← Product Code [HQE](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE) · K954816 # STORZ DP4800 DELUXE , STORZ DP4801 BASIC W/REFLUX, DP4801 BASIC POSTERIOR VITRECTOMY PACK WITH VARIABLE PORT CUTTER & RX (K954816) _Storz Instrument Co. · HQE · Mar 4, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K954816 ## Device Facts - **Applicant:** Storz Instrument Co. - **Product Code:** [HQE](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE.md) - **Decision Date:** Mar 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4150 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic - **Attributes:** Therapeutic ## Intended Use The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectomy probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy. ## Device Story Surgical accessory packs containing vitrectomy probe, tubing set, and collection cassette; used with STORZ PREMIERE® or DAISY® Microsurgical Systems. Probe utilizes pneumatic guillotine cutting mechanism; 20-gauge needle size. Used in ophthalmic surgery by surgeons. Safety feature: probe cutter opens when turned off. Single-patient use; provided sterile in PETG tray with TYVEK lid. Facilitates vitreous cutting and aspiration during posterior vitrectomy. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Type 304 stainless steel probe; pneumatic drive mechanism; guillotine cutting action; 20-gauge needle. Sterile, single-patient use. Packaging: PETG tray with TYVEK lid. ## Regulatory Identification A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens. ## Special Controls *Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Predicate Devices - STORZ MVS-3201 ([K953575](/device/K953575.md)) - STORZ DP4400 ([K953575](/device/K953575.md)) - STORZ DP4400VP ([K953575](/device/K953575.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} LOTZ MAR - 4 1996 K954816 Premarket Notification STORZ Instrument Company # 510(k) SUMMARY OF SAFETY AND EFFICACY The following information is submitted in accordance with the requirements of 21 CFR 807.92: Contact Person: Manager, Regulatory Affairs Date Prepared: October 16, 1995 Proprietary Names: STORZ DP4801 Basic Posterior Vitrectomy Pack; STORZ DP4800 Deluxe Posterior Vitrectomy Pack; STORZ Basic Posterior Vitrectomy Pack with Variable Port Cutter. Common/Usual Name: Ophthalmic surgical system accessory packs for posterior Vitrectomy Classification Name: Instrument, vitreous cutting and aspirating, AC-powered (86HQE) Device Description/Intended Use: The STORZ DP4801, DP4800, and DP4801VP surgical accessory packs contain a vitrectomy probe and attached tubing set to be used in conjunction with the STORZ PREMIERE® or DAISY® Microsurgical Systems in the performance of posterior vitrectomy. Predicate Device: The STORZ DP4801, DP4800, and DP4801VP are substantially equivalent to the STORZ MVS-3201, DP4400 and DP4400VP anterior vitrectomy packs (K953575). Predicate Comparison: A chart comparing the STORZ DP4801, DP4800, and DP4801VP posterior vitrectomy packs to the predicate device, 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 Court Industrial Blvd. MO 63122-6094 5051 491 STORZ STI 225-2365 {1} # DEVICE COMPARISON CHART | DEVICE CHARACTERISTIC | Storz DP4801 PACK | Storz DP4800 PACK | Storz DP4801VP PACK | PREDICATE DEVICES: Storz MVS3201 PACK Storz DP4400 PACK Storz DP4400VP PACK | | --- | --- | --- | --- | --- | | Pack Contents | Vitrectomy Probe with Tube Set and Collection Cassette | Vitrectomy Probe with Tube Set, Collection Cassette plus Deluxe Accessories | Vitrectomy Probe with Tube Set and Collection Cassette | Vitrectomy Probe with Tube Set | | Indication For Use | Posterior Vitrectomy | Posterior Vitrectomy | Posterior Vitrectomy | Anterior Vitrectomy | | Opthalmic Surgical System to be Used | STORZ PREMIERE® and DAISY® Systems | STORZ PREMIERE® and DAISY® Systems | STORZ PREMIERE® and DAISY® Systems | STORZ PREMIERE®, Protegé, and DAISY® Systems | | Probe Cutting Mechanism Type | Guillotine | Guillotine | Guillotine | Guillotine | | Probe Drive Mechanism Type | Pneumatic | Pneumatic | Pneumatic | Pneumatic | | Does Probe Cutter Open When Turned Off As A Safety Measure? | YES | YES | YES | YES | | Probe Needle Size | 20 Gauge | 20 Gauge | 20 Gauge | 20 Gauge | | Patient Contact Materials | Type 304 Stainless Steel | Type 304 Stainless Steel | Type 304 Stainless Steel | Type 304 Stainless Steel | | Instructions For Use Included In Pack? | YES | YES | YES | YES | {2} # DEVICE COMPARISON CHART | DEVICE CHARACTERISTIC | Storz DP4801 PACK | Storz DP4800 PACK | Storz DP4801VP PACK | PREDICATE DEVICES: Storz MVS3201 PACK Storz DP4400 PACK Storz DP4400VP PACK | | --- | --- | --- | --- | --- | | Labeled For Single Patient Use Only? | YES | YES | YES | YES | | Labeled Per 21CFR §801.109(b)? | YES | YES | YES | YES | | Provided Sterile? | YES | YES | YES | YES | | Packaging | PETG Tray with TYVEK Lid | PETG Tray with TYVEK Lid | PETG Tray with TYVEK Lid | PETG Tray with TYVEK Lid | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K954816](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQE/K954816) **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