(207 days)
Not Found
No
The summary describes image processing but does not mention AI, ML, deep learning, or any related concepts. The principle of operation is based on acquiring and displaying images with an isocenter marker, which is a standard image processing task, not necessarily AI/ML.
No.
MIGUE is a device used to aid in patient setup for radiation therapy procedures by accurately placing the patient at the isocenter of a linear accelerator. It does not directly provide therapy or affect the body through medical intervention; rather, it is a tool for precise positioning during a therapeutic procedure.
No
The device is intended to aid in patient target to radiation beam set-up for radiation therapy, focusing on patient positioning and image acquisition for treatment delivery, rather than diagnosing a medical condition.
No
The device description explicitly states it consists of three units, including a "MIGUE Main Unit" with hardware components (Fluoroscopic Channels, rigid ring) and an "Electronics Cabinet," in addition to the software on the Console Workstation PC. This indicates it is a hardware and software system, not software-only.
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. This testing is performed outside of the body (in vitro).
- MIGUE's Function: MIGUE is used to position a patient externally for radiation therapy. It uses X-ray imaging to align the patient with the radiation beam. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for "patient target to radiation beam set-up for administration of radiation therapy." This is an external positioning and imaging task, not an in vitro diagnostic test.
Therefore, MIGUE falls under the category of a medical device used for patient positioning and imaging in the context of radiation therapy, not an IVD.
N/A
Intended Use / Indications for Use
MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.
The device consists of three units:
-
- MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images.
-
- Console Workstation PC with embedded software, used for control, display and image processing.
-
- Electronics Cabinet.
Principle of operation:
- a) Acquire two images, one from each channel.
- b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
all body procedures
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): 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.
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
K0522/2
SECTION 4 - 510(k) SUMMARY
[Submitted pursuant to 21 CFR 807.92(a)]
Summary Date: October 17, 2005
1. Submitter Information
Submitter:
Direx Systems Corporation 11 Mercer Road Natick Business Park Natick, MA 01760
| Telephone: | (508) 651-0900 |
|---|---|
| Fax: | (508) 651-8125 |
| Contact Person | Larisa Gershtein |
| QA Manager | |
| Contact Person e-mail address: | lgershtein@direxusa.com |
2. Device
| Trade / Proprietary Name: | MIGUE |
|---|---|
| Classification Name: | Accelerator, Linear, Medical |
| Classification Name/ Product code: | 90 IYE |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.5050 |
3. Predicate Devices
3Dscope K041213 ExacTrac X-Ray 6D K040585
4. Device Description
MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.
1
The device consists of three units:
-
- MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images.
-
- Console Workstation PC with embedded software, used for control, display and image processing.
-
- Electronics Cabinet.
Principle of operation:
- a) Acquire two images, one from each channel.
- b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.
5. Indications for Use
MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.
6. Technological Characteristics
The Substantial Equivalence table provides a comparison of MIGUE's technological characteristics to those of the predicate devices. The table is located in Section 8 of this submission.
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. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Larisa Gershtein Quality Assurance Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021
Re: K052212 Trade/Device Name: MIGUE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 9, 2006 Received: February 10, 2006
Dear Ms. Gershtein:
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 stred 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, weret 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 provices , labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affer ting 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 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) I 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.
MAR 1 0 2006
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally 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 promoter 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 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at inst the netition the 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 3 - INDICATIONS FOR USE STATEMENT
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K052212 Device Name: MIGUE Indications for Use:
MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
510(k) Number _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over the Counter Use___________________________________________________________________________________________________________________________________________________________________________
David A. Syverson
(Division Sign-Off)
Division of Reproductive, Abdominal, ological Devic