SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY
K954717 · Sodem Diffusion SA · HBB · Jan 22, 1997 · Neurology
Device Facts
| Record ID | K954717 |
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| Device Name | SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY |
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| Applicant | Sodem Diffusion SA |
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| Product Code | HBB · Neurology |
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| Decision Date | Jan 22, 1997 |
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| Decision | SESE |
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| Submission Type | Traditional |
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| Regulation | 21 CFR 882.4370 |
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| Device Class | Class 2 |
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| Attributes | Therapeutic |
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Intended 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
Related Devices
- K020069 — MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM · Medtronic Midas Rex · Mar 18, 2002
- K013091 — ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM · Von Zeppelin GmbH · Jan 25, 2002
- K253772 — Velocity Alpha MR High Speed Surgical Drill System · Adeor Medical AG · Mar 6, 2026
- K994175 — MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE · Sodemsystems · Dec 21, 1999
- K023070 — SODEM HIGH SPEED SYSTEM (PNEUMATIC) · Sodemsystems · Jan 28, 2003
Submission Summary (Full Text)
{0}
JAN 22 1997
K954717
# APPENDIX E
## 510(k) Summary
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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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