STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK
K961874 · Storz Instrument Co. · HQC · Aug 6, 1996 · Ophthalmic
Device Facts
| Record ID | K961874 |
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| Device Name | STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK |
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| Applicant | Storz Instrument Co. |
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| Product Code | HQC · Ophthalmic |
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| Decision Date | Aug 6, 1996 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 886.4670 |
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| Device Class | Class 2 |
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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)
Related Devices
- K955901 — STORZ DP4310DELUXE PHACO PACK WITHOUT REFLUX · Storz Instrument Co. · Mar 28, 1996
- K980100 — STORZ DP4210 VENTURI ECONOMY ANTERIOR PACK AND DP5000 ASC DAYPACK · Storz Instrument Co. · Jun 1, 1998
- K961831 — STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK · Storz Instrument Co. · Aug 6, 1996
- K990292 — I/A (IRRIGATION/ASPIRATION) PACK, POSTERIOR VITRECOMY PACK, ANTERIOR VIRECTOMY PACK, PHACOEMULSIFICATION PACK, ADMIINISN · Ophthalmic Consultants, Inc. · Nov 19, 1999
- K073023 — STERILS SINGLE-USE I/A HANDPIECES · Bausch & Lomb, Inc. · Mar 12, 2008
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
(314) 225-5051
FAX (314) 225-7365
75
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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 |
