STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION

K960003 · Storz Instrument Co. · HQC · Aug 29, 1996 · Ophthalmic

Device Facts

• Record ID: K960003
• Device Name: STORZ D7116 MICROVIT VITRECTOMY CUTTER EXTENSION
• Applicant: Storz Instrument Co.
• Product Code: HQC · Ophthalmic
• Decision Date: Aug 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4670
• Device Class: Class 2

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.

Indications for Use

Indicated for use during vitrectomy procedures, according to the surgeon's preferred technique.

Regulatory Classification

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)

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
[phone]
FAX [phone]
29

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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 |