(23 days)
Not Found
No
The document describes a receive-only MRI coil and its physical characteristics. There is no mention of AI, ML, image processing beyond basic signal acquisition, or any data processing algorithms that would suggest the use of AI/ML. The performance studies focus on hardware performance and image quality as assessed by a radiologist, not on algorithmic performance.
No
The device is a receive-only coil used for obtaining diagnostic images, which assist in diagnosis, not provide therapy.
Yes
The device obtains diagnostic images that, when interpreted by a trained physician, assist in diagnosis.
No
The device description explicitly 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 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. They are used to examine these samples outside of the body.
- Device Function: The InkSpace Imaging Small Body Array is a receive-only coil used in Magnetic Resonance Imaging (MRI). MRI is an imaging technique that uses magnetic fields and radio waves to create detailed images of organs and tissues inside the body.
- Intended Use: The intended use clearly states it's for "obtaining diagnostic images of general human anatomy... in Siemens 1.5T magnetic resonance imaging systems." This is an in vivo (within the living body) imaging process, not an in vitro test on a sample.
The device is a component of an MRI system, which is a medical imaging device, not an in vitro diagnostic device.
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 1.5T magnetic 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 Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for 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 flexible to conform to patients' anatomies.
Mentions image processing
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.
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
Use of the device during these procedures should be performed by appropriately trained MRI technologists, and interpretation of the images produced by these scans should be performed only by board certified radiologists.
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
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. Data source and annotation protocol are not described.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 for 1.5T scanners:
- Image Signal to Noise (SNR)
- Image Uniformity
- Surface Heating
- Decoupling Circuit
- EMC - Immunity, Electrostatic Discharge
- General Electrical/Mechanical Safety
- Acquired Image Quality
In addition to the above listed nonclinical testing, a risk analysis was performed to validate that the following testing performed on the InkSpace Imaging Small Body Array for 3.0T scanners (predicate device) could be applied to the InkSpace Imaging Small Body Array for 1.5T scanners 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 1.5T MRI Systems when compared to the predicate device.
Clinical Testing Summary: Not applicable. Clinical testing was not required to demonstrate substantial equivalence of the modified 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): 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.
InkSpace Imaging Small Body Array (K233444)
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.
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Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2024
InkSpace Imaging, Inc. % Taras Bouzakine Director, Regulatory Affairs Veranex, Inc. 5420 Wade Park Blvd, Suite 204 Raleigh, North Carolina 27607
Re: K243675
Trade/Device Name: InkSpace Imaging Small Body Arrav Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: MOS Dated: November 27, 2024 Received: November 27, 2024
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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
For comprehensive regulatory information about medical devices and radiation-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-regulatory
2
assistance/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,
FDA
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 Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
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 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, vield 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
This summary of the Special 510(k) premarket notification for the InkSpace Imaging Small Body Array is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR$807.92.
5
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. 5420 Wade Park Blvd, Suite 204 Raleigh, NC 27607 USA Phone: 603-205-4874 Email: taras.bouzakine@yeranex.com
Date Prepared: December 18, 2024
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 Small Body Array (K233444)
DEVICE DESCRIPTION [807.92(A)(4)]
The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for 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 flexible to conform to patients' anatomies.
6
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 1.5T 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 for 1.5T scanners are substantially equivalent to the predicate device, the InkSpace Imaging Small Body Array for 3.0T scanners (K233444). 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.
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| Table 1: Summary of Technological Characteristics | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | --------------------------------------------------- |
| Characteristics | Subject Device:
InkSpace Imaging Small Body Array - 1.5T | Predicate Device:
InkSpace Imaging Small Body Array - 3.0T
(K233444) | 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 Small Body Array for
Siemens 1.5T MRI systems is indicated for use
as an alternative to a traditional MRI receive
array. The conformal fit and blanket-like
construction are designed to decrease anxiety
and optimize convenience for both the patient
and the technologist during the MRI scan. Use
of the device during these procedures should be
performed by appropriately trained MRI
technologists, and interpretation of the images
produced by these scans should be performed
only by board certified radiologists. | The InkSpace Imaging Small Body Array for
Siemens 3.0T MRI systems is indicated for use as
an alternative to a traditional MRI receive array.
The conformal fit and blanket-like construction are
designed to decrease anxiety and optimize
convenience for both the patient and the
technologist during the MRI scan. Use of the
device during these procedures should be
performed by appropriately trained MRI
technologists, and interpretation of the images
produced by these scans should be performed only
by board certified radiologists. | Intended use of the modified
device maintains the same general
purpose and function as the
predicate device, differing only
by target MRI system field
strength (1.5T vs. 3.0T). |
| 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 1.5T magnetic resonance imaging
systems. These images, when interpreted by a
trained physician, yield information that may
assist in diagnosis. | 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 field strength (1.5T vs.
3.0T). |
| Patient Anatomy
and Population | Imaging of general human anatomy, such as
cardiac, spine, shoulder, elbow, knee, foot, and
prostate. | Imaging of general human anatomy, such as
cardiac, spine, shoulder, elbow, knee, foot, and
prostate. | N/A (Same). |
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| Table 1: Summary of Technological Characteristics (cont.) | |
|---|---|
| ----------------------------------------------------------- | -- |
| Table 1: Summary of Technological Characteristics (cont.) | |||
|---|---|---|---|
| Characteristics | Subject Device: | ||
| InkSpace Imaging Small Body Array - 1.5T | Predicate Device: | ||
| InkSpace Imaging Small Body Array - 3.0T | |||
| (K233444) | Substantial Equivalence | ||
| Rationale | |||
| Comparison of | |||
| Technological | |||
| Characteristics | 24 channel, receive-only phased array, designed | ||
| for 1.5T MR systems (63.6 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. | 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. | Different receive frequencies | ||
| (63.6 MHz vs. 123.2 MHz) due to | |||
| operation at 1.5T vs. 3.0T. This | |||
| difference is fully verified. | |||
| Compatible MRI | |||
| Systems | Siemens 1.5T MRI Systems | Siemens 3.0T MRI Systems | Different MR field strength, same |
| OEM. This difference is fully | |||
| verified. | |||
| Biocompatibility | ISO 10993 testing | ISO 10993 testing | N/A (Same). |
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SUBSTANTIAL EQUIVALENCE
The InkSpace Imaging Small Body Array for 1.5T scanners is substantially equivalent to the predicate device, the InkSpace Imaging Small Body Array for 3.0T scanners, 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 effectiveness. 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 Small Body Array for 3.0T scanners (predicate device) is still applicable to the modified InkSpace Imaging Small Body Array for 1.5T scanners (subject of this submission).
Additional analysis was conducted based on the differences between 1.5T MR and 3.0T MR systems. These results and representative scan 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 for 1.5T scanners:
- . Image Signal to Noise (SNR)
- Image Uniformity
- Surface Heating
- Decoupling Circuit
- EMC - Immunity, Electrostatic Discharge
- General Electrical/Mechanical Safety
- Acquired Image Quality ●
In addition to the above listed nonclinical testing, a risk analysis was performed to validate that the following testing performed on the InkSpace Imaging Small Body Array for 3.0T scanners (predicate device) could be applied to the InkSpace Imaging Small Body Array for 1.5T scanners 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
10
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 1.5T 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 the modified 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.