(98 days)
Not Found
No
The summary describes a radiation therapy treatment planning system with image registration capabilities, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithmic development. The focus is on dose calculation and image registration, which are standard functionalities in such systems and do not inherently require AI/ML.
No.
The device is a treatment planning system that calculates radiation dose distributions; it does not directly administer therapy itself.
No
The device is described as a treatment planning system for radiation therapy, calculating dose distributions, rather than diagnosing a disease or condition.
Yes
The device description focuses entirely on the software's functionality for treatment planning, dose calculation, and image registration. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MIRS Function: MIRS is a treatment planning system for radiation therapy. It uses medical images (RMI, CT, PET, angiography) to create 3D dose distributions within the patient's body for a given treatment plan. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for creating treatment plans for patients receiving radiation therapy.
- Device Description: The description reinforces its role in treatment planning and dose distribution calculation based on imaging data.
Therefore, MIRS falls under the category of a medical device used for treatment planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MIRS ™ is used to create treatment plans for patients for whom radiation therapy has been prescribed. The system will calculate and display three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS can be used for different treatment modalities of radiation therapy, as conventional therapy. Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Radiosurgery with Conic Collimators.
Product codes
MUJ
Device Description
MIRS ™ is used to create treatment plans for patients for whom external beam radiation therapy has been MIRS Is used to create trouncell pails to pay three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS (Module Integrated Radiotherapy System) is a modular patient for a given reatment planning system for different treatment modalities of radiation therapy, from three univelsional radiotherapy to Conformal Radiation Therapy, Intensity Modulated Radiation Therapy and Conventional radioneraly with Conic Collimators. MIRS supports any stereotactic frame. MIRS has automatic multimodality image registration, with and without fiducials. Besides 3D RMI and CT images studies with any orientation (axial, coronal or sagital), MIRS supports registration of functional RMI, PET and angiography.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D RMI, CT, functional RMI, PET, angiography
Anatomical Site
Not Found
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)
The proposed device's performance was compared to the predicate device's performance as described in section 10 of this submission. All of the items contained in the tables of section 10 have been found to be substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K010464, K082606, K010784, K973936, K002147, K031975, K080601, K951581, K993923, K915691
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.
Not Found
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).
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
Ke90682
V. Arredondo 2684-2ª Piso ♦ 1426 Buenos Aires ♦ Argentina Tel: (54) 114896-0989
510(K) SUMMARY
MAY 4 2009
MIRS ™
| Submitter: | Nuclemed S.A.
V. Arredondo 2684 - 2ª Piso
1426 Buenos Aires - Argentina
Phone: (54) 11 4896-0989 |
|-----------------|-----------------------------------------------------------------------------------------------------------|
| Contact Person: | Raymond J Kelly IV
Arazy Group
56B Shadowbrook, Dr Hudson, NH 0305
Phone: (603) 595-0095 |
Fax: (603) 595-0095
E-mail: ray@arazygroup.com
December 8th, 2008
Device Names:
Date:
MIRS ™ Module Integrated Radiotherapy System Trade Name: Module Integrated Radiotherapy System Common Name: System, Planning, Radiation Therapy Treatment Classification Name:
Legally Marketed Device to Which Substantial Equivalence is Claimed:
The MIRS ™ unit is substantially equivalent (SE) to Rad Calc (K010464) cleared in 2001, CDMS (K082606) cleared in 2008, PLATO SRS (K010784) cleared in 2001, FOCUS SRS (K973936 + K002147) cleared in 1998, IMSure (K031975) cleared in 2000, ERGO++ (K080601) cleared in 2008, ADAC Pinnacle3 (K951581) cleared in 1996, Pinnacle3 (K993923) cleared in 2000, and the FOCUS RTP (K915691) cleared in 1995. .'
Page #:
5.1
Traditional Premarket Notification for MIRS, Nuclemed S.A.
1
Image /page/1/Picture/0 description: The image shows the logo for NUCLEMED. The logo consists of a stylized letter N above the word "NUCLEMED". The letter N is black and white and appears to be made up of several smaller squares. The word "NUCLEMED" is written in a simple, sans-serif font.
Nuclem V. Arredondo 2684-2ª Piso ♦ 1426 Buenos Aires ♦ Argentina Tel: (54) 114896-0989
510(K) SUMMARY (CONTINUED)
MIRS ™
Device Description:
MIRS ™ is used to create treatment plans for patients for whom external beam radiation therapy has been MIRS ** Is used to create trouncell pails to pay three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS (Module Integrated Radiotherapy System) is a modular patient for a given reatment planning system for different treatment modalities of radiation therapy, from three univelsional radiotherapy to Conformal Radiation Therapy, Intensity Modulated Radiation Therapy and Conventional radioneraly with Conic Collimators. MIRS supports any stereotactic frame. MIRS has automatic multimodality image registration, with and without fiducials. Besides 3D RMI and CT images studies with any orientation (axial, coronal or sagital), MIRS supports registration of functional RMI, PET and angiography.
Intended Use:
MIRS ™ is used to create treatment plans for patients for whom radiation therapy has been prescribed. The system will calculate and display three dimensional radiation dose distributions within the patient for a given treatment plan set up. MIRS can be used for different treatment modalities of radiation therapy, as conventional therapy. Conformal Radiation Therapy, Intensity Modulated Radiation Therapy, and Radiosurgery with Conic Collimators.
Technological Characteristics Comparison to Predicate Device:
The proposed device was compared to the predicate devices as described in section 9 of this submission. All of the items contained in the tables of section 9 have been found to be substantially equivalent.
Performance Data:
The proposed device's performance was compared to the predicate device's performance as described in section 10 of this submission. All of the items contained in the tables of section 10 have been found to be substantially equivalent.
Traditional Premarket Notification for MIRS, Nuclemed S.A.
Page #: 5.2
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The logo is in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
MAY 4 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nuclemed S.A. % Mr. Raymond Kelly Senior Consultant Arazy Group, Medes Argentina 56B Shadowbrook Dr. HUDSON NH 03051
Re: K090182 -
Trade/Device Name: MIRSTM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: January 15, 2009 Received: February 3, 2009
Dear Mr. Kelly:
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.
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); medical device reporting (reporting of medical device-related adverse, events) (21 CFR 803); 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
21 CFR 876.xxx (Gastroenterology/Renal/Urology) (240) 276-0115 (240) 276-0115 (Obstetrics/Gynecology) 21 CFR 884.xxx (Radiology) (240) 276-0120 21 CFR 892.xxx Other (240) 276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Lois McMurtry
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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7
Nuclemed S.A. V. Arredondo 2684-2ª Piso ♦ 1426 Buenos Aires ♦ Argentina Tel: (54) 114896-0989
INDICATIONS FOR USE
2090182 510(k) Number (if known):
MIRS™M Device Name:
Indications For Use:
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Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(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
Traditional Premarket Notification for MIRS, Nuclemed S.A.