(86 days)
Not Found
No
The description focuses on computer-controlled cutting based on existing treatment planning system files, with no mention of AI or ML algorithms for interpretation or processing.
No
The device is described as a computer-controlled cutting tool for fabricating customized shielding blocks used in radiotherapy, not a device directly used in a therapeutic manner on a patient. It is a tool for a radiotherapy process, not a therapeutic device itself.
No
The device is described as a cutting tool for fabricating and positioning individualized shielding blocks for radiotherapy. Its function is to produce physical shields based on treatment plans, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The device description explicitly states it is a "computer-controlled cutting tool" and mentions "automatic hot-wire-cutting," indicating it includes hardware components beyond just software.
Based on the provided information, the 2-D AUTIMO system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "fabrication and positioning in radiotherapy of individualized (irregular) shielding blocks." This is a physical process related to preparing equipment for radiation therapy, not a diagnostic test performed on biological samples.
- Device Description: The device is described as a "computer-controlled cutting tool to produce customized shielding blocks." This further reinforces its role in manufacturing physical objects for treatment, not analyzing biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
The 2-D AUTIMO system is a manufacturing tool used in the preparation of radiotherapy treatment, not a diagnostic device.
N/A
Intended Use / Indications for Use
The 2.0-D AUTIMO System is intended for the fabrication and positioning in radiotherapy of irregular shielding blocks.
Product codes
IXI
Device Description
The AUTIMO 2-D model is a computer-controlled cutting tool to produce customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatment-planning system operating on a LAN. The GE-Target, Siemens Helax, and Theratronics Theraplan systems are examples of such treatment-planning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.
The 2-D model allows automatic hot-wire-cutting of styrofoam molds such as lung blocks and irregular sections.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 2.0-D AUTIMO System and demonstrates that it is substantially equivalent to the predicate device.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
510(k) Summary
HEK
Radiation Therapy Beam-Shaping Device, 21 Common/Classification Name: CFR 892.5710
HEK Medizintechnik GmgH Sponsor: Kaninchenborn 24-28 Postfach 1832 D-23560 Lübeck : *-GERMANY
Tel: (+49) 451 5300444 FAX: (+49) 451 5300450
Contact:
ﻣﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴ
Reinhard Schröder
Prepared:
March 13, 1997
LEGALLY MARKETED PREDICATE DEVICES · A.
The AUTIMO 2-D System is substantially equivalent to its predecessor device currently marketed by HEK Medizintechnik, the MCP-70-SE (K844180).
B. DEVICE DESCRIPTION
The AUTIMO 2-D model is a computer-controlled cutting tool to produce customized shielding blocks for use in radiotherapy. The computer accepts files from existing treatment-planning system operating on a The GE-Target, Siemens Helax, and Theratronics Theraplan LAN. systems are examples of such treatment-planning software. The computer interprets the files from the planning system and communicates with the AUTIMO device through a serial port.
The 2-D model allows automatic hot-wire-cutting of styrofoam molds such as lung blocks and irregular sections.
C. INTENDED USE
The 2.0-D AUTIMO System is intended for the fabrication and positioning in radiotherapy of irregular shielding blocks.
1
TECHNOLOGICAL CHARACTERISTICS D.
The 2.0-D AUTIMO System has the same technological characteristics as the predicate device. The AUTIMO is simply a modification with updated hardware and cosmetic changes from the predicate device.
E. TESTING
HEK Medizintechnik carried out testing to address the following issues:
- (1) electrical safety
- ﺔ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤ (2) eletromagnetic compatibility
The results from these tests supported the safety and effectiveness of the 2.0-D AUTIMO System and demonstrates that it is substantially equivalent to the predicate device.
F. CONCLUSIONS
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 2.0-D AUTIMO systems and its comparison of AUTIMO characteristics with those of the predicate device that the 2.0-D AUTIMO system is 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 is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a person with outstretched arms. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HEK Medizintechnik. GmbH c/o T. Whit Athey, Ph.D. S INN 13 Senior Consultant C. L. McIntosh & Associates. Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, MD 20852
Re: K971001 GmbH AUTIMO 2-D Dose Modification System Dated: March 19, 1997 Received: March 19, 1997 Regulatory Class: II ... . . ... .. 21 CFR 892.5710/Procode: 90 IXI
Dear Dr. Athey:
给
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 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 does not affect any obligation you might have under sections 51 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 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) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/cdrh/dsmamain.html".
Sincerely yours,
William Yx
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
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ _ AUTIMO_2-D
Indications For Use:
-
- The 2-D AUTIMO system is intended for the fabrication and positioning in radiotherapy of indivdualized (irregular) shielding blocks.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
- The 2-D AUTIMO system is intended for the fabrication and positioning in radiotherapy of indivdualized (irregular) shielding blocks.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Repreductive, Abdominal, ENT, and Radiological Devices
Radiological Devices
510(k) Number K971001
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
000000