← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K960024 # STORZ D7120 PHACO HANDPIECE MAINTENANCE KIT & STORZ D7125 PHACO HANDPIECE NEEDLE WRENCH (K960024) _Storz Instrument Co. · HQC · Sep 20, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K960024 ## Device Facts - **Applicant:** Storz Instrument Co. - **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md) - **Decision Date:** Sep 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4670 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Intended Use The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114), and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece. ## Device Story Maintenance kit (D7120) and needle wrench (D7125) serve as accessories for phacoemulsification microsurgical systems. Kit includes syringe, stopcock fluidics connectors, needle wrench, and aspirator brush. Used by clinical staff to clean and maintain ultrasonic handpieces; facilitates assembly and disassembly of handpiece components. Non-sterile tools; intended for post-operative maintenance to ensure device functionality. Benefits patient by ensuring proper instrument hygiene and mechanical integrity during cataract extraction procedures. ## Clinical Evidence Bench testing only. ## Technological Characteristics Manual surgical tools including syringe, stopcock, fluidics connectors, needle wrench, and aspirator brush. Non-sterile. Designed for mechanical cleaning and assembly of phacoemulsification handpieces. ## Regulatory 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 - Alcon Series 20000 LEGACY ([K952213](/device/K952213.md)) - AMO Prestige Advanced Cataract Extraction System (K number unknown) ## Reference Devices - Storz DAISY ([K854508](/device/K854508.md)) - Storz Protegé ([K921758](/device/K921758.md)) - Storz Protegé ([K950114](/device/K950114.md)) - Storz PREMIERE ([K894278](/device/K894278.md)) - Storz PREMIERE ([K921460](/device/K921460.md)) - Storz PREMIERE ([K946227](/device/K946227.md)) - Phacoemulsification Handpiece ([K935926](/device/K935926.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K96 0024 storz Premarket Notification STORZ Instrument Company SEP 20 1996 # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The following information is submitted in accordance with the requirements of 21 CFR 807.92: Contact Person: Manager, Regulatory Affairs Date Prepared: December 28, 1995 Proprietary Names: Storz D7120 Phaco Handpiece Maintenance Kit and Storz D7125 Needle Wrench. Common/Usual Name: Ophthalmic microsurgical system accessories for phacoemulsification. Classification Name: System, Phacofragmentation (86 HQC). Device Description/Intended Use: The Storz D7120 Phaco Handpiece Maintenance Kit and the Storz D7125 Needle Wrench are intended to be used as accessories to Storz DAISY® (K854508), Storz Protegé® (K921758 and K950114), and PREMIERE® (K894278, K921460, and K946227) Microsurgical Systems for use in performing phacoemulsification. The D7120 contains an assortment of tools useful in cleaning and maintaining the Phacoemulsification Hndpiece (K935926) and the D7125 is an individual tool used in the assembly and disassembly of the handpiece. Predicate Device: The Storz D7120 and D7125 are substantially equivalent to similar cleaning and maintenance tools recommended by manuals for the Alcon Series 20000™ LEGACY™ (K952213) and the AMO® Prestige™ Advanced Cataract Extraction System™ (K number unknown) systems. Predicate Comparison: A chart comparing the Storz D7120 and D7125 to the predicate devices, demonstrating substantial equivalence, is attached. Submitted by: Michael H. Southworth 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 63122-6694 (314) 225-5051 FAX (314) 225-7365 {1} 56 # DEVICE COMPARISON CHART | Device Characteristic | AMO® Prestige™ | SERIES 20000® LEGACY™ | Storz D7120 and D7125 | | --- | --- | --- | --- | | Intended Use | Cleaning Ultrasonic Handpiece Immediately After Use | Cleaning Ultrasonic Handpiece Immediately After Use | Cleaning Ultrasonic Handpiece Immediately After Use | | Tools Recommended / Included | Recommended: Syringe, Fluidics Connectors, Tip Wrench | Recommended: Syringe, Fluidics Connectors, Tip Wrench | Included: Syringe, Stopcock Fluidics Connectors, Needle Wrench, Aspirator Brush | | Instrument Type | Phacoemulsification Handpiece | Phacoemulsification Handpiece | Phacoemulsification Handpiece | | Tools Provided Sterile? | No | No | No | | Tools Commonly Available Or Available From Supplier? | Yes | Yes | Yes | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K960024](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K960024) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com