(316 days)
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No
The device description and performance studies focus on mechanical properties and radiolucence, with no mention of AI or ML algorithms for analysis, decision-making, or control.
No.
The device is used to clamp a patient's head and neck in position during surgical procedures and its performance studies relate to its mechanical properties and radiolucency, not the treatment or diagnosis of a disease.
No
The device is described as a clamping system used to position a patient's head and neck during surgical procedures. Its function is mechanical support, not to acquire, process, or analyze medical images or data for diagnostic purposes. The mention of "x-rays or similar diagnostic activity" refers to the device's compatibility with such activities, not its involvement in performing them.
No
The device description explicitly details a physical, four-point clamping system made of specific materials, and the performance studies involve testing the deflection and durability of physical components like skull pins. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Clamping of a patient's head and neck in a particular position during surgical procedures." This is a mechanical function performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a physical clamping system used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
- Input Imaging Modality: While x-rays are mentioned, they are used in conjunction with the device during the surgical procedure, not as the primary input for a diagnostic test performed by the device itself. The device is designed to minimize interference with imaging, not to perform the imaging or analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely mechanical support during surgery.
N/A
Intended Use / Indications for Use
Clamping of a patient's head and neck in a particular position during surgical procedures.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
patient's head and neck
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.4460 Neurosurgical head holder (skull clamp).
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows a date stamp. The stamp reads "SEP 12 1988". The text is in a bold, sans-serif font and is black in color.
Image /page/0/Picture/1 description: The image shows the word "MIZUHO" in white letters against a black background. The letters are bold and sans-serif. The black background is a rounded rectangle.
Mizuho America Inc. 123 Brimbal Avenue, Beverly, MA 01915 800-699-CLIP(2547) TEL: 508-921-1718 FAX: 508-921-4003
510(k) SUMMARY
Mizuho Radiolucent Head Frame
Applicant:
Mizuho America Inc. 123 Brimbal Avenue Beverly, MA 01915
Contact: Brian Connelly
Telephone: 508-921-1718 FAX: 508-921-4003
Submitted by:
Curtin & Associates International 1200 East Street Dedham, MA 02026
Contact: Donald A. Lincoln
Telephone: 617-329-1955 FAX: 617-329-2529
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
1
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.