(188 days)
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.
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.
The provided document describes the 510(k) summary for the HEK AUTIMO 2.5-D and 3-D systems, which are computer-controlled cutting tool systems for producing customized shielding blocks in radiotherapy.
The document does not contain information related to software performance acceptance criteria or a study proving adherence to such criteria. Instead, it focuses on the device's substantial equivalence to a predicate device based on electrical safety and electromagnetic compatibility testing.
Therefore, I cannot provide the requested information in the format specified. The document explicitly states:
- "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."
- "The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device."
This indicates that the "study" mentioned in the document primarily pertains to hardware safety and EMC, rather than a clinical or performance study of an AI algorithm or software functionality that would necessitate the details requested (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance).
The "predicate device" mentioned is the MCP-70-SE (K844180), and the new AUTIMO system is deemed "substantially equivalent" based on its technological characteristics being the same as the predicate, with only updated hardware and cosmetic changes.
In summary, none of the specific information requested about acceptance criteria for device performance, study details (sample sizes, provenance, ground truth, expert review, MRMC, standalone), or training set data is present in this 510(k) summary because the device is a physical cutting tool system, not an AI/software-driven diagnostic or treatment planning system requiring such evaluations.
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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: (+49) 451 5300444 FAX: (+49) 451 5300450
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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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.
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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 (301) 594-4613. Additionally, for question 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/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
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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: (+49) 451 5300444 FAX: (+49) 451 5300450
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 (301) 594-4613. Additionally, for question 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/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
COOOO
§ 892.5710 Radiation therapy beam-shaping block.
(a)
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.(b)
Classification. Class II.