← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K960003

# STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION (K960003)

_Storz Instrument Co. · HQC · Aug 29, 1996 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K960003

## Device Facts

- **Applicant:** Storz Instrument Co.
- **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md)
- **Decision Date:** Aug 29, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4670
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Intended Use

The Storz device is intended to be used as an accessory to the Storz Microvit® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manipulation of the instrument.

## Device Story

Accessory snap-on grip extension for Storz Microvit® Vitrectomy Cutter; facilitates instrument manipulation during ophthalmic surgery. Device attaches to existing cutter without altering cutter function. Used by surgeons in clinical/OR settings to improve ergonomics/handling of vitrectomy probes.

## Clinical Evidence

Bench testing only; no clinical data provided.

## Technological Characteristics

Mechanical snap-on grip extension; annular form factor; non-powered; no electronic or software components.

## 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 MVS-3201 Vitrectomy Probe Pack ([K953575](/device/K953575.md))

## Submission Summary (Full Text)

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K960003

storz®

AUG 29 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: Manager, Regulatory Affairs

Date Prepared: December 28, 1995

Proprietary Names: STORZ D7116 Microvit® Vitrectomy Cutter Extension.

Common/Usual Name: Ophthalmic surgical system accessory grip extension for vitrectomy cutter.

Classification Name: Instrument, vitreous cutting and aspirating, AC powered (36HQC).

Device Description/Intended Use: The Storz device is intended to be used as an accessory to the Storz Microvit® Vitrectomy Cutter to provide a snap-on grip extension for the cutter to facilitate manipulation of the instrument. The D7116 does not affect the functioning of the cutter. A drawing of the D7116 and a drawing of the cutter are attached as Exhibits 1 and 2 respectively.

Predicate Device: The Storz D7116 is substantially equivalent to a Storz MVS-3201 Vitrectomy Probe Pack (K953575).

Predicate Comparison: A chart comparing the Storz D7116 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

STORZ®
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122-6694
(314) 225-5051
FAX (314) 225-7365
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# DEVICE COMPARISON CHART

|  Device Characteristic | Storz MVS-3201 Vitrectomy Probe | Vitrectomy Probe With D7116 Extension  |
| --- | --- | --- |
|  Rear Aspect Annular Grip? | Yes | Yes  |
|  Indication for Use | Vitrectomy, Surgeon's Preferred Technique | Vitrectomy, Surgeon's Preferred Technique  |
|  Alterations to Probe Required? | No | No  |

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K960003](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K960003)

**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).

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