STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE

K960061 · Storz Instrument Co. · HQE · Sep 18, 1996 · Ophthalmic

Device Facts

• Record ID: K960061
• Device Name: STORZ D7108 MICROSCISSORS HANDPIECE/STORZ D7106 MICROSCISSORS DRIVE TUBE
• Applicant: Storz Instrument Co.
• Product Code: HQE · Ophthalmic
• Decision Date: Sep 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.

Device Story

Reusable, electrically powered, pneumatic handpiece (D7108) and drive tube (D7106) for ophthalmic surgery; connects to Storz PREMIERE® or DAISY™ microsurgical systems. Input: pneumatic pressure from microsurgical system; output: mechanical reciprocating motion of attached microscissors blades. Operated by ophthalmologist in OR. Features manual override lever for non-powered blade operation. Benefits: enables precise cutting of posterior segment intraocular tissue.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrically powered, pneumatic handpiece; reusable; manual override lever; connects to external microsurgical system for air pressure drive; compatible with detachable microscissors.

Indications for Use

Indicated for cutting intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.

Regulatory Classification

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

• Escalon™ Trek Medical Vertical Automated Scissors

Reference Devices

• Storz PREMIERE® Microsurgical System
• Storz DAISY™ Microsurgical System
• Alcon STTO VM™
• MVS XII™
• MVS XX™

Submission Summary (Full Text)

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storz
K 960061

# SEP 18 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:** Audrey Swearingen, Regulatory Affairs Associate
**Date Prepared:** January 3, 1996
**Proprietary Names:** Storz D7108 Microscissors Handpiece and Storz D7106 Microscissors Drive Tube.
**Common/Usual Names:** Microscissors handpiece and drive tube
**Classification Name:** Vitreous aspiration and cutting instrument, AC-powered, (86HQE)

**Device Description/Intended Use:** The Storz D7108 Microscissors Handpiece is a reusable, electrically powered, pneumatic handpiece that is used to operate a variety of detachable microscissors. A selected microscissors attachment screws on to the tip of the D7108 Microscissors Handpiece. The D7108 handpiece attaches to the Storz D7106 Microscissors Drive Tube, which in turn connects to the Storz PREMIERE® or the Storz DAISY™ Ophthalmic Microsurgical System. As the “Scissors” function of the microsurgical system is activated, the piston inside the D7108 handpiece is driven forward and backward by air pressure, causing the blades of the attached microscissors to open and close rapidly. The handpiece also has a manual over-ride lever near the tip of the handpiece that allows the physician to manually operate the scissors without requiring external power.

The D7108 handpiece, as connected to the D7106 drive tube and detachable microscissors, is intended to be used with the Storz PREMIERE® or Storz DAISY™ Microsurgical Systems to cut intraocular tissue in the posterior segment of the eye during ophthalmic surgical procedures.

**Predicate Device:** The Storz D7108 Microscissors Handpiece and D7106 Microscissors Drive Tube, as used together, are substantially equivalent to the Escalon™ Trek Medical Vertical Automated Scissors.

**Predicate Comparison:** A chart comparing the Storz D7108 and D7106 to the predicate device, demonstration substantial equivalence, is attached.

STORZ
3365 Tree Court Industrial Blvd.
St Louis, MO 63122-6694
[phone]
Telex 961491 STORZ STL
FAX [phone]
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Submitted By:

Audrey Swearingen
Storz Instrument Company
3365 Tree Court Industrial Blvd.
St. Louis, MO 63122
Phone: [phone]

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# Storz D7108 Microscissors Handpiece / Storz D7106 Microscissors Drive Tube

## DEVICE COMPARISON CHART

| Device Characteristic | Storz D7108 and D7106 | Escalon™ Trek Medical Vertical Automated Scissors |
| --- | --- | --- |
| Intended Use | To be attached to microscissors for cutting of posterior intraocular tissue. | Cutting of posterior intraocular tissue. |
| Components | D7108 Microscissor Handpiece and D7106 Microscissor Drive Tube | Microscissor handpiece, microscissors, and drive tube. |
| Recommended Microsurgical System | Storz PREMIERE® and Storz DAISY™ | Storz PREMIERE®, Alcon STTO VM™, MVS XII™, and MVS XX™. |
| Compatible with single and multi cut modes? | Yes | Yes |
| Reusable? | Yes | Yes |
| Manual operation capability? | Yes | Unknown |