(242 days)
Not Found
No
The device descriptions and intended uses focus solely on physical positioning aids for radiation therapy and imaging. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device's intended use is to aid in patient positioning during radiation therapy and image acquisition for treatment planning, not to directly treat or diagnose a disease or condition itself.
No
The device description indicates that the FlexBoard™, EagleBoard™, and BreastBoard SX™ are designed to aid in the positioning of patients for radiation therapy and image acquisition for treatment planning. They are physical aids, not tools for diagnosing diseases.
No
The device description clearly details physical components such as baseplates, locking systems, breast treatment modules, hand grips, and adjustable features, indicating it is a hardware device used for patient positioning.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used to aid in the positioning of patients during radiation therapy and image acquisition for treatment planning. This is a physical positioning function, not a diagnostic test performed on biological samples.
- Device Description: The device descriptions detail physical baseplates and accessories designed for patient positioning and support. There is no mention of reagents, assays, or any components used to analyze biological specimens.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for diagnosis, monitoring, or screening of diseases
The devices described are medical devices used in the context of radiation therapy and medical imaging, specifically for patient positioning. They are not designed to perform diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The FlexBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
The EagleBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The 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 BreastBoard SX™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
Product codes
IYE, LNH
Device Description
FlexBoard™: The FlexBoard™ base is a lightweight baseplate with a locking system specially designed to host multiple types of breast treatment modules, in order to facilitate the positioning of the patient for breast and chest treatments. Multiple variants of FlexBoard™ breast treatment modules are available. To enable enhanced treatment possibilities, the 122930 EagleBoard™-2 Base device can be used with the 172120 FlexBoard™ BTM-EX breast module as part of the FlexBoard™ setup.
EagleBoard™: The EagleBoard™ devices consist of baseplates with a tapered design, and accessories, such as hand grips, which can be used together to support the positioning of the patient for breast and chest treatments. The 122930 EagleBoard™-2 Base device can be utilized both as part of a FlexBoard™ setup, or individually on the treatment table. The 122950 EagleBoard™-2 Base, MR and 122850 EagleBoard™ MR devices are intended to be utilized individually on the treatment table.
BreastBoard SX™: The BreastBoard SX™ is a lightweight baseplate designed to facilitate the positioning of patients for breast and chest treatments. The BreastBoard SX™ is adjustable and can be secured at various tilt positions. It features an adjustable bottom-stop, arm support possibilities for positioning the patient's arms above their head, place for a head rest, and fixation points for thermoplastic masks.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR)
Anatomical Site
breast and chest region
Indicated Patient Age Range
18 and older
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Mechanical non-clinical testing and other performance data demonstrated that the devices performed as intended and that the differences in technological characteristics did not raise any new issues of safety or effectiveness.
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.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
MacroMedics BV % Elizabeth Hajos QARA Manager Oostbaan 670 Moordrecht, South Holland 2841 ML The Netherlands
Re: K213439
Trade/Device Name: FlexBoard™, EagleBoard™, BreastBoard SXTM Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: May 23, 2022 Received: May 27, 2022
Dear Elizabeth Hajos:
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 medical devices and radiation-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
Julie Sullivan, Ph.D. Assistant Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213439
Device Name FlexBoard™ EagleBoard™ BreastBoard SXTM
Indications for Use (Describe)
The FlexBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
The EagleBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The 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 BreastBoard SX™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a stylized letter "m" inside a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font.
Product Name - Patient Positioning Devices 510(k) Summary; K213439
1. Submitter Details
Name: MacroMedics BV
Address: Oostbaan 670, 2841ML Moordrecht, The Netherlands
Contact Person: Elizabeth Hajos
Phone Number: +31 (0)182 389777
Prepared: 23-JUN-2022
2. Device Details
Trade Name: FlexBoard™, EagleBoard™, BreastBoard SX™
Common Name: Patient Positioning Devices
Classification: Class II
Requlation: EagleBoard™: 21 CFR 892.5050, 21 CFR 892.1000 FlexBoard™, BreastBoard SX™: 21 CFR 892.5050
Regulation Name: Medical Charged-Particle Radiation Therapy System, System, Nuclear Magnetic Resonance Imaging
Product Code: EagleBoard™: IYE, LNH FlexBoard™, BreastBoard SX™: IYE
Review Panel: Radiology
3. Predicate Device Details
| 510k
Number | Device Name | Manufacturer | New Device for
which Substantial
Equivalence is
claimed |
| ---------------- | ------------- | -------------- | ------------------------------------------------------------------ |
|---|
4
Image /page/4/Picture/0 description: The image shows the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized letter "m" enclosed in a circle on the left, followed by the company name "macromedics" in a bold, sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in a smaller, lighter font.
| K211001 | C-Qual M™
Breastboard;
Monarch™ Overhead
Arm Positioner | MEDTEC, Inc. d/b/a "CIVCO
Medical Solutions" and
"CIVCO
Radiotherapy" | FlexBoard™
EagleBoard™ |
|---------|------------------------------------------------------------------|--------------------------------------------------------------------------------|---------------------------|
| K142420 | BreastBoard LX™ | MacroMedics BV | BreastBoard SX™ |
4. Subiect Device Description, Intended Use, Technological Characteristics, Substantial Equivalence & Conclusion
4.1 Device (1) - FlexBoard™
| Item code | Brand Name | Device Identifier |
|---|---|---|
| 172110 | FlexBoard™ base | 08720168160492 |
| 172120 | FlexBoard™ BTM-EX | 08720168160508 |
| 173660 | FlexBoard™ BTM-LX | 08720168160966 |
| 174630 | FlexBoard™ BTM-SX | 08720168160744 |
| 122300 | Upper AS TS/MBLX, set/2 | 08719425704005 |
| 122330 | Cranial AS for BBLX/TS, set/2 | 08719425704029 |
| 125300 | Rigid UAS set/2 | 08719425704319 |
| 125320 | Adjust. UAS set/2 | 08719425704326 |
Intended Use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Indications for Use: The FlexBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
Description
The FlexBoard™ base is a lightweight baseplate with a locking system specially designed to host multiple types of breast treatment modules, in order to facilitate the positioning of the patient for breast and chest treatments. Multiple variants of FlexBoard™ breast treatment modules are available. To enable enhanced treatment possibilities, the 122930 EagleBoard™-2 Base device can be used with the 172120 FlexBoard™ BTM-EX breast module as part of the FlexBoard™ setup.
Discussion of Indications for Use
The Indications for Use of the FlexBoard™ device and the predicate device differ in that the FlexBoard™ device is indicated for use with patients aged 18 and above, whilst the predicate device is indicated for use with patients aged 12 and above. This does not affect the safety or effectiveness of the device as breast and chest tumors do not typically occur in patients younger than 18 years and therefore the device is indicated for the typically appropriate population. The indications also differ in that, whilst the FlexBoard™ device is only indicated for use in Computed Tomography (CT)
5
Image /page/5/Picture/0 description: The image shows the logo for "macromedics". The logo consists of a stylized letter "m" enclosed in a circle on the left, followed by the word "macromedics" in a sans-serif font. Below the word "macromedics" is the phrase "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The color of the logo and text is a light blue.
imaging systems, the predicate device is indicated for use in both Computed Tomography (CT) and Magnetic Resonance (MR) imaging systems. This difference only indicates that there are fewer possibilities for the use of the FlexBoard™ device in imaging systems than there are with the predicate device, but this does not affect the safety or effectiveness of the device is used as labelled.
Comparison of technological characteristics
The designs of the MacroMedics subject device and the predicate device are equivalent in shape, use and functionality. Both the MEDTEC, Inc. d/b/a "CIVCO Medical Solutions" and "CIVCO Radiotherapy" device and the MacroMedics devices feature a lightweight base plate which facilitates the placement of a breast treatment module and other devices and accessories. Both the predicate device and the FlexBoard™ device aid in the overhead-arm-positioning of the patient for breast and chest treatment. The technological characteristics differ in that the predicate device is indicated for use in the MRI environment whilst the FlexBoard™ device is not due to differences in materials. This difference has been addressed in the previous section.
Performance Data
Mechanical non-clinical testing and other performance data demonstrated that the devices performed as intended and that the differences in technological characteristics did not raise any new issues of safety or effectiveness.
Substantial equivalence summary
MacroMedics claims the proposed FlexBoard™ devices to be substantially equivalent to the devices previously cleared by the FDA in the 510(k) specified above. These devices are also cleared for use in a radiotherapy environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs and intended uses.
Conclusion
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.
4.2 Device (2) - EagleBoard™
Model / Variants
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 122850 | EagleBoard™ MR | 08719425704159 |
| 122860 | T-Grip for EagleBoard™ MR | 08719425702193 |
| 122870 | U-Grip for EagleBoard™ MR | 08719425702209 |
| 122930 | EagleBoard™-2 Base | 08720168160515 |
| 122940 | EagleBoard™-2 M-Grip | 08720168160522 |
6
Image /page/6/Picture/0 description: The image shows the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized "M" symbol on the left, followed by the company name "macromedics" in a bold, sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in a smaller font. The entire logo is in a light blue color.
| 122950 | EagleBoard™-2 Base, MR | 08720168161406 |
|---|---|---|
| 122960 | EagleBoard™-2 Adaptor HS RE | 08720168160539 |
| 122970 | EagleBoard™-2 M-Grip, MR | 08720168161413 |
Intended Use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Indications for Use: The EaqleBoard™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, and electron treatments. The 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.
Description
The EagleBoard™ devices consist of baseplates with a tapered design, and accessories, such as hand grips, which can be used together to support the positioning of the patient for breast and chest treatments. The 122930 EagleBoard™-2 Base device can be utilized both as part of a FlexBoard™ setup, or individually on the treatment table. The 122950 EagleBoard™-2 Base, MR and 122850 EagleBoard™ MR devices are intended to be utilized individually on the treatment table.
Discussion of Indications for Use
The Indications for Use of the EagleBoard™ device and the predicate device differ in that the EagleBoard™ device is indicated for use with patients aged 18 and above, whilst the predicate device is indicated for use with patients aged 12 and above. This does not affect the safety or effectiveness of the device as breast and chest tumors do not typically occur in patients younger than 18 years and therefore the device is indicated for the typically appropriate population.
Comparison of technological characteristics
The designs of the MacroMedics subject device and predicate device are equivalent in shape, construction, materials and functionality. Both the predicate device and the EagleBoard™ devices aid in the overhead-arm-positioning of the patient for breast and chest treatment. The EagleBoard™ devices differ from the predicate device in that the 122950 EagleBoard™-2 Base, MR and 122850 EaqleBoard™ MR devices are designed to be used only individually on the treatment table.
Performance Data
Mechanical non-clinical testing and other performance data demonstrated that the devices performed as intended and that the differences in technological characteristics did not raise any new issues of safety or effectiveness.
7
Image /page/7/Picture/0 description: The image shows the logo for Macromedics, a company that provides solutions in radiotherapy. The logo consists of a stylized "m" symbol in a circle, followed by the company name "macromedics" in a sans-serif font. Below the company name is the tagline "SOLUTIONS IN RADIOTHERAPY" in a smaller font. The logo is in a light blue color.
Substantial equivalence summary
MacroMedics claims the proposed EagleBoard™ devices to be substantially equivalent to the devices previously cleared by the FDA in the 510(k) specified above. These devices are also cleared for use in a radiotherapy and/or the MR environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs and intended uses.
| Selling code | Brand name | Device Identifier |
|---|---|---|
| 172410 | BreastBoard SXTM | 08719425707174 |
| 125300 | Rigid UAS, set/2 | 08719425704319 |
| 125320 | Adjust. UAS set/2 | 08719425704326 |
| 173510 | Low Bridge Support, RE | 08719425705446 |
| 173530 | High Bridge Support, RE | 08719425702759 |
| 121180 | MaxSupportTM Extender | 08719425703978 |
| 122590 | BottomStop Adaption | 08719425702155 |
| 172420 | BreastBoard SXTM set/2 Profiles | 08719425702254 |
4.3 Device (3) - BreastBoard SX™
Intended Use: Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Indications for Use: The BreastBoard SX™ is indicated to aid in the positioning of patients 18 and older undergoing radiation therapy of the breast and chest region, including photon, proton, and electron treatments. The device is also used to position the patient during image acquisition to support treatment planning including in Computed Tomography (CT) imaging systems.
Description
The BreastBoard SX™ is a lightweight baseplate designed to facilitate the positioning of patients for breast and chest treatments. The BreastBoard SX™ is adjustable and can be secured at various tilt positions. It features an adjustable bottom-stop, arm support possibilities for positioning the patient's arms above their head, place for a head rest, and fixation points for thermoplastic masks.
Discussion of Indications for Use
The Indications for Use of the BreastBoard SX™ device and the predicate device differ in that the Indications for the BreastBoard SX™ define an appropriate population of patients 18 and older underqoing radiation therapy of the breast and chest region, and specify image acquisition to support treatment planning, whilst the Indications of the predicate device are more general. This does not affect the safety and effectiveness of the device but only serves to outline the appropriate patient population and clinical uses more specifically.
8
Image /page/8/Picture/0 description: The image shows the logo for "macromedics", a company that provides solutions in radiotherapy. The logo consists of a stylized "m" symbol on the left, followed by the company name in a sans-serif font. Below the company name, the tagline "SOLUTIONS IN RADIOTHERAPY" is written in smaller letters. The color of the logo and text is a light blue.
Comparison of technological characteristics
The designs of the MacroMedics subject device and predicate device are equivalent in design, materials, construction and functionality. Both the predicate device and the BreastBoard SX™ device aid in the overhead-arm-positioning of the patient for breast and chest treatment. The technological characteristics differ in that the BreastBoard SX™ has fewer adjustment possibilities than the predicate device.
Performance Data
Mechanical non-clinical testing and other performance data demonstrated that the devices performed as intended and that the differences in technological characteristics did not raise any new issues of safety or effectiveness.
Substantial equivalence summary
MacroMedics claims the proposed BreastBoard SX™ devices to be substantially equivalent to the devices previously cleared by the FDA in the 510(k) specified above. These devices are also cleared for use in a radiotherapy environment.
MacroMedics claims this equivalence because the proposed devices have equivalent designs and intended uses.
Conclusion
The substantial equivalence comparison in this premarket submission together with the additional provided information has demonstrated substantial equivalence to the predicate devices with respect to use, safety and effectiveness for their intended and indicated use.