(53 days)
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.
The Monteris medical AtamA™ System is comprised of two major subsystems: (i) a MR head coil functionality, and (ii) a patient stabilization functionality. These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI. The Head Coil Subsystem is comprised of a novel design of a standard split-array multichannel (8 channel) receive coil in the form of a common Lower Coil and two interchangeable Upper Coils (only one used at any time) and the appropriate coil configuration data, known as "coil files", for the selected MR system to be used. The design of the two-part Head Coil system is such that, in conjunction with the rest of the AtamA System, openings in the two-part coil can be rotated around the patient's head to allow surgical access to essentially any supratentorial aspect of the patient's head, and still allow for the collection of MR data without repositioning the patient or moving the coils within the MR system. This will allow for more expedient collection of high quality MR data, minimize moving the patient, and maintenance of spatial registration (required for or supporting stereotactic procedures). The Stabilization subsystem is comprised of three major components and their accessories. The major components are: A Head Fixation Ring (HFR) apparatus, A Cradle that fixates the HFR and the two-part Coil relative to each other and the MRI system bore, and A patient Board that allows for the effective transport of the patient to and from various procedures and procedure locations while maintaining the stability and spatial registration of the patient.
The provided document describes a medical device, the Monteris Medical AtamA™ System, and its substantial equivalence to predicate devices, rather than a study proving the device meets a specific set of acceptance criteria based on clinical performance metrics. The document explicitly states: "This application does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence to the stated predicate devices."
Therefore, I cannot provide information for many of the requested categories related to clinical performance studies. However, I can extract information regarding non-clinical performance and the device's characteristics.
Here’s a breakdown of what can be inferred or directly stated from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics in the way one would expect for a clinical performance study (e.g., sensitivity, specificity, accuracy). Instead, it states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | In compliance with ISO 10993 |
| Bench Testing | In compliance with product specifications, medical community expectations, and product labeling |
| Coil Functionality | Performance testing to recognized standards (NEMA Magnetic Resonance Imaging standards where appropriate) and actual values of predicate devices |
| Technical Characteristics | Materially the same as predicate devices (split array 8-channel MR head coil design, construction, materials, principles of head stabilization/immobilization) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable, as no clinical performance study with a test set was mentioned or conducted. The non-clinical performance data appears to be from bench testing and biocompatibility assessments, not human subject data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable, as no clinical performance study with a test set was mentioned or conducted.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance study with a test set was mentioned or conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a head coil and stabilization system, not an AI-assisted diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a hardware device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance, the "ground truth" or reference points were:
- ISO 10993 for biocompatibility.
- Product specifications, expectations of the medical community, and product labeling for bench testing.
- Recognized standards (NEMA Magnetic Resonance Imaging standards) and actual/reported values of predicate devices for coil functionality.
8. The sample size for the training set
Not applicable, as no training set for an algorithm was mentioned or used.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm was mentioned or used.
Summary of the study conducted (as per the document):
The document explicitly states that the application for the Monteris Medical AtamA™ System does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence. Instead, the substantial equivalence to predicate devices is supported by:
- Non-Clinical Performance Data:
- Biocompatibility analysis: Demonstrated compliance with ISO 10993.
- Bench testing: Demonstrated compliance with product specifications, the expectations of the medical community, and product labeling.
- Performance testing for Coil functionality: Conducted according to recognized standards (NEMA Magnetic Resonance Imaging standards, where appropriate) and by comparing to actual or reported values of predicate devices.
- Technological Characteristics: The device's technical modes of action and technical principles are materially the same as the predicate devices, including split array 8-channel MR head coil design, construction, functionally similar materials, and the same principles of head stabilization/immobilization. The design differences are in integration and utilization for expediency and convenience.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of a stylized graphic element to the left of the text "MONTERIS" in all caps. Below "MONTERIS" is the word "MEDICAL" in a smaller font size. The logo is in black and white.
Section 5: 510(k) Summary
APR - 8 2011
KI10411
Device Information:
| Category | Comments |
|---|---|
| Sponsor: | Monteris Medical, Inc.100 - 78 Innovation DriveWinnipeg, ManitobaCANADA R3T 6C2Tel: 204-272-2220Fax: 204-272-2219www.monteris.com |
| Establishment Registration Number | 3005840757 |
| Correspondent Contact Information: | K. Jeff Wilson, Ph.D.Monteris Medical, Inc.100 - 78 Innovation DriveWinnipeg, MB R3T 6C2 CANADATel: 204-272-2220Fax: 204-272-2219 |
| Device Common Name: | Head Coil and Stabilization System |
| Device Classification & Product Code: | Class II, MOS |
| Device Classification Name & Citation | Magnetic resonance diagnostic device21CFR892.1000 |
| Device Proprietary Name: | Monteris Medical AtamA™ System |
Predicate Devices Information:
| Predicate Device: | Noras OR Head Coil 1.5 T |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. (Noras) |
| K# | K060758 |
| Common Name: | Noras OR Head Coil 1.5 T |
| Device Classification Name & Citation: | Magnetic resonance diagnostic device21CFR892.1000 |
| Device Classification & Product Code: | Class II, MOS |
| Predicate Device: | Noras OR Head Holder |
|---|---|
| Manufacturer: | Siemens Medical Solutions USA, Inc. (Noras) |
| K# | K071179 |
| Common Name: | OR Head Holder |
| Device Classification Name & Citation: | Neurosurgical head holder (skull clamp)21CFR882.4460 |
| Device Classification & Product Code: | Class II, HBL |
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of a stylized graphic to the left of the company name, "MONTERIS", with the word "MEDICAL" underneath. The graphic is a black, abstract shape that resembles a stylized "M" or a mountain range with a curved element on top.
AtamA™ Premarket Notification: Traditional 510(k)
| Predicate Device: | Intra-operative Coil and Head FixationDevice (major component of Neuro II-SEIntra-operative Imaging System) |
|---|---|
| Manufacturer: | IMRIS |
| KH | Major Component of K071099 |
| Common Name: | Head Coil Kit |
| Device Classification Name & Citation: | Magnetic resonance diagnostic device21CFR892.1000 |
| Device Classification & Product Code: | Class II, LNH |
b. Date Summary Prepared - Mage Summ 10.Feb.2011
c. Description of Device of Device
The Monteris medical AtamA™ System is comprised of two major subsystems: (i) a MR head coil functionality, and (ii) a patient stabilization functionality. These two subsystems have been designed to work independently and in unison to meet the varied needs of neurosurgical procedures utilizing MRI.
The Head Coil Subsystem is comprised of a novel design of a standard split-array multichannel (8 channel) receive coil in the form of a common Lower Coil and two interchangeable Upper Coils (only one used at any time) and the appropriate coil configuration data, known as "coil files", for the selected MR system to be used.
The design of the two-part Head Coil system is such that, in conjunction with the rest of the AtamA System, openings in the two-part coil can be rotated around the patient's head to allow surgical access to essentially any supratentorial aspect of the patient's head, and still allow for the collection of MR data without repositioning the patient or moving the coils within the MR system. This will allow for more expedient collection of high quality MR data, minimize moving the patient, and maintenance of spatial registration (required for or supporting stereotactic procedures).
The Stabilization subsystem is comprised of three major components and their accessories. The major components are:
- A Head Fixation Ring (HFR) apparatus, .
- . A Cradle that fixates the HFR and the two-part Coil relative to each other and the MRI system bore, and
- . A patient Board that allows for the effective transport of the patient to and from various procedures and procedure locations while maintaining the stability and spatial registration of the patient.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of a stylized graphic to the left of the company name. The word "MEDICAL" is printed in a smaller font size below the company name.
Intended 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.
The intended use of the AtamA System is essentially the same as the intended use of the predicate devices, as are the indications for use.
Technological Characteristics
The technical modes of action and technical principles are materially the same as the predicate devices, including: split array 8-channel MR head coil design and construction, materials being functionally similar in all cases (identical in several aspects), and relying upon the same principles of head stabilization/immobilization. The design differences are in how the AtamA System utilizes and integrates these technical characteristics in an expedient and convenient system.
Non-Clinical Performance Data
Performance testing was performed to recognized standards for the Coil functionality and to actual values of predicate devices measured in parallel of predicate devices (when available), or to values reported by the manufacturers of the predicates. NEMA Magnetic Resonance Imaging standards, where appropriate were followed. Biocompatibility, per ISO 10993, was demonstrated.
Clinical Performance Data - - - - - - - - - - - - - - - - - - - - - - - - - - - -
This application does not rely on any clinical investigations or clinical performance testing in support of substantial equivalence to the stated predicate devices.
Summary of Performance Data
Biocompatibility analysis demonstrates that the AtamA system is in compliance with ISO 10993.
Bench testing has demonstrated that the device is in compliance with the product specification, the expectations of the medical community and the product labeling.
{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 stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
K. Jeff Wilson, Ph.D. Vice President. Clinical and Regulatory Affairs Monteris Medical 100-78 Innovation Drive Winnipeg, MB R3T 6C2 CANADA
APR - 8 2011
Re: K110411
Trade/Device Name: Monteris Medical AtamATM System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 10, 2011 Received: February 14, 2011
Dear Dr. Wilson:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
{4}------------------------------------------------
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image contains the logo for Monteris Medical. The logo consists of a stylized graphic to the left of the word "MONTERIS" in all caps. Below "MONTERIS" is the word "MEDICAL" in a smaller font size, also in all caps. The logo is black and white.
SECTION 4: INDICATIONS FOR USE STATEMENT
| Indications for Use | |
|---|---|
| 510(k) Number (if known): | K110411 |
| Device Name: | Monteris Medical AtamA™ System |
| 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. |
| Prescription Use | X AND/OR Over-The-Counter Use |
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of ___
Mary S Pastel
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K
§ 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.