(45 days)
No
The device description and intended use focus on a physical accessory for patient positioning and image co-registration using physical markers, with no mention of AI or ML algorithms for image analysis or processing.
No
The device is described as an accessory for imaging, designed to aid in patient positioning and provide reproducible anatomical markers for consistent imaging sessions, and does not directly treat or diagnose a condition.
No
The device is an accessory for routine head MR that is designed to provide reproducible anatomical markers and aid in patient positioning for consistent anatomical images over multiple imaging sessions. It does not diagnose any condition itself.
No
The device description explicitly states it is a "simple device, worn externally on the head" and describes physical components like "reference block" and "reference tubes," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The AnatoMark Noninvasive Head Reference System is an external device used during imaging procedures (MR and CT) to aid in patient positioning and provide reproducible anatomical markers for image co-registration. It does not analyze or interact with any biological specimens from the patient.
- Intended Use: The intended use is focused on improving the consistency and co-registration of medical images, not on analyzing biological samples for diagnostic purposes.
Therefore, the AnatoMark Noninvasive Head Reference System falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient's cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and MR images.
Product codes
90 LNH
Device Description
The AnatoMark Noninvasive Head Reference System is a simple device, worn externally on the head, designed for use in routine head or brain MRI to provide reference markers that are visible on magnetic resonance (MR) images.
The AnatoMark Noninvasive Head Reference System is intended to provide fiduciary marks that are visible on magnetic resonance (MR) images. The device may also be used to provide MRI/CT co-registration of fiduciary marks. The device is worn externally on the head, is simple and non-invasive, and wearing it is somewhat similar to the wearing of eveglasses.
The device is intended to be used with the "scout" or localization image sequence to establish a reproducible reference plane within the MR system's imaging coordinate system for the subsequent imaging session. At each of three reference locations on the device there is a reference block that contains two reference tubes that appear on MR images. The reference marks are physically implemented as cylinders set in the reference block such that they are orthogonal to each other and cross at their midpoints. When imaged slightly out of plane of the midpoints, the cross-sections of the small cylinders appear as two fiduciary marks that are not side by side. When imaged in the plane of the midpoints, however, the fiduciary marks are side by side. By adjusting the plane of the images such that all three pairs of reference marks show side by side, a reproducible reference plane may be established.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR) images, CT images
Anatomical Site
head, brain, cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Interneuron Pharmaceuticals has carried out testing of the device to demonstrate that it provides reproducible reference markers. This testing indicated that the accuracy is substantially equivalent to the accuracy of the predicate device.
Key Metrics
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.
0
AnatoMark™ Noninvasive Head Reference System
Common/ClassificationName: Accessory to MR Imaging System, 21 CFR 892.1000
Interneuron Pharmaceuticals, Inc. 99 Havden Avenue, Suite 200 Lexington, MA 02173
Telephone: 781-861-8444 FAX: 781-863-2564
Contact: Sonja Loar, Pharm.D., Prepared: April 8, 1998
LEGALLY MARKETED PREDICATE DEVICES A.
The AnatoMark Noninvasive Head Reference System is an accessory to MR devices (21 CFR 892.1000). It shares some features with the Laitinen Stereoadapter 5000 (K881131), cleared as a stereotaxic instrument (21 CFR 882.4560), and the Codman Fiducial Marker System (K953568), cleared as a radiographic film marker (21 CFR 892.1640).
DEVICE DESCRIPTION 8.
The AnatoMark Noninvasive Head Reference System is a simple device, worn externally on the head, designed for use in routine head or brain MRI to provide reference markers that are visible on magnetic resonance (MR) images.
**** The AnatoMark Noninvasive Head Reference System is intended to provide fiduciary marks that are visible on magnetic resonance (MR) images. The device may also be used to provide MRI/CT co-registration of fiduciary marks. The device is worn externally on the head, is simple and non-invasive, and wearing it is somewhat similar to the wearing of eveglasses.
The device is intended to be used with the "scout" or localization image sequence to establish a reproducible reference plane within the MR system's imaging coordinate system for the subsequent imaging session. At each of three reference locations on the device there is a reference block that contains two reference tubes that appear on MR images. The reference marks are physically implemented as cylinders set in the reference block such that they are orthogonal to each other and cross at their midpoints. When imaged slightly out of plane of the midpoints, the cross-sections of the small cylinders appear as two fiduciary marks that are not side by side. When imaged in the plane of the midpoints,
AnatoMark Noninvasive Head Reference System - summary
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1
however, the fiduciary marks are side by side. By adjusting the plane of the images such that all three pairs of reference marks show side by side, a reproducible reference plane may be established.
C. INTENDED USE
The AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient's cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and MR images.
D. SUBSTANTIAL EQUIVALENCE SUMMARY
The AnatoMark Noninvasive Head Reference System does not have the identical indications for use as the predicate devices, but it has the same intended use. The AnatoMark Noninvasive Head Reference System has the same technological characteristics as the predicate devices.
The descriptive characteristics may not be precise enough to assure equivalence, so Interneuron Pharmaceuticals has carried out performance testing to assure equivalence. The resulting performance data do, in fact, demonstrate equivalence. The flowchart for the substantial equivalence algorithm leads to a substantial equivalence decision.
ய் TECHNOLOGICAL CHARACTERISTICS
- The AnatoMark Noninvasive Head Reference System has the "same ﺴﺘﺨﺪﻣﺎ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍﻟﻤﺴﺘﺨﺪﻣﺎﺕ ﺍ technological characteristics" as the Laitinen Stereoadapter 5000. Both provide reference markers that are made of materials that can be easily visualized on MR images.
AnatoMark Noninvasive Head Reference System - summary
2
F. TESTING
Interneuron Pharmaceuticals has carried out testing of the device to demonstrate that it provides reproducible reference markers. This testing indicated that the accuracy is substantially equivalent to the accuracy of the predicate device.
CONCLUSIONS G.
This 510(k) has demonstrated that the AnatoMark Noninvasive Head Reference System is substantially equivalent to presently marketed devices.
AnatoMark Noninvasive Head Reference System - summary
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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN
V.P. Regulatory & Scientific Affairs Interneuron Pharmaceuticals, Inc.
99 Hayden Avenue, Suite 200 Lexington, MA 02173
Re:
K981398 Head Reference System (MRI/CT Anatomical Marker) Dated: April 15, 1998 Received: April 17, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Ms. Loar:
Sonja Barton Loar
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally market 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrb/dsmalan.html".
Sincerely yours,
Kiliani Yin
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
K981398 510(k) Number (if known): ___
Device Name: AnatoMark Noninvasive Head Reference System
Indications For Use:
The AnatoMark Noninvasive Head Reference System is an accessory for routine head MR that is designed to provide reproducible anatomical markers. The Head Reference System is designed to aid in patient positioning to achieve consistent anatomical images over multiple imaging sessions. The head localizer produces a set of six fiduciary marks on axial images that are positioned reproducibly with reference to stable anatomical structures internal to the patient's cranium. The fiduciary marks are also visible in CT images, making possible the co-registration of CT and MR images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Seyssom
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use