(48 days)
Not Found
No
The device description details a physical positioning and immobilization device for radiation therapy and imaging. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical properties like MR safety and biocompatibility.
No
The device is used to position patients during radiation therapy and image acquisition for treatment planning, not to directly treat or diagnose a disease.
No
This device is described as a "Breastboard and Overhead Arm Positioner" used to position patients during radiation therapy and imaging for treatment planning. Its function is to support and immobilize the patient, not to diagnose medical conditions.
No
The device description clearly details physical components like a Base, Back Support, Bottom Stop, Angle Supports, Lock, Overhead Arm Positioner, Hand Grip, Head Support, and Thermoplastic Frame. The performance studies also focus on testing the physical device for MR safety and biocompatibility.
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 (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for positioning and supporting patients during radiation therapy and imaging procedures. It is a physical device that the patient interacts with externally.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens.
- Intended Use: The intended use is focused on patient positioning and support for treatment and imaging, not on analyzing biological samples for diagnostic purposes.
Therefore, this device falls under the category of a medical device used for patient positioning and support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.
Product codes
IYE, LNH
Device Description
The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board.
The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° angles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the angular position of the Support.
The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support.
A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard.
The Overhead Arm Positioner provides support for the patient’s arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally.
A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support.
The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus.
The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile. The devices are used in a healthcare facility/hospital. The following model is included in this submission:
Part No. MTM410 Device Name C-Qual MRTM Breastboard and MonarchTM Overhead Arm Positioner
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems.
Anatomical Site
breast and chest region
Indicated Patient Age Range
adult and adolescent patients, not intended for use with patients under 12 years of age.
Intended User / Care Setting
healthcare facility/hospital
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)
To add MR indications to the Breastboard and Overhead Arm Positioner (MTM410), the device was tested for MR safety and compatibility in accordance with ASTM Standard F2052-15. Testing was also completed using ASTM Standards F2213-06 and F2119-07 as guidance. The device passed the acceptance criteria for magnetically induced torque and magnetically induced displacement force and demonstrate that the device is safe for use in field strengths of 1.5 T and 3.0 T. Image artifact was observed, with the worst case artifact occurring near the location of the locking knob on the Breastboard. Information regarding size of this artifact has been included in the Instructions for Use. In addition to MR safety testing, other nonclinical testing demonstrated that the differences in technological characteristics did not raise any new issues of safety or effectiveness.
Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-5:2009 and ISO 10993-10:2010. The Breastboard and Overhead Arm Positioner is intended for limited contact duration (
§ 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
May 20, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MEDTEC, Inc. dba CIVCO Medical Solutions and CIVCO Radiotherapy % Ms. Alena Newgren Regulatory Manager 1401 8th Street SE ORANGE CITY IA 51041
Re: K211001
Trade/Device Name: C-Qual M" Breastboard; Monarch™ Overhead Arm Positioner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: March 31, 2021 Received: April 2, 2021
Dear Ms. Newgren:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211001
Device Name
C-Qual M Breastboard with Monarch Overhead Arm Positioner
Indications for Use (Describe)
The device is indicated to aid in supporting adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.
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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Image /page/3/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font. The logo is simple and modern, and the blue color gives it a professional and trustworthy look.
510(k) Summary
A. Submitter Information
| | Submitter Name & Address: MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO
Radiotherapy"
1401 8th St. SE
Orange City, IA 51041 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Alena Krishna, Regulatory Affairs Manager
Telephone: 319-248-6650
Alena.Newgren@civcort.com |
| Date Summary Prepared: | March 31, 2021 |
| Trade Names: | C-Qual M™ Breastboard; Monarch™ Overhead Arm Positioner |
| Common Names: | Breastboard; Overhead Arm Positioner |
| Classification Names &
Numbers: | Medical charged-particle radiation therapy system (892.5050)
System, Nuclear Magnetic Resonance Imaging (892.1000) |
| Device Class: | Class II |
| Review Panels: | Radiology |
| Product Codes: | IYE, LNH |
B. Predicate Devices
The Breastboard and Overhead Arm Positioner are substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer |
|---|---|
| K180021: Proton Positioning and Immobilization Devices | |
| (Breast Devices) | CIVCO Radiotherapy |
The purpose of this 510(k) is to add MR to the indications for use for the MTM410.
C. Device Descriptions
The Breastboard and Overhead Arm Positioner are used to position the patient during external beam radiation therapy. The Breastboard is comprised of a Base, Back Support, and Bottom Stop. The Base serves as the foundation of the assembly and provides a mounting surface for the Back Support, Angle Supports, and the Bottom Stop. The inferior end of the Back Support
www.civcort.com
4
Image /page/4/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font, with a blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.
is mounted to the Base while the superior end of the Back Support is raised/lowered as needed for patient setup using Low Angle Supports. The Bottom Stop is located near the inferior end of the Base and prevents the patient from sliding down the Board.
The Low Angle Support is used to position the Back Support at 5°, 7.5°, 10°, 12.5°, and 15° anqles. Features on the High Angle Support receive the cutouts on the Low Angle Support and hold the anqular position of the Support.
The High Angle Support is used to position the Back Support at 17.5°, 20°, 22.5°, and 25° angles. Features on the Base receive the cutouts on the High Angle Support and hold the angular position of the Support.
A Lock provides a method of locking the Back Support to the Base at 0° to facilitate easier handling and storage of the Breastboard.
The Overhead Arm Positioner provides support for the patient's arms above the head and is attached to the Back Support via a locking assembly. The Overhead Arm Positioner adjusts longitudinally on the Back Support to accommodate a variety of patient sizes. A Hand Grip is mounted on the Overhead Arm Positioner and the location of the Hand Grip is adjustable longitudinally.
A Head Support rests on a recessed area of the Overhead Arm Positioner and provides a cushion for positioning of the head of the patient. The Head Support can also be mounted directly on the Breastboard. A Thermoplastic Frame may also be mounted to the Overhead Arm Positioner to enable attachment of a thermoplastic mask for additional patient support.
The Breastboard and Overhead Arm Positioner can also be used for supporting and elevating patients undergoing treatment who cannot lay down flat on the table due to their habitus.
The Breastboard and Overhead Arm Positioner are reusable devices that are provided nonsterile. The devices are used in a healthcare facility/hospital. The following model is included in this submission:
| Part No. | Device Name |
|---|---|
| MTM410 | C-Qual MRTM Breastboard and MonarchTM Overhead Arm Positioner |
D. Indications for Use/Intended Use Statements
Indications for Use/Intended Use: The device is indicated to aid in supporting and positioning adult and adolescent patients undergoing radiation therapy of the breast and chest region including electron, photon, and proton treatments. Device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography
www.civcort.com
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Image /page/5/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a stylized font. A blue circle is placed above the V. Below the word "CIVCO" is the word "Radiotherapy" in a smaller font.
(CT) and Magnetic Resonance (MR) imaging systems. The device is not intended for use with patients under 12 years of age.
E. Comparison of Technological Characteristics
There are no technological differences between the predicate and proposed device. Both the proposed and predicate Breastboard are comprised of a Base, Back Support, and Bottom Stop. Both devices consist of High Angle and Low Angle Supports that allow elevation from 5 to 25° in 2.5 degree increments. The Overhead Arm Positioner adjusts longitudinally on the Back Support via a locking assembly.
F. Non-Clinical Testing
To add MR indications to the Breastboard and Overhead Arm Positioner (MTM410), the device was tested for MR safety and compatibility in accordance with ASTM Standard F2052-15. Testing was also completed using ASTM Standards F2213-06 and F2119-07 as guidance. The device passed the acceptance criteria for magnetically induced torque and magnetically induced displacement force and demonstrate that the device is safe for use in field strengths of 1.5 T and 3.0 T. Image artifact was observed, with the worst case artifact occurring near the location of the locking knob on the Breastboard. Information regarding size of this artifact has been included in the Instructions for Use. In addition to MR safety testing, other nonclinical testing demonstrated that the differences in technological characteristics did not raise any new issues of safety or effectiveness.
Biocompatibility testing was completed for patient-contacting materials in accordance with ISO 10993-5:2009 and ISO 10993-10:2010. The Breastboard and Overhead Arm Positioner is intended for limited contact duration (