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510(k) Data Aggregation
(177 days)
General Positioning Devices: The device is indicated to aid in supporting and positioning adult and pediatric patients undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. Devices include Couchtops, Cushions, Cushions, and Accessories. The following are other positioning devices:
Head. Neck. and Shoulders Device is indicated to aid in supporting, positioning, and/or immobilization of adult and pediatric patients undergoing radiation therapy of the head, brain, neck, and spine including radiosurgery and electron, photon, and proton treatments. The device is also used during image acquisition to support treatment planning. Devices include Overlays, Extensions, Thermoplastic Masks, and Cushions.
Support Garments: The device is indicated to aid in supporting adolescents undergoing radiation therapy including electron, photon treatments. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
Breast Positioning Devices: 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. The device is also used during image acquisition to support treatment planning. The device is not intended for use with patients under 12 years of age.
The CIVCO Positioning and Immobilization devices have been used for many years and were previously cleared under other 510(k) is to have these identical Class II products cleared for use in Proton Therapy environment.
The Head, Neck, and Shoulder Devices are used to treat cancer of the head, neck, brain and spine. Organs that are located in these anatomical regions are applicable.
The General Positioning Devices are used to treat cancer of the spine, thorax, breast, abdomen, pelvis and prostate. Organs that are located in these anatomical regions are applicable.
The Support Garments are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The Breast Positioning Devices are used to treat cancer of the breast, thorax and abdominal area. Organs that are located in these anatomical regions are applicable.
The devices are intended for therapeutic treatment (including proton, photon, and electron beam therapy) and diagnostics (including CT and MR as indicated). The devices will be used in a variety of types of external beam radiation therapy including Intensity Modulated Proton Therapy (IMPT), Intensity Modulated Radiation Therapy (IMRT), Pencil Beam Proton Therapy (PBPT), Image Guided Radiation Therapy (IGRT), Volumetric Modulated Arc Therapy (VMAT), Stereotactic Radiosurgery (SRS), Stereotactic Radiotherapy (SRT), Stereotactic Body Radiation Therapy (SBRT), and Craniospinal Treatment.
The intended users of the devices are radiation oncology therapists, medical physicists, and oncologists. The provider selects the appropriate equipment based on a patient's individual clinical goals and unique constraints.
Thermoplastic mask, AccuForm Cushion, and Support Garment devices are single patient use. All devices are non-powered and static.
The subject devices are reusable or disposable as provided in product labeling, provided non-sterile, and are used in a healthcare facility/hospital. The devices are labeled for MR safety, as applicable.
This document is a 510(k) Pre-market Notification for medical devices, specifically Proton Positioning and Immobilization Devices. It is a submission to the FDA to demonstrate substantial equivalence to legally marketed predicate devices, primarily for the modified intended use/indications for use to include proton treatment and pediatric/adolescent use.
The document does not describe a study involving an algorithm or artificial intelligence (AI) with acceptance criteria in the traditional sense of a computer-aided diagnosis (CAD) or AI-driven diagnostic device. Instead, it describes non-clinical performance testing for physical medical devices. Therefore, many of the requested details about acceptance criteria, ground truth establishment, expert consensus, and multi-reader multi-case (MRMC) studies are not applicable to this type of device submission.
Here's an interpretation of the relevant information provided, framed as closely as possible to your request for acceptance criteria and study proof for a medical device:
Device Type: Physical Medical Devices (Positioning and Immobilization for Radiation Therapy)
Purpose of Submission: To expand the Indications for Use of existing, previously cleared devices to include proton treatment and pediatric/adolescent use.
1. Table of "Acceptance Criteria" (Performance Goals) and Reported Device Performance
Given that this is a 510(k) for physical positioning devices, the "acceptance criteria" are not quantitative performance metrics like sensitivity/specificity for an AI algorithm. Instead, they are functional performance goals related to the physical interaction with the proton beam and patient. The "reported device performance" is the confirmation that these functional goals are met.
| Acceptance Criteria (Performance Goal) | Reported Device Performance (Conclusion from Testing) |
|---|---|
| Primary Goal: Device will not perturb or impact the proton beam in a way that cannot be accounted for in the facility's proton treatment planning process. | Devices evaluated, including edge effects, were considered safe and effective for use with proton. The performance tests confirmed that these devices would not perturb or impact the proton beam in a way that cannot be accounted for in the proton treatment planning process. (No recognized threshold for proton attenuation; criteria based on non-perturbation given facility's planning capabilities). |
| Maintain safety and effectiveness with expanded use (proton treatment, pediatric/adolescent use). | The risk analysis confirmed the safety and effectiveness of similar devices used for pediatrics/adolescents and Proton Therapy, ensuring no new issues are raised. CIVCO devices were found to be safe and effective for use with adults, pediatrics, and/or adolescents in the Proton Therapy environment. |
| No additional biocompatibility issues with expanded use. | All devices are previously cleared and manufactured with the same or substantially equivalent material that was previously cleared, thus no additional biocompatibility testing is required. |
| Devices used in MRI environment maintain their MR safety. | Devices labeled for use in an MRI environment were previously cleared by predicate 510(k)s included in this submission. Therefore, no additional MR testing is required. |
| Mechanical function without software/electronics. | Confirmed: The devices are mechanical without the use of software or electronics. |
| Limited contact duration ( |
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