ATLASPLAN

K980584 · Radionics, Inc. · HAW · May 18, 1998 · Neurology

Device Facts

• Record ID: K980584
• Device Name: ATLASPLAN
• Applicant: Radionics, Inc.
• Product Code: HAW · Neurology
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Stereotactic planning software; correlates patient CT/MRI scans with digitized brain anatomical atlas. Clinician uses workstation to view entry/target points and anatomical labels; outputs BRW coordinates for procedure planning. Used in neurosurgery, radiotherapy, and radiosurgery contexts. Assists clinicians in surgical/treatment planning by mapping patient-specific anatomy to standardized atlas data.

Clinical Evidence

No clinical data. Safety and effectiveness established via unit testing of software features.

Technological Characteristics

Software-based stereotactic planning tool; workstation-based; utilizes digitized brain atlas; outputs BRW coordinates. No specific hardware materials or connectivity standards specified.

Indications for Use

Indicated for pre- and intra-operative planning of stereotactic procedures in patients undergoing neurosurgery, radiotherapy, or radiosurgery, utilizing CT or MRI anatomical data.

Regulatory Classification

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.

Predicate Devices

• Medical Instrumentation and Diagnostics Corporation (MIDCO) cass System (K894263A, K911750, K921740)

Submission Summary (Full Text)

{0}------------------------------------------------

### AtlasPlan 510(k)

K980584

# 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<br>intra-operative planning of stereotactic<br>procedures. This software module correlates<br>a patient's anatomy (obtained from CT or<br>MRI scans) with an anatomical atlas of the<br>brain. AtlasPlan may be used alone or in<br>conjunction with neurosurgery, radiotherapy,<br>and radiosurgery planning systems. |
| Predicate Device: | Medical Instrumentation and Diagnostics<br>Corporation (MIDCO) cass System<br>(#K894263A, 9/1/89; #K911750, 10/15/91;<br>#K921740, 4/7/93) |
| Establishment Name and<br>Address: | Radionics Software Applications, Inc.<br>22 Terry Avenue<br>Burlington, MA 01803 |
| Contact Name and Phone | Nichole Riek, [phone] |
| Date Summary was prepared | February 13, 1998 |
| Establishment Registration<br>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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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