(90 days)
Not Found
No
The description focuses on correlating patient anatomy with a digitized atlas and comparing scans with a digitized stereotactic atlas. There is no mention of AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML, or image processing techniques that might imply AI/ML. The predicate devices are also from a time period where AI/ML in medical devices was less common.
No
The device is described as a "stereotactic planning tool" used for pre- and intra-operative planning. Its function is to correlate patient anatomy with an anatomical atlas and output coordinates for further procedure planning, rather than directly treating or diagnosing a condition.
No
This device is for pre- and intra-operative planning, correlating patient anatomy with an anatomical atlas of the brain to assist in surgical procedures. It does not perform diagnosis or analyze medical images to detect conditions.
Yes
The device description explicitly states "AtlasPlan is a stereotactic planning tool which gives the clinician access to a digitized atlas of the brain." and "The AtlasPlan system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available MIDCO cass System." The description focuses on the software's function of comparing patient scans with a digitized atlas and outputting coordinates, without mentioning any specific hardware components included in the submission. While it utilizes a workstation and patient scans (which require hardware to acquire), the device itself, as described, appears to be the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pre- and intra-operative planning of stereotactic procedures." This involves using imaging data to guide surgical or radiation procedures directly on the patient.
- Device Description: The description reinforces this by stating it's a "stereotactic planning tool" that compares patient scans with a brain atlas to determine entry and target points and output coordinates for procedure planning.
- Lack of In Vitro Activity: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the analysis of biological specimens.
The device is clearly focused on in vivo planning and guidance for medical procedures performed directly on the patient.
N/A
Intended Use / Indications for Use
AtlasPlan is intended to be used for pre- and intra-operative planning of stereotactic procedures. This software module correlates a patient's anatomy (obtained from CT or MRI scans) with an anatomical atlas of the brain. AtlasPlan may be used alone or in conjunction with neurosurgery, radiotherapy, and radiosurgery planning systems.
Product codes
HAW
Device Description
AtlasPlan is a stereotactic planning tool which gives the clinician access to a digitized atlas of the brain. The AtlasPlan system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available MIDCO cass System. Like the cass System, AtlasPlan utilizes a workstation to compare patient scans (CT or MRI) with a digitized stereotactic atlas. In addition, both systems allow the user to view entry and target points and labels for anatomical structures. Both systems output BRW coordinates for use in further procedure planning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MRI scans
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, neurosurgery, radiotherapy, and radiosurgery planning systems
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 RSA AtlasPlan system/unit testing rigorously tests the features of the software. The results of the testing indicate that AtlasPlan is safe and reliable for its intended use.
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
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
AtlasPlan 510(k)
Appendix A: Summary of Safety and Effectiveness
General Information
| Classification: | Class II |
|---|---|
| Common Name: | Image Correlation System |
| Device Trade Name: | AtlasPlan |
| Intended Use: | AtlasPlan is intended to be used for pre- and |
| intra-operative planning of stereotactic | |
| procedures. This software module correlates | |
| a patient's anatomy (obtained from CT or | |
| MRI scans) with an anatomical atlas of the | |
| brain. AtlasPlan may be used alone or in | |
| conjunction with neurosurgery, radiotherapy, | |
| and radiosurgery planning systems. | |
| Predicate Device: | Medical Instrumentation and Diagnostics |
| Corporation (MIDCO) cass System | |
| (#K894263A, 9/1/89; #K911750, 10/15/91; | |
| #K921740, 4/7/93) | |
| Establishment Name and | |
| Address: | Radionics Software Applications, Inc. |
| 22 Terry Avenue | |
| Burlington, MA 01803 | |
| Contact Name and Phone | Nichole Riek, (781) 272-1233 |
| Date Summary was prepared | February 13, 1998 |
| Establishment Registration | |
| Number: | 1222895 |
| Performance Standards: | None established under Section 514 |
Substantial Equivalence Determination
A summary of the information contained in this premarket notification that addresses safety and effectiveness follows.
Description of the Device and Basis for Substantial Equivalence
AtlasPlan is a stereotactic planning tool which gives the clinician access to a digitized atlas of the brain. The AtlasPlan system, addressed in this premarket notification, has the same intended use and technological characteristics as the commercially available MIDCO cass System. Like the cass System, AtlasPlan utilizes a workstation to compare patient scans (CT or MRI) with a digitized stereotactic atlas. In addition, both systems allow the user to view entry and target points and labels for anatomical structures. Both systems output BRW coordinates for use in further procedure planning.
1
AtlasPlan 510(k)
Appendix A: Summary of Safety and Effectiveness (Continued)
Safety Summary
The RSA AtlasPlan system/unit testing rigorously tests the features of the software. The results of the testing indicate that AtlasPlan is safe and reliable for its intended use.
General Safety and Effectiveness Concerns
The device labeling contains a User's Manual which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. In addition, thorough training and support is provided to clinics that acquire and use AtlasPlan. This information promotes safe and effective use of the device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines that suggest the shape of a bird's head and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 1998
Ms. Nichole Riek ·Regulatory Engineer Radionics Software Applications, Inc. 22 Terry Avenue Burlington, Massachusetts 01803-2516
Re: K980584 Trade Name: Atlas Plan™ Regulatory Class: II Product Code: HAW Dated: February 11, 1998 ~ February 17, 1998 Received:
Dear Ms. Riek:
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 enolosure) 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 The general controls provisions of the Act 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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.
3
Page 2 - Ms. Riek
This letter will allow you to beqin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 qeneral 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/cdrh/dsmamain.html".
Sincerely yours,
CS. Mr. Hittinger, Ph.D.
M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
AtlasPlan 510(k)
Section II: Indications for Use
Indications for Use:
AtlasPlan is intended to be used for pre- and intra-operative planning of stereotactic procedures. This software module correlates a patient's anatomy (obtained from CT or MRI scans) with an anatomical atlas of the brain. AtlasPlan may be used alone or in conjunction with neurosurgery, radiotherapy, and radiosurgery planning systems.
Prescription Use (Per 21 CFR 801.109)
todele
ivision S
AtlasPlan 510(k) II - 1