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.
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)
{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
(314) 225-5051
FAX (314) 225-7365
75
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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 |
