(476 days)
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No
The document does not mention AI, ML, or related terms, and the description focuses on traditional 3D radiation treatment planning methods.
No
This device is a radiation treatment planning software, which is used to plan the treatment, not deliver it. Therefore, it is not a therapeutic device itself.
No
TriMed Plan is described as radiation treatment planning software, which helps in planning the treatment for patients undergoing radiation therapy, rather than diagnosing a condition.
Yes
The device is described as "radiation treatment planning software" and a "comprehensive 3D radiation treatment planning system" running on standard personal computers. The description focuses entirely on software functionalities and calculations, with no mention of proprietary hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- TriMed Plan's Function: TriMed Plan is a radiation treatment planning software. Its purpose is to plan and model the delivery of radiation therapy to a patient's body, not to analyze samples taken from the body.
- Intended Use: The intended use clearly states it provides "radiation treatment planning capability" for external beam sources.
- Device Description: The description details its function in modeling "dose distribution of radiation of patient undergoing photon or electron therapy."
The device is a medical device used in the planning phase of radiation therapy, which is an in-vivo treatment, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
TriMed Plan is used to plan radiation therapy treatments employing linear accelerators and other similar teletherapy devices with X-ray energy from 1 MV to 24 MV, as well as Cobalt-60, and electron energy from 4 MeV to 50 MeV. TriMed Plan uses 3D radiotherapy treatment approaches to combine modality plans, asymmetric and non-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges.
Indication for User: TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems.
TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. Tribed Plan uses 3D conformal therapy treatment approaches to combine modality plans, I rimed I har asso on-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges. The resulting treatment plan from this system is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.
Prescription Use
Product codes (comma separated list FDA assigned to the subject device)
90 MUJ
Device Description
TriMed Plan is a comprehensive 3D radiation treatment planning system for modeling dose distribution of radiation of patient undergoing photon or electron therapy based on modern personal workstation running Windows NT, Windows 2000 and Windows XP. External beam dose calculations for both photon and electron machines are all in 3-dimensional volume that support coplanar and non-coplanar fields. Beam modifiers include hand block, customized block, multi-leaf collimators, and wedge. Different energies and modalities can be combined into the same plan. State-of-the-art 2D/3D graphics user interface makes the system very user friendly.
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
qualified medical personnel
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)
Software development, validation and verification of the TriMed Plan has been conducted according to the policies and procedures discussed in the 510(k), which includes engineering diagrams, fault tree analyses, the Verification and Validation documentation, and all pertinent reference articles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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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
JUL 2 3 2004
TriMed Systems, Inc.
KOSTOR
SUMMARY OF SAFETY AND EFFECTIVENCESS
| 1. Submitter's Information: | Dated: March 28, 2003
TriMed Systems, Inc.
1804 Loehr Estates Ct.
Ballwin, MO 63021 |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact:
Sherry Zhang
VP of Quality Assurance And Regulatory Affairs |
| 2. Common or Usual Name:
Product Name:
Classification Name: | Radiation Treatment Planing System
TriMed TPS
System, Simulation, Radiation Therapy
RA(90)KPQ Class 2
21 CFR 892.5050 |
| Version Number: | 2.2 |
| 3. Predicate Device: | CadPlan Version 2.62
Radiation Therapy Treatment Planning System
K962950
Varian Cadplan |
| 4. Description: | TriMed Plan is a comprehensive 3D radiation treatment
planning system for modeling dose distribution of radiation
of patient undergoing photon or electron therapy based on
modern personal workstation running Windows NT,
Windows 2000 and Windows XP. External beam dose
calculations for both photon and electron machines are all
in 3-dimensional volume that support coplanar and non-
coplanar fields. Beam modifiers include hand block,
customized block, multi-leaf collimators, and wedge.
Different energies and modalities can be combined into the
same plan. State-of-the-art 2D/3D graphics user interface
makes the system very user friendly. |
| 5. Intended Use: | TriMed Plan is used to plan radiation therapy treatments
employing linear accelerators and other similar teletherapy
devices with X-ray energy from 1 MV to 24 MV, as well as
Cobalt-60, and electron energy from 4 MeV to 50 MeV.
TriMed Plan uses 3D radiotherapy treatment approaches to
combine modality plans, asymmetric and non-coplanar
fields, total body irradiation, multi-leaf collimators, hand
blocking, customized blocking, and wedges. |
1
6. Technological Considerations:
TriMed Plan has no significant differences in design, materials, energy source or other technological characteristics compared to the predicate device.
7. Software Development and Verification:
Software development, validation and verification of the TriMed Plan has been conducted according to the policies and procedures discussed in the 510(k), which includes engineering diagrams, fault tree analyses, the Verification and Validation documentation, and all pertinent reference articles.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or other bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2004
Ms. Sherry Zhang VP of Quality Assurance and Regulatory Affairs TriMed Systems, Inc. 1804 Loehr Estates Ct., BALLWIN MO 63021
Re: K031088
Trade/Device Name: TriMed Plan 2.2 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: June 24, 2004
Received: June 25, 2004
Dear Ms. Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed 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 enclosers) vo ttgms.
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to commerce pror to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, devices that have occh roomstred in aquire approval of a premarket approval application (PMA). and Costlictic Act (110) that to not required to the general controls provisions of the Act. The I ou may, therefore, marries include requirements for annual registration, listing of general controls provisions or ractice, 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 If your device is classinod (500 a0070) cols. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to satin additions, 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 i loast be advised that I Dr over device complies with other requirements of the Act that I DX has made a cerefits and regulations administered by other Federal agencies. You must comply or any I cacares and reguirements, including, but not limited to: registration and listing (21 CFR Part with an the Free Prequirement 801); good manufacturing practice requirements as set forth in the our ; idocimig (21 CFR Part 820); and if applicable, the electronic product quality by control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to organization of substantial equivalence of your device to a legally premarket notication: "The Privation 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 If you desire spoolite at one of the following numbers, based on the regulation number at the top of the 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 Additionally, for quebellers of (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Othphallos av (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on Jour responder 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. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indication for Use
510(k) Number:
Device Name: TriMed Plan - Radiation Treatment Planning System
Indication for User: TriMed Plan is a radiation treatment planning software developed by TriMed Systems, Inc, running on IBM compatible personal computers with Microsoft Windows operating systems.
TriMed Plan provides radiation treatment planning capability, for both photon and electron external beam sources, to satisfy the prescription of the radiation oncology. Tribed Plan uses 3D conformal therapy treatment approaches to combine modality plans, I rimed I har asso on-coplanar fields, total body irradiation, multi-leaf collimators, hand blocking, customized blocking, and wedges. The resulting treatment plan from this system is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.
Prescription Use
Nancyc bridon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031088