(107 days)
No
The summary describes a standard MRI system and does not mention AI or ML in the device description, intended use, or performance studies. The image processing mentioned is typical for MRI reconstruction and not indicative of AI/ML.
No
The device is described as an imaging device used to produce images for diagnostic purposes, not for treating specific conditions or diseases.
Yes
The device is an MRI system that produces images of the neonatal head. The "Intended Use / Indications for Use" section states that "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis," which explicitly indicates its role in the diagnostic process.
No
The device description explicitly states it is a "1Tesla Permanent MRI system," which is a hardware device. While it includes image processing, it is not solely software.
Based on the provided information, the Embrace Neonatal MRI System is not an IVD (In Vitro Diagnostic) device.
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.
- Embrace Neonatal MRI System Function: The description clearly states that the Embrace Neonatal MRI System is a magnetic resonance imaging device that produces images of the internal structure of the neonatal head. It works by using magnetic fields and radiofrequency pulses to generate signals from the body, which are then processed into images.
- No Sample Analysis: The device does not analyze samples taken from the body. It directly images the body itself.
Therefore, the Embrace Neonatal MRI System falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
Product codes
LNH, MOS
Device Description
The Embrace Neonatal MRI System is a 1Tesla Permanent MRI system producing MR images of Neonatal head. During MRI scan, body parts to be imaged are held within a uniform static magnetic field, and are subject to sequences of RF pulses and gradient magnetic fields. The signal from the precession of the magnetization created by these fields is sampled and processed to produce image data.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Neonatal Head
Indicated Patient Age Range
neonates
Intended User / Care Setting
trained physician / Hospital setting
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
The subject of this premarket submission, Embrace Neonatal MRI System, did not require clinical studies to support substantial equivalence. Since neonates are a vulnerable patient population, for this particular device, the benefits of sample clinical images did not outweigh the risks associated with acquisition of those images. Therefore, substantial equivalence of the Embrace Neonatal MRI System was determined based on phantom images that demonstrate the ability of the system to provide diagnostic quality images, and sample clinical images of the neonatal head were not necessary to support the premarket submission for this device.
Key Metrics
Not Found
Predicate Device(s)
K160185 Wrist 3 MRI System
Reference Device(s)
K161918 SREE MRI Transport Incubator
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2017
Aspect Imaging Ltd. % Israel Citron Vice President Quality Assurance and Regulatory Affairs 27 Shaked Street Industrial Area, Hevel Modi'in P.O. Box 926 Shoham, 6085001 Israel
Re: K170978
Trade/Device Name: Embrace Neonatal MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: June 4, 2017 Received: June 7, 2017
Dear Israel Citron:
This letter corrects our substantially equivalent letter of July 19, 2017.
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. 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
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael D'Hara For
Robert A. Ochs. Ph.I Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Embrace Neonatal MRI System
Indications for Use (Describe)
The Embrace Neonatal MRI System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal head with circumference of up to 38 cm and weight between 1Kg and 4.5 Kg. When interpreted by a trained physician, these images provide information that can be useful in determining a 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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Image /page/3/Picture/1 description: The image contains the logo for Aspect Imaging. The logo consists of a stylized cube made up of three layers, with each layer a different color: teal, green, and yellow. To the right of the cube is the company name, "aspectimaging," written in a sans-serif font, with the word "aspect" in purple and "imaging" in gray.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | March 28, 2017 |
| Submitter: | Aspect Imaging Ltd. |
| 27 Shaked St. | |
| Industrial Area Hevel Modi'in | |
| P.O. Box 926 | |
| Shoham, 6085001 | |
| ISRAEL | |
| Primary Contact Person: | Israel A. Citron |
| VP Quality Assurance and Regulatory Affairs | |
| Aspect Imaging LTD | |
| Tel: +972-73-223-9000 Ext 90 | |
| Fax: +972-3-716-5606 | |
| E mail: icitron@aspectimaging.com | |
| Device Trade Name: | Embrace Neonatal MRI System |
| Common/Usual Name: | MRI System |
| Product Classification | II |
| Classification Name: | Magnetic Resonance Diagnostic Device (21 CFR |
| 892.1000) | |
| Product Code: | LNH, MOS |
| Predicate Device(s): | K160185 Wrist 3 MRI System |
| Reference Device(s) | K161918 SREE MRI Transport Incubator* |
| *referenced for the Patient Bed main specifications | |
| Device Description: | The Embrace Neonatal MRI System is a 1Tesla Permanent |
| MRI system producing MR images of Neonatal head. During | |
| MRI scan, body parts to be imaged are held within a uniform | |
| static magnetic field, and are subject to sequences of RF pulses | |
| and gradient magnetic fields. The signal from the precession of | |
| the magnetization created by these fields is sampled and | |
| processed to produce image data. | |
| Intended Use: | The Embrace Neonatal MRI System is indicated for use as a |
| magnetic resonance imaging device for producing axial, sagittal, | |
| coronal and oblique images that displays the internal structure of |
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Image /page/4/Picture/0 description: The image contains the logo for Aspect Imaging. The logo consists of a geometric shape on the left and the company name on the right. The geometric shape is made up of three stacked squares, each in a different color: blue, green, and yellow. The company name is written in a sans-serif font, with the word "aspect" in purple and the word "imaging" in gray.
510(k) Premarket Notification Submission
| Comparison of
Specifications | Predicate Device
Wrist 3 MRI System (K160185) | Proposed Device
Embrace Neonatal MRI
System |
|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indication for
Use | The Wrist 3 MRI System is
intended for use as a magnetic
resonance imaging device for
producing axial, sagittal,
coronal, and oblique images of
the internal structure of the
Wrist and Hand. When
interpreted by a trained
physician, these images provide
information that can be useful
in determining a diagnosis. | The Embrace Neonatal MRI
System is indicated for use as a
magnetic resonance imaging device
for producing axial, sagittal,
coronal and oblique images that
displays the internal structure of
neonatal head with circumference
of up to 38 cm and weight between
1Kg and 4.5 Kg. When interpreted
by a trained physician, these
images provide information that
can be useful in determining a
diagnosis. |
| Patient Population | Patients requiring MR images of
the wrist and Hand | Patients requiring MR images of
the Neonatal Head |
| Anatomical Sites | Wrist and Hand | Neonatal Head |
| Environment of Use | Hospital or clinical setting | Hospital setting |
| Energy Used and/or delivered | Magnetic Resonance | Magnetic Resonance |
| Human Factors | The Wrist 3 MRI System is
designed similar to other
commercially available MRI
Systems and therefore is familiar
and easy for use for the user.
Furthermore, the device contains a
user-friendly software interface
through which the user may easily
access all device functions. | The Embrace Neonatal MRI
System is designed similar to
other commercially available MRI
Systems and therefore is familiar
and easy for use for the user.
Furthermore, the device contains a
user-friendly software interface
through which the user may easily
access all device functions. |
| Hardware Changes | | |
| Magnet: | | |
| - Physical Dimensions
- Bore opening
- Weight
Field Strength
Gradient: | 138x87x82 cm
85x220 mm
1300 (1700 with Trolley) Kg
1 Tesla Permanent Magnet | 171x145x229 cm
184x260 mm
5500 (5680 with PB) Kg
1 Tesla Permanent Magnet |
| -Strength | 215 mT/m | 150 mT/m |
| -Rise Time | 0.2 mSec | 0.3 mSec |
| -Slew Rate | 1074 T/m/Sec | 500 T/m/Sec |
| Computer: | | |
| -Display: | 15" Touch Display | 24" LED Display |
| RF Coils
Coil Type | 2 Coils: Small/Large
TX/RX | 1 Head Coils
TX/RX |
| | | |
| Coil Geometry | Oval | Cylindrical |
| Inner dimensions (mm) | 60X100X169 / 75X135X192 | 143 Diameter |
| Coil Design | Linear Volume | Linear Volume |
| Patient Bed: | Reference device | Proposed Device |
| Comparison of | SREE MRI Transport | Embrace Neonatal MRI |
| Specifications | Incubator (K161918) | System |
| Target population | pre- and term newborns and infants up
to 1 month of age and 4.5Kg whole
body weight or 55cm whole body
length (21.7"). | neonates with head circumference
of up to 38 cm and weight
between 1Kg and 4.5 Kg |
| -Dimensions | 121.9cm L x 40.6cm W x 30.5cn H | 60.6cm W x 120cm H x 140cm L |
| -Patient weight capacity | 4.5Kg Max | 4.5 Kg Max |
| Compartment length | 55 cm | 58 cm |
| Set Temperature | 28 °C - 39°C | 20.5 °C - 36.5°C |
| Warm Up time | 45 minutes | 50 minutes |
| Temperature control | Air | Air |
| Humidity control | no | no |
| MRI compatibility | 1.5 and 3 T | Aspect Embrace 1T |
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510(k) Premarket Notification Submission
Determination of Substantial Equivalence:
Summary of Nonclinical Testing:
The Embrace Neonatal MRI System and its applications were tested to comply with the below voluntary consensus standards.
- ES/IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-33 l
- IEC 60601-2-20
- IEC 60601-1-6
- ' IEC 62304
- 트 NEMA MS-1
- NEMA MS-2
- NEMA MS-3
- NEMA MS-5
- 트 NEMA MS-12
In addition, System and Software verification and Validation testing were performed to demonstrate performance of the device as part of design controls activity.
The following design control activities were applied to the development of the system:
- Risk Management
- Requirements Management
- Design Reviews
- Unit level module verification
- System Integration verification
- Performance verification
- Safety and EMC testing
- 트 Simulated use validation testing
- Sample phantom images
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Image /page/6/Picture/0 description: The image shows the logo for Aspect Imaging. The logo consists of a stack of three squares in different colors, with the top square being blue, the middle square being green, and the bottom square being yellow. To the right of the squares is the word "aspectimaging" in purple.
Summary of Clinical Tests:
The subject of this premarket submission, Embrace Neonatal MRI System, did not require clinical studies to support substantial equivalence. Since neonates are a vulnerable patient population, for this particular device, the benefits of sample clinical images did not outweigh the risks associated with acquisition of those images. Therefore, substantial equivalence of the Embrace Neonatal MRI System was determined based on phantom images that demonstrate the ability of the system to provide diagnostic quality images, and sample clinical images of the neonatal head were not necessary to support the premarket submission for this device.
Based on bench testing and phantom image studies, Aspect Conclusion: Imaging LTD believes the Embrace Neonatal MRI System is as safe, as effective, as its predicate device and did not raise new safety or effectiveness issues.
Aspect Imaging LTD considers the Embrace Neonatal MRI system to be substantially equivalent to its predicate device.