The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are flexible to conform to patients' anatomies.

AI/ML Overview

The provided text does not describe a study involving a device that uses AI or machine learning, nor does it provide a comparative effectiveness study with human readers. Instead, it describes a Magnetic Resonance (MR) Receive-only Coil and its substantial equivalence to a predicate device.

Therefore, many of the requested elements about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable based on the provided document.

However, I can extract information related to the device's performance testing from the document:

Device: InkSpace Imaging Small Body Array (a receive-only coil for MRI systems)

1. Table of acceptance criteria and the reported device performance:

The document refers to performance testing in accordance with the "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway" guidance document. It lists the tests performed, implying these tests are the acceptance criteria. The performance results are stated to have met established specifications.

Acceptance Criteria (Nonclinical Test)	Reported Device Performance
Image Signal to Noise (SNR)	Met established specifications
Image Uniformity	Met established specifications
Surface Heating	Met established specifications
Decoupling Circuit	Met established specifications
EMC - Immunity, Electrostatic Discharge	Met established specifications
General Electrical/Mechanical Safety	Met established specifications
Acquired Image Quality	Met established specifications (Analyzed based on sample clinical images and reviewed by a board-certified radiologist)

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify exact sample sizes (e.g., number of coils tested, number of images reviewed) for the nonclinical tests. It refers to "sample clinical images" for the acquired image quality analysis.
Data Provenance: Not specified in terms of country of origin. The test data are generated from nonclinical bench testing and analysis of sample clinical images. The data is retrospective in the sense that the images are existing data used for evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: "a board-certified radiologist" (implies one, though it could be a general statement about the type of expert).
Qualifications: "board-certified radiologist."

4. Adjudication method for the test set:

The document mentions a "review of their clinical quality by a board-certified radiologist." This implies a single expert review, not an adjudication process involving multiple experts for consensus.

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:

No. An MRMC study was not performed. This device is a passive component (MRI coil), not an AI/ML algorithm that assists human readers.

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

N/A. This is not an algorithm; it's hardware. Its performance is assessed through its physical and electromagnetic properties, with the final output (images) being subject to human interpretation.

7. The type of ground truth used:

For "Acquired Image Quality," the ground truth was established by the subjective "clinical quality" assessment by a "board-certified radiologist." Other tests (SNR, Uniformity, etc.) likely relied on objective measurements against engineering specifications.

8. The sample size for the training set:

N/A. This device does not involve a training set as it's a hardware component, not an AI/ML model.

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

N/A. (See point 8)

Summary

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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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2024

InkSpace Imaging, Inc. % Taras Bouzakine Director, Regulatory Affairs Veranex, Inc. 5420 Wade Park Blvd, Suite 204 Raleigh, North Carolina 27607

Re: K243675

Trade/Device Name: InkSpace Imaging Small Body Arrav Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 27, 2024 Received: November 27, 2024

Dear Taras Bouzakine:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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,

FDA

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243675

Device Name

InkSpace Imaging Small Body Array

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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This summary of the Special 510(k) premarket notification for the InkSpace Imaging Small Body Array is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR$807.92.

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GENERAL INFORMATION [807.92(A)(1)]

Applicant:

InkSpace Imaging, Inc. 5635 West Las Positas Blvd, Suite 403/404 Pleasanton, CA 94588 USA Phone: 925-425-7410

Contact Person:

Taras Bouzakine Director, Regulatory Affairs, Veranex, Inc. 5420 Wade Park Blvd, Suite 204 Raleigh, NC 27607 USA Phone: 603-205-4874 Email: taras.bouzakine@yeranex.com

Date Prepared: December 18, 2024

DEVICE INFORMATION [807.92(A)(2)]

Classification:

Class II per 21 CFR§892.1000

Product Code:

MOS

Trade Name:

InkSpace Imaging Small Body Array

Generic/Common Name:

Coil, Magnetic Resonance, Specialty

PREDICATE DEVICE(S) [807.92(A)(3)]

InkSpace Imaging Small Body Array (K233444)

DEVICE DESCRIPTION [807.92(A)(4)]

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INDICATIONS FOR USE [807.92(A)(5)]

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(A)(6)]

The technological characteristics of the modified InkSpace Imaging Small Body Array for 1.5T scanners are substantially equivalent to the predicate device, the InkSpace Imaging Small Body Array for 3.0T scanners (K233444). Table 1 lists the technological characteristics of the predicate and modified devices and provides rationale to support a determination of substantial equivalence. Any differences between the devices do not raise any new or different questions of safety or effectiveness.

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				Table 1: Summary of Technological Characteristics
--	--	--	--	---------------------------------------------------

Characteristics	Subject Device:InkSpace Imaging Small Body Array - 1.5T	Predicate Device:InkSpace Imaging Small Body Array - 3.0T(K233444)	Substantial EquivalenceRationale
Classification	Magnetic Resonance Diagnostic Device per 21CFR§892.1000	Magnetic Resonance Diagnostic Device per 21CFR§892.1000	N/A (Same).
Product Code	MOS (Coil, Magnetic Resonance, Specialty)	MOS (Coil, Magnetic Resonance, Specialty)	N/A (Same).
Intended Use	The InkSpace Imaging Small Body Array forSiemens 1.5T MRI systems is indicated for useas an alternative to a traditional MRI receivearray. The conformal fit and blanket-likeconstruction are designed to decrease anxietyand optimize convenience for both the patientand the technologist during the MRI scan. Useof the device during these procedures should beperformed by appropriately trained MRItechnologists, and interpretation of the imagesproduced by these scans should be performedonly by board certified radiologists.	The InkSpace Imaging Small Body Array forSiemens 3.0T MRI systems is indicated for use asan alternative to a traditional MRI receive array.The conformal fit and blanket-like construction aredesigned to decrease anxiety and optimizeconvenience for both the patient and thetechnologist during the MRI scan. Use of thedevice during these procedures should beperformed by appropriately trained MRItechnologists, and interpretation of the imagesproduced by these scans should be performed onlyby board certified radiologists.	Intended use of the modifieddevice maintains the same generalpurpose and function as thepredicate device, differing onlyby target MRI system fieldstrength (1.5T vs. 3.0T).
Indications forUse	The InkSpace Imaging Small Body Array is areceive-only coil, used for obtaining diagnosticimages of general human anatomy in adult andpediatric patients such as cardiac, spine,shoulder, elbow, knee, foot, and prostate inSiemens 1.5T magnetic resonance imagingsystems. These images, when interpreted by atrained physician, yield information that mayassist in diagnosis.	The InkSpace Imaging Small Body Array is areceive-only coil, used for obtaining diagnosticimages of general human anatomy in adult andpediatric patients such as cardiac, spine,shoulder, elbow, knee, foot, and prostate inSiemens 3.0T magnetic resonance imagingsystems. These images, when interpreted by atrained physician, yield information that may assistin diagnosis.	Indications for Use of themodified device maintains thesame general purpose andfunction as the predicate device,differing only by target MRIsystem field strength (1.5T vs.3.0T).
Patient Anatomyand Population	Imaging of general human anatomy, such ascardiac, spine, shoulder, elbow, knee, foot, andprostate.	Imaging of general human anatomy, such ascardiac, spine, shoulder, elbow, knee, foot, andprostate.	N/A (Same).

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Table 1: Summary of Technological Characteristics (cont.)
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Table 1: Summary of Technological Characteristics (cont.)
Characteristics	Subject Device:InkSpace Imaging Small Body Array - 1.5T	Predicate Device:InkSpace Imaging Small Body Array - 3.0T(K233444)	Substantial EquivalenceRationale
Comparison ofTechnologicalCharacteristics	24 channel, receive-only phased array, designedfor 1.5T MR systems (63.6 MHz, hydrogen).Device is reusable, non-sterile, and byprescription only.Device is made of soft, pliable materials, and iscomposed of two identical 12ch pads.	24 channel, receive-only phased array, designedfor 3.0T MR systems (123.2 MHz, hydrogen).Device is reusable, non-sterile, and by prescriptiononly.Device is made of soft, pliable materials, and iscomposed of two identical 12ch pads.	Different receive frequencies(63.6 MHz vs. 123.2 MHz) due tooperation at 1.5T vs. 3.0T. Thisdifference is fully verified.
Compatible MRISystems	Siemens 1.5T MRI Systems	Siemens 3.0T MRI Systems	Different MR field strength, sameOEM. This difference is fullyverified.
Biocompatibility	ISO 10993 testing	ISO 10993 testing	N/A (Same).

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SUBSTANTIAL EQUIVALENCE

The InkSpace Imaging Small Body Array for 1.5T scanners is substantially equivalent to the predicate device, the InkSpace Imaging Small Body Array for 3.0T scanners, with regard to function, intended use, and physical characteristics. There are no differences in the technological characteristics between the devices which would raise any different questions of safety or effectiveness. Thus, the InkSpace Imaging Small Body Array is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(B)]

Performance testing was performed in accordance with the FDA Guidance Document entitled, "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway," issued December 11, 2020.

Some of the nonclinical testing conducted on the InkSpace Imaging Small Body Array for 3.0T scanners (predicate device) is still applicable to the modified InkSpace Imaging Small Body Array for 1.5T scanners (subject of this submission).

Additional analysis was conducted based on the differences between 1.5T MR and 3.0T MR systems. These results and representative scan images listed below have been included as part of this submission.

[807.92(b)(1)] Nonclinical Testing Summary:

The nonclinical. bench tests, per the FDA Guidance Document entitled. "Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway," were performed on the InkSpace Imaging Small Body Array for 1.5T scanners:

. Image Signal to Noise (SNR)
Image Uniformity
Surface Heating
Decoupling Circuit
EMC - Immunity, Electrostatic Discharge
General Electrical/Mechanical Safety
Acquired Image Quality ●

In addition to the above listed nonclinical testing, a risk analysis was performed to validate that the following testing performed on the InkSpace Imaging Small Body Array for 3.0T scanners (predicate device) could be applied to the InkSpace Imaging Small Body Array for 1.5T scanners without retesting:

Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation) ●
Usability Testing ●
Transit Testing

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the InkSpace Imaging Small Body Array meet the

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established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the InkSpace Imaging Small Body Array does not raise different questions of safety or effectiveness for MR imaging examinations with Siemens 1.5T MRI Systems when compared to the predicate device.

[807.92(b)(2)] Clinical Testing Summary:

Not applicable. Clinical testing was not required to demonstrate substantial equivalence of the modified InkSpace Imaging Small Body Array to the predicate device. Acquired image quality was analyzed based on sample clinical images. These images, as well as a review of their clinical quality by a board-certified radiologist, have been included as part of this submission.

CONCLUSIONS [807.92(B)(3)]

Based on the results from the nonclinical tests performed in support of the InkSpace Imaging Small Body Array, it is concluded that the modified device is safe, effective, and performs at least as safely and effectively as the legally marketed predicate device.

SUMMARY

The InkSpace Imaging Small Body Array is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.