(74 days)
Not Found
No
The device description focuses on mechanical structures for patient positioning and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
Explanation: The device is used to position a patient for radiation therapy, not to deliver therapy itself. It is a positioning aid, not a therapeutic device.
No
The device is described as a positioning device for breast radiation therapy and imaging, and its components primarily facilitate patient support and positioning, rather than directly diagnosing conditions. Although it mentions compatibility with CT for imaging, the device itself doesn't perform diagnostic functions; it provides the physical setup for them.
No
The device description clearly outlines rigid mechanical structures, tabletops, bases, and spacers, indicating it is a hardware device used for patient positioning.
No, 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 includes tests for diagnosing, monitoring, or screening for diseases or conditions.
- Pronex Function: The description clearly states that Pronex is used to position a patient for prone breast radiation therapy. It's a physical support structure that helps with the delivery of a medical treatment (radiation therapy).
- No Specimen Analysis: The device does not involve the collection or analysis of any biological specimens from the patient.
The device is a positioning device used in the context of medical treatment.
N/A
Intended Use / Indications for Use
Pronex is used to position a patient for prone breast radiation therapy.
Product codes
IYE
Device Description
The device comprise two rigid mechanical structures, each incorporating:
- A tabletop for supporting a patient's torso in the prone position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical.
- A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment.
The imaging-oriented supporting structure is CTradiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position.
The respective couches provide positioning motion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
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.
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SECTION 3 510(K) SUMMARY
DEC - 7 2010
Pronex
510(K) number K102765
| Date Prepared | September 2010 |
|---|---|
| Applicant's Name | Direx Systems Corporation |
| 437 Turnpike Street | |
| Canton, MA 02021 | |
| Tel:(339) 502-6013 | |
| Contact Person: | Fax:(339) 502-6018 |
| Ms. Larisa Gershtein | |
| Trade Name | e-mail:lgershtein@direxusa.com |
| Pronex | |
| Classification Name | Medical Charged -Particle Radiation Therapy System |
| Classification | The FDA has classified this type of devices as class II |
| (Product code IYE,21 CFR. 892.5050). Radiology Panel | |
| reviews this type of device. | |
| Predicate Devices | ClearVue prone Breast Treatment Table, K090349, |
| Establishment | Prone Breast Positioning Board, Model 37-018, K971382 |
| 1224828 | |
| Registration Number | |
| Intended use | Positioning a patient for prone breast radiation therapy. |
| Device Description | The device comprise two rigid mechanical structures, |
| each incorporating: | |
| * A tabletop for supporting a patient's torso in the prone |
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position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical.
- A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment.
The imaging-oriented supporting structure is CTradiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position.
The respective couches provide positioning motion. The intended use, functionality, technological characteristics and materials of the device are similar to those of the predicate devices. Analysis of similarities and differences led Direx Systems Corp. to conclude that the device is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues
Substantial Equivalence
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Larisa Gershtein QA Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021
DEC - 7 2010
Re: K102765
Trade/Device Name: Pronex Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 15, 2010 Received: September 24, 2010
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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 a legally 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Dan
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is black and white and features the word "Direx" in large, bold letters. Below the word "Direx" is a horizontal line, and below that is the text "SYSTEMS CORP." in smaller letters. The logo is simple and professional.
SECTION 2 INDICATIONS FOR USE STATEMENT
Indications for Use Statement
510(k) Number (if known):
1/102765
DEC - 7 2010
Device Name: Pronex
Indications for Use:
Pronex is used to position a patient for prone breast radiation therapy.
Prescription Use - Yes (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
|---|---|
| (Division Sign-Off) | |
| Division of Radiological Devices | |
| Office of In Vitro Diagnostic Device Evaluation and Safety | |
| 510K. | K102765 |