(36 days)
Not Found
No
The device description and performance studies focus on mechanical immobilization and positional accuracy, with no mention of AI/ML algorithms for image analysis, treatment planning, or other functions. The mention of "camera systems" for SGRT refers to the input method, not an AI/ML processing component within the device itself.
No
The device is described as an "Immobilization System" used to position and/or immobilize patients undergoing radiation therapy, and for image acquisition to support treatment planning. It does not actively treat or diagnose a disease.
No
The device is an immobilization system used to position and/or immobilize patients during radiation therapy and image acquisition for treatment planning, not to diagnose a medical condition.
No
The device description clearly outlines physical components like baseplates, bowls, locking levers, pins, and thermoplastic masks, which are hardware used for patient immobilization.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Solstice and Solstat Immobilization Systems are physical devices used to position and immobilize patients during radiation therapy and image acquisition. They do not analyze biological specimens.
- Intended Use: The intended use clearly states positioning and immobilization for radiation therapy and image acquisition to support treatment planning. This is a physical support and positioning function, not an in vitro diagnostic function.
- Device Description: The description details the mechanical components and how they are used to hold the patient in place. There is no mention of analyzing biological samples.
Therefore, the Solstice and Solstat Immobilization Systems fall under the category of medical devices used for patient positioning and support, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
-
Solstice™ SRS Immobilization System (when used with customizable cushion):
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning. -
Solstice™ SRS Immobilization System (when used with headrest):
The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning. -
Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:
The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.
Product codes (comma separated list FDA assigned to the subject device)
IYE, LNH
Device Description
The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.
The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.
The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.
The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR) Imaging
Anatomical Site
head, brain, and neck
Indicated Patient Age Range
adult and pediatric patients
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)
Non-clinical testing was completed to confirm that the proposed devices are as safe and effective as the predicate devices and to confirm that the changes in technological characteristics do not raise any new issues of safety or effectiveness.
For the Solstat Device, a scientific rationale was used to address RF heating, magnetically induced torque, and magnetically induced displacement force. The Solstat device was tested for image artifact using ASTM Standard F2119-07 as guidance and is considered MR Safe.
For the Solstice Device, non-clinical testing using camera systems was done to substantiate the use for Stereotactic Radiosurgery (SRS) and Stereotactic Radiotherapv (SRT). Based on data obtained we can state that intrafraction movement during a 5-minute scanning window to the 99.73% Confidence Interval is less than 1.000mm. Additionally, based on the data obtained, we can state that intrafaction movement during a 30 minute scanning the 95.45% confidence intervals is less than 1mm.
Therefore, the Tilting Head Fixation System appropriately immobilizes a patient for SRS/SRT such that the intrafractional shifts are less than 1mm within a 5-mintute window with 99.73% confidence, and within a 30-minute window with 95.45% confidence.
Based on testing with VisionRT's AlignRT system, Solstat, and the Open-Face thermoplastic mask can be used for Surface Guided Radiation Therapy (SGRT) as the Region of Interest (ROI) is able to be seen by the camera system.
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.
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September 7, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and most prominent.
MEDTEC Inc. dba CIVCO MEDICAL SOLUTIONS % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313
Re: K182079
Trade/Device Name: Solstice™ SRS Immobilization System; Solstat™ Immobilization System; Solstice™ Thermoplastic Mask Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE, LNH Dated: July 31, 2018 Received: August 2, 2018
Dear Mr. Job:
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jeff Ballew
for Robert A. 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) K182079
Device Name
(1 & 2) Solstice™ SRS Immobilization System (3) Solstat™ Immobilization System ; Solstice™ Thermoplastic Mask
Indications for Use (Describe)
- Solstice™ SRS Immobilization System (when used with customizable cushion):
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon treatments. The device is also used during image acquisition. including Computed Tomography (CT), to support treatment planning.
- Solstice™ SRS Immobilization System (when used with headrest):
The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.
- Solstat™ Immobilization System & Solstice™ Thermoplastic Mask:
The device is indicated to position and/or immobilize adult and pediatic patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.
| 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 logo for CIVCO Radiotherapy. The logo is in blue and consists of the word "CIVCO" in a sans-serif font, with a small blue circle above the "V". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
Section 5 - 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 Newgren, Regulatory Specialist
Telephone: 319-248-6650, Fax: 877-613-6300
alena.newgren@civcort.com |
| Date Summary Prepared: | May 21, 2018 |
| Trade Name: | Solstice™ SRS Immobilization System; Solstat™
Immobilization System; Solstice™ Thermoplastic Mask |
| Common Name: | Tilting Head Fixation System; Static Head Fixation System;
Open-Face Thermoplastic Mask |
| 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 proposed devices are substantially equivalent to the following predicate devices:
| Predicate Devices | Manufacturer |
|---|---|
| Systems Prone Head and Neck Immobilization System included in | |
| CDR Systems Precision Patient Positioning System (K122888) | CDR Systems, Inc. |
The purpose of this 510(k) is to 1) release new SRS/SRT/SGRT compatible system, 2) and 2) identify intended use statements for the proposed devices. CIVCO Radiotherapy has not submitted any prior submissions for the proposed devices.
C. Device Descriptions
The Tilting Head Fixation (Solstice) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and the locking level
www.CivcoRT.com
Corporate Office | 2303 Jones Boulevard Suite B | Coralville, IA 52241 | USA | office +1 (319) 248.6757 | info@CivoRT.com
Global Sales Office | 1401 8th Street SE | Orange City, IA 51041 | USA | office +1 (712) 737.8688 | fax +1 (877) 613.6300
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Image /page/4/Picture/0 description: The image shows the logo for CIVCO Radiotherapy. The logo is in blue and features the word "CIVCO" in a bold, sans-serif font. A small blue circle is placed above the "V" in CIVCO. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
allows the bowl to be tilted up to 10º in relation to the baseplate at infinite intervals. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can immobilize the patient to under 1 millimeters. The provider can correct the patient position for simulation and treatments by tilting the device.
The Static Head Fixation (Solstat) device is comprised of a baseplate and bowl with a locking lever. The bowl is permanently attached to the baseplate and cannot be tilted. The baseplate is attached to the treatment or simulation couch top or overlay by pins. When used with customizable cushion and thermoplastic mask, the system can reproduce the patient position to under 3 millimeters within a treatment cycle.
The Open-Face Thermoplastic mask is comprised of a thermoplastic mask bonded with a frame. The frame has five swivel clamps that allow secure attachment onto either the Solstice or Solstat device. When heated, the thermoplastic mask can be formed around the patient anatomy and allows the Region of Interest (ROI) to be capture by camera systems, allowing Surface Guided Radiation Therapy to occur via camera systems. The same mask will be used throughout the course of the treatment. The Open-Face style mask is ideal for Surface Guided Radiation Therapy (SGRT) via camera systems.
The Solstice Immobilization device and Solstat Immobilization device are reusable devices that are provided non-sterile. Solstat and Solstice thermoplastic are single-patient reusable and is provided non-sterile and manufactured of non-magnetic materials. The devices are used in a healthcare facility/hospital. All devices are intended to be used on adult and pediatric patients. The following models are included in this submission:
| Device
| Family | Part No. | Device Name |
|---|---|---|
| Tilting Head | ||
| Fixation | ||
| System | CHS03 | Solstice SRS Immobilization System |
| with Type-S Base | ||
| CHS04 | Solstice SRS Immobilization System | |
| with Posi Style Base | ||
| Static Head | ||
| Fixation | ||
| System | CHS05 | |
| CHS06 | Solstat Immobilization System with Posi | |
| Style Base | ||
| Open Face | ||
| Thermoplastic | ||
| Mask | MTAPCIN1832SG | |
| MTAPCIN1832SG | Thermoplastic Mask, Narrow Frame, Open | |
| Face |
www.CivcoRT.com
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Image /page/5/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is in blue and features the word "CIVCO" in a stylized font. The "V" in CIVCO has a light blue circle above it. Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
D. Indications for Use/Intended Use Statements
Indications for Use:
Solstice™ SRS Head Immobilization System (when used with customizable cushion): The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.
Solstice™ Head Immobilization System (when used with headrest):
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT), to support treatment planning.
Solstat Head Immobilization System and Open-Face Thermoplastic Mask:
The device is indicated to position and/or immobilize adult and pediatric patients undergoing radiation therapy of the head, brain, and neck, including Surface Guided Radiation Therapy (SGRT) and electron, photon, and proton treatments. The device is also used during image acquisition, including Computed Tomography (CT) Magnetic Resonance (MR) Imaging, to support treatment planning.
Device-Specific Intended Use:
Solstice SRS Head Immobilization:
The device is intended to immobilize the patient by encapsulating the head and provide corrective tilting of the head for treatment and simulation.
Solstat Head Immobilization System and Open-Face Thermoplastic Mask: The device is intended to immobilize the patient by encapsulating the head for treatment and simulation such as MRI.
E. Comparison of Technological Characteristics
Technological characteristics that have changed between the proposed and predicate devices include changes in design and materials. The proposed Solstice Tilting Head Fixation System and predicate allow SRS/SRT and use headrests and thermoplastic masks, but the proposed Tilting device allows for infinitely adjustable angles from -5° to +5°, either used with customizable cushion (for SRS/SRT) or reusable headrest, and open-face mask to be used with camera systems and SGRT. Both the Solstat Static Head Fixation System and predicate system allow for patient immobilization, but the proposed device allows for use of customizable cushion and open-face mask to be used with camera
www.CivcoRT.com
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Image /page/6/Picture/0 description: The image shows the CIVCO Radiotherapy logo. The logo is blue and features the word "CIVCO" in a bold, sans-serif font. A small blue circle is placed above the "V" in "CIVCO". Below the word "CIVCO" is the word "Radiotherapy" in a smaller, sans-serif font.
systems and surface guided radiation therapy(SGRT). Different materials were used to manufacture the proposed devices and were selected with MR safety and effectiveness considerations.
| # | Feature | Predicate Device
(CDR Systems Prone
Head and Neck
Immobilization System) | CIVCO Device
(Solstice SRS
Immobilization System) | CIVCO Device (Solstat
Immobilization System
and Open-Face
Thermoplastic Mask) |
|---|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Indications for
Use | CDR Systems Precision
Patient Positioning System is
indicated to assist in the
proper positioning of patients
for radiation therapy and
radiosurgery simulation and
treatment including electron,
photon and proton
treatments. Place a clean
sheet over the device to
ensure a clean device from
patient to patient. | Tilting Head Immobilization
System (when used with
customizable cushion):
The device is indicated to
position and/or immobilize
adult and pediatric patients
undergoing radiation therapy
of the head, brain, and neck,
including Stereotactic
Radiosurgery (SRS),
Stereotactic Radiotherapy
(SRT), Surface Guided
Radiation Therapy (SGRT)
and electron, photon, and
proton treatments. The
device is also used during
image acquisition, including
Computed Tomography (CT),
to support treatment
planning.
Tilting Head Immobilization
System (when used with
headrest):
The device is indicated to
position and/or immobilize
adult and pediatric patients
undergoing radiation therapyof the head, brain, and neck,
including Surface Guided
Radiation Therapy (SGRT)
and electron, photon, and
proton treatments. The
device is also used during
image acquisition, including
Computed Tomography (CT),
to support treatment
planning. | The device is indicated to
position and/or immobilize
adult and pediatric patients
undergoing radiation therapy
of the head, brain, and neck,
including Surface Guided
Radiation Therapy (SGRT)
and electron, photon, and
proton treatments. The device
is also used during image
acquisition, including
Computed Tomography (CT)
Magnetic Resonance (MR)
Imaging, to support treatment
planning. |
| 2 | Classification | Class II (K122888) | Class II | Class II |
| 3 | Features | A headboard that attaches to
a baseplate that locates onto
a couch tabletop, onto a CDR | The Tilting Head Fixation
System can be attached to
the treatment or simulation | The Static Head Fixation
System can be attached to
the treatment or simulation |
| # | Feature | Predicate Device
(CDR Systems Prone
Head and Neck
Immobilization System) | CIVCO Device
(Solstice SRS
Immobilization System) | CIVCO Device (Solstat
Immobilization System
and Open-Face
Thermoplastic Mask) |
| | | Couch Overlay or Couch
Extension and provides
adjustable positive and
negative tilt for patient's
head. Can be used for
support of a patient's head in
supine or prone position. A
low temperature
thermoplastic mask can be
used for additional
immobilization. | couch, extension, or overlay
along with other optional
positioning and
immobilization devices and
accessories. The
thermoplastic mask is
attached onto the device and
is molded to the patient's
facial anatomy. The patient
lies directly on the treatment
surface in the supine
position. | couch, extension, or overlay
along with other optional
positioning and
immobilization devices and
accessories. The
thermoplastic mask is
attached onto the device and
is molded to the patient's
facial anatomy. The patient
lies directly on the treatment
surface in the supine position. |
| 4 | Materials | Carbon fiber/epoxy laminate
material with foam core.
MR Safe - Kevlar/epoxy
laminate material with foam
core. | Carbon Fiber, Black Acetal,
Kydex-T, Nylon,
Polycarbonate | Static Head Fixation(MR):
Kydex-T, Nylon,
Polycarbonate
Thermoplastic Mask(MR):
Polycaprolactone,
Polycarbonate |
| 5 | Device Body
Contact
Category | Limited contact duration (