(17 days)
Not Found
No
The description focuses on the hardware (sensor, adaptor, cable) and basic software functions (data conversion, storage, display). There is no mention of AI/ML for image processing, analysis, or any other function.
No
The device is an intraoral X-ray sensor used for diagnostic imaging, not for treating any condition.
Yes
The device's Intended Use states it is for "intraoral diagnostic purposes" and produces "digital images that can be displayed and archived digitally," which are then "viewed by dentists" for diagnosis.
No
The device description explicitly states that the subject device consists of a sensor, adaptor, and cable, in addition to software. This indicates the presence of physical hardware components that are integral to the device's function of acquiring X-ray images.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The described device is an intraoral X-ray sensor. Its function is to capture digital images of the internal structures of the mouth using X-rays generated by a separate machine. It does not analyze biological specimens.
- Intended Use: The intended use is for "intraoral diagnostic purposes" using X-ray imaging, not for analyzing samples taken from the body.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The digital intraoral X-ray sensors XVD2121 Plus, XVD2530 are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. Each can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The subject device digital intraoral X-ray sensor, XVD2121 Plus or XVD2530, is used as X-ray receptor to acquire dental X-ray radiographic images in clinical entities. The subject device doesn't emit X-rays. The X-rays are to be generated from X-ray dental machine, a separate device. The subject device can be used by trained dental professionals for patients receiving intraoral X-ray imaging examinations and produces digital images that can be displayed, and archived digitally. To acquire X-ray intraoral radiographic image, first the X-rays are to be generated from the X-ray dental machine and passing through human teeth and surrounding anatomy; then the attenuated X-ray beams are detected by the sensor and subsequently converted into digital data that are to be transmitted to the software (computer). The imaging data are then stored in DICOM format images that can be displayed on the monitor and viewed by dentists.
The subject device digital intraoral X-ray sensor consists of sensor, adaptor, cable, and software (computer or laptop NOT part of the device), as shown in Fig.1.
The intraoral sensor detects the incident X-rays and converts X-rays into digital signal or data. The sensor consists of tiny silicon chip-based pixels and their associated electronics encased in a plastic housing. The intraoral sensor is small, thin, flat, rigid rectangular box (as denoted (1) in Fig.1 ), usually black in color and similar in size to intraoral film packets. Sensors vary in thickness from about 5 to 7 mm. Sensor is cabled to allow data to be transferred directly from the mouth to the computer (software) via the USB port.
When used clinically the sensor shall be covered with a protective plastic barrier envelope for infection control purposes. New sheath is required for each new patient and must be disposed of after patient use. One usually slide the sensor into the sheath to provide a secure barrier around the sensor (as shown in Fig. 2). The protective cover sheath is disposable and is a separate device, NOT a part of this device.
To acquire the intraoral X-ray radiographic images, the sensor (with sheath) is placed inside the mouth as X-ray receptor. First the X-rays are to be generated from the dental X-ray generating machine outside of the mouth (as shown in Fig. 3). The X-rays pass through and are attenuated by tooth/teeth and surrounding anatomy; the attenuated X-rays are detected by the sensor and then converted into digital data that are to be transmitted to the software (computer).
The digital data are then stored in DICOM format image that can be displayed on the monitor and viewed by dentists. The key clinical feature of intraoral sensor is the rapid availability of the image after exposure. The sensor is utilized as X-ray receptor, and does NOT emit X-rays. The X-ray generating equipment is a separate device. NOT a part of subject device.
The physical size of model XVD2530 is 31.5mm * 38.5mm, while that of model XVD2121 Plus is 26.5mm * 32mm. The effective imaging area of model XVD2530 is 29.5mm * 24.6mm, while that of model XVD2121 Plus is 20.0mm * 19.8mm. The differences between model XVD2121 Plus and model XVD2530 are the physical sizes and effective imaging areas. Otherwise model XVD2121 Plus and model XVD2530 are exactly same device. Different size is offered to better fit with size of oral cavity of individual patient and different anatomic region, such as posterior teeth or anterior teeth.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Intraoral (mouth, teeth, surrounding anatomy)
Indicated Patient Age Range
Not Found (General population excluding pregnant women)
Intended User / Care Setting
Trained dental professionals / dental practice
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, (integration and functional) including phantom tests were conducted for the subject device during product development. The general purpose of each tests is to verify and validate the performance and functionality of the subject device.
System Validation testings include:
- Acceptance test (workflow and user manual test)
- Legal and Regulatory test
System Verification testings include:
- System Integration Test (functional)
- Functionality verification
- Image Quality (IQ) Evaluation
Testing covers all related aspects that contribute to the device performance and functions. The test specification and acceptance criteria are related to the corresponding requirements. The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Actual spatial resolution: 7 lp/mm
- Low contrast resolution: The imaging can distinguish 1mm -diameter hole on aluminum plates
- Image non-uniformity:
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is written in a clear, sans-serif font. The FDA logo is commonly used on products and materials related to food and drug regulation in the United States.
February 17, 2022
Shenzhen Xpectvision Technology Co., Ltd. % Mengsi Peng Regulatory Affairs Manager B507, Block A and B. Nanshan Medical Device Industrial Park, Nanhai Avenue 1019, Nanshan District Shenzhen, Guangdong 518067 CHINA
Re: K220277
Trade/Device Name: XVD2121 Plus, XVD2530 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 17, 2022 Received: January 31, 2022
Dear Mengsi Peng:
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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,
Laurel Burk Assistant Director Diagnostic X-ray Systems Team 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) K220277
Device Name XVD2121 Plus, XVD2530
Indications for Use (Describe)
The digital intraoral X-ray sensors XVD2121 Plus, XVD2530 are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. Each can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.
| 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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Section 5 510(k) Summary K220277
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510 (k) Summary
(As Required by 21 CFR 807.92)
1. Date Prepared
January 17, 2022
2. Submitter's Information
| Company Name: | Shenzhen Xpectvision Technology Co., Ltd. |
|---|---|
| Company Address: | B507, Block A and B, |
| Nanshan Medical Device Industrial Park, | |
| Nanhai Avenue 1019, Nanshan District, | |
| Shenzhen City, Guangdong Province, China. | |
| Contact Person: | Mengsi Peng |
| Phone: | (+86) 0755-26897621 |
| Email: | msp1022@xpectvision.com |
3. Device/Trade Name, Common Name, and Classification Name
| Device/Trade Name: | XVD2121 Plus, XVD2530 |
|---|---|
| Common Name: | intraoral X-ray sensor |
| Classification Name: | Extraoral Source X-Ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Device Class: | Class II |
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4. Identification of Predicate Device(s)
Relevant information of predicate device within this submission are as follows:
| Manufacturer: | Schick Technologies Inc |
|---|---|
| Device/Trade Name: | Computed Oral Radiology System |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Classification Name: | Extraoral source x-ray system |
| FDA 510 (k) #: | K072134 |
| Device Class: | Class II |
5. Indications for Use
The digital intraoral X-ray sensors XVD2121 Plus, XVD2530 are intended for any dental practice that uses X-ray equipment for intraoral diagnostic purposes. Each can be used by trained dental professionals for patients receiving intraoral X-ray examinations and produces digital images that can be displayed and archived digitally.
6. Description of the Device
The subject device digital intraoral X-ray sensor, XVD2121 Plus or XVD2530, is used as X-ray receptor to acquire dental X-ray radiographic images in clinical entities. The subject device doesn't emit X-rays. The X-rays are to be generated from X-ray dental machine, a separate device. The subject device can be used by trained dental professionals for patients receiving intraoral X-ray imaging examinations and produces digital images that can be displayed, and archived digitally. To acquire X-ray intraoral radiographic image, first the X-rays are to be generated from the X-ray dental machine and passing through human teeth and surrounding anatomy; then the attenuated X-ray beams are detected by the sensor and subsequently converted into digital data that are to be transmitted to the software (computer). The imaging data are then stored in DICOM format images that can be displayed on the monitor and viewed by dentists.
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The subject device digital intraoral X-ray sensor consists of sensor, adaptor, cable, and software (computer or laptop NOT part of the device), as shown in Fig.1.
Image /page/6/Figure/1 description: The image shows a device setup with four labeled components. Component 1 is a black square device connected by a cable to component 2, a small, rounded device with a light. Component 2 is connected via a cable to component 3, a USB connector. Component 3 is plugged into component 4, a laptop displaying an image processing application.
Figure 1. Components of the device
The intraoral sensor detects the incident X-rays and converts X-rays into digital signal or data. The sensor consists of tiny silicon chip-based pixels and their associated electronics encased in a plastic housing. The intraoral sensor is small, thin, flat, rigid rectangular box (as denoted (1) in Fig.1 ), usually black in color and similar in size to intraoral film packets. Sensors vary in thickness from about 5 to 7 mm. Sensor is cabled to allow data to be transferred directly from the mouth to the computer (software) via the USB port.
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Image /page/7/Picture/0 description: The image shows a dental X-ray sensor in a clear plastic bag. The sensor is black and rectangular, with a cable extending from one side. The cable is also black and appears to be flexible. The plastic bag is sealed around the sensor and cable, protecting it from contamination.
Figure 2. Sensor inside a protective plastic sheath
When used clinically the sensor shall be covered with a protective plastic barrier envelope for infection control purposes. New sheath is required for each new patient and must be disposed of after patient use. One usually slide the sensor into the sheath to provide a secure barrier around the sensor (as shown in Fig. 2). The protective cover sheath is disposable and is a separate device, NOT a part of this device.
Image /page/7/Picture/3 description: The image shows a person getting an x-ray of their mouth. The person is facing to the right, and their mouth is open. A device is pointed at their mouth, and a beam of light is shining into their mouth. The x-ray is being taken to check for any problems with the person's teeth or gums.
Figure 3. Placement of sensor (with sheath) during intraoral X-ray imaging
To acquire the intraoral X-ray radiographic images, the sensor (with sheath) is placed inside the mouth as X-ray receptor. First the X-rays are to be generated from the dental X-ray generating machine outside of the mouth (as shown in Fig. 3). The X-rays pass through and are attenuated by tooth/teeth and surrounding anatomy; the attenuated X-rays are detected by the sensor and then converted into digital data that are to be transmitted to the software (computer).
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The digital data are then stored in DICOM format image that can be displayed on the monitor and viewed by dentists. The key clinical feature of intraoral sensor is the rapid availability of the image after exposure. The sensor is utilized as X-ray receptor, and does NOT emit X-rays. The X-ray generating equipment is a separate device. NOT a part of subject device.
Image /page/8/Figure/1 description: The image shows two sets of technical drawings of an object, each set containing a side view and a front view. The first set of drawings shows the object with dimensions of 5.8 ± 0.1 mm for the side view and 26.5 ± 0.1 mm in width and 32.0 ± 0.1 mm in height for the front view. The second set of drawings shows the object with dimensions of 6.0 ± 0.1 mm for the side view and 31.5 ± 0.1 mm in width and 38.5 ± 0.1 mm in height for the front view.
(a) Model XVD2121 Plus (b) Model XVD2530 Figure 4. Lateral and frontal view of the sensor (the shaded region denotes effective imaging area)
The physical size of model XVD2530 is 31.5mm * 38.5mm, while that of model XVD2121 Plus is 26.5mm * 32mm. The effective imaging area of model XVD2530 is 29.5mm * 24.6mm, while that of model XVD2121 Plus is 20.0mm * 19.8mm. The differences between model XVD2121 Plus and model XVD2530 are the physical sizes and effective imaging areas. Otherwise model XVD2121 Plus and model XVD2530 are exactly same device. Different size is offered to better fit with size of oral cavity of individual patient and different anatomic region, such as posterior teeth or anterior teeth.
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7. Comparable Technological Characteristics
| Description | Predicate Device | Subject Device |
|---|---|---|
| Device/Trade | ||
| name | Computed Oral Radiology | |
| System | XVD2121 Plus, XVD2530 | |
| 510(K) number | K072134 | K220277 |
| Classification | ||
| name | Extraoral Source X-ray | |
| System | Same | |
| Product code | MUH | Same |
| Regulation | ||
| number | 21 CFR 872.1800 | Same |
| Panel | Radiology | Same |
| Classification | II | Same |
| Indications for use | The Computed Oral | |
| Radiology System is | ||
| indicated for patients | ||
| undergoing an intra-oral | ||
| dental x-ray examination. | ||
| It produces instant, | ||
| digital, intra-oral images | ||
| of a patient's mouth while | ||
| reducing the necessary x- | ||
| ray dosage. | The digital intraoral X-ray | |
| sensors XVD2121 Plus, | ||
| XVD2530 are intended | ||
| for any dental practice | ||
| that uses X-ray equipment | ||
| for intraoral diagnostic | ||
| purposes. Each can be | ||
| used by trained dental | ||
| professionals for patients | ||
| receiving intraoral X-ray | ||
| examinations and | ||
| produces digital images | ||
| that can be displayed and | ||
| archived digitally. | ||
| Intended user | ||
| group | Trained dental | |
| professionals | Same | |
| Description | Predicate Device | Subject Device |
| Device | ||
| components | Image: sensor, adaptor, cable, and USB connector. | XVD2121 Plus |
| Image: XVD2121 Plus | ||
| same | ||
| XVD2530 | ||
| Image: XVD2530 | ||
| same | ||
| Sensor area | Size 1: 23.6mm x 31.9mm | |
| Size 2: 25.4mm x 38.3mm | ||
| Size 3: 31.2mm x 43.0mm | XVD2121 Plus: | |
| 26.5mm x 32mm | ||
| XVD2530 | ||
| 31.5mm x 38.5mm | ||
| Effective imaging | ||
| area | Size 1: 18mm x 24mm | |
| Size 2: 20mm x 30mm | ||
| Size 3: 25.6mm x 36mm | XVD2121 Plus: | |
| 20.0mm x 19.8mm | ||
| XVD2530: | ||
| 24.6mm x 29.5mm | ||
| Deployment | ||
| methods where | ||
| relevant | Covered with a protective | |
| sheath then placed inside the | ||
| mouth. | Same | |
| Description | Predicate Device | Subject Device |
| Contact body site | The device does not | |
| directly contact with | ||
| human body or organ. |
Note: When used
clinically the sensor
shall be covered with a
protective plastic barrier
envelope for infection
control purposes and
then placed inside the
mouth during imaging
procedure. The
protective cover sheath
is disposable and is a
separate device, NOT a
part of this device. | Same |
| Patient
populations | General population
(excluding pregnant
women) who are
evaluated by the dentist to
need intraoral X-ray
imaging examination. | Same |
| Installation type | Portable | Same |
| Sensor structure | Scintillator
- CMOS | Semiconductor
- CMOS ASIC |
| Actual spatial
resolution | 7 lp/mm | Same |
| Low contrast
resolution | The imaging can
distinguish 1mm -
diameter
hole on aluminum plates | Same |
| Image non-
uniformity | $≤$ 2% | Same |
| Description | Predicate Device | Subject Device |
| Ghost and artifact | No | Same |
| Gray scale | 12 bit | 16 bit |
| Power
consumption | 5V DC, 250mA | 5V DC, 100mA |
| Communications | USB 2.0 | Same |
| Cooling | Ambient air cooling | Same |
| Protection against
matter/water | IP68 | IP67 |
| Protection against
shock | Type BF applied part | Same |
| Operation
environment | Temperature: 10 to 40°C
Humidity: ≤ 75% (Non-
Condensing)
Atmospheric pressure:
700hPa ~ 1060hPa | Temperature: 10 to 40°C
Humidity: ≤ 80% (Non-
Condensing)
Atmospheric pressure:
700hPa ~ 1060hPa |
| Storage and
Transportation
environment | Temperature: -40 to 70°C
Humidity: 10 to 100%
(Non - Condensing)
Atmospheric pressure:
500hPa ~ 1060hPa | Temperature: -20 to 55°C
Humidity: ≤ 93% (No
condensation)
Atmospheric pressure:
700hPa ~ 1060hPa |
| Software | Zoom Window | XVDental |
| Standards
Compliance | IEC 60601-1:2005+A1:2012
IEC 60601-1-2:2014 | IEC 60601-1:2005+A1:2012
IEC 60601-1-2:2014
IEC 60601-2-65:2017 |
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8. Non-clinical Performance Testing
Non-clinical testing, (integration and functional) including phantom tests were conducted for the subject device during product development. The general purpose of each tests is to verify and validate the performance and functionality of the subject device.
System Validation testings include:
- Acceptance test (workflow and user manual test) ●
- Legal and Regulatory test
System Verification testings include:
- System Integration Test (functional) ●
- Functionality verification
- Image Quality (IQ) Evaluation ●
Testing covers all related aspects that contribute to the device performance and functions. The test specification and acceptance criteria are related to the corresponding requirements. The test results show that all of the performance specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claim of substantial equivalence.
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A list of FDA-recognized consensus standards and general guidance documents considered for testing the subject device is listed as follows:
-
- FDA-recognized consensus standards
- IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing ● in medical imaging departments - Part 3-4: Acceptance tests -Imaging performance of dental X-ray.
- IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Requirements for the basic safety and essential performance of dental intraoral X-ray equipment.
-
- FDA Guidance Documents
- FDA Guidance for the Medical X-Ray Imaging Devices Conformance with IEC Standards.
- O FDA Guidance for the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)].
- FDA Guidance for the Device Labeling #G91.
- FDA Guidance for the Information to Support a Claim of O Electromagnetic Compatibility (EMC) of Electrically - Powered Medical Devices.
- FDA Guidance for the Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.
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9. Electrical Safety and EMC Testing
Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the subject device in accordance with the following standards or guide document(s):
- IEC 60601-1:2005+CORR. 1:2006+CORR. 2:2007+A1:2012 Medical ● electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- . FDA Guidance for the Information to Support a a Claim of Electromagnetic Compatibility (EMC) of Electrically - Powered Medical Devices.
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10. Software and Cybersecurity
The subject device is a hardware-based device that incorporates software. Tests are conducted for all software components developed in product development and for the complete product itself. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.
In accordance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", the software documentation is also included in this submission that covers the following aspects:
- Software description
- Software hazard analysis ●
- Software requirements specifications ●
- Software architecture design chart ●
- Software design specifications ●
- Software traceability analysis ●
- Software development environment description ●
- Verification & Validation testing ●
- Revision level history
- Unresolved anomalies
The submitter conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from the subject device to an external recipient.
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Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices," is discussed in associated Cybersecurity documentation.
11. Biocompatibility Information
The subject device does NOT contact directly with human body or organ, hence no biocompatibility testing was performed.
12. Sterility Information
No sterility testing was accomplished, as this device is not delivered sterile, nor does it require sterility.
13. Clinical Testing
Clinical data is NOT required for a finding of substantial equivalence.
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14. Conclusion
As discussed above, the subject device, either model XVD2121 Plus or model XVD2530, employs the same fundamental technology and has a set of same or similar technological characteristics as the predicate device. The non-clinical data supports the safety of the device. The hardware and software verification and validation demonstrates that the subject device should perform as intended in the specified use conditions. The data included in this submission demonstrates that the subject device performs comparably to the predicate device currently marketed for the same intended use. The differences between the subject device and predicate device do not raise different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate device.