← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K962131 # STORZ D4600 AIR EXCHANGE LINE PACK (K962131) _Storz Instrument Co. · HQC · Aug 23, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K962131 ## Device Facts - **Applicant:** Storz Instrument Co. - **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md) - **Decision Date:** Aug 23, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.4670 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Intended Use The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye. ## Device Story Accessory tubing pack for ophthalmic microsurgical systems; routes air from system to posterior chamber of eye during surgery. Single-patient use; sterile; gamma-irradiated. Used by ophthalmic surgeons in clinical settings to facilitate air/fluid exchange. Device provides physical pathway for air delivery; no active electronic or software components. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Tubing set for air delivery; sterile; gamma irradiation sterilization; packaging includes Tyvek® and PET/PE pouch. No electronic components, software, or active sensing. ## 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 D4600 Air Exchange Line Pack ([K894278](/device/K894278.md)) - Intek International, Inc. TR-9006-11 Air Delivery Tubing System ([K832761](/device/K832761.md)) ## Reference Devices - Storz PREMIERE® Microsurgical System ([K894278](/device/K894278.md), [K921460](/device/K921460.md), [K946227](/device/K946227.md)) - Storz DAISY® Microsurgical System ([K854508](/device/K854508.md)) - Escalon™ CFAE-40 Air/Fluid Exchange Pump ## 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} K962131 storz® AUG 23 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 31, 1996 Proprietary Name: Storz D4600 Air Exchange Line Pack. Common/Usual Name: Ophthalmic surgical system accessory pack for posterior segment procedures. Classification Name: System, Phacofragmentation (86 HQC). Device Description/Intended Use: The Storz D4600 is intended to be used as an accessory to the Storz PREMIERE® (K894278, K921460, K946227) or Storz DAISY® (K854508) Microsurgical Systems for use in air and fluid exchange during posterior segment ophthalmic surgical procedures. The D4600 Air Exchange Line provides the initial pathway through which air generated by the microsurgical system is routed into the posterior chamber of the eye. Predicate Device: The proposed Storz D4600 Air Exchange Line Pack is substantially equivalent to the existing Storz D4600 Air Exchange Line Pack (K894278), and to the Intek International, Inc. TR-9006-11 Air Delivery Tubing System (K832761). Predicate Comparison: A chart comparing the Storz D4600 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 58 {1} 59 # DEVICE COMPARISON CHART ## Storz D4600 Air Exchange Line Pack | Device | Storz D4600, modified | Storz D4600, existing | Intek International TR9006-11 | | --- | --- | --- | --- | | Intended Use | To deliver air to the eye during posterior ophthalmic surgical procedures | To deliver air to the eye during posterior ophthalmic surgical procedures | To deliver air to the eye during ophthalmic surgical procedures | | Recommended System | Storz PREMIERE® or Storz Daisy™ Microsurgical Systems | Storz PREMIERE® or Storz Daisy™ Microsurgical Systems | Escalon™ CFAE-40 Air/Fluid Exchange Pump | | Instructions For Use Included? | Yes | No | Unknown | | Single Patient Use? | Yes | Yes | Yes | | Provided Sterile? | Yes | Yes | Yes | | Sterilization Method | Gamma Irradiation | Gamma Irradiation | Unknown | | Packaging | Singly in Tyvek® and PET/PE Pouch, Ten pouches per Box | Singly in Tyvek® and PET/PE Pouch, Ten pouches per Box | Unknown package type, Ten units per Box | --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K962131](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K962131) **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