AUTIMO 2.5-D AND AUTIMO 3-D

K972016 · C.L. Mcintosh & Assoc., Inc. · IXI · Dec 4, 1997 · Radiology

Device Facts

• Record ID: K972016
• Device Name: AUTIMO 2.5-D AND AUTIMO 3-D
• Applicant: C.L. Mcintosh & Assoc., Inc.
• Product Code: IXI · Radiology
• Decision Date: Dec 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5710
• Device Class: Class 2

Intended Use

The 2.5 D and 3-D AUTIMO systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, compensators, and dose modifiers.

Device Story

AUTIMO 2.5-D and 3-D are computer-controlled cutting tool systems for radiotherapy. Device receives digital files from external treatment planning systems (e.g., GE-Target, Siemens Helax, Theratronics Theraplan) via LAN. Computer interprets planning data and communicates with cutting hardware via serial port to fabricate customized shielding blocks, dose modifiers, and compensators. Used in clinical radiotherapy settings to assist in beam shaping. Output is physical shielding/modification hardware used by clinicians to optimize radiation delivery to patients.

Clinical Evidence

Bench testing only. Testing addressed electrical safety and electromagnetic compatibility to demonstrate substantial equivalence.

Technological Characteristics

Computer-controlled cutting tool system. Hardware-based modification of predicate device. Connectivity via LAN for treatment planning data input and serial port for device communication.

Indications for Use

Indicated for patients undergoing radiotherapy requiring the fabrication and positioning of irregular shielding blocks, dose modifiers, and compensators.

Regulatory Classification

Identification

A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.

Predicate Devices

• MCP-70-SE (K844180)

Submission Summary (Full Text)

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# 510(k) Summary

## HEK

## DEC - 4 1997

Common/Classification Name:

Radiation Therapy Beam-Shaping Device, 21 CFR 892.5710

Sponsor:

HEK Medizintechnik GmgH Kaninchenborn 24-28 Postfach 1832 D-23560 Lübeck GERMANY

Tel: [phone] FAX: [phone]

Contact:

Reinhard Schröder

Prepared:

April 2, 1997

## LEGALLY MARKETED PREDICATE DEVICES A.

The AUTIMO 2.5-D and 3-D System is substantially equivalent to its predecessor device currently marketed by HEK Medizintechnik, the MCP-70-SE (K844180).

### DEVICE DESCRIPTION B.

The AUTIMO 2.5-D and 3-D models are computer-controlled cutting tool systems for producing customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatmentplanning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatmentplanning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.

## C. INTENDED USE

The 2.5-D and 3-D AUTIMO Systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, dose modifiers, and compensators.

## D. TECHNOLOGICAL CHARACTERISTICS

The 2.5-D and 3-D AUTIMO Systems have the same technological

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{1}------------------------------------------------

characteristics as the predicate device. The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device.

## TESTING E.

HEK Medizintechnik carried out testing to address the following issues:

- (1) electrical safety
- (2) eletromagnetic compatibility

The results from these tests supported the safety and effectiveness of the 2.5-D and 3-D AUTIMO Systems and demonstrates that it is substantially equivalent to the predicate device.

## CONCLUSIONS F.

The HEK AUTIMO device has the same intended use and target population as the predicate device. HEK has demonstrated through its performance tests on the 2.5-D and 3-D AUTIMO systems and its comparison of AUTIMO characteristics with those of the predicate device that the 2.5 and 3-D AUTIMO systems are substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re:

K972016 AUTIMO 2.5-D Dose Modication System Dated: September 8, 1997 Received: September 9, 1997 Regulatory class: II 21 CFR 892.5710/Procode: 90 IXI

DEC - 4 1997

Dear Dr. Athey:

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, 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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. Pailure 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 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 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 question 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 general 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,

h. William Yu

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

{3}------------------------------------------------

# 510(k) Summary

## HEK

## DEC - 4 1997

Common/Classification Name:

Radiation Therapy Beam-Shaping Device, 21 CFR 892.5710

Sponsor:

HEK Medizintechnik GmgH Kaninchenborn 24-28 Postfach 1832 D-23560 Lübeck GERMANY

Tel: [phone] FAX: [phone]

Contact:

Reinhard Schröder

Prepared:

April 2, 1997

## LEGALLY MARKETED PREDICATE DEVICES A.

The AUTIMO 2.5-D and 3-D System is substantially equivalent to its predecessor device currently marketed by HEK Medizintechnik, the MCP-70-SE (K844180).

### DEVICE DESCRIPTION B.

The AUTIMO 2.5-D and 3-D models are computer-controlled cutting tool systems for producing customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatmentplanning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatmentplanning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.

## C. INTENDED USE

The 2.5-D and 3-D AUTIMO Systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, dose modifiers, and compensators.

## D. TECHNOLOGICAL CHARACTERISTICS

The 2.5-D and 3-D AUTIMO Systems have the same technological

000026

{4}------------------------------------------------

characteristics as the predicate device. The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device.

## TESTING E.

HEK Medizintechnik carried out testing to address the following issues:

- (1) electrical safety
- (2) eletromagnetic compatibility

The results from these tests supported the safety and effectiveness of the 2.5-D and 3-D AUTIMO Systems and demonstrates that it is substantially equivalent to the predicate device.

## CONCLUSIONS F.

The HEK AUTIMO device has the same intended use and target population as the predicate device. HEK has demonstrated through its performance tests on the 2.5-D and 3-D AUTIMO systems and its comparison of AUTIMO characteristics with those of the predicate device that the 2.5 and 3-D AUTIMO systems are substantially equivalent to the predicate device.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

T. Whit Athey, Ph.D. Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re:

K972016 AUTIMO 2.5-D Dose Modication System Dated: September 8, 1997 Received: September 9, 1997 Regulatory class: II 21 CFR 892.5710/Procode: 90 IXI

DEC - 4 1997

Dear Dr. Athey:

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, 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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. Pailure 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 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 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 question 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 general 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,

h. Vilian Yu

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

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## STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | K972016 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

Indications For Use:

The 2.5 D and 3-D AUTIMO systems are intended for the fabrication and positioning in radiotherapy of irregular shielding blocks, compensators, and dose modifiers.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

thind C. Seymon

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use

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