(60 days)
Not Found
No
The 510(k) summary describes a receive-only MRI coil and does not mention any AI or ML capabilities in its intended use, device description, or performance studies.
No
The device is a receive-only coil for MRI systems, used for obtaining diagnostic images. Its purpose is to assist in diagnosis by providing information, not to provide therapy.
No
The device is a receive-only coil used for obtaining diagnostic images. It does not perform the diagnosis itself, but rather provides data for a trained physician to interpret.
No
The device description clearly states it is a "phased array, receive-only coil" comprised of physical components like "flexible pads" and "individual elements," indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description clearly states that this device is a receive-only coil used for obtaining diagnostic images of pediatric cardiac and body within the patient using magnetic resonance imaging. It does not involve the analysis of biological samples.
- The intended use is for obtaining diagnostic images directly from the patient. The information derived from these images is then interpreted by a physician. This is a core function of medical imaging devices, not IVDs.
The device described is a medical imaging accessory (an MRI coil) used for in vivo (within the living body) diagnostic imaging.
N/A
Intended Use / Indications for Use
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.
Product codes
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic resonance imaging systems
Anatomical Site
pediatric cardiac and body
Indicated Patient Age Range
pediatric
Intended User / Care Setting
trained physician
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)
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
InkSpace Imaging Pediatric Body Array
Indications for Use (Describe)
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.
| 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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3
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)
4
DEVICE DESCRIPTION [807.92(a)(4)]
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.
INDICATIONS FOR USE [807.92(a)(5)]
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.
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.
5
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 Device
per 21 CFR§892.1000 | Magnetic Resonance Diagnostic Device
per 21 CFR§892.1000 | Same |
| Product Code | MOS (Coil, Magnetic Resonance,
Specialty) | MOS (Coil, Magnetic Resonance,
Specialty) | Same |
| Indications for
Use | 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. | The Pediatric Body-Cardiac Coil is a
receive-only coil, used for obtaining
diagnostic images of pediatric cardiac and
body in Philips Achieva 3.0T magnetic
resonance imaging systems. These images
when interpreted by a trained physician,
yield information that may assist in
diagnosis. | Similar. Only difference is the type of
MRI system. The proposed device is used
with the GE 3.0T MRI system while the
predicate device is used with the Philips
Achieva 3.0T MRI system. |
| Patient Anatomy
and Population | Imaging of general body part regions
including cardiac regions; designed for
pediatric patients. | Imaging of general body part regions
including cardiac regions; designed for
pediatric patients. | Same |
| Comparison of
Technological
Characteristics | 24 channel, receive-only phased array,
designed for 3.0T MR systems (127.73
MHz, hydrogen).
Device is reusable, non-sterile, and by
prescription only.
Device is made of soft, pliable materials,
and is composed of an anterior and a
posterior pad. | 8 channel, receive-only phased array,
designed for 3.0T MR systems (127.73
MHz, hydrogen).
Device is reusable, non-sterile, and by
prescription only.
Device is made of rigid materials and is
composed of a base plate coil and an
anterior coil. | Similar. Differences do not raise any new
or different questions of safety and
effectiveness. |
| | Compatible MRI
Systems | GE 3.0T MRI Systems | Philips 3.0T MRI Systems |
| Biocompatibility | ISO 10993 testing | ISO 10993 testing | Same |