(143 days)
No
The device description and performance studies focus on mechanical fixation and MR compatibility, with no mention of AI/ML algorithms or data processing.
No
The device is described as a head fixation frame used to hold the patient's head for MRI procedures, not to treat a condition or disease.
No
The device is described as a head fixation frame, which is used to hold the patient's head in a particular position during MRI procedures. Its function is to secure the head, not to diagnose medical conditions or process diagnostic images.
No
The device description explicitly details physical components (Ring, Base, Posts, skull pins, brass inserts, titanium pin tips) and describes it as a re-usable, non-sterile device designed to clamp and hold the patient's head, indicating it is a hardware device.
Based on the provided information, the Arcus Head Fixation Frame is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. They are used in vitro (outside the body).
- Arcus Head Fixation Frame Function: The Arcus Head Fixation Frame is a physical device used in vivo (within the body, or rather, attached to the body) to hold a patient's head in a specific position during an MRI procedure. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states it's for "clamping and holding the patient's head" for MRI procedures. This is a mechanical function, not a diagnostic test performed on a sample.
Therefore, the Arcus Head Fixation Frame is a medical device, but it falls under a different category than IVD devices.
N/A
Intended Use / Indications for Use
The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
Product codes
HBL
Device Description
The Arcus Head Fixation Frame (HFF) is designed to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets. It consists of a Ring that secures the patient's skull using hand tightened skull pins, allowing for removal of the Ring for pinning the patient away from the rest of the HFF. The Arcus HFF provides vertical, rotational, and angular adjustment of the Ring once in the Base to assist in patient positioning. It has six Posts that can be mounted onto the Ring to hold four different lengths of Fixation Screws, offering flexibility for locating Skull Pins on the patient's skull. The device is secured to the scanner table using features normally used to attach straps for securing patients. It is designed for use with Siemens Avanto, Espree, Symphony, Sonata, Tria, and Verio MRI Scanners. The Arcus HFF is reusable and sold non-sterile, not requiring sterilization. It is MR Conditional, containing brass inserts and titanium pin tips (Titanium Pin Tips are an accessory, not packaged with the device, and marketed by Pro Med Instruments, Inc. (K001808)). Its composition includes Garolite G-10, brass (threaded inserts), and titanium (fasteners). The shape of the skull clamp is a Ring, which can be U-shaped (partial ring) or Circular (full ring).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Brain structure and targets (head)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed to verify the Arcus HFF secures the patient's skull to the HFF. The method of securing HFF to the scanner table is unchanged from the predicate device and did not require repetition of testing. Additional testing to confirm MR safety regarding heating, image distortion, and magnetic attraction were completed. Testing confirmed the Arcus HFF met the Product Specification Requirements. The tests demonstrated that the Arcus HFF functions as intended and is substantially equivalent to the legally marketed predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SurgiVision, Inc.'s Head Fixation Arc and Table Base (K091439)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters FDA in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2019
MRI Interventions, Inc. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004
Re: K191701
Trade/Device Name: Arcus Head Fixation Frame Regulation Number: 21 CFR 882.4460 Regulation Name: Neurosurgical Head Holder (Skull Clamp) Regulatory Class: Class II Product Code: HBL Dated: October 16, 2019 Received: October 16, 2019
Dear John Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known)
Device Name
Arcus Head Fixation Frame
Indications for Use (Describe)
The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY MRI Interventions, Inc.'s Arcus Head Fixation Frame
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MRI Interventions, Inc. 5 Musick Irvine, CA 92618 Phone: 949-900-6833 Fax: 949-900-6834 Contact Person: Peter Piferi, C.O.O Date Prepared: October 16, 2019
Name of Device and Name/Address of Sponsor
Arcus Head Fixation Frame MRI Interventions, Inc. 5 Musick Irvine, CA 92618
Common or Usual Name Neurosurgical head holder (skull clamp)
Classification 21 C.F.R. § 882.4460
Product Code HBL
Predicate Device SurgiVision, Inc.'s Head Fixation Arc and Table Base (K091439)
Intended Use / Indications for Use
The Arcus Head Fixation Frame is intended for use as a device to clamp and hold the patient's head in a particular position for procedures requiring Magnetic Resonance Imaging (MRI) of the brain structure and targets.
Technological Characteristics
The technical modes of action and technical principles are materially the same as the predicate device, including: head fixation frame (HFF) design and construction, materials being functionally similar in all cases (identical in several aspects), and relying upon the same principles of head stabilization/immobilization including the securing/clamping of the scanner table and the physician locating and securing the patient's skull using hand tightened skull pins. The primary design differences are as follow:
- . The Arcus HFF allows removal of the Ring (that secures the patient's skull in the skull pins) so the physician can pin the patient away from the rest of the HFF with good visibility to
4
complete the pinning. This allows the physician to pin a patient while they are in a supine position and then move them to the scanner table to position the patient in the prone position and secure the Ring in the Base of the HFF.
- . The Arcus HFF provides vertical, rotational, and angular adjustment of the Ring once in the Base to assist the positioning of patients that might have neck or spinal abnormities that hinder normal head fixation. The Ring is then secured to the Base.
- . The Arcus HFF has (6) Posts that can be mounted onto the Ring to hold 4 different lengths of Fixation Screws, providing the physician flexibility when locating the Skull Pins (that are inserted into the ends of the fixation screws) on the patient's skull. The Arcus HFF is secured to the scanner table in the same manner as the predicate device, using features on the scanner table that normally are used to attach straps for securing the patient.
The Arcus HFF is designed for use with Siemens Avanto, Espree, Symphony, Sonata, Tria, and Verio MRI Scanners.
The Arcus HFF is re-usable and is sold non-sterile. The device does not require sterilization.
The Arcus HFF is MR Conditional, as it contains brass inserts and titanium pin tips which will be present during MRI scanning. Only the Titanium Pin tips contact the patient. The Pin Tips are an accessory to the device system and are not packaged with the device. The Sterile Titanium Pin Tips are marketed by Pro Med Instruments, Inc. (K001808).
Performance Data
Bench testing was performed to verify the Arcus HFF secures the patient's skull to the HFF. The method of securing HFF to the scanner table is unchanged from the predicate device and did not require repetition of testing. Additional testing to confirm MR safety regarding heating, image distortion, and magnetic attraction were completed. Testing confirmed the Arcus HFF met the Product Specification Requirements.
The tests demonstrated that the Arcus HFF functions as intended and is substantially equivalent to the legally marketed predicate.
The following recognized consensus standards were utilized in the development of the Arcus HFF:
- . ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- . ASTM F2052: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment.
- ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive ● Implant.
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Substantial Equivalence
The Head Fixation Arc and Table Base and the Arcus Head Fixation Frame have identical intended use and indications for use. As shown in the below table, the technological characteristics of the Arcus HFF are substantially similar to those of the predicate device. Any minor differences do not raise new questions of safety or effectiveness.
| Characteristic | Arcus Head Fixation Frame
(candidate) | Head Fixation Arc and Table
Base - K091439
(predicate) |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification Regulation | 21 C.F.R. § 882.4460 | 21 C.F.R. § 882.4460 |
| Product Code | HBL | HBL |
| Prescription device | Yes | Yes |
| Composition | Garolite G-10 | Fiberglass |
| | Same as Predicate | Delrin |
| | Same as Predicate | PEEK |
| | | Ceramic |
| | Brass (threaded inserts) | |
| | Titanium (fasteners) | |
| Shape of Skull Clamp | Ring | Fixation Arc |
| | U-shaped (partial ring) or
Circular (full ring) | U-Shaped Arc |
| Scanner Table
attachment method | Same as predicate | Clamps to scanner table
features that are normally used
for securing patients. |
| Types of scanner tables
intended to fit. | Same as predicate | The Table Base (shown) is
designed to mate with Siemens
Avanto MRI. Minor
modifications of the table Base
would allow the mating to other
MRI systems. |
| Skull Clamp adjustability | Removable Ring.
Cradle secures the Ring.
Cradle adjusts in "Y" direction.
Cradle top adjusts in the "Z"
direction. | Permanently attached to the
table clamps. |
| Fixation Screw locating | Screw locations have 360°
positioning. Up to 6 locations
can be used in the 13 positions
on the ring. | 4 Screw locations are fixed. |
| Head Fixation Screws
(hand tightened) | Same as Predicate | Yes |
| ***Sterile Titanium Pin
tips
(needed for the procedure
but not provided with the
product) | Same as Predicate | Yes
(mfg. by Pro Med Instruments -
DORO) |
| Characteristic | Arcus Head Fixation Frame
(candidate) | Head Fixation Arc and Table
Base - K091439
(predicate) |
| Sold Sterile | Same as Predicate | No |
| Requires Sterilization
before Use | Same as Predicate | No |
| MRI Safe | *MR Conditional | **MR Conditional |
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- Considered conditional due to the use of the titanium pin tips.
** Considered conditional due to the presence of brass inserts and the use of the titanium pin tips.
*** These are not provided with the product but are obtained by the hospitals from either DORO or MRII (as a distributor). They are sterile disposables. They are listed here because they are necessary for the use of the HFF.
Conclusions
The Arcus HFF is as safe and effective as the Head Fixation Arc and Table Base. The Arcus HFF has the same intended use and indications for use, as well as substantially similar technological characteristics as its predicate device. The minor technological differences between the Arcus HFF and its predicate device raise no new issues of safety or effectiveness. Thus, the is substantially equivalent.