SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

K954717 · Sodem Diffusion SA · HBB · Jan 22, 1997 · Neurology

Device Facts

• Record ID: K954717
• Device Name: SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
• Applicant: Sodem Diffusion SA
• Product Code: HBB · Neurology
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4370
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.

Device Story

Modular pneumatic high-speed surgical instrument system; consists of handpiece, adapters, spindles, and burrs. Operates via compressed air or nitrogen; controlled by foot pedal. Used in neurosurgery and median sternotomy. Physician-operated in clinical/OR settings. Provides high-speed cutting/drilling (0-85,000 rpm) for bone resection. Benefits patient by enabling precise surgical access and bone removal during neurosurgical and sternotomy procedures.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Pneumatic high-speed motor; 0-85,000 rpm range. Materials: surgical stainless steel. Power source: compressed air or nitrogen. Control: foot pedal. Modular design with interchangeable spindles and burrs. Sterilization: non-sterile, requires user-facility decontamination and resterilization.

Indications for Use

Indicated for neurosurgical procedures including spine and craniotomy, and median sternotomy.

Regulatory Classification

Identification

A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.

Predicate Devices

• Zeppelin M.D.S. (K922299)
• Zimmer Ultra Power System
• Anspach System 65K (K831756)
• Midas Rex System

Submission Summary (Full Text)

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JAN 22 1997
K954717

# APPENDIX E

## 510(k) Summary

SODEM High Speed System 510(k)
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510(k) Summary for the
SODEM HIGH SPEED SYSTEM
(Per 21 CFR 807 92)

1. APPLICANT

sodemsystems
Sodem Diffusion S.A.
110, ch. du Pont-du Centenaire
CH- 1228 Geneva, Switzerland
Contact Person: Mr. Eric Bouvier
Telephone Number: 41 (22) 794 96 96
Facsimile Number: 41 (22) 794 45 46
Date of Summary Preparation: October 11, 1995

2. DEVICE NAME

Trade Name: SODEM HIGH SPEED SYSTEM

Classification Name: Powered simple cranial drills, burrs, and accessories
Pneumatic cranial drill motors for neurosurgery
Blades, saw, surgical cardiovascular
Pneumatically powered saw

Common/Usual Name: Surgical power system

3. PREDICATE DEVICES

The SODEM HIGH SPEED SYSTEM claims equivalence to the following systems:

- Zeppelin M.D.S. (K922299)
- Zimmer Ultra Power System (No K Number Identified)
- Anspach System 65K (K831756)
- Midas Rex System (No K Number Identified)

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# 4. DEVICE DESCRIPTION

The SODEM HIGH SPEED SYSTEM is a modular, pneumatic, high speed instrument system consisting of a handpiece and accessories/attachments (including but not limited to adapter, spindles, and burrs).

# 5. INTENDED USE

The SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is intended for use for neurosurgery (spine and craniotomy) and median sternotomy.

# 6. BASIS FOR CLAIM OF SUBSTANTIAL EQUIVALENCE

sodemsystems claims substantial equivalence to other pneumatic high speed surgical instruments, specifically the Zeppelin M.D.S System, Zimmer Ultra Power System, Midas Rex System, the Anspach 65K System. This claim is based on equivalence in:

Intended Use: The intended use of the SODEM HIGH SPEED SYSTEM (with associated accessories/attachments) is identical to that of the cited predicate systems as cited above.

Materials: The materials of the SODEM HIGH SPEED SYSTEM which are in direct patient contact are surgical stainless steel. The direct contact materials of the cited predicate devices are identical. The types of stainless steel used for these devices are well accepted in these applications, with a long history of satisfactory performance and biocompatibility.

Sterility Status: The handpieces and accessories to the SODEM HIGH SPEED SYSTEM are, like the cited predicate systems, provided non-sterile, require decontamination after use, and resterilization by the user facility.

No accessories to the SODEM HIGH SPEED SYSTEM are provided sterile, while some, but not necessarily all accessories (burrs etc) to the Zimmer Ultra Power, Midas Rex and Anspach 65K are provided sterile.

Energy Consumed - Pneumatic Power: The SODEM HIGH SPEED SYSTEM (Pneumatic Handpiece), the Zimmer Ultra Power, the Zeppelin M.D.S., Midas Rex, and Anspach 65K Systems operate using compressed air or nitrogen and controlled by foot pedal. The power of the SODEM HIGH SPEED SYSTEM is adjustable from 0-85,000 rpm. Ranges are

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similar for cited predicate devices: Zimmer Ultra Power 0-70,000, Zeppelin M.D.S. 0-85,000, Midas Rex 0-72,000, and Anspach 65K System 0-65,000.

Operational Principles: The SODEM HIGH SPEED SYSTEM and all cited predicate systems use the same operational principles.

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