(308 days)
Not Found
Not Found
No
The description focuses on a direct translation process (ASCII to G code) without mentioning any learning, adaptation, or complex pattern recognition typically associated with AI/ML.
No
The device translates a treatment plan into G code for a milling machine to produce a compensating shield. It does not directly interact with the patient or perform a diagnostic/therapeutic function itself. The compensating shield might be a therapeutic device, but the software creating its G code is not.
No
The device translates a treatment plan into G code for a milling machine to produce a compensating shield. It does not perform any diagnostic function such as identifying a disease or condition.
Yes
The device's intended use is described as software that translates data for use on a milling machine, and there is no mention of any associated hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use of this software is to translate treatment plan data into G code for a milling machine to produce a physical object (a compensating shield). It does not involve analyzing biological samples.
- The description focuses on manufacturing. The process described is about taking digital design information and converting it into instructions for a manufacturing process. This is distinct from diagnostic testing.
The software's function is related to the manufacturing of a medical device (the compensating shield), but the software itself is not performing a diagnostic test on a patient sample.
N/A
Intended Use / Indications for Use
Software translates the ASCII output from a treatment plan to G code for use on a milling machine. Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.
Product codes
90 IXI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 7 2002
Mr. Donald Riibe Regulatory Affairs RA Department MED-TEC, Inc. 1401 Eighth Street SE P.O. Box 320 ORANGE CITY IA 51041 Re: K013875 Trade/Device Name: MED-TEC Compensator Block Cutter Software Regulation Number: 21 CFR §892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: 90 IXI Dated: June 24, 2002 Received: July 1, 2002
Dear Mr. Riibe:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 9.2a
Page __ 1_ of __ 1_
510(k) Number (if known):_k013875
Device Name: _ MED-TEC Compensator Block Cutter Software
Indications For Use:
Software translates the ASCII output from a treatment plan to G code for use on a milling machine.
Works with various treatment plan outputs and translates the treatment plan into G code that can be used on a milling machine to produce a compensating shield.
(PLEAS DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Digman
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Prescription Use V Per 21 CFR 801.109
OR
Over-The-Counter USE
(Optional Format 1-2-96)