MIZUHO RADIOLUCENT HEAD FRAME

K955012 · Mizuho America, Inc. · HBL · Sep 12, 1996 · Neurology

Device Facts

• Record ID: K955012
• Device Name: MIZUHO RADIOLUCENT HEAD FRAME
• Applicant: Mizuho America, Inc.
• Product Code: HBL · Neurology
• Decision Date: Sep 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4460
• Device Class: Class 2

Intended Use

Clamping of a patient’s head and neck in a particular position during surgical procedures.

Device Story

Four-point skull clamp system; secures patient head/neck during neurosurgery. Radiolucent carbon fiber construction minimizes X-ray/imaging interference. Used in OR by neurosurgeons; attaches to existing operating table mounts. Reusable metal/non-metal pins provide stabilization. Device ensures patient positioning; facilitates intraoperative imaging without artifact interference.

Clinical Evidence

Bench testing only. Deflection under load testing compared subject device to metal predicate, showing equivalent performance. Durability testing of reusable skull pins performed over 40 high-temperature sterilization cycles (274°F) showed no significant change in break load compared to unprocessed pins. Radiolucence verified via representative X-ray imaging showing minimal interference.

Technological Characteristics

Four-point skull clamp; carbon fiber main components; reusable metal/non-metal pins. Mechanical stabilization principle. Compatible with existing operating table attachments. Sterilization via high-temperature pre-vacuum cycle.

Indications for Use

Indicated for patients undergoing neurosurgical procedures requiring head and neck stabilization.

Regulatory Classification

Identification

A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures.

Predicate Devices

• Malcolm-Rand Radiolucent Headrest
• Sugita Multi-Purpose Head Frame

Submission Summary (Full Text)

{0}

Mizuho

SEP 12 1998

Mizuho America Inc.
123 Brimbal Avenue,
Beverly, MA 01915
800-699-CLIP(2547)
TEL: [phone]
FAX: [phone]

K955012

# 510(k) SUMMARY

## Mizuho Radiolucent Head Frame

Applicant:
Mizuho America Inc.
123 Brimbal Avenue
Beverly, MA 01915

Contact: Brian Connelly
Telephone: [phone]
FAX: [phone]

Submitted by:
Curtin & Associates International
1200 East Street
Dedham, MA 02026

Contact: Donald A. Lincoln
Telephone: [phone]
FAX: [phone]

Date this Summary was prepared: 26 October 1995

Trade Name: Mizuho Radiolucent Head Frame
Common Name: Skull Clamp or Head Holder
Classification Name: Neurosurgical Head Holder (Skull Clamp)

Legally Marketed Devices to Which Substantial Equivalence is claimed:
- Malcolm-Rand Radiolucent Headrest
- Sugita Multi-Purpose Head Frame

SUGITA The leading name in neurosurgical instrumentation

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510(k) SUMMARY-continued
Mizuho Radiolucent Head Frame

Description of Device: The device uses a four (4) point system to clamp a patient’s head during surgical procedures. The material used was selected to reduce or eliminate interference normally associated with all metal skull clamps should x-rays or similar diagnostic activity be utilized during the procedure.

Intended Use of the Device: Clamping of a patient’s head and neck in a particular position during surgical procedures.

Summary of Technological Characteristics: The four (4) point systems is found in each of the legally marketed devices to which substantial equivalence is claimed. The devices components will function in conjunction with operating table attachments currently marketed by Mizuho America. The radiolucent characteristic is similar to that which is found in the Malcolm-Rand system. In each system, the main components are carbon fiber. The Malcom-Rand system uses disposable pins which are attached to the end of the four (4) screws while the proposed Mizuho device will have reusable pins which are a combination of metal and non-metal.

Summary of test data:

Deflection Under Load: The device was assembled onto an operating table and loads applied. The metal device was subjected to the same test procedure. The results show that the devices deflect essentially the same amount.

Durability of Reusable Skull Pins: Testing of sample skull pins was conducted in which they were processed in a hospital using a normal high temperature pre-vacuum cycle for that hospital, 274°F for four (4) minutes. Pins were removed after 5, 10, 20 and 40 cycles for destructive testing. There was essentially no change in the results compared with unprocessed pins. The break load during all testing was substantially higher than that which is used in surgical procedures.

Radiolucence: Representative x-rays included in advertising show that the interference resulting from the use of this device is minimal.

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