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510(k) Data Aggregation
(211 days)
Patient Positioning Devices
Positioning of the patient during radiotherapy and radio diagnostics, including MR where indicated.
Baseplates and headsupports which are designed to position the head and neck and on which thermoplastic masks can be attached to fix the head and neck of the patient. Baseplates can be positioned on the couch using CouchStrips. The ExaFix-IMRT baseplates are attached onto the couches and extent the head of the patient from the couch at the cranial side. Various accessories offered for specific patient head and neck set-ups. The different headsupports are designed for different head positions. Different blocks are available for lifting the head, wedges and ExaTilt to incline the head. For the Exafix-5 baseplate an acrylic alternative (Exafix-5a) is available for identical head- and neck positioning in the MR environment. For the IMRT baseplates a glassfiber alternative (Exafix IMRT baseplate MR) is available for identical head- and neck positioning in MR environment. The MR safe devices have a 3Pin slot on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment.
The BreastBoard LX and ThoraxSupports are devices which position the breast and lung area of a patient. The arms are placed above the head and a headsupport can be placed into the baseplate. The backsupport of the BreastBoard LX can be tilted, to tilt the upperpart of the patient´s body for other treatment possibilities. The ThoraxSupport does not have this tilting possibility. Various accessories are provided for positioning of the arms or the thorax. For the ThoraxSupport a glassfiber MR alternative (Thoraxsupport MR) is available for identical lung and thorax positioning in MR environment. The MR safe device has a 3Pin slot on the bottomside and is compatible with the glassfiber 3Pin CouchStrip. The MR unsafe devices are not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment.
Baseplates which are designed to position the pelvic or (lower) extremities of a patient. The Pelvic Prone Board positions the patient in prone position with the arms in cranial direction, belly is placed in an aperture. The shape of the pelvic prone board moves the small bowel and reduces the irradiated small bowel volume while treating the lower abdomen. The LEPS position the legs on a KneeSupport which can be tilted and the feet are positioned in a FeetSupport. Both baseplates can be positioned on the couch using fixation rails. For the Pelvic Prone Board a glassfiber MR alternative (Pelvic Prone Board MR) is available for identical positioning in MR environment. The LEPS is a MR safe device. The MR safe devices have 3Pin slots on the bottomside and are compatible with the glassfiber 3Pin CouchStrip. The MR unsafe device is not compatible with the 3Pin MR safe CouchStrip, which prevents the use in the wrong environment.
The SBRT systems (Stereotactic Body Radiation Therapy Systems) are devices which can position various bodyparts of the patient. The MacroMedics SBRT systems are carbon fiber baseplates over which various plastic bridges can be placed with attached accessories to position the patient's body. The SBRT OmniBoard does have an inclination possibility of the upper body. The accessories are identical, but the baseboards are different, each baseboard has slightly different features for customer preferences. The patient set-up is similar on all boards, supine position with the arms mainly positioned above the patient's head. Bottom, knees and feet positioned in indexed positions. Vacuumcushions are used for positioning by moulding the cushion around the patients and then take the air out with a vacuumpump. The contrashape of the patient stays in the cushion during the treatment. CouchStrips are strips which connect the patient positioning device onto the couch at indexed positions. Depending on the indexing system of the couch, width of the couch, preference in transverse adjustability and required MR safety different types are available. The SBRT carbon fiber baseplates are MR unsafe and have a 2Pin CouchStrip slot. They are not compatible with the 3Pin MR CouchStrip, which prevents the use in the wrong environment. The CouchStrips for MR are made out of MR safe materials and have 3pins. MR unsafe devices have a 2Pin CouchStrip slot on the bottomside and are not compatible with this 3Pin MR CouchStrip. The Vacuumcushions are MR safe.
MacroMedics thermoplastic masks are developed in order to position the individual patient. The thermoplastic masks are placed in a waterbath of about 70 degrees where they become flexible. After drying and cooling, they make a perfect contramould of the bodypart which needs to be positioned. Plastic profiles attach the mask onto the baseplate. Masks and profiles are available in many different shapes, in order to fit on different baseplates and bodyparts. DSPS offers a possibility to create a thermoplastic mask for both occipital- and facial areas for extra accurate positioning. Both masks are attached onto the DSPS cradle, and the DSPS cradle is attached onto the baseplate. MacroMedics thermoplastic masks with plastic profiles are MR safe.
This document describes a 510(k) premarket notification for "Patient Positioning Devices" by MacroMedics BV. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The acceptance criteria and the study that proves the device meets them are based on this claim of substantial equivalence.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet. Instead, the "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device.
The reported device performance is a direct comparison of technological characteristics and intended use.
| Acceptance Criteria (based on substantial equivalence) | Reported Device Performance |
|---|---|
| Equivalent Intended Use/Indications for Use: The device must have the same or similar intended use as the predicate device. | "Positioning of the patient during radiotherapy and radiodiagnostics, including MR where indicated." This is identical to the stated indications for use for all predicate devices referenced. |
| Equivalent Design: The device's design must be similar to the predicate device. | "The designs of the MacroMedics and predicate [system type] positioning systems are equivalent in shape, construction, materials and functionality." (Stated for Head and Neck, Lung and Thorax, Pelvic and Lower Extremities, and Thermoplastic systems). "The designs of the MacroMedics and predicate SBRT positioning systems are equivalent in construction, accessories, materials and functionality." |
| Equivalent Construction Materials: The materials used must be similar or new materials must be demonstrated to be equally safe and effective. | Comparisons are made (e.g., carbon fiber, PE foam, acrylic for head and neck; carbon fiber with plastic, aluminum, foam for lung and thorax; carbon fiber with plastic and foam for pelvic; thermoplastics for thermoplastic systems). For new materials like glass fiber (for MR extensions) and PU-foam (for headsupports), biocompatibility and MR safety are explicitly stated as having been "described in this 510(k)." MacroMedics CouchStrips are described as having "almost identical dimensions and materials" to CIVCO LokBars, with a carbon fiber alternative added. |
| Equivalent Functionality: The device must perform its function similarly to the predicate. | "Both the Sinmed devices and the MacroMedics devices are made out of carbon fiber, PE foam and acrylic." (Head and Neck) "Both the predicate and the MacroMedics SBRT devices are made out of carbon fiber baseplates with bridges of plastic..." (SBRT systems) "Both the predicate and the MacroMedics masks are made out of thermoplastics which are cut in shape and glued or welded into plastic injection moulded profiles." (Thermoplastic systems) |
| Equivalent Target Population: The device should be used for the same patient population. | "equivalent designs, intended uses, target population, patient positioning and used materials." (Repeated across all summaries). |
| Similar Position and Immobilization Characteristics: Even with small technological differences, the core function of patient positioning and immobilization must be consistent. | "Although small technological differences exist, these products have similar position and immobilization characteristics for use radiotherapy and radiodiagnostics." (Repeated across all summaries). |
| MR Safety where indicated: For devices claimed to be MR-safe, this must be demonstrated. | For MR-safe alternatives, the material (e.g., glass fiber) is specifically mentioned, and it's stated that "both the biocompatibility and the MR safety of these new materials have been described in this 510(k)." The design also incorporates features (e.g., 3Pin slots for MR safe CouchStrip, and incompatibility with MR unsafe CouchStrips) intended to prevent incorrect usage in MR environments. |
| Biocompatibility of new materials: Any new materials must be biocompatible. | Explicitly stated for new materials like glass fiber and PU-foam ("both the biocompatibility and the MR safety of these new materials have been described in this 510(k)."). |
2. Sample Size Used for the Test Set and Data Provenance
This is a design and feature comparison study, not a clinical or performance study with a "test set" in the sense of patient data. The "sample" here comprises the various devices produced by MacroMedics (ExaFix-5, ExaTilt, BreastBoard LX, SBRT EAMIS, etc.) and their respective predicate devices.
- Sample Size: Not applicable in the context of statistical sampling for a test set. All relevant MacroMedics devices for each category (Head and Neck, Lung and Thorax, Pelvic and Lower Extremities, SBRT, Thermoplastic) were compared against their identified predicate devices.
- Data Provenance: This is not a study involving patient data. The "data" are the specifications, designs, and material descriptions of the MacroMedics devices and the predicate devices. This information would be derived from internal engineering documents for the MacroMedics devices and publicly available or predicate device manufacturer information for the predicates. The country of origin for MacroMedics is The Netherlands. The study is a retrospective comparison of device characteristics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context refers to the characteristics and intended use of the predicate devices and the MacroMedics devices. This is established through engineering specifications, material composition, and regulatory filings. It does not require expert consensus on a test set of data points. The "experts" involved are the company's R&D, quality, and regulatory teams responsible for designing the device and preparing the 510(k) submission, and potentially an independent review by an MR safety expert or toxicologist if new materials were used and specific test reports were included in the full submission, but this is not detailed in the summary provided.
4. Adjudication Method for the Test Set
Not applicable. There is no test set of results requiring adjudication. The comparison is based on documented specifications and characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
Not applicable. This device is a physical patient positioning system, not an AI diagnostic or assistive device. Therefore, no MRMC study or AI-related effectiveness analysis was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is the established safety and effectiveness profile of the predicate devices, as determined by their prior FDA clearance (510(k) numbers are provided). For the MacroMedics devices, the "ground truth" is their design specifications, material composition, and intended function as described by the manufacturer. The comparison aims to show that these characteristics are sufficiently similar or improved without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not a machine learning or AI device.
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(161 days)
MRI PATIENT POSITIONING DEVICES
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
The CIVCO Patient Support Devices have been used for many years and were previously cleared under 510(k)'s. This 510(k) is to have these identical Class II products cleared for use in an MRI environment.
This 510(k) pertains to MRI Patient Positioning Devices, which are Class II devices intended to support and position patients during an MRI. The submission is for identical products previously cleared under other 510(k)s, now seeking clearance for use in an MRI environment.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
Key Finding: The provided document does not contain information about specific acceptance criteria or a study that proves the device meets those criteria, particularly in the context of performance metrics or clinical outcomes. This submission is a 510(k) Premarket Notification for Substantial Equivalence, which primarily focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical performance studies.
The document highlights the device's classification as Class II and its regulatory pathway via substantial equivalence to previously cleared predicate devices. The FDA's letter explicitly states: "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... to legally marketed predicate devices." This implies that the acceptance criteria are met by demonstrating equivalence to existing products, rather than through novel performance testing.
Therefore, many of the requested details about acceptance criteria and study particulars are not present in this type of submission.
Here's a breakdown based on the available information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) is substantial equivalence to predicate devices in terms of intended use, design, materials, and safety for use in an MRI environment. The document implies that the device is identical to previously cleared devices but is now seeking specific clearance for MRI compatibility.
- Reported Device Performance: The document does not provide quantifiable performance metrics or a study demonstrating specific device performance against a set of numerical acceptance criteria. The "performance" is implicitly demonstrated through the device's classification as "identical Class II products cleared for use in an MRI environment" (implying safety and functionality within that environment, likely based on material compatibility and design).
Acceptance Criteria Reported Device Performance Substantial equivalence to predicate devices for intended use and safety in MRI environment. The device (MRI Patient Positioning Devices) is deemed substantially equivalent to the listed predicate devices (e.g., K950866 MEDTEC Inc, Hip Fix; K080072 CIVCO Medical Solutions, MRI Patient Positioning Devices; K060737 SINMED Positioning Devices; K973842 MEDTEC Inc, Carbon Fiber Conformal Couch Top). The FDA's letter explicitly states a finding of substantial equivalence based on the provided 510(k) premarket notification. The devices are described as "identical Class II products cleared for use in an MRI environment," suggesting that their design, materials, and functionality are consistent with existing, cleared MRI-compatible positioning devices, thereby meeting the safety and efficacy standards for their intended use in MRI. Compliance with general controls and relevant special controls (if any) for Class II devices. The FDA letter reminds the submitter of compliance with general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration) and potential additional controls for Class II devices. The act of receiving the 510(k) clearance implies that the information submitted satisfies these regulatory requirements for market entry. -
Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission does not describe a test set or data provenance for a clinical performance study. The substantial equivalence is based on comparing the new device's characteristics to cleared predicate devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a passive patient positioning device, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This submission does not involve ground truth determination for performance evaluation. The "ground truth" equivalent would be the established safety and efficacy profiles of the predicate devices.
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The sample size for the training set: Not applicable. This device is not an AI/machine learning product and does not involve a training set.
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How the ground truth for the training set was established: Not applicable. As above, no training set is involved.
In summary: This 510(k) submission is for a medical device that demonstrates substantial equivalence to existing products. The information provided does not detail clinical performance studies with specific acceptance criteria, test sets, or ground truth establishment typically associated with novel or high-risk devices or software. The "acceptance" is the FDA's determination of substantial equivalence, allowing the device to be marketed.
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(145 days)
MRI PATIENT POSITIONING DEVICES
Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.
The Civco Patient Support Devices have been used for many years and were previously cleared under 510(k)'s before the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MRI environment.
This 510(k) submission (K080072) is for "MRI Patient Positioning Devices" and focuses on demonstrating substantial equivalence to previously cleared devices. The core of the submission revolves around proving the safety and effectiveness of these devices for use in an MRI environment, as they were previously Class I exempt and are now being cleared for MRI use.
The document does not provide a typical "study" with specific acceptance criteria and reported device performance in the way one might expect for an AI/software device or a diagnostic device. Instead, the "study" is a series of tests to ensure MRI compatibility and safety.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|
| Safety for use in an MRI environment | "These products have been tested to demonstrate that they can be safely used in an MRI environment." (No specific quantitative metrics or test results are provided in this summary, but the FDA clearance implies these tests were satisfactory.) |
| Equivalent intended uses | Claimed: "the proposed devices have equivalent intended uses... as compared to the predicate devices." (The intended use "aid in the support and positioning of patients during an MRI" is consistent with the predicate devices' presumed function.) |
| Equivalent manufacturing materials | Claimed: "the proposed devices have equivalent... manufacturing materials... as compared to the predicate devices." |
| Equivalent operating principles | Claimed: "the proposed devices have equivalent... operating principals... as compared to the predicate devices." (As simple positioning devices, their operating principle is passive support.) |
| Equivalent physical, operational specifications | Claimed: "the proposed devices have equivalent... physical, operational specifications as compared to the predicate devices." |
| No significant differences affecting safety and effectiveness | Claimed: "There are no significant differences between the proposed and predicate devices except that they have now been tested for use in an MRI environment. The product labeline, including brochures has been updated. These differences have no effect on safety and effectiveness." (The key 'difference' is the MRI testing, which is presented as an addition to safety, not a compromise.) |
2. Sample Size for the Test Set and Data Provenance
The document does not specify a "test set" in the context of data for an algorithm. Instead, it refers to the physical devices themselves. The sample size would be the number of physical MRI Patient Positioning Devices tested for MRI compatibility. This number is not disclosed in the provided text.
Data provenance (country of origin, retrospective/prospective) is not applicable here as it's not a data-driven study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. "Ground truth" in the context of device performance for physical products like patient positioning devices (especially for MRI compatibility) typically involves engineering tests, material compatibility assessments, and MRI safety protocols, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
Not applicable. There's no interpretive test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device or an AI assistant for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the device's main claim (MRI safety) would be established through:
- Engineering Standards and Test Results: Compliance with recognized MRI safety standards (e.g., ASTM F2503 for "MR Safe," "MR Conditional," "MR Unsafe"). These standards outline specific tests for magnetic attraction, RF-induced heating, image artifact, etc.
- Material Compatibility: Assessment of the materials used in the devices for their magnetic properties and potential for heating in an MRI environment.
- Regulatory Compliance: Meeting the requirements of the FDA for safe medical devices.
The document only states "These products have been tested to demonstrate that they can be safely used in an MRI environment," implying these types of tests were performed.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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