(302 days)
Not Found
No
The provided text does not mention AI, ML, or related terms, and there is no description of training or test sets, which are typical for AI/ML-based devices.
No
The device is a treatment planning system, not the treatment device itself. It plans the radiation dose but does not deliver the therapy.
No
Explanation: The device description clearly states it is a "Radiation Therapy Treatment Planning System for radiation dose planning," which focuses on treatment execution, not diagnosis.
Yes
The device is described as a "Radiation Therapy Treatment Planning System," which is inherently a software-based system used for calculations and planning. While it interacts with hardware (linear accelerators, teletherapy devices), the core device itself, as described, is the planning software. The description focuses on its function in dose planning and its compatibility with various radiation sources, all of which are software-driven tasks within a treatment planning system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly described as a "Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment." This is a system used for planning a medical procedure (radiation therapy) on a living patient, not for examining specimens taken from the body.
- Device Description: The description reinforces the intended use, focusing on planning radiation treatments with external beam devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting diseases or conditions based on in vitro analysis, or providing information for diagnosis based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on planning a therapeutic intervention.
N/A
Intended Use / Indications for Use
The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
Product codes
MUJ
Device Description
The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, PET-Spec
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
oncology clinic
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
MAY 2 0 2005
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
October 30, 2003
General Provisions 1.
RADIATION TREATMENT PLANNING SYSTEM Common/Usual Name:
Proprietary Name: WIMRT
Applicant Name and Address:
Prodigm Group, Inc. 19078 Chaparral Drive Penn Valley, CA 95946 Telephone: 530-432-5846 Fax: 530-432-2882
Name of Predicate Devices: 2.
- (1)
l
| Manufacturer | K Number |
|---|---|
| NOMOS Corvus Inverse Planning System | K940663 |
| Varian Helios Inverse Planning Module | K984532 |
| ADAC Laboratories P3IMRT Module | K002237 |
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, "... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
1
Classification 3.
This device is classified as a class II device according to 21 CFR 892.5050 .
4. Performance Standards
Performance standards for Brachytherapy applicators have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description ડ.
The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
6. Biocompatibility
No new issues of biocompataibility are raised with regard to this device.
Summary of Substantial Equivalence 7.
This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device. It utilizes materials that are already in use in other medical devices. No new issues of safety or effectiveness are introduced by using this device.
2
| Specification | WIMRT Module | ADAC P3IMRT Module | Varian Helios Inverse
Planning Module | NOMOS Corvus Inverse
Planning System |
|----------------------------------------------------------|------------------------------------------------------|-----------------------------------------|------------------------------------------|------------------------------------------------|
| K Number | This filing | K002237 | K984532 | K940663 |
| Application
(Use) | Inverse Planning | Inverse Planning | Inverse Plannning | Inverse Planning |
| Imaging
Modalities
Supported | CT, MR, PET-Spec | CT, MR, PET-Spec | CT, MR. PET-Spec | CT, MR, PET-Spec |
| Dose
Calculation
Algorithm | Super-position
Convolution | Super-position
Convolution | Pencil Beam Convolution | Finite Sum Pencil Beam |
| Optimization
Engine | Simulated
Annealing and
Descending
Gradient | Collapsing
Gradient | Cone Descending Gradient | Simulated Annealing and
Descending Gradient |
| IMRT
Modalities
Supported | Sliding Window
and Step and
Shoot | Sliding Window
and Step and
Shoot | Sliding Window and Step
and Shoot | Step and Shoot |
| Operating
System | Windows | UNIX | Windows 2000/Windows
NT | NeXT Step and UNIX |
| Image
Registration | Automatic | Manual and Automatic | Manual and Automatic | Manual and Automatic |
| Automated
Planning | Yes | Yes via Scripts | Yes via Templates | No |
| Inhomogeneity
Corrections | Yes | Yes | Yes | Yes |
| Forward IMRT
via Field
within a Field
technique | Yes | Yes | Yes | No |
| Forward IMRT
via MLC Based
compensators | Yes | No | Yes | No |
Prodigm Group, Inc: WIMRT - 510(K)
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 0 2005
Lee Potts President Prodigm Group, Inc. 19078 Chaparral Drive PENN VALLEY CA 95946
Re: K041971 Trade/Device Name: WIMRT Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 25 2005 Received: May 2, 2005
Dear Mr. Potts:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced w chave and have determined the device is substantially equivalent (for the indications for use stated in above and nave determinerarketed predicate devices marketed in interstate commerce prior to the chorolore) to regarly man date of the Medical Device Amendments, or to devices that have been May 20, 1770, the charantinent 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 do not require upproval or a provisions of the Act. The general controls provisions of the Act device, suojoer to the general 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 (Premarket n your do roo is classion (t to such additional controls. Existing major regulations affecting your Apploval), it they of sabject to actively 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 I DA has made a deceminations administered by other Federal agencies. You must comply with all the I oderal building, 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) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maneting of substantial equivalence of your device to a legally premarket nothleation: "The PDA midning of backanding or 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 specific advice for your derice of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation charact, cornation on your responsibilities under the Act from the 807.97). You may obtain other general missance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
5
Indications for Use
510(k) Number: To be assigned Ko41971
Device Name: WIMRT
Indications for Use:
The TOPSLANE product ARTP with WIMRT is a Radiation Therapy Treatment in the The TOF SEANL produce Artifing of patients undergoing external beam treatment in the oncology clinic. ARTP with WIMRT is used to plan radiation treatments with linear accelerators oncology cinne. Arth mail relies with x-ray energies from 1 to 25MV, as well as Cobalt-60, and electron energies from 1 to 25 MeV.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
or
ﻢ
ﺎ ﺗﻌ
Over-The Counter Use: ____ (Per 21 CFR 801.109)
David A. Johnson
(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devices 510(k) Number _
Prodigm Group, Inc: WIMRT - 510(K)