection cassette; material: Phillips K-Resin; single-patient use; sterile; sterilization method: Gamma Irradiation; packaging: Tyvek and PET/PE pouch.

Indications for Use

Indicated for use as a reservoir for aspirated fluid and tissue 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 DP5100 Ambulatory Surgery Center (ASC) Collection Cassette Pack (K894278, K921758)
• Storz DP4101 Basic Irrigation / Aspiration Pack (K953078)

Reference Devices

• Storz DAISY (K854508)
• Storz Protegé (K921758, K950114)
• Storz PREMIERE (K894278, K921460, K946227)

Submission Summary (Full Text)

{0}

K961874

storz

AUG 6 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 DP5100 Anterior Collection Cassette Pack
**Common/Usual Name:** Ophthalmic microsurgical system accessory pack for anterior segment surgical procedures.
**Classification Name:** System, Phacofragmentation (86 HQC).

**Device Description/Intended Use:** The Storz DP5100 surgical accessory pack contains a single collection cassette. This component is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Ophthalmic Microsurgical Systems as a reservoir for aspirated fluid and tissue collected during anterior segment ophthalmic surgical procedures.

**Predicate Device:** The modified Storz DP5100 is substantially equivalent to the existing Storz DP5100 Ambulatory Surgery Center (ASC) Collection Cassette Pack (K894278, K921758), and to the Storz DP4101 Basic Irrigation / Aspiration Pack (K953078).

**Predicate Comparison:** A chart comparing the Storz DP5100, as modified, 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 63122-6694
[phone]
FAX [phone]
75

{1}

76
2100217

# DEVICE COMPARISON CHART

## Storz DP5100 Anterior Collection Cassette Pack

| Device | Storz DP5100, modified | Storz DP5100, existing | Storz DP4101 |
| --- | --- | --- | --- |
| Intended Use | Collection of Aspirant during Anterior Segment Ophthalmic Surgery | Collection of Aspirant during Anterior Segment Ophthalmic Surgery | Delivery of Irrigant and Collection of Aspirant during Anterior Segment Ophthalmic Surgery |
| Components | Anterior Collection Cassette, Instruction Sheet | Anterior Collection Cassette | I/A Tubing, Test Chamber, Anterior Collection Cassette, Instruction Sheet |
| Single Patient Use? | Yes | Yes | Yes |
| Cassette Material | Phillips K-Resin® | LEXAN™ | Phillips K-Resin® |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Tyvek® and PET/PE Pouch, Six pouches per Box | Tyvek® and PET/PE Pouch, Six Pouches per Box | High-impact Polystyrene Tray With Tyvek® Lid, Six Packs per Box |