STORZ DP5200 IRRIGATION ADDMINISTRATION SET PACK
K961831 · Storz Instrument Co. · HQC · Aug 6, 1996 · Ophthalmic
Device Facts
| Record ID | K961831 |
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| Device Name | STORZ DP5200 IRRIGATION ADDMINISTRATION SET 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 DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir, to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
Device Story
Accessory pack for ophthalmic microsurgical systems; provides fluid pathway from irrigation reservoir to surgical handpiece. Used in clinical/surgical settings by ophthalmologists/surgical staff. Single-patient use; sterile. Facilitates fluid delivery during phacofragmentation or related procedures.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Irrigation administration set; includes tubing and instruction sheet. Materials: Tyvek and PET/PE pouch packaging. Sterilization: Gamma irradiation. Standalone accessory; non-electronic.
Indications for Use
Indicated for use during ophthalmic surgical procedures requiring delivery of irrigation fluid via Storz DAISY, Protegé, and PREMIERE microsurgical systems.
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 DP5200 Ambulatory Surgery Center (ASC) Irrigation Administration Set Pack (K894278, K921758)
- Storz DP4310 Deluxe Phaco Pack (K955901)
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
- K962131 — STORZ D4600 AIR EXCHANGE LINE PACK · Storz Instrument Co. · Aug 23, 1996
- K961874 — STORZ DP5100 ANTERIOR COLLECTION CASSETTE 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
- K961820 — STORZ DP4600 ANTERIOR INTRAOCULAR PRESSURE CONTROL PACK · Storz Instrument Co. · Jul 25, 1996
Submission Summary (Full Text)
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K961831
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 DP5200 Irrigation Administration Set Pack.
Common/Usual Name: Microsurgical system accessory pack for delivery of irrigation fluid during ophthalmic surgical procedures.
Classification Name: System, Phacofragmentation (86 HQC).
Device Description/Intended Use: The Storz DP5200 is intended to be used as an accessory to the Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114) and Storz PREMIERE® (K894278, K921460, K946227) Microsurgical Systems as a pathway for delivery of irrigation fluid from the irrigation reservoir, to the surgical handpiece irrigation line, during ophthalmic surgical procedures.
Predicate Devices: The modified Storz DP5200 is substantially equivalent to the Storz existing DP5200 Ambulatory Surgery Center (ASC) Irrigation Administration Set Pack (K894278, K921758) and to the Storz DP4310 Deluxe Phaco Pack (K955901).
Predicate Comparison: A chart comparing the Storz DP5200 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
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122
614/225-5051
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# DEVICE COMPARISON CHART
## Storz DP5200 Irrigation Administration Set Pack
| Device | Storz DP5200, modified | Storz DP5200, existing | Storz DP4310 |
| --- | --- | --- | --- |
| Intended Use | Delivery of Irrigation Fluid during Ophthalmic Surgical Procedures | Delivery of Irrigation Fluid during Ophthalmic Surgical Procedures | Delivery of Irrigation Fluid and Removal of Aspirant during Ophthalmic Surgical Procedures |
| Pack Components | Irrigation Administration Set, Instruction Sheet | Irrigation Administration Set | Irrigation Administration Set, I/A Tubing, I/A test Chamber, Tube Stopper, Irrigation Sleeve, Collection Cassette, Mayo Arm Drape, Auxiliary Drape, Needle Wrench, Luer cap, Instruciton Sheet |
| Recommended Systems | Storz Protegé®, PREMIERE®, and DAISY® Microsurgical Systems | Storz Protegé®, PREMIERE®, and DAISY® Microsurgical Systems | Storz Protegé®, PREMIERE®, and DAISY® Microsurgical Systems |
| Single Patient Use? | Yes | Yes | Yes |
| Provided Sterile? | Yes | Yes | Yes |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |
| Packaging | Tyvek® and PET/PE Pouch | Tyvek® and PET/PE Pouch | High impact Polystyrene Tray with Tyvek Lid |
