Who is the manufacturer of InkSpace Imaging Body Array?

Inkspace Imaging, Inc. filed the 510(k) submission for InkSpace Imaging Body Array (K223487).

What is the FDA product code for InkSpace Imaging Body Array?

MOS. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for InkSpace Imaging Body Array?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like InkSpace Imaging Body Array?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

InkSpace Imaging Body Array

K223487 · Inkspace Imaging, Inc. · MOS · Dec 8, 2022 · Radiology

Device Facts

Record ID	K223487
Device Name	InkSpace Imaging Body Array
Applicant	Inkspace Imaging, Inc.
Product Code	MOS · Radiology
Decision Date	Dec 8, 2022
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

InkSpace Imaging Body Array is a 24-channel, receive-only phased array RF coil designed for GE 3.0T MRI systems. Comprised of two flexible anterior and posterior pads containing 12 elements each, the device conforms to patient anatomy to provide high-resolution diagnostic images. Used in clinical settings by radiologists and MRI technicians, the coil captures hydrogen signals to produce images interpreted by physicians for diagnostic assistance. The device is reusable and non-sterile. It functions as a passive hardware component within the MRI workflow; it does not perform automated analysis or processing. The primary benefit is improved signal-to-noise ratio and uniformity for body and cardiac imaging across pediatric and adult populations.

Clinical Evidence

No clinical trials were conducted. Substantial equivalence was demonstrated via nonclinical bench testing (SNR, uniformity, surface heating, decoupling, EMC, electrical/mechanical safety) and biocompatibility testing (ISO 10993). Sample clinical images from adult patients were reviewed by a board-certified radiologist to confirm image quality.

Technological Characteristics

24-channel, receive-only phased array RF coil; 3.0T MRI compatible (127.73 MHz, hydrogen). Construction: soft, pliable materials (anterior/posterior pads). Reusable, non-sterile. Biocompatibility per ISO 10993. No software or active electronic processing components.

Indications for Use

Indicated for pediatric patients (cardiac and body imaging) and adult patients (general anatomy including spine, shoulder, elbow, knee, foot, and prostate) undergoing MRI on GE 3.0T systems.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

InkSpace Imaging Pediatric Body Array (K213397)

Related Devices

K233444 — InkSpace Imaging Small Body Array · Inkspace Imaging, Inc. · Jan 8, 2024
K073236 — NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE · Neocoil · Nov 30, 2007
K213397 — InkSpace Imaging Pediatric Body Array · Inkspace Imaging, Inc. · Dec 17, 2021
K103365 — DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A · Ge Healthcare Coils (Usa Instruments, Inc.) · Jan 12, 2011
K243675 — InkSpace Imaging Small Body Array · Inkspace Imaging, Inc. · Dec 20, 2024

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > 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." {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.