(17 days)
Not Found
No
The document describes a receive-only MRI coil and its performance characteristics. There is no mention of AI, ML, or any image processing that would suggest the use of such technologies. The focus is on the hardware's ability to acquire images for interpretation by a trained physician.
No.
The device is used for obtaining diagnostic images to assist in diagnosis, not for treating a condition.
No
Explanation: The device is a receive-only coil for an MRI system, which aids in obtaining diagnostic images. It does not perform the diagnosis itself; the images it helps create are interpreted by a trained physician to assist in diagnosis. Therefore, the device itself is not a diagnostic device.
No
The device description explicitly states it is a "phased array, receive-only coil" comprised of "two individual flexible pads" containing "individual elements." This clearly describes a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The InkSpace Imaging Body Array is a receive-only coil for an MRI system. Its function is to acquire magnetic resonance signals from the patient's body in vivo (within the living body).
- Intended Use: The intended use is to obtain diagnostic images of the body. These images are then interpreted by a physician. This is a form of in vivo imaging, not in vitro testing.
The device is a component of an imaging system used for diagnosis, but it does not perform tests on samples taken from the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MOS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Pediatric Population: cardiac and body
Adult Population: general human anatomy, such as spine, shoulder, elbow, knee, foot, and prostate
Indicated Patient Age Range
Pediatric Population, Adult Population
Intended User / Care Setting
trained physician / Not Found
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
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 board-certified radiologist, have been included as part of this submission.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Testing Summary:
- Image Signal to Noise (SNR)
- Image Uniformity
- Surface Heating
- Decoupling Circuit
- EMC Immunity, Electrostatic Discharge
- General Electrical/Mechanical Safety
- Acquired Image Quality
- 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
1
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
2
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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3
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)]
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
4
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:
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 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 Body
Array (K213397) | InkSpace Imaging Body Array | Substantial
Equivalence
Rationale |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Magnetic Resonance Diagnostic Device
per 21 CFR§892.1000 | Magnetic Resonance Diagnostic Device
per 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 Body
Array is a receive-only RF coil designed
for use with GE 3.0T MRI systems. It is
used for obtaining diagnostic images of
the body and cardiac regions of pediatric
patients in magnetic resonance imaging
systems. The nucleus detected is
hydrogen. Anatomic Regions:
Cardiac/Body for pediatric patients. | Pediatric Population:
The InkSpace Imaging Body Array is a
receive-only RF coil designed for use
with GE 3.0T MRI systems. It is used for
obtaining diagnostic images of the body
and cardiac regions of pediatric patients
in magnetic resonance imaging systems.
The nucleus detected is hydrogen.
Anatomic Regions: Cardiac/Body for
pediatric patients.
Adult Population:
The InkSpace Imaging Body Array is a
receive-only RF coil designed for use
with GE 3.0T MRI systems. It is used for
obtaining diagnostic images of general
human anatomy such as spine, shoulder,
elbow, knee, foot, and prostate for adult | Intended use
of the
modified
device and
predicate
device
maintain the
same general
purpose and
function. |
| Characteristics | InkSpace Imaging Pediatric Body
Array (K213397) | InkSpace Imaging Body Array | Substantial
Equivalence
Rationale |
| 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. | 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
in GE 3.0T magnetic resonance imaging
systems. These images, when interpreted
by a trained physician, yield information
that may assist in diagnosis. | Patient
population
updated from
pediatric only
to pediatric
and adult. |
| 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; intended for
pediatric patients.
Imaging of general human anatomy, such
as spine, shoulder, elbow, knee, foot, and
prostate; intended for adult patients. | Patient
population
updated from
pediatric only
to pediatric
and adult. |
| 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. | 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. | N/A (Same). |
| Compatible MRI
Systems | 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
5
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.
6
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.
7
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.