(175 days)
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No
The description focuses on deterministic processes for generating tool paths based on a predefined compensator specification, with no mention of learning, adaptation, or data-driven decision making characteristic of AI/ML.
No
Explanation: MillComp is a program used to manufacture compensators for radiation therapy, not a device that directly applies therapy. It is a manufacturing tool, not a therapeutic device.
No
MillComp is described as a program that generates tool paths to manufacture radiation therapy compensators, which are devices used to modify treatment beams. It does not perform any diagnostic function of identifying or characterizing a disease or medical condition.
Yes
The device is described as a "program" that takes a compensator specification as input and generates tool paths for a milling machine. It does not mention any hardware components being part of the device itself, only that it interacts with external systems (treatment planning systems) and outputs data for a milling machine.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- MillComp's Function: MillComp is a software program used to manufacture physical compensators for radiation therapy. These compensators are placed in the radiation beam outside the patient's body to modify the radiation dose distribution.
- No Specimen Analysis: MillComp does not analyze any biological specimens from a patient. Its input is a compensator specification, and its output is a tool path program for a milling machine.
Therefore, MillComp falls under the category of a medical device used in the delivery of radiation therapy, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MillComp is used to manufacture compensators that are designed for radiation therapy treatment beams. MillComp may be used with any system that can design compensators such that the thickness over the area of the beam is specified at some known source to compensator distance in a plane perpendicular to the central axis. The thickness on an evenly spaced grid may be specified on divergent rays or on rays perpendicular to the plane of the compensator which is perpendicular to the central ray. If on divergent rays, the milled surface may be specified as towards the x-ray source or as towards the patient.
Product codes
90 IYE
Device Description
MillComp is a program that will write the tool path program to mill radiation therapy compensators on an end mill. Compensators are attenuators that are to be inserted into the x-ray beams for the purpose of modifying the field distribution over the area of the treatment beam. MillComp takes as input a compensator specification. The compensator specification will come from multiple sources, such as current therapy treatment planning systems, and is converted into a standard specification file format that MillComp can read. The conversion programs to read a compensator specification and write out the standard file format will be written on an as need basis according to the customer's needs. MillComp will read the specification file, generate the surface defined in the specification, and compute the tool paths necessary to cut the surface in solid lead, cerrobend, or other material, on a three axis end milling machine.
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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
MillComp File: m510ksum.doc Date: May 4, 2001
DEC 0 4 2001
1/ 011 845
510(k) Summary
MillComp is a program that will write the tool path program to mill radiation therapy compensators on an end mill. Compensators are attenuators that are to be inserted into the x-ray beams for the purpose of modifying the field distribution over the area of the treatment beam. MillComp takes as input a compensator specification. The compensator specification will come from multiple sources, such as current therapy treatment planning systems, and is converted into a standard specification file format that MillComp can read. The conversion programs to read a compensator specification and write out the standard file format will be written on an as need basis according to the customer's needs. MillComp will read the specification file, generate the surface defined in the specification, and compute the tool paths necessary to cut the surface in solid lead, cerrobend, or other material, on a three axis end milling machine.
Document Approved by: Wendel Dean Renner Date: Title: President
Wendel Dean Kenner
May 30, 2001
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2001
Mr. Wendel Dean Renner President Math Resolutions, LLC 5975 Gales Lane COLUMBIA MD 21045
Re: K011845
Trade/Device Name: Millcomp Version 1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: II Product Code: 90 IYE Dated: September 18, 2001 Received: September 20, 2001
Dear Mr. Renner:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to tegain) at the Medical Device Amendments, or to conimeres prior to May 20, 1977) is accordance with the provisions of the Federal Food, Drug, de necs that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, mains 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 or any I vathatos a 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 (21 Or It I ar our of ); faceming (21 CFR Part 820); and if applicable, the electronic form in the quality of evel provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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/dsmaldsmamain.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
3
MillComp File: 4 May 2001 Date: minduse.doc
510(k) number: Device name: MillComp Indications for Use:
MillComp is used to manufacture compensators that are designed for radiation therapy treatment beams. MillComp may be used with any system that can design compensators such that the thickness over the area of the beam is specified at some known source to compensator distance in a plane perpendicular to the central axis. The thickness on an evenly spaced grid may be specified on divergent rays or on rays perpendicular to the plane of the compensator which is perpendicular to the central ray. If on divergent rays, the milled surface may be specified as towards the x-ray source or as towards the patient.
Document Approved by: Wendel Dean Renner Date: Title: President
Wendell Dean Kenna
May 30, 2001
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
Nancy Brogdon
(Division Sign Off)
Division of Reproductive, Abdomina
and Radiological Devices K011845
510(k) Number
(Optional Formal 1-2-96)