(114 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the performance studies focus on standard device testing rather than algorithmic performance.
No
The device is described as an X-ray source for producing diagnostic dental radiographs, indicating its purpose is for imaging and diagnosis, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system is used "for producing diagnostic dental radiographs" and "provides 2D imaging for diagnostic purposes and 3D imaging as an adjunctive tool," clearly indicating its role in diagnosis.
No
The device description explicitly lists multiple hardware components, including an X-ray Source Array (Tube), Detector Holder, High voltage Electronics, and other physical parts necessary for generating and capturing X-ray images. While it includes software, it is not solely software.
Based on the provided information, the Portray System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Portray System Function: The Portray System is an extraoral X-ray system that produces diagnostic dental radiographs. It uses X-rays to create images of the teeth, jaw, and other oral structures. This is an in vivo imaging technique, meaning it is performed on a living organism, not on samples taken from the body.
- No Mention of Samples: The description of the Portray System and its intended use does not involve the analysis of any biological samples.
Therefore, the Portray System falls under the category of medical imaging devices, specifically dental X-ray systems, rather than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
EHD
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Adult and children older than 5
Intended User / Care Setting
Not Found
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
RiX70 DC, K182206
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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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3
510(k) Summary
| Date Summary Prepared: | April 2, 2021 |
|---|---|
| 510(k) Owner: | Surround Medical Systems |
| Contact Person: | Elizabeth Sullivan |
| VP Engineering | |
| 175 Southport Drive | |
| Suite 900 | |
| Morrisville, NC 27560 | |
| 919-424-4900 | |
| Device Name: | Portray System |
| Trade Name: | Portray System |
| Common Name: | Extraoral source dental x-ray system |
| Regulation: | 21 CFR 872.1800, Extraoral source |
| X-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
4
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 DC | |
| K182206 | ||
| Regulation | ||
| Number / Product | ||
| Code | 21 CFR 872.1800 / EHD | |
| Conclusion – Substantially equivalent. Both the proposed and predicate device | ||
| fall 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 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. | The RiX70 DC is designed for the | |
| acquisition of intraoral images of the | ||
| teeth, jaw and the mouth structure for | ||
| diagnostic purposes. | ||
| Conclusion - Substantially equivalent. Both the proposed and predicate device | ||
| are intended for acquisition of intraoral images using an extraoral x-ray source. | ||
| The intended use statement for the predicate does not specifically indicate that the | ||
| x-ray source is extraoral, however the associated regulation and FDA product code | ||
| is specific to extraoral x-ray devices. The proposed Portray System includes the | ||
| ability to view the 2D images in a 3D format. This imaging capability is an | ||
| adjunctive tool only and does not raise new questions of safety or effectiveness. | ||
| Target | ||
| Anatomical Sites | Oral Cavity | |
| Conclusion - Substantially equivalent. Both the proposed and predicate device | ||
| target the oral cavity. | Oral Cavity | |
| Principle of use | X-ray tube | |
| Conclusion - Substantially equivalent. Both the proposed and predicate device | ||
| use X-ray tubes. | X-ray tube | |
| Installation | ||
| Configuration | Wall-mounted | |
| Conclusion - Substantially equivalent. Both the proposed and predicate device | ||
| are installed on a wall. The predicate offers an additional stand-mobile version in | ||
| addition to the wall mounted version. However, this difference has no impact on | ||
| substantial equivalence | Wall-mounted standard version and | |
| Stand mobile version |
Comparison of Technological Characteristics with Predicate Devices:
5
Traditional 510(k) Premarket Notification Portray
| Comparison of Technological Characteristics with Predicate Devices: | |
|---|---|
| Device | Proposed Device | Predicate device |
|---|---|---|
| Intraoral Tomosynthesis System | ||
| (Portray System) | RiX70 DC | |
| K182206 | ||
| X-ray emission | ||
| control | Wired control | |
| Conclusion - 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 potential | ||
| Conclusion - 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 | Tungsten | |
| Conclusion - Substantially equivalent. The anode material of both the proposed and predicate device is Tungsten. | Tungsten | |
| Tube Voltage | 60 kV, 70 kV | |
| Conclusion - 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 mA | |
| Conclusion - 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 tube | ||
| Anode 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 | 0.7 | |
| Conclusion - 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 |