(81 days)
Not Found
No
The summary describes a receive-only MRI coil and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for obtaining diagnostic images to assist in diagnosis, not for treating a condition or disease.
No
Explanation: The device is a receive-only coil for an MRI system, which obtains images. It is explicitly stated that these images, when interpreted by a trained physician, "yield information that may assist in diagnosis," indicating that the coil itself is not performing the diagnosis.
No
The device description explicitly states it is a "phased array, receive-only coil" comprised of "two individual flexible pads, each containing 12 individual elements," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The InkSpace Imaging Small Body Array is a receive-only coil for an MRI system. Its function is to acquire diagnostic images of the human body, not to analyze specimens from the human body.
- Intended Use: The intended use is to obtain diagnostic images of general human anatomy. This is a function of an imaging device, not an IVD.
The device is clearly an accessory for a medical imaging system (MRI) used for in-vivo imaging, not in-vitro diagnostics.
N/A
Intended Use / Indications for Use
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 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 Small Body Array is a phased array, receive-only coil intended to work with Siemens 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution 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 optimized to be flexible to conform to patients' anatomies.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate
Indicated Patient Age Range
adult and pediatric patients
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.
Nonclinical testing summarized:
- . 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)
In addition to the above nonclinical testing, a risk analysis was performed to validate that the following testing performed on the InkSpace Imaging Body Array (predicate device) could be applied to the InkSpace Imaging Small Body Array 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 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 3.0T MRI Systems when compared to the predicate device.
Clinical testing was not required to demonstrate substantial equivalence of 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.
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.
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.
January 8, 2024
InkSpace Imaging, Inc. % Taras Bouzakine Director, Regulatory Affairs Veranex. Inc. 224 Airport Parkway, Suite 250 San Jose. California 95110
Re: K233444
Trade/Device Name: InkSpace Imaging Small Body Array Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: December 14, 2023 Received: December 15, 2023
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.
1
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 (QS) 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.
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.
2
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.g.K.
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 Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
InkSpace Imaging Small Body Array
Indications for Use (Describe)
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 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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4
510(k) Notification K233444
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@veranex.com
Date Prepared: November 3, 2023
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 Body Array (K223487)
DEVICE DESCRIPTION [807.92(A)(4)]
The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution 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 optimized to be flexible to conform to patients' anatomies.
5
INDICATIONS FOR USE [807.92(A)(5)]
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 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 Small Body Array are substantially equivalent to the predicate device, InkSpace Imaging Body Array (K223487). 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.
6
510(k) SUMMARY
| Characteristics | Predicate Device:
InkSpace Imaging Body Array (K223487) | Subject Device:
InkSpace Imaging Small 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 | 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 patients in magnetic resonance imaging
systems. The nucleus detected is hydrogen. | The InkSpace Imaging Small Body Array is a
receive-only RF coil designed for use with
Siemens 3.0T MRI systems. It is 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 magnetic resonance imaging systems.
The nucleus detected is hydrogen. | Intended use of the modified
device maintains the same general
purpose and function as the
predicate device, differing only
by target MRI system. |
| 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 | 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 3.0T
magnetic resonance imaging systems. These
images, when interpreted by a trained physician,
yield information that may assist in diagnosis. | Indications for Use of the
modified device maintains the
same general purpose and
function as the predicate device,
differing only by target MRI
system. |
| Characteristics | Predicate Device:
InkSpace Imaging Body Array (K223487) | Subject Device:
InkSpace Imaging Small Body Array | Substantial Equivalence
Rationale |
| | 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 Anatomy
and Population | 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. | Imaging of general human anatomy in adult and
pediatric patients, such as cardiac, spine, shoulder,
elbow, knee, foot, and prostate. | N/A (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. | 24 channel, receive-only phased array, designed
for 3.0T MR systems (123.2 MHz, hydrogen).
Device is reusable, non-sterile, and by prescription
only.
Device is made of soft, pliable materials, and is
composed of two identical 12ch pads. | N/A (Same). |
| Compatible MRI
Systems | GE 3.0T MRI Systems | Siemens 3.0T MRI Systems | Differed target MRI system
vendor. Same magnetic field
strength. |
| Biocompatibility | ISO 10993 testing | ISO 10993 testing | N/A (Same). |
Table 1: Summary of Technological Characteristics
7
510(k) SUMMARY
8
SUBSTANTIAL EQUIVALENCE
The InkSpace Imaging Small Body Array is substantially equivalent to the predicate device, InkSpace Imaging 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 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 Body Array (predicate device) is still applicable to the InkSpace Imaging Small Body Array.
Additional analysis was conducted based on variations between the devices and differences between MR system vendors. These results and 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:
- . 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)
In addition to the above nonclinical testing, a risk analysis was performed to validate that the following testing performed on the InkSpace Imaging Body Array (predicate device) could be applied to the InkSpace Imaging Small Body Array without retesting:
- . Biocompatibility Testing (Cytotoxicity, Sensitization, Irritation)
- Usability Testing .
- Transit Testing ●
9
510(K) SUMMARY
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 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 3.0T 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 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.