The InkSpace Imaging Pediatric 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.

Device Description

The InkSpace Imaging Pediatric 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 pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population 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 a pediatric patient's anatomy.

AI/ML Overview

The InkSpace Imaging Pediatric Body Array is a receive-only coil for pediatric cardiac and body imaging in GE 3.0T MRI systems. Its acceptance criteria and performance are based on non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Image Performance	Signal to Noise (SNR) meets specifications	Testing conducted, results suggest specifications met
	Image Uniformity meets specifications	Testing conducted, results suggest specifications met
	Acquired Image Quality is clinically acceptable	Analyzed based on sample clinical images; found acceptable by board-certified radiologist
Safety	Surface Heating within acceptable limits	Testing conducted, results suggest limits met
	Decoupling Circuit functions as intended	Testing conducted, results suggest proper function
	EMC Immunity, Electrostatic Discharge meets standards	Testing conducted, results suggest standards met
	General Electrical/Mechanical Safety meets standards	Testing conducted, results suggest standards met
Biocompatibility	No Cytotoxicity	Testing (ISO 10993) conducted, results suggest no cytotoxicity
	No Sensitization	Testing (ISO 10993) conducted, results suggest no sensitization
	No Irritation	Testing (ISO 10993) conducted, results suggest no irritation
Usability	Device is usable	Usability Testing conducted
Durability/Transit	Device withstands transit	Transit Testing conducted

Study Proving Acceptance Criteria:

The device's acceptance criteria were proven through a series of nonclinical tests conducted 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.

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

Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial with patient data. The testing primarily involved bench testing and technical evaluations of the device itself. For "Acquired Image Quality," sample clinical images were analyzed.
Data Provenance: Not explicitly stated as "country of origin" for patient data, since the primary testing was non-clinical. The "sample clinical images" used for image quality analysis would presumably be from a clinical setting, but no details on their origin (e.g., country, specific institution, retrospective/prospective collection) are provided.

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

Number of Experts: One expert.
Qualifications of Experts: "A board-certified radiologist."

4. Adjudication method for the test set:

The document mentions "a review of their clinical quality by a board-certified radiologist" for the acquired image quality. This implies a single-reader adjudication for the image quality assessment. There is no mention of a multi-reader, consensus, or other adjudication methods.

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 comparative effectiveness study was not done. This device is a hardware component (MRI coil), not an AI-assisted diagnostic tool.

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

Yes, in essence, standalone performance was assessed through the nonclinical bench testing. The "device performance" metrics (SNR, uniformity, heating, electrical safety, etc.) were evaluated for the coil itself, independent of human interpretation or interaction beyond its operational use in an MRI system. The image quality analysis, while reviewed by a radiologist, evaluated the device's output (the images) when compared to clinical expectations, not the radiologist's performance with or without the device.

7. The type of ground truth used:

For the technical performance aspects (SNR, uniformity, heating, electrical safety, biocompatibility, etc.), the "ground truth" was established by engineering specifications, recognized industry standards (e.g., ISO 10993), and regulatory guidance documents (FDA Guidance Document for MR Receive-only Coil).
For "Acquired Image Quality," the ground truth was based on the clinical interpretation and judgment of a board-certified radiologist regarding the diagnostic utility of the sample images produced by the device.

8. The sample size for the training set:

Not applicable. This device is a hardware component (MRI coil); it does not involve machine learning or an "algorithm" in the sense of requiring a training set for model development.

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

Not applicable, as there is no training set for this hardware device.

Summary

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December 17, 2021

Image /page/0/Picture/1 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

InkSpace Imaging, Inc. % Taras Bouzakine Director, Regulatory Affairs Experien Group, LLC 224 Airport Parkway, Suite 250 SAN JOSE CA 95110

Re: K213397

Trade/Device Name: InkSpace Imaging Pediatric Body Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: MOS Dated: October 15, 2021 Received: October 18, 2021

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 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

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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 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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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)

Device Name

InkSpace Imaging Pediatric 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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510(k) Notification K213397

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, Experien Group, LLC Regulatory Consultant for InkSpace Imaging, Inc. 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA

Date Prepared: October 15, 2021

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

InkSpace Imaging Pediatric Body Array

Generic/Common Name:

Coil, Magnetic Resonance, Specialty

Classification:

Class II per 21 CFR§892.1000

Product Code:

MOS

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

Pediatric Body-Cardiac Coil (K101949)

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DEVICE DESCRIPTION [807.92(a)(4)]

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

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

The InkSpace Imaging Pediatric Body Array and its predicate, the Pediatric Body-Cardiac Coil (K101949), are classified as receive-only coils for 3.0 Tesla magnetic resonance imaging systems and are intended for use in obtaining diagnostic images of the body and cardiac regions of pediatric populations. Both devices detect hydrogen as the resonant nuclei and use phased array coil configurations to enhance overall signal to noise ratio. The proposed device and its predicate device have similar technological characteristics and employ the same operating principles. The primary technological difference between the two devices is that the predicate device utilizes an 8-element phased array RF structure, as opposed to the 24-elements of the proposed device. These minor differences in technological characteristics between the InkSpace Imaging Pediatric Body Array and the Pediatric Body-Cardiac Coil have been evaluated and determined to not raise any new or different questions of safety or effectiveness and thus is substantially equivalent to the predicate device.

SUBSTANTIAL EQUIVALENCE

A comparison table summarizing the specifications and features of the InkSpace Imaging Pediatric Body Array and the predicate device, the Pediatric Body-Cardiac Coil, is included in the Substantial Equivalence Table.

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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 necessary nonclinical testing was conducted on the InkSpace Imaging Pediatric Body Array to support a determination of substantial equivalence to the predicate device.

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

The nonclinical testing included:

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

In addition to the above nonclinical testing, the InkSpace Imaging Pediatric Body Array also 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 the design of the InkSpace Imaging Pediatric 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 Pediatric Body Array does not raise new or different questions of safety or effectiveness for pediatric body MR imaging examinations when compared to the predicate device.

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

Not applicable. Clinical testing was not required to support substantial equivalence of the InkSpace Imaging Pediatric 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 Pediatric Body Array, it is concluded that the proposed device is safe, effective, and performs at least as safely and effectively as the legally marketed predicate device.

SUMMARY

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

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Substantial Equivalence Table

Device Name	InkSpace Imaging Pediatric Body Array(Subject Device)	Pediatric Body-Cardiac Coil(Predicate)	Comparison
Classification	Magnetic Resonance Diagnostic Deviceper 21 CFR§892.1000	Magnetic Resonance Diagnostic Deviceper 21 CFR§892.1000	Same
Product Code	MOS (Coil, Magnetic Resonance,Specialty)	MOS (Coil, Magnetic Resonance,Specialty)	Same
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. These images,when interpreted by a trained physician,yield information that may assist indiagnosis.	The Pediatric Body-Cardiac Coil is areceive-only coil, used for obtainingdiagnostic images of pediatric cardiac andbody in Philips Achieva 3.0T magneticresonance imaging systems. These imageswhen interpreted by a trained physician,yield information that may assist indiagnosis.	Similar. Only difference is the type ofMRI system. The proposed device is usedwith the GE 3.0T MRI system while thepredicate device is used with the PhilipsAchieva 3.0T MRI system.
Patient Anatomyand Population	Imaging of general body part regionsincluding cardiac regions; designed forpediatric patients.	Imaging of general body part regionsincluding cardiac regions; designed forpediatric patients.	Same
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.	8 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 rigid materials and iscomposed of a base plate coil and ananterior coil.	Similar. Differences do not raise any newor different questions of safety andeffectiveness.
	Compatible MRISystems	GE 3.0T MRI Systems	Philips 3.0T MRI Systems
Biocompatibility	ISO 10993 testing	ISO 10993 testing	Same

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.