(174 days)
Not Found
No
The summary describes a physical device (MR head coil and patient stabilization system) for collecting MR data and stabilizing the patient's head. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts. The focus is entirely on the hardware and its compatibility with MR systems.
No.
The device is used for collecting MR data and images of the brain and stabilizing the patient's head during neurosurgical procedures and imaging. It does not provide any therapy or treatment.
Yes
The device is described as collecting MR data and images, and specifically states that "When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis." Additionally, it mentions the head coil can be used as a "standard diagnostic head coil for diagnostic MR imaging."
No
The device description explicitly states that the AtamA™ System is comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus. These are physical hardware components, not software.
Based on the provided information, 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 specimens outside of the body.
- Device Function: The AtamA™ System is a medical device used in conjunction with an MR imaging system to collect MR data and images of the human brain within the body. It is a physical apparatus for positioning and stabilizing the patient during imaging and surgery.
- Intended Use: The intended use clearly states the collection of MR data and images of the human brain and patient stabilization during neurosurgical procedures and imaging. This is an in vivo (within the living organism) process, not an in vitro process.
- Device Description: The description details physical components like a head coil and patient stabilization system, which are used directly on the patient.
The device is a tool for acquiring medical images and stabilizing the patient during procedures. While the images obtained can be used for diagnosis, the device itself is not performing a diagnostic test on a sample outside the body.
N/A
Intended Use / Indications for Use
The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.
The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.
The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
MOS
Device Description
The AtamA™ System is comprised of two subsystems:
- (i) MR Head Coil
- (ii) Patient Stabilization System
These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. In addition, the patient head fixation ring subsystem and patient board can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. Also, the head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
Specifically, the AtamA System allows a streamlined workflow for procedures requiring the patient to undergo MRI examination before, during, or after neurosurgical procedures. The AtamA System maintains patient head fixation while providing a patient board for convenient, safe and effective method of moving the patient from an OR table to transport gurney to MRI couch without the need to unpin and re-pin the patient.
This submission clears the use of the additional 3.0 Telsa AtamA Head Coil for use with specific Siemens and Imris 3.0 Telsa MRI Systems, and the expanded labeling of the components of the Patient Stabilization System for their compatibility with both 1.5 Tesla and 3.0 Telsa systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) imaging system
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Physician in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room.
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)
Bench testing in accordance with NEMA Standards has demonstrated that the 3.0 Tesla MR Head Coil is compatible with 3.0 Telsa MRI systems. An analysis of materials has shown that the AtamA Patient Stabilization Subsystem is also compatible with 3.0 Tesla MR environments and can be labeled with 1.5T and 3.0 T MR Conditional Compatibility.
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
Image /page/0/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold letters, with the word "MEDICAL" in smaller letters underneath. Above the word "MONTERIS" is a graphic of several small circles arranged in a semi-circular shape.
Premarket Notif cation K132444
510(k) Summary
JAN 2 7 2014
న
Device Information
| Category | Comments |
|---|---|
| Date Summary Prepared | 22 January 2014 |
| Sponsor | Monteris Medical Corporation |
| 16305 36th Avenue North, Suite 200 | |
| Plymouth, Minnesota 55446 USA | |
| Tel: 763-253-4710 | |
| Fax: 763-746-0084 | |
| Contact: Brooke Ren, Ph.D. | |
| Sr. VP of Operations | |
| BRen@Monteris.com | |
| Correspondent Contact Information | Craig J. Coombs |
| President, Coombs Medical Device | |
| Consulting, Inc. | |
| 1193 Sherman St | |
| Alameda, CA 94501 | |
| Tel: 510-337-0140 | |
| Fax: 510-337-0416 | |
| CraigJCoombs@gmail.com | |
| Device Trade Name | AtamA™ System |
| Device Common Name | Head Coil and Patient Stabilization System |
| Device Classification & Product Code | Class II, MOS |
| Device Classification Name & Citation | Magnetic Resonance Diagnostic Device |
| 21CFR 892.1000 | |
| Device Proprietary Name | Monteris Medical AtamA™ System |
Predicate Device Information
| Predicate Device Trade Name | Monteris Medical AtamA™ Head Coil and
Stabilization System |
|---------------------------------------|---------------------------------------------------------------|
| Manufacturer | Monteris Medical |
| 510(k) Number | K110411 |
| Device Common Name | Head Coil and Patient Stabilization System |
| Device Classification Name & Citation | Magnetic Resonance Diagnostic Device
21CFR 892.1000 |
| Device Classification & Product Code | Class II, MOS |
1
Image /page/1/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" is a series of small circles arranged in a semi-circular pattern.
Premarket Notification K132444
Description of Device
The AtamA"" System is comprised of two subsystems:
- (i) MR Head Coil
- (ii) Patient Stabilization System
These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. In addition, the patient head fixation ring subsystem and patient board can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed. Also, the head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
Specifically, the AtamA System allows a streamlined workflow for procedures requiring the patient to undergo MRI examination before, during, or after neurosurgical procedures. The AtamA System maintains patient head fixation while providing a patient board for convenient, safe and effective method of moving the patient from an OR table to transport gurney to MRI couch without the need to unpin and re-pin the patient.
This submission clears the use of the additional 3.0 Telsa AtamA Head Coil for use with specific Siemens and Imris 3.0 Telsa MRI Systems, and the expanded labeling of the components of the Patient Stabilization System for their compatibility with both 1.5 Tesla and 3.0 Telsa systems.
2
Image /page/2/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are several small circles arranged in a semi-circular pattern.
Premarket Notification K132444
Indications for Use
The intended use of the AtamA™ System (comprised of two major subsystems: a MRhead coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.
The patient head-stabilizing apparatus can also be used for other neurosurgical procedures requiring the patient's head to be stabilized or fixed.
The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.
Comparison to Predicate Device
The proposed Monteris Medical AtamA System is substantially equivalent in intended use, technology, design, materials, and physician use to the current Monteris Medical AtamA Head Coil and Patient Stabilization System, cleared under 510(k) Number K110411 for use in 1.5 Tesla MR Systems.
The testing described below demonstrates that the proposed addition of a 3.0 Tesla MR head coil and associated labeling changes on the AtamA System for 3.0 Tesla MR conditional compatibility do not raise any issues of safety or efficacy.
All patient contacting materials are identical in composition, source, and use with respect to the predicate device. The technical modes of action and technical principles are materially the same the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. Above the word "MONTERIS" are several small circles arranged in a semi-circular shape.
Premarket Notification K132444
| Parameter or
Characteristic | Predicate AtamA™
System | New AtamA
System |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K110411 | K132444 |
| FDA Product
Classification / Code | 21 CFR 892.1000 / MOS | Same |
| Indications for Use | The intended use of the AtamA™ System
(comprised of two major subsystems: a MR
head coil apparatus and a patient stabilization
apparatus), in conjunction with a magnetic
resonance (MR) imaging system, is the
collection of MR data and images of the human
brain before, during, and at the end of brain
surgery, in a standard operating room, diagnostic
MR rooms, or in a MR intra-operative room,
while stabilizing the patient's head during
neurosurgical procedures and imaging.
The patient head-stabilizing apparatus can also
be used for other neurosurgical procedures
requiring the patient's head to be stabilized or
fixed.
The head coil can also be used as a standard
diagnostic head coil for diagnostic MR imaging.
When interpreted by a trained physician, these
images provide information that can be useful in
determining diagnosis. | Same |
| Operating Principle /
Technology | Receive-only, 8-channel split array head coil
accompanied by head fixation apparatus that
interfaces with MRI systems. | Same |
| Design | The AtamA System is comprised of two
subsystems:
• MR Head Coil
• Patient Stabilization system | Same |
| Materials | Thermoplastics / Titanium / Brass | Same |
| Use Location | Operating Room / MRI Diagnostic Suite | Same |
| MRI Compatibility of
Head Coil | 1.5T Conditional | 1.5T / 3.0T
Conditional |
| MRI Compatibility of
Stabilization Subsystem | 1.5T Conditional | 1.5T / 3.0T
Conditional |
4
Image /page/4/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, sans-serif font, with the word "MEDICAL" in a smaller font size underneath. Above the word "MONTERIS" is a semi-circular arrangement of small, circular shapes, resembling cells or bubbles.
Page 5 of 5
Premarket Notification
K132444
Summary of Supporting Data
The proposed AtamA 3.0 Tesla MR Head Coil is made by the same manufacturer, and is of the same basic design. as the currently marketed AtamA 1.5 Telsa MR Head Coil. Bench testing in accordance with NEMA Standards has demonstrated that the 3.0 Tesla MR Head Coil is compatible with 3.0 Telsa MRI systems.
An analysis of materials has shown that the AtamA Patient Stabilization Subsystem is also compatible with 3.0 Tesla MR environments and can be labeled with 1.5T and 3.0 T MR Conditional Compatibility.
Conclusions
It can be concluded from the results that the Monteris Medical AtamA System is safe and effective for use in both the 1.5 and 3.0 Tesla MRI environments and can be labeled with both 1.5 T and 3.0 T MR Conditional Compatibility.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2014
MONTERIS MEDICAL BROOKE REN 1193 SHERMAN STREET ALAMEDA CA 94501
Re: K132444
Trade/Device Name: AtamA 10 System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: December 9, 2013 Received: December 11, 2013
Dear Dr. Ren:
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 contrôls 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 subiect 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll
6
Page 2-Dr. Ren
free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Hrehar 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
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K132444
Device Name
Monteris Medical AtamATM System
Indications for Use (Describe)
The intended use of the AtamA™ System (comprised of two major subsystems: a MR head coil apparatus and a patient stabilization apparatus), in conjunction with a magnetic resonance (MR) imaging system, is the collection of MR data and images of the human brain before, during, and at the end of brain surgery, in a standard operating room, diagnostic MR rooms, or in a MR intra-operative room, while stabilizing the patient's head during neurosurgical procedures and imaging.
The patient head-stabilizing apparatus can also be used for other nequiring the paient's head to be stabilized or fixed.
The head coil can also be used as a standard diagnostic head coil for diagnostic MR imaging.
When interpreted by a trained physician, these images provide information that can be useful in determining 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)
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 |
|---|---|
| ------------------------------------------------------------------------------ | ------------------- |
FORM FDA 3881 (1/14)
PSC Publishing Services ( 10) ) 441-67-41 EF
8
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