Pediatric Population: The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis. Adult Population: The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adults, such as spine, shoulder, elbow, knee, foot, and prostate resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Device Description

The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed to fit the pediatric and adult populations for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to pediatric and adult patients' anatomies.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical device called the "InkSpace Imaging Body Array," which is a receive-only coil for Magnetic Resonance Imaging (MRI) systems. The document focuses on demonstrating substantial equivalence to a predicate device (InkSpace Imaging Pediatric Body Array, K213397) rather than establishing novel acceptance criteria for a new device's performance.

Therefore, the acceptance criteria and study detailed in this document are primarily concerned with demonstrating that the modified device (InkSpace Imaging Body Array) functions as safely and effectively as its predicate device (InkSpace Imaging Pediatric Body Array). The "acceptance criteria" here are implicitly related to the performance characteristics of an MRI coil, and the "study" is a set of non-clinical tests and an assessment of acquired image quality.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the InkSpace Imaging Body Array as if it were a new device needing to meet predefined thresholds. Instead, it states that the device had to demonstrate substantial equivalence to the predicate. The "performance criteria" referenced in the guidance document are general for MR receive-only coils, and the testing was done to ensure the modified device meets established specifications and does not raise different questions of safety or effectiveness compared to the predicate.

The table below summarizes the characteristics that were assessed for "performance" in the context of substantial equivalence:

Characteristic Assessed	Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance (Summary)
Image Signal to Noise (SNR)	Consistent with or comparable to the predicate device and established specifications for MR receive-only coils.	Nonclinical testing demonstrating the device meets established specificationsnecessary for consistent performance.
Image Uniformity	Consistent with or comparable to the predicate device and established specifications for MR receive-only coils.	Nonclinical testing demonstrating the device meets established specificationsnecessary for consistent performance.
Surface Heating	Within safe limits, comparable to the predicate device, and meeting established specifications.	Nonclinical testing demonstrating the device meets established specifications for consistent performance and does not raise different questions of safety.
Decoupling Circuit	Functioning correctly and safely, comparable to the predicate device.	Nonclinical testing demonstrating the device meets established specificationsfor consistent performance and does not raise different questions of safety.
EMC Immunity, Electrostatic Discharge	Meeting regulatory standards and comparable to the predicate device.	Nonclinical testing demonstrating the device meets established specificationsfor consistent performance and does not raise different questions of safety.
General Electrical/Mechanical Safety	Meeting relevant safety standards and comparable to the predicate device.	Nonclinical testing demonstrating the device meets established specifications for consistent performance and does not raise different questions of safety.
Acquired Image Quality (Adult Patients)	Images of clinical quality, providing information that may assist in diagnosis by a trained physician (similar to predicate's indication).	Sample clinical images from adult patients were reviewed, and their clinical quality was confirmed by a board-certified radiologist. The general conclusion is that the device is "safe, effective, and performs at least as safely and effectively as the legally marketed predicate device."
Biocompatibility Testing	Meeting ISO 10993 standards for cytotoxicity, sensitization, and irritation, similar to the predicate device.	Performed (referenced as having been done on the predicate and still applicable, and also implied for the modified device).
Usability Testing	Demonstrating safe and effective use, comparable to the predicate device.	Performed (referenced as having been done on the predicate).
Transit Testing	Ensuring integrity and functionality after transport, comparable to the predicate device.	Performed (referenced as having been done on the predicate).

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

Sample Size for Acquired Image Quality: Not explicitly stated as a number. The document refers to "sample clinical images from adult patients" and an "analysis of acquired image quality... based on sample clinical images from adult patients." This implies a qualitative assessment on a subset of images rather than a large-scale, quantitatively defined test set.
Data Provenance: Not specified for the "sample clinical images from adult patients." It does not mention country of origin, nor whether the data was retrospective or prospective.

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." This indicates one expert.
Qualifications of Experts: "board-certified radiologist." No specific experience level (e.g., "10 years of experience") is provided, but board certification implies a high level of qualification in the field.

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

Adjudication Method: Not applicable or "none" in the typical sense of multiple readers adjudicating cases. The review of clinical quality was performed by "a board-certified radiologist" (singular), suggesting a single-reader assessment for clinical quality.

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

MRMC Study: No. The device is a receive-only MRI coil, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this device and was not conducted. The study was to establish substantial equivalence for the coil itself.

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

Standalone Performance: No. This device is an MRI coil, which is a hardware component that produces images. It is not an algorithm, and thus, "standalone" algorithmic performance without human-in-the-loop is not applicable. The performance is assessed on the quality of the images it produces for human interpretation.

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

Type of Ground Truth: For the "acquired image quality" assessment, the ground truth was the expert opinion/review of a board-certified radiologist regarding the clinical quality of the images. For the more objective non-clinical tests (SNR, uniformity, heating, etc.), the "ground truth" would be engineering specifications and regulatory standards.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document describes a medical device (MRI coil), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of algorithm development. The non-clinical testing and image review are for validation/verification, not training.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this hardware device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

December 8, 2022

InkSpace Imaging, Inc. % Taras Bouzakine Director Veranex. Inc. 224 Airport Parkway, Suite 250 SAN JOSE CA 95110

Re: K223487

Trade/Device Name: InkSpace Imaging Body Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: November 18, 2022 Received: November 21, 2022

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 (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.

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

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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 (OS) 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 mediation-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,

D. R. Keefe

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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

510(k) Number (if known)

K223487

Device Name InkSpace Imaging Body Array

Indications for Use (Describe)

Pediatric Population:

The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

Adult Population:

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

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) Notification K_223487

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. 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA Phone: 603-205-4874 Email: taras.bouzakine@veranexsolutions.com

Date Prepared: November 18, 2022

DEVICE INFORMATION [807.92(A)(2)]

Classification: Class II per 21 CFR§892.1000

Product Code:

MOS

Trade Name: InkSpace Imaging Body Array

Generic/Common Name:

Coil, Magnetic Resonance, Specialty

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

InkSpace Imaging Pediatric Body Array (K213397)

DEVICE DESCRIPTION [807.92(A)(4)]

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placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to pediatric and adult patients' anatomies.

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

Pediatric Population:

Adult Population:

The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adults, such as spine, shoulder, elbow, knee, foot, and prostate in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

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

The technological characteristics of the modified InkSpace Imaging Body Array are substantially equivalent to the predicate device, InkSpace Imaging Pediatric Body Array (K213397). 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.

Characteristics	InkSpace Imaging Pediatric BodyArray (K213397)	InkSpace Imaging Body Array	SubstantialEquivalenceRationale
Classification	Magnetic Resonance Diagnostic Deviceper 21 CFR§892.1000	Magnetic Resonance Diagnostic Deviceper 21 CFR§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 Pediatric BodyArray is a receive-only RF coil designedfor use with GE 3.0T MRI systems. It isused for obtaining diagnostic images ofthe body and cardiac regions of pediatricpatients in magnetic resonance imagingsystems. The nucleus detected ishydrogen. Anatomic Regions:Cardiac/Body for pediatric patients.	Pediatric Population:The InkSpace Imaging Body Array is areceive-only RF coil designed for usewith GE 3.0T MRI systems. It is used forobtaining diagnostic images of the bodyand cardiac regions of pediatric patientsin magnetic resonance imaging systems.The nucleus detected is hydrogen.Anatomic Regions: Cardiac/Body forpediatric patients.Adult Population:The InkSpace Imaging Body Array is areceive-only RF coil designed for usewith GE 3.0T MRI systems. It is used forobtaining diagnostic images of generalhuman anatomy such as spine, shoulder,elbow, knee, foot, and prostate for adult	Intended useof themodifieddevice andpredicatedevicemaintain thesame generalpurpose andfunction.
Characteristics	InkSpace Imaging Pediatric BodyArray (K213397)	InkSpace Imaging Body Array	SubstantialEquivalenceRationale
Indications forUse	The InkSpace Imaging Pediatric BodyArray is a receive-only coil, used forobtaining diagnostic images of pediatriccardiac and body in GE 3.0T magneticresonance imaging systems. Theseimages, when interpreted by a trainedphysician, yield information that mayassist in diagnosis.	Pediatric Population:The InkSpace Imaging Body Array is areceive-only coil, used for obtainingdiagnostic images of pediatric cardiacand body in GE 3.0T magnetic resonanceimaging systems. These images, wheninterpreted by a trained physician, yieldinformation that may assist in diagnosis.Adult Population:The InkSpace Imaging Body Array is areceive-only coil, used for obtainingdiagnostic images of general humananatomy in adults, such as spine,shoulder, elbow, knee, foot, and prostatein GE 3.0T magnetic resonance imagingsystems. These images, when interpretedby a trained physician, yield informationthat may assist in diagnosis.	Patientpopulationupdated frompediatric onlyto pediatricand adult.
Patient Anatomyand Population	Imaging of general body part regionsincluding cardiac regions; designed forpediatric patients.	Imaging of general body part regionsincluding cardiac regions; intended forpediatric patients.Imaging of general human anatomy, suchas spine, shoulder, elbow, knee, foot, andprostate; intended for adult patients.	Patientpopulationupdated frompediatric onlyto pediatricand adult.
Comparison ofTechnologicalCharacteristics	24 channel, receive-only phased array,designed for 3.0T MR systems (127.73MHz, hydrogen).Device is reusable, non-sterile, and byprescription only.Device is made of soft, pliable materials,and is composed of an anterior and aposterior pad.	24 channel, receive-only phased array,designed for 3.0T MR systems (127.73MHz, hydrogen).Device is reusable, non-sterile, and byprescription only.Device is made of soft, pliable materials,and is composed of an anterior and aposterior pad.	N/A (Same).
Compatible MRISystems	GE 3.0T MRI Systems	GE 3.0T MRI Systems	N/A (Same).
Biocompatibility	ISO 10993 testing	ISO 10993 testing	N/A (Same).

Table 1: Summary of Technological Characteristics

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Table 1: Summary of Technological Characteristics (Cont.)

SUBSTANTIAL EQUIVALENCE

The InkSpace Imaging Body Array is substantially equivalent to the predicate device, InkSpace Imaging Pediatric Body Array 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 efficacy. Thus, the modified InkSpace Imaging Body Array is substantially equivalent to the predicate device.

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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.

All applicable nonclinical testing conducted on the InkSpace Imaging Pediatric Body Array (predicate device) is still applicable to the modified InkSpace Imaging Body Array.

Additional analysis of acquired image quality was conducted based on sample clinical images from adult patients. These images, as well as a review of their clinical quality by a boardcertified radiologist, have been included as part of this submission.

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

The nonclinical, bench testing previously performed on the InkSpace Imaging Pediatric Body Array:

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

Additional testing performed on the InkSpace Imaging Body Array:

Acquired Image Ouality
In addition to the above nonclinical testing, the InkSpace Imaging Pediatric Body Array also previously underwent the following testing:
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 Body Array meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the InkSpace Imaging Body Array does not raise different questions of safety or effectiveness for MR imaging examinations 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 InkSpace Imaging Body Array to the predicate device. Acquired image quality from adult patients 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.

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510(k) SUMMARY

CONCLUSIONS [807.92(b)(3)]

Based on the results from the nonclinical tests performed in support of the InkSpace Imaging 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 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.