(114 days)
The Portray System is an extraoral X-ray source (intraoral X-ray system for producing diagnostic dental radiographs of the teeth, jav, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.
The Portray System, an extraoral X-ray source (intraoral X-ray detection) dental X-ray system, is a nanotechnology-based 2D and 3D extraoral imaging system offering high resolution X-ray image quality and diagnostic accuracy. The 3D image provides a layer-by-layer virtual dissection of the oral cavity when viewed as Tomosynthesis. Alternatively, when viewed as Synthetic 2D, the image provides a rotatable representation of a 2D image taken from the same point in space. 3D images are to be used only as an adjunct to 2D image analysis.
The Portray System is comprised of the following components:
- Computer ●
- User Interface Software ●
- High voltage Electronics ●
- Wall-mount ●
- Articulating Arm .
- X-ray Source Array (Tube) .
- . X-ray Shielding
- X-ray Collimator ●
- Detector Holder ●
- . Intraoral X-ray Detector
The Portray Detector Holder and off-the-shelf detector sleeve are accessories to the Portray System and the sole patient contacting components.
The Portray system will be available in a single, wallmounted configuration.
The Portray system software will support interoperability with electronic patient records and storage of X-ray images in a persistent database located on a Local Area Network (LAN).
The provided document does not contain information about acceptance criteria, reported device performance in a table, or a study specifically designed to demonstrate the device meets acceptance criteria. The document is a 510(k) summary for the Portray System, focusing on demonstrating substantial equivalence to a predicate device.
However, based on the non-clinical performance data section, some aspects relevant to performance evaluation are mentioned. I will extract those that relate to specific quantifiable characteristics typically associated with acceptance criteria, even though explicit "acceptance criteria" values are not stated.
Here's an attempt to structure the information based on your request, identifying what is available in the document and what is not:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists technical specifications and compares them to a predicate device, noting their substantial equivalence without providing specific performance data for the Portray System against predefined acceptance thresholds.
For example, for "Focal spot size," it states the Portray System's size is 0.7 and the predicate's is 0.4, and then concludes substantial equivalence because the Portray device meets "internal requirements and requirements specified in IEC 61223-3-4 on image resolution." However, the actual thresholds or the Portray System's specific resolution performance are not reported.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document states, "Assessment of Clinical Data: No clinical data was required to demonstrate substantial equivalence." The non-clinical performance testing does not specify "test sets" in the context of clinical studies or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical data or ground truth establishment by experts for image interpretation is mentioned. The testing was non-clinical performance data (e.g., electrical safety, electromagnetic compatibility, image quality metrics).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical data or expert adjudication is discussed.
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. The document does not describe the Portray System as an AI-assisted device for image interpretation, nor does it mention any MRMC studies. The 3D imaging is stated to be an "adjunctive tool."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as the Portray System is an X-ray system for image acquisition, not an algorithm for image analysis per se. Its 3D imaging capability is an "adjunctive tool," indicating it's intended to supplement human review of 2D images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies requiring a ground truth for diagnostic accuracy were performed or reported. Non-clinical performance assessments would use physical measurement standards and established engineering tests (e.g., measuring focal spot size, linearity of air kerma).
8. The sample size for the training set
Not applicable. The document does not describe any machine learning or AI components that would require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or machine learning components.
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July 28, 2021
Image /page/0/Picture/1 description: The image shows the logo of 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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Surround Medical Systems % Ms. Elizabeth Sullivan VP, Engineering 175 Southport Dr. Suite 900 MORRISVILLE NC 27560
Re: K211014
Trade/Device Name: Portray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: EHD Dated: June 25, 2021 Received: June 28, 2021
Dear Ms. Sullivan:
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); 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
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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
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
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Indications for Use
510(k) Number (if known) K211014
Device Name Portray System
Indications for Use (Describe)
The Portray System is an extraoral X-ray source (intraoral X-ray system for producing diagnostic dental radiographs of the teeth, jav, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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510(k) Summary
| Date Summary Prepared: | April 2, 2021 |
|---|---|
| 510(k) Owner: | Surround Medical Systems |
| Contact Person: | Elizabeth SullivanVP Engineering175 Southport DriveSuite 900Morrisville, NC 27560919-424-4900 |
| Device Name: | Portray System |
| Trade Name: | Portray System |
| Common Name: | Extraoral source dental x-ray system |
| Regulation: | 21 CFR 872.1800, Extraoral sourceX-ray system |
| Class: | II |
| Product Code: | EHD |
| Predicate Device(s): | RiX70 DC, K182206 |
| Device Description: | The Portray System, an extraoral X-ray source (intraoral X-ray detection) dental X-ray system, is a nanotechnology-based 2D and 3D extraoral imaging system offering high resolution X-ray image quality and diagnostic accuracy. The 3D image provides a layer-by-layer virtual dissection of the oral cavity when viewed as Tomosynthesis. Alternatively, when viewed as Synthetic 2D, the image provides a rotatable representation of a 2D image taken from the same point in space. 3D images are to be used only as an adjunct to 2D image analysis. |
The Portray System is comprised of the following components:
- Computer ●
- User Interface Software ●
- High voltage Electronics ●
- Wall-mount ●
- Articulating Arm .
- X-ray Source Array (Tube) .
- . X-ray Shielding
- X-ray Collimator ●
- Detector Holder ●
- . Intraoral X-ray Detector
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The Portray Detector Holder and off-the-shelf detector sleeve are accessories to the Portray System and the sole patient contacting components.
The Portray system will be available in a single, wallmounted configuration.
The Portray system software will support interoperability with electronic patient records and storage of X-ray images in a persistent database located on a Local Area Network (LAN).
- Statement of Intended Use: The Portray System is an extraoral X-ray source (intraoral X-ray detection) dental X-ray system for producing diagnostic dental radiographs of the teeth, jaw, and other oral structures. The system provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool.
| Device | Proposed Device | Predicate device |
|---|---|---|
| Intraoral Tomosynthesis System(Portray System) | RiX70 DCK182206 | |
| RegulationNumber / ProductCode | 21 CFR 872.1800 / EHDConclusion – Substantially equivalent. Both the proposed and predicate devicefall under the same regulation and product code. | 21 CFR 872.1800 / EHD |
| Intended Use | The Portray System is an extraoral X-ray source (intraoral X-ray detection)dental X-ray system for producingdiagnostic dental radiographs of theteeth, jaw, and other oral structures.The system provides 2D imaging fordiagnostic purposes and 3D imaging asan adjunctive tool. | The RiX70 DC is designed for theacquisition of intraoral images of theteeth, jaw and the mouth structure fordiagnostic purposes. |
| Conclusion - Substantially equivalent. Both the proposed and predicate deviceare intended for acquisition of intraoral images using an extraoral x-ray source.The intended use statement for the predicate does not specifically indicate that thex-ray source is extraoral, however the associated regulation and FDA product codeis specific to extraoral x-ray devices. The proposed Portray System includes theability to view the 2D images in a 3D format. This imaging capability is anadjunctive tool only and does not raise new questions of safety or effectiveness. | ||
| TargetAnatomical Sites | Oral CavityConclusion - Substantially equivalent. Both the proposed and predicate devicetarget the oral cavity. | Oral Cavity |
| Principle of use | X-ray tubeConclusion - Substantially equivalent. Both the proposed and predicate deviceuse X-ray tubes. | X-ray tube |
| InstallationConfiguration | Wall-mountedConclusion - Substantially equivalent. Both the proposed and predicate deviceare installed on a wall. The predicate offers an additional stand-mobile version inaddition to the wall mounted version. However, this difference has no impact onsubstantial equivalence | Wall-mounted standard version andStand mobile version |
Comparison of Technological Characteristics with Predicate Devices:
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Traditional 510(k) Premarket Notification Portray
| Comparison of Technological Characteristics with Predicate Devices: | |
|---|---|
| Device | Proposed Device | Predicate device |
|---|---|---|
| Intraoral Tomosynthesis System(Portray System) | RiX70 DCK182206 | |
| X-ray emissioncontrol | Wired controlConclusion - Substantially equivalent. Both the proposed and predicate device have wired control of x-ray emission. | Wired Control |
| HV generator | High frequency DC generation,constant output potentialConclusion - Substantially equivalent. Both the proposed and predicate device generate the high voltage DC output with high frequency converters and have constant potential outputs. | High frequency DC generation,constant output potential |
| Cathode Material | Carbon Nanotube (CNT)Conclusion - Substantially equivalent. The cathodes of the Portray device and the predicate device use different materials to achieve an electron source within the X-ray Tube. The Portray device uses energized CNTs as a cold cathode, while the predicate device uses a heated filament. While the mechanism by which the electrons are generated differ, the resulting X-ray tubes are capable of producing radiation which meets safety and efficacy standards of 60601-2-65 and 61223-3-4. Therefore, the differing cathode material has no impact on safety or efficacy. | Heated Tungsten Filament |
| Anode Material | TungstenConclusion - Substantially equivalent. The anode material of both the proposed and predicate device is Tungsten. | Tungsten |
| Tube Voltage | 60 kV, 70 kVConclusion - Substantially equivalent. Both the proposed and predicate device have tube voltages of 60 kV and 70 kV. The difference of Portray not including a tube voltage of 65 kV does not impact substantial equivalence. | 60, 65, 70 kV |
| Tube Current | 7 mAConclusion - Substantially equivalent. Both the proposed and predicate device have a tube current of 7 mA. | 7 mA |
| Exposure Time | 0.04 - 0.25 sec (2D)0.063 - 1 sec (3D)Conclusion - Substantially equivalent. Both the proposed and predicate device have an exposure time between 0.04 and 0.25 seconds. The exposure time for 3D images is also within the exposure time for the predicate's 2D image acquisition. | 0.02 - 2 sec |
| X-ray tubeAnode angle | 12°Conclusion - Substantially equivalent. Both the proposed and predicate device have an anode angle within the approximate anode angle range for most x-ray tubes. A smaller angle expects a larger focal spot size. | 16° |
| Focal spot size | 0.7Conclusion - Substantially equivalent. The focal spot size of the Portray device is larger than that of the predicate devices. The size of a focal spot has two implications in an X-ray system, namely that smaller focal spots generate more heat at the anode and produce superior resolution. By increasing the focal spot size, there are no new concerns relating to safety of the device because there is less heat produced at the focal spots. By increasing focal spot size, the spatial resolution of the Portray device is likely less than that of the predicates. However, the Portray device meets both internal requirements and requirements specified in IEC 61223-3-4 on image resolution. Therefore, the increased focal spot size has no impact on efficacy. | 0.4 |
| Leakage radiation | < 0.25 mGy/h (@ 1 m)Conclusion - Substantially equivalent. Both the proposed and predicate device | < 0.25 mGy/h (@ 1 m) |
| Device | Proposed Device | Predicate device |
| Intraoral Tomosynthesis System(Portray System) | RiX70 DCK182206 | |
| Focal filmdistance | Source to end of Cone Distance: 308 mmSource to Detector Distance: 400 mm | Standard round (fix): 200 mm (8") |
| Conclusion - Substantially equivalent. The focal film distance for Portray meetsthe requirements of IEC 60601-2-65 of at least 20 cm (200 mm). The dimensionaldifferences between Portray and the predicates reflect a design choice and do notraise any questions of safety or efficacy. | ||
| Dimensions of x-ray beam cone | Rectangular: 36.65mmx36.65mm | Short round (fix): Ø 60 mmStandard rectangular (removable): 45 x 35 mm |
| Conclusion - Substantially equivalent. Portray is intended to only be used withthe included electronic detector and utilizes a permanent beam limiting device toensure that the dimensions of the x-ray beam are restricted to the active area ofthe detector in compliance with IEC 60601-2-65. The differences in thedimensions of the x-ray beam do not raise any questions of safety or efficacy. | ||
| Exposure timescontrol | Microprocessor controlled exposuretimes | Microprocessor controlled exposuretimes |
| Conclusion - Substantially equivalent. Both the proposed and predicate devicecontrol exposure time via microprocessor. | ||
| Exposure modes | Preset loading factors or manual mode | Preset loading factors or manual mode |
| Conclusion - Substantially equivalent. Both the proposed and predicate devicehave preset loading factors as well as manual method of adjusting exposuremodes. | ||
| Selectableparameter | Patient type, anatomical position, 2Dor 3D mode, X-ray Tube voltage,exposure time | Patient type, anatomical position, filmtype, X-ray Tube voltage, exposuretime |
| Conclusion - Substantially equivalent. Both the proposed and predicate devicehave the same selectable parameters, with two exceptions. The Portray system hasa selectable mode. The 2D mode and adjunct 3D mode from the Portray Systemhave exposure parameters contained within the predicate device's exposureparameters, so this does not raise any questions of safety or efficacy. Film type isnot selectable on the Portray System. However, this has no impact on substantialequivalence as the Portray System only supports digital detectors. | ||
| Patient type | Adult and children older than 5 | Adult and child |
| Conclusion - Substantially equivalent. Both the proposed and predicate devicemay be used for adults and children. The predicate's use on children includesthose aged 2-5, while the Portray System does not recommend using on childrenyounger than 5. The difference in patient type for the Portray System is becauseit is believed that children under the age of 5 are undergoing dental developmentsuch that Dental Professionals can see between their teeth, and the use of an X-ray system would not add any benefit. There are no reasons for exclusion of thisgroup from a safety or effectiveness perspective- only to avoid unnecessaryexposure to X-ray radiation. | ||
| Film type | Digital sensor | Photo-stimulated plate or digitalsensor |
| Conclusion - Substantially equivalent. Both the proposed and predicate deviceuse digital sensors to capture images. |
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Traditional 510(k) Premarket Notification Portray
rison of Technological Characteristics with Predicate Device
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Traditional 510(k) Premarket Notification Portray
| Comparison of Technological Characteristics with Predicate Devices: | |
|---|---|
| --------------------------------------------------------------------- | -- |
| Device | Proposed Device | Predicate device |
|---|---|---|
| Intraoral Tomosynthesis System(Portray System) | RiX70 DCK182206 | |
| Image Type | 2D and 3D | 2D |
| Conclusion - Substantially equivalent. Both the proposed and predicate devicecapture 2D images. The Portray Device can create a tomosynthesis reconstructionto create a 3D representation. The 3D presentation is adjunctive to 2D. Atomosynthesis reconstruction is a stack of multiple 2D images where each imageis a slice of the object being imaged at a fixed incremental distance away from thedetector. | ||
| Standards | IEC 60601-1 | IEC 60601-1 |
| IEC 60601-1-2 | IEC 60601-1-2 | |
| IEC 60601-1-3 | IEC 60601-1-3 | |
| IEC 60601-1-6 | IEC 60601-1-6 | |
| IEC 60601-2-65 | IEC 60601-2-65 | |
| IEC 62304 | IEC 62304 | |
| IEC 61223-3-4 | ||
| Conclusion - Substantially equivalent. Both the proposed and predicate devicecomply to the same standards. The additional identified standard IEC 61223-3-4is utilized for purposes of evaluating performance. There are no newtechnological characteristics which warrant the additional standard evaluation. |
Non-Clinical Performance Data: Non-clinical performance testing was performed to verify substantial equivalence to predicate devices. Testing included:
- Electrical Safety ●
- Electromagnetic Compatibility
- Human Factors ●
- Cybersecurity and Patient Information Protection .
- Reliability and Accelerated Aging ●
- Software Verification and Validation
- Intended Use Validation ●
- Exit Field Dimensions ●
- Focal Spot Size
- Linearity and Coefficient of Variation of Air Kerma ●
- Line Pair Resolution
- . Low Contrast Resolution
- Assessment of Clinical Data: No clinical data was required to demonstrate substantial equivalence.
- Based on the indications for use, technological Overall Conclusions: characteristics, and comparison to predicate device, the Portray System has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.