(215 days)
No
The summary describes standard image processing and treatment planning functions without mentioning AI/ML terms or capabilities.
No
The device is a software used for treatment planning and visualization, it does not directly apply therapy. It aids in determining precise locations for irradiation and visualizing dose, which are pre-treatment steps for therapeutic devices like radiation therapy machines.
No
The device is described as a treatment planning system for radiation therapy, used for tasks like determining target location and visualizing treatment beams and dose, rather than diagnosing diseases.
Yes
The description explicitly states "The software is used..." and details functions that are purely computational and visualization-based, without mentioning any associated hardware components that are part of the device itself. The predicate devices are also treatment planning systems, which are typically software-based.
Based on the provided information, 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.
- Device Function: The description clearly states the software's function is to:
- Import CT images.
- Determine the precise location of a target (tumor or lesion) within the body using implanted fiducials.
- Define and visualize treatment beam locations (likely for radiation therapy).
- Visualize dose to the target and other structures.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples from the patient. The input is imaging data (CT scans), and the output is related to treatment planning and visualization based on anatomical location.
This device falls under the category of medical imaging software used for treatment planning, specifically in the context of radiation therapy or similar procedures. It is a tool to assist healthcare professionals in delivering treatment, not a diagnostic test performed on a biological sample.
N/A
Intended Use / Indications for Use
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
Product codes
90 MUJ
Device Description
Not Found
Mentions image processing
The software is used to electronically import CT images containing the target to be irradiated...
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
Anatomical Site
intracranial diseases (such as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas), hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
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)
Not Found
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
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2002
Lee Myers, MD Director of Operations Northwest Medical Physics Equipment, Inc. 21031 67th Ave W LYNNWOOD WA 98036
Re: K012575
Trade/Device Name: pReference IMRT Treatment Planning Module Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system
Regulatory Class: II Product Code: 90 MUJ Dated: December 20, 2001 Received: December 21, 2001
Dear Dr. Myers:
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.
1
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 notheation. The I Dri Imaling of sossion 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 spective 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 Additionally, for questions on and please note the regulation entitled, "Misbranding Other of Compinated to premarket notification" (21 CFR Part 807.97). Other general information on by received to premained from the Division of Small Manufacturers, your responsional 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
2
Section D- Statement of Indications for Use
Page of
K0/2575
510 (k) Number (if known):
Device Name: pReference IMRT Treatment Planning Module .
Indications For Use:
The indications for use are applicable as previously presented for pReference TPS (K970464), such intracranial diseases as gliomas, neuromas, meningiomas, astroctyomas, arteriovenous malformations, and metastatic carcinomas.
The expanded indications for use are also applicable as previously presented for pReference Treatment System (K983793), including hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, and prostatic tumors.
The software is used to electronically import CT images containing the target to be irradiated, to determine the precise location of the target with respect to implanted fiducials, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K012575 |
| Prescription Use | OR | Over-The-Counter Use __________ | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
pReference IMRT Treatment Planning Module DRAERD Premarket Notification 510(k) D-1
08/07/01 a1620_imrt_510k.ms.doc