(91 days)
Not Found
Not Found
No
The summary describes a physical positioning and immobilization system for radiation therapy, with no mention of software, image processing, AI, or ML.
No
The device is described as a 'positioning and immobilization system' used during radiation therapy, indicating it is an accessory to a therapeutic procedure rather than a therapeutic device itself.
No
The device is described as a "positioning and immobilization system" for radiation therapy, which helps to set-up and reproduce the supine position of a breast patient. This function is for treatment delivery, not for diagnosing a medical condition.
No
The device description clearly identifies it as a "positioning and immobilization system" made of "Carbon Fibre," indicating it is a physical hardware device used for patient positioning during radiation therapy.
Based on the provided information, the Raycast MammoRx Carbon Fibre Breast Board is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for positioning and immobilization of a patient during radiation therapy. This is a physical support and positioning device used on the patient, not a test performed on a sample taken from the patient.
- Device Description: While the description is "Not Found," the intended use clearly places it outside the realm of in vitro diagnostics.
- No Mention of Biological Samples: IVDs are designed to examine biological samples (blood, urine, tissue, etc.) to provide information about a patient's health. There is no indication that this device interacts with or analyzes any biological samples.
Therefore, the Raycast MammoRx Carbon Fibre Breast Board is a medical device used in radiation therapy, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.
Product codes
IYE
Device Description
The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.
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): 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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized caduceus or a family of three people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Orfit Industries NV % Mr. Raymond Kelly Consultant Licensale, Inc. 68 Southwoods Terr. SOUTHBURY CT 06488
Re: K162355
Trade/Device Name: Raycast MammoRx Carbon Fibre Breast Board Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: October 9, 2016 Received: October 14, 2016
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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Raycast MammoRx Carbon Fibre Breast Board
Indications for Use (Describe)
The Raycast MammoRx Carbon Fibre Breast Board is a positioning and immobilization system to set-up and reproduce the supine position of a breast patient during radiation therapy.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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