(84 days)
Not Found
No
The summary describes a passive RF coil for MRI and does not mention any AI/ML components or image processing capabilities.
No
The device is described as producing "diagnostic images," indicating it's used for diagnosis rather than treatment.
Yes
The device is described as producing "diagnostic images," which directly indicates its role in diagnosis.
No
The device description explicitly states it is a "local RF coil" and a "sixteen-channel receive-only array coil," which are hardware components used in MRI systems. The performance studies also focus on hardware characteristics like surface heating, SNR, and uniformity.
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.
- Device Function: The Pediatric 16 is an MRI coil. Its function is to receive radiofrequency signals during an MRI scan to produce images of the head and neck. It does not analyze biological samples.
- Intended Use: The intended use is to "produce diagnostic images... that can be interpreted by a trained physician." This is a function of an imaging device, not an IVD.
- Device Description: The description clearly states it's a "local RF coil intended to be used with the MAGNETOM Aera and Skyra MR systems." This further confirms its role in the imaging process.
The device is a component of an MRI system, which is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pediatric 16 is intended for use with the Siemens 1.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician.
Product codes
MOS
Device Description
This filing describes local RF coils intended to be used with the MAGNETOM Aera and Skyra MR systems.
The Pediatric 16 is a sixteen-channel receive-only array coil designed for magnetic resonance imaging (MRI) using the Siemens MAGNETOM Aera (1,5T) and Skyra (3T) MR systems. The Pediatric 16 is intended to be used for imaging of the head and neck of neonates and infants.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
head and neck
Indicated Patient Age Range
neonates and infants
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)
The Pediatric 16 was tested to and found to conform to AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Surface heating was tested in both plugged in and unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41℃ in either configuration.
The SNR and uniformity of the Pediatric 16 was analyzed per and found to conform to NEMA MS 9-2008.
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.
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K140998
Page 1 of 3
JUL 1 1 2014
Section 5: 510(k) Summary
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
- Applicant 1.
Quality Electrodynamics, LLC. (QED) 700 Beta Drive, Suite 100 Mayfield Village, OH 44143
2. Contact
Kathleen Aras Director, Regulatory and Quality Affairs (440) 484-2964 kathleen.aras@qualedyn.com
3. Date Prepared
16 April 2014
4. Tradenames
Pediatric 16
Pediatric 16, A 1.5T Tim Coil
Pediatric 16, A 3T Tim Coil
5. Common name
Coil, magnetic resonance, specialty
Classification 6.
21 CFR 892.1000
7. Equivalent Device
Infant Array, Advanced Imaging Research, Inc., K113365
8. Device Description
This filing describes local RF coils intended to be used with the MAGNETOM Aera and Skyra MR systems.
1
The Pediatric 16 is a sixteen-channel receive-only array coil designed for magnetic resonance imaging (MRI) using the Siemens MAGNETOM Aera (1,5T) and Skyra (3T) MR systems. The Pediatric 16 is intended to be used for imaging of the head and neck of neonates and infants.
9. Indications for Use
The Pediatric 16 is intended for use with the Siemens 1.5T/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician.
Summary of Technological Characteristics Compared to the 10. Predicate Device
Quality Electrodynamics believes that the Pediatric 16 is substantially equivalent to the Infant Array manufactured by Advanced Imaging Research and cleared through 510(k) #K113365 on March 29 2012.
The Pediatric 16 and the Infant Array are both receive-only, array RF coils intended to provide images of the head and neck in neonates and infants. Both the Pediatric 16 and the Infant Array are intended to be used with the Siemens 1.5T and 3T MR systems. The intended uses of the devices are essentially identical.
Summary of Non-Clinical Performance Testing as Basis for 11. Substantial Equivalence
The Pediatric 16 was tested to and found to conform to AAMI/ANSI ES60601-1 and IEC 60601-2-33.
Surface heating was tested in both plugged in and unplugged configurations according to AAMI/ANSI ES60601-1. The measured temperature of the surface of the coil never exceeded the maximum limit of 41℃ in either configuration.
The SNR and uniformity of the Pediatric 16 was analyzed per and found to conform to NEMA MS 9-2008.
12. Conclusion
It is the opinion of Quality Electrodynamics that the Pediatric 16 is substantially equivalent to the above-listed, legally-marketed predicate device. Non-clinical performance testing verified that the use of the
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K140998
Page 3 of 3
Quality Electrodynamics coils does not result in any new potential hazards.
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Quality Electrodynamics, LLC. Traditional 510(k) Pediatric 16
CONFIDENTIAL P a g e | 5-3
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3
Image /page/3/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight or a series of flowing lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2014
Quality Electrodynamics, LLC % Ms. Kathleen Aras Director, Regulatory and Quality Affairs 700 Beta Drive, Suite 100 MAYFIELD VILLAGE OH 44143
Re: K140998
Trade/Device Name: Pediatric 16, A 1.5T Tim Coil/Pediatric 16, A 3T Tim Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: April 16, 2014 Received: April 18, 2014
Dear Ms. Aras:
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.
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 device-related 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.
4
Page 2-Ms. Aras
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 yours,
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140998
Device Name Pediatric 16
Indications for Use (Describe) The Pediatric 16 is intended for use with the Siemens 1.57/3T MRI systems to produce diagnostic images of the head and neck of neonates and infants that can be interpreted by a trained physician
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D. O'Hara
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