(78 days)
Not Found
No
The summary describes specialty coils for an existing MRI system and focuses on image quality metrics (SNR, uniformity) and equivalence to predicate devices. There is no mention of AI/ML in the device description, intended use, or performance studies.
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its purpose is to produce images that "assist in diagnosis," indicating a diagnostic rather than therapeutic function.
No
The document states that the "Speciality Coils are intended to be used in conjunction with the MAGNETOM ESSENZA, a Magnetic Resonance Diagnostic Device." This implies that the coils themselves are accessories to a diagnostic device, rather than being diagnostic devices in their own right. Their function is to "present images," which are then "interpreted by a trained physician" to "assist in diagnosis."
No
The device description explicitly states that the device is a set of "Speciality Coils," which are hardware components used in conjunction with an MRI system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in conjunction with an MRDD to produce images of the internal structure and/or function of the body. These images are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic process, where the device interacts with the living body.
- Device Description: The description reinforces the use of the coils with an MRDD to present images reflecting spatial distribution and other physical parameters derived from the images. This is consistent with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
Therefore, the device described is a component of an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Speciality Coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the body. 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 Speciality Coils are intended to be used in conjunction with the MAGNETOM ESSENZA, a Magnetic Resonance Diagnostic Device. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced.
The Speciality Coils will include: 8-Channel Wrist Coil, 4-Channel Special-Purpose Coil, 8-Channel Foot-Ankle Coil, and the Focus Shoulder Array Coil, Small for the existing 1.5T MAGNETOM ESSENZA Magnetic Resonance System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Body (internal structure and/or function) - specifically Wrist, Foot-Ankle, Shoulder, and general "Special-Purpose" imaging implied
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician / Not Found
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)
Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness.
The following parameters were considered for the new Speciality Coils:
[Safety] -Biocompatibility
[Performance] -Signal to Noise Ratio -Image Uniformity
Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices.
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.
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.
0
Section 5: 510(k) Summary
5 510(k) Summary
JAN 1 3 2009
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
- I. General Information
Siemens Medical Solutions USA, Inc. Establishment 51 Valley Stream Parkway Malvern. PA 19355
Registration Number 2240869
Manufacturer
Siemens Mindit Magnetic Resonance Ltd.
Siemens MRI Center, Gaoxin C. Ave. 2nd Hi-Tech Industrial Park, ShenZhen 518057, PR. China
Registration Number 3004754211
Contact
Elizabeth Lazaro Technical Specialist. Regulatory Submissions 51 Vallev Stream Parkway Malvern. PA 19355 Phone: (610)448-3393 Fax: (610) 448-1787 e-mail:Elizabeth.lazaro@siemens.com
Device Name
Speciality Coils for MAGNETOM ESSENZA Trade Name: Coil, Magnetic Resonance Speciality Classification Name: Class II 21 CFR § 892.1000 Device Class: MOS Product Code: Classification Panel: Radiology
Performance Standards
None established under Section 514 the Food, Drug, and Cosmetic Act.
1
II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The Speciality Coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the body. These images when interpreted by a trained physician yield information that may assist in diagnosis.
Device Description
The Speciality Coils are intended to be used in conjunction with the MAGNETOM ESSENZA, a Magnetic Resonance Diagnostic Device. These coils will be used to present images which reflect the spatial distribution and the other physical parameters derived from the images may also be produced.
The Speciality Coils will include: 8-Channel Wrist Coil, 4-Channel Special-Purpose Coil, 8-Channel Foot-Ankle Coil, and the Focus Shoulder Array Coil, Small for the existing 1.5T MAGNETOM ESSENZA Magnetic Resonance System.
Substantial Equivalence
Siemens believes that, within the meaning of the Safe Medical Device Act of 1990, the MAGNETOM ESSENZA with Speciality Coils are substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|----------------------------------------------------------------------------------------|-------------------------|-----------------------|
| Siemens MAGNETOM Avanto 1.5 T
(8-Channel Wrist Coil, 8-Channel Foot-
Ankle Coil) | K032428 | Oct 16, 2003 |
| Siemens MAGNETOM ESSENZA 1.5 T
(Focus Shoulder Array Coil) | K071925 | Aug 14, 2007 |
| MACHNET CAROTIDS COIL ARRAY
ASSEMBLY | K012491 | Oct 24, 2001 |
2
General Safety and Effectiveness Concerns:
The following safety and performance parameters:
[Safety]
-Maximum Static Field
-Rate of Change of Magnetic Field
-RF Power Deposition
-Acoustic Noise Level
[Performance] -Geometric Distortion -Slice Profile, Thickness and Gap -High Contrast Spatial Resolution
Specified by the FDA Guidance document for MR Diagnostic Devices are unaffected by the modifications described within this notification.
The following parameters were considered for the new Speciality Coils:
[Safety] -Biocompatibility
[Performance] -Signal to Noise Ratio -Image Uniformity
No new materials were used for the new speciality coils compared to their predicate device. Therefore no new biocompatibility tests were performed. Signal to Noise Ratio (SNR) and image uniformity tests were performed for the new speciality coils and the results presented in this submission show that they are equivalent with the predicate devices.
Conclusion as to Substantial Equivalence
Laboratory testing was performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three thick, curved lines and a wavy line at the bottom.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AN 1 3 2009
Ms. Elizabeth Lazaro Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway MALVERN PA 19533
Re: K083166
Trade/Device Name: Speciality Coils for MAGNETOM ESSENZA Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: September 23, 2008 Received: September 27, 2008
Dear Ms. Lazaro:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
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; 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.
Sincerely yours,
Janine M. Morris
Tanine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
4 Indications for Use Statement
510(k) Number (if known)
Speciality Coils for MAGNETOM ESSENZA Device Name:
Indications for Use:
The speciality coils are indicated for use in conjunction with the 1.5T MAGNETOM ESSENZA, a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, and that displays the internal structure and/or function of the body.
These images when interpreted by a trained physician yield information that may assist in diagnosis.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
| Prescription Use | / | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | -------------------------------------------- | ---- | ---------------------- |
(Division/Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
Page
Siemens 510(k) Premarket Notifiqat(ke Number