← Product Code [HBL](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL) · K955012 # MIZUHO RADIOLUCENT HEAD FRAME (K955012) _Mizuho America, Inc. · HBL · Sep 12, 1996 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K955012 ## Device Facts - **Applicant:** Mizuho America, Inc. - **Product Code:** [HBL](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL.md) - **Decision Date:** Sep 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4460 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Mizuho SEP 12 1998 Mizuho America Inc. 123 Brimbal Avenue, Beverly, MA 01915 800-699-CLIP(2547) TEL: 508-921-1718 FAX: 508-921-4003 K955012 # 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 SUGITA The leading name in neurosurgical instrumentation {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. 2 --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K955012](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HBL/K955012) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com