← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K961874 # STORZ DP5100 ANTERIOR COLLECTION CASSETTE PACK (K961874) _Storz Instrument Co. · HQC · Aug 6, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K961874 ## Device Facts - **Applicant:** Storz Instrument Co. - **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md) - **Decision Date:** Aug 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4670 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## 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. ## 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 - Storz DP5100 Ambulatory Surgery Center (ASC) Collection Cassette Pack ([K894278](/device/K894278.md), [K921758](/device/K921758.md)) - Storz DP4101 Basic Irrigation / Aspiration Pack ([K953078](/device/K953078.md)) ## Reference Devices - Storz DAISY ([K854508](/device/K854508.md)) - Storz Protegé ([K921758](/device/K921758.md), [K950114](/device/K950114.md)) - Storz PREMIERE ([K894278](/device/K894278.md), [K921460](/device/K921460.md), [K946227](/device/K946227.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} 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 {1} 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 | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K961874](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K961874) **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