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.

Device Description

The Arcus Head Fixation Frame is a re-usable, non-sterile device 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 with skull pins, a Base that secures the Ring, and Posts that hold Fixation Screws. The device is secured to the scanner table. It is designed for use with specific Siemens MRI Scanners. The device is MR Conditional and contains brass inserts and titanium pin tips.

AI/ML Overview

This document describes a 510(k) premarket notification for the Arcus Head Fixation Frame. It does not contain information about the acceptance criteria and study designs that are typically associated with artificial intelligence/machine learning (AI/ML) powered medical devices. The device described in this document is a physical medical device (neurosurgical head holder/skull clamp), not an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI/ML device based on this text.

However, I can extract the relevant performance data and comparisons for the physical device as presented in the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a tabular format as would be seen for an AI/ML device's performance metrics (e.g., sensitivity, specificity thresholds). Instead, it states that "Testing confirmed the Arcus HFF met the Product Specification Requirements." The performance data is primarily focused on demonstrating equivalence to a predicate device and confirming basic functionalities and safety for an MRI environment.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Arcus Head Fixation Frame)
Head Fixation	Secure patient's skull to HFF.	Bench testing performed to verify Arcus HFF secures the patient's skull to the HFF. Functions as intended.
MR Safety (Heating)	Meet product specification requirements for heating in MR environment.	Testing confirmed Arcus HFF met Product Specification Requirements. MR Conditional.
MR Safety (Image Distortion)	Meet product specification requirements for image distortion in MR environment.	Testing confirmed Arcus HFF met Product Specification Requirements.
MR Safety (Magnetic Attraction)	Meet product specification requirements for magnetic attraction in MR environment.	Testing confirmed Arcus HFF met Product Specification Requirements. MR Conditional.
Biological Evaluation	Conform to ISO 10993-1.	Utilized ISO 10993-1. (Implied conformance as part of substantial equivalence).
Displacement Force in MR Environment	Conform to ASTM F2052.	Utilized ASTM F2052. (Implied conformance as part of substantial equivalence).
MR Image Artifacts from Passive Implant	Conform to ASTM F2119-07.	Utilized ASTM F2119-07. (Implied conformance as part of substantial equivalence).
Substantial Equivalence to Predicate	Same intended use, indications for use, and substantially similar technological characteristics.	Has identical intended use and indications for use. Technological characteristics are substantially similar, with minor differences raising no new safety/effectiveness issues.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and therefore not provided in the document, as it pertains to a physical device evaluation through bench testing, not an AI/ML algorithm trained and tested on data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as this is a physical device submission without data-driven ground truth. The "ground truth" for this device would be its physical properties and performance under specific test conditions, established through engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as it is a physical device evaluation, not a clinical study involving reader performance or expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is a physical head fixation frame, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a physical head fixation frame, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this physical device, the "ground truth" is established through:

Engineering specifications and design: The device is designed to meet certain physical and mechanical criteria.
Regulatory standards: Adherence to recognized consensus standards like ISO 10993-1, ASTM F2052, and ASTM F2119-07, which define acceptable physical and biological performance.
Bench testing: Direct experimental verification of physical properties (e.g., securing head, MR safety properties).
Predicate device comparison: The performance and safety of the device are judged largely against the established performance and safety of a legally marketed predicate device.

8. The sample size for the training set

This information is not applicable as the device is a physical head fixation frame, not an AI/ML algorithm that undergoes training.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

Summary

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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)

K191701

Device Name

Arcus Head Fixation Frame

Indications for Use (Describe)

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

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

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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 TableBase - 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) orCircular (full ring)	U-Shaped Arc
Scanner Tableattachment method	Same as predicate	Clamps to scanner tablefeatures that are normally usedfor securing patients.
Types of scanner tablesintended to fit.	Same as predicate	The Table Base (shown) isdesigned to mate with SiemensAvanto MRI. Minormodifications of the table Basewould allow the mating to otherMRI 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 thetable clamps.
Fixation Screw locating	Screw locations have 360°positioning. Up to 6 locationscan be used in the 13 positionson the ring.	4 Screw locations are fixed.
Head Fixation Screws(hand tightened)	Same as Predicate	Yes
***Sterile Titanium Pintips(needed for the procedurebut not provided with theproduct)	Same as Predicate	Yes(mfg. by Pro Med Instruments -DORO)
Characteristic	Arcus Head Fixation Frame(candidate)	Head Fixation Arc and TableBase - K091439(predicate)
Sold Sterile	Same as Predicate	No
Requires Sterilizationbefore 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.

Regulation Number and Section

§ 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).