(23 days)
No
The description focuses on the hardware and basic digital conversion process of the X-ray detector. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology.
No
The device is described as a "Digital X-ray detector" for "general radiographic diagnosis" and is intended to "capture projection radiographic images." Its purpose is diagnostic imaging, not treatment.
Yes
The "Intended Use / Indications for Use" section states: "The EXPD 4343P / EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy." This explicitly mentions its use for diagnosis.
No
The device description explicitly details a physical flat-panel detector that captures X-rays and converts them into digital signals, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
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 detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The EXPD 4343P / EXPD 3643P Digital X-ray detector is used to capture images of the inside of the human body using X-rays. It is a diagnostic imaging device, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states "general radiographic diagnosis of human anatomy," which involves imaging the body directly, not testing samples from it.
Therefore, based on the provided information, this device falls under the category of a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The EXPD 4343P / EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Product codes
MQB
Device Description
The EXPD 4343P / EXPD 3643P is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 4343P differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The x-ray generator, a necessary component for a complete diagnostic system, is not part of the device. The subject detector is supported by software, Econsole1 (cleared under K152172). The subject software is the same as the predicate.
The EXPD 4343P / EXPD 3643P Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta. The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy (General Radiography)
Indicated Patient Age Range
Not Found
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
Non-clinical performance testing was conducted to compare main physical values like DQE and MTF between the subject device and the predicate device. The results demonstrated that the DQE and MTF of the subject device are basically equal to or at a lower performance level than the predicate device. The subject devices performance is considered equal or worse than the predicate device. The device complies with international and FDA-recognized consensus standards including ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 62220-1 Edition 1.0 2015-03, ISO 14971 Second edition 2007-03-01, IEC 60601-1-6 Edition 3.1, PS 3.1 - 3.20 (2016), IEC 60601-1-2 Edition 4.0, and ANSI AAMI IEC 62304:2006.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DQE: EXPD 4343P: 50.0 % at 1.0 lp/mm; EXPD 3643P: 52.3 % at 1.0 lp/mm
MTF: EXPD 4343P: 52.3 % at 2.0 lp/mm; EXPD 3643P: 46.8 % at 2.0 lp/mm
Resolution: 3.5 lp/mm
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
November 22, 2019
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, with the word "ADMINISTRATION" underneath.
DRTECH Corporation % Mr. Dongwook Shin Regulatory Affairs Responsible Suite No.1, 1 Floor / Suite No.2, 3 Floor, 29 Dunchon-daero 541 beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do 13216 REPUBLIC OF KOREA
Re: K193031
Trade/Device Name: EXPD 4343P/ EXPD 3643P Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 29, 2019 Received: October 30, 2019
Dear Mr. Dongwook Shin:
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
1
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 (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) K193031
Device Name EXPD 4343P / EXPD 3643P
Indications for Use (Describe)
The EXPD 4343P / EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
| 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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3
510(k) Summary
[As required by 21 CFR 807.92]
K193031
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
11/15/2019
2. Submitter's Information [21 CFR 807.92(a) (1)]
- . Name of Sponsor: DRTECH Corporation Address: Suite No.1, 1 Floor / Suite No. 2, 3 Floor, 29, Dunchon-daero541 beon-gil, ● Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea ● Contact Name: DONGWOOK, SHIN
- Telephone No.: + 82-31-779-7783 ●
- Fax No .: + 82-31-779-7790 ●
- . Email Address : dwshin@drtech.co.kr
- Registration Number: 3005172103 ●
- Name of Manufacturer: Same as Sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
- Trade Name: EXPD 4343P / EXPD 3643P ●
- Common Name: Digital Flat Panel X-ray Detector ●
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology ●
- Classification Regulation: 21 CFR 892.1680 ●
- Product Code: MOB ●
- Device Class: . II
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
- 510(k) Number: K192400
- Applicant: DRTECH Corporation
- Trade Name: EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG ●
- Classification Name: Stationary X-ray System ●
- Classification Panel: Radiology
- Classification Regulation: 21 CFR 892.1680 ●
- Product Code: MQB ●
- Device Class: . II
006 1/7 510(k) Summary
4
5. Description of the Modified Device [21 CFR 807.92(a) (4)]
Addition of EXPD 4343P / EXPD 3643P: The differences between the subject devices and the predicate devices are TFT panel and performance (MTF & DQE). Predicate devices used Amorphous silicon TFT, however, subject devices use IGZO TFT.
IGZO is compound of indium(In)-gallium(Ga)-zinc(Zn)oxygen(O) and this compound is utilized as semiconductor material of TFT. Semiconductor material is only different material between conventional amorphous silicon TFT, that utilizing silicon as semiconductor material, and amorphous IGZO TFT. As IGZO has less resistance and leakage current on TFT switch off status than conventional amorphous silicon TFT, resistance capacity delay time for signal output could be reduced compare to conventional amorphous silicon TFT and also, line noise could be reduced compare to conventional amorphous silicon TFT. Difference between amorphous IGZO and conventional amorphous silicon TFT is shown in below table and right figure.
Image /page/4/Figure/6 description: The image shows a graph of transfer characteristics, with the x-axis representing gate voltage in volts and the y-axis representing log drain current in amperes. There are two curves on the graph, one for IGZO and one for a-Si. The graph shows that the IGZO curve has a lower leakage current and a lower Ron than the a-Si curve. The graph also indicates the regions where the TFT switch is off and on.
| Category | IGZO TFT | a-Si TFT |
|---|---|---|
| Active Layer | ||
| (Semiconductor | ||
| Material) | indium(In)-gallium(Ga)-zinc(Zn)- | |
| oxygen(O) | Silicon(Si):H | |
| Crystal structure | Amorphous | Amorphous |
| On Resistance(Ron) | 0.1~0.9MΩ | 1~10MΩ |
| Leakage current | ||
| (TFT switch off status) | $10^{-15}$ A | $10^{-14}$ A |
The EXPD 4343P / EXPD 3643P is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 4343P differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.
The x-ray generator, a necessary component for a complete diagnostic system, is not part of the device. The subject detector is supported by software, Econsole1 (cleared under K152172). The subject software is the same as the predicate.
6. Indication for Use [21 CFR 807.92(a)(5)]
The EXPD 4343P / EXPD 3643P Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
006 2/7 510(k) Summary
5
7. Technological Characteristics [21 CFR 807.92(a)(6)]
The EXPD 4343P / EXPD 3643P Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into visible light is then collected by an optical sensor, which generates an electric charges representation of the spatial distribution of the incoming X-ray quanta.
The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
Comparisons with the predicate, devices show the technological characteristics of the EXPD 4343P / EXPD 3643P to be same to the predicate devices. EXPD 4343P / EXPD 3643P is functionally identical to the predicate devices.
| Parameter | Subject Device | Predicate Device | |
|---|---|---|---|
| 510(K) Number | K193031 | K192400 | |
| Manufacturer | DRTECH Corporation | DRTECH Corporation | |
| Model Name | EXPD 4343P | ||
| EXPD 3643P | EVS 4343A / EVS 4343AG | ||
| EVS 3643A / EVS 3643AG | |||
| Classification Name | Stationary X-ray System | ||
| Classification Panel | Radiology | ||
| Classification | |||
| Regulation | 21 CFR 892.1680 | ||
| Product Code | MQB | ||
| Device Class | Class II | ||
| Intended Use | The EXPD 4343P / EXPD 3643P | ||
| Digital X-ray detector is indicated for | |||
| digital imaging solution designed for | |||
| providing general radiographic | |||
| diagnosis of human anatomy. This | |||
| device is intended to replace film or | |||
| screen based radiographic systems in | |||
| all general purpose diagnostic | |||
| procedures. This device is not intended | |||
| for mammography applications | The EVS 4343A / EVS 4343AG / EVS | ||
| 3643A / EVS 3643AG Digital X-ray | |||
| detector is indicated for digital imaging | |||
| solution designed for providing general | |||
| radiographic diagnosis of human | |||
| anatomy. This device is intended to | |||
| replace film or screen based | |||
| radiographic systems in all general | |||
| purpose diagnostic procedures. This | |||
| device is not intended for | |||
| mammography applications. | |||
| Design | Panel Shape | ||
| EXPD 4343P: Square Panel | EVS 4343A: Square Panel | ||
| EVS 4343AG: Square Panel | |||
| EXPD 3643P: Rectangular Panel | EVS 3643A: Rectangular Panel | ||
| EVS 3643AG: Rectangular Panel | |||
| Detector | |||
| Size | |||
| EXPD 4343P: 17" X 17" | EVS 4343A: 17" X 17" | ||
| EVS 4343AG: 17" X 17" | |||
| EXPD 3643P: 13" X 17" | EVS 3643A: 13" X 17" | ||
| EVS 3643AG: 13" X 17" | |||
| Parameter | Subject Device | Predicate Device | |
| Dimensions | EXPD 4343P: | ||
| 460(W) x 483(L) x 15.5(H) | |||
| EXPD 3643P: | |||
| 460(W) × 409(L) x 15.5(H) | EVS 4343A: | ||
| 460(W) x 483(L) x 15.5(H) | |||
| EVS 4343AG: | |||
| 460(W) x 483(L) x 15.5(H) | |||
| EVS 3643A: | |||
| 460(W) × 409(L) × 15.5(H) | |||
| EVS 3643AG: | |||
| 460(W) × 409(L) × 15.5(H) | |||
| Pixel Pitch | 140μm | 140μm | |
| Image Size | EXPD 4343P: 3,072 x 3,072 | ||
| EXPD 3643P: 2,560 x 3,072 | EVS 4343A: 3,072 x 3,072 | ||
| EVS 4343AG: 3,072 x 3,072 | |||
| EVS 3643A: 2,560 x 3,072 | |||
| EVS 3643AG: 2,560 x 3,072 | |||
| Scintillator & TFT | |||
| Materials | TFT -IGZO | ||
| EXPD 4343P / EXPD 3643P: CsI | TFT -amorphous Silicon | ||
| EVS 4343A/EVS 3643A: CsI | |||
| EVS 4343AG/ EVS 3643AG: GOS | |||
| Performance | DQE | EXPD 4343P: 50.0 % at 1.0 lp/mm | |
| EXPD 3643P: 52.3 % at 1.0 lp/mm | EVS 4343A: 52.9% at 1.0 lp/mm | ||
| EVS 4343AG: 27.2 % at 1.0 lp/mm | |||
| EVS 3643A: 50.5% at 1.0 lp/mm | |||
| EVS 3643AG: 26.3 % at 1.0 lp/mm | |||
| MTF | EXPD 4343P: 52.3 % at 2.0 lp/mm | ||
| EXPD 3643P: 46.8 % at 2.0 lp/mm | EVS 4343A: 44.1% at 2.0 lp/mm | ||
| EVS 4343AG: 49.2% at 2.0 lp/mm | |||
| EVS 3643A: 44.5% at 2.0 lp/mm | |||
| EVS 3643AG: 46.3% at 2.0 lp/mm | |||
| Resolution | 3.5 lp/mm | 3.5 lp/mm | |
| Anatomical Sites | General Radiography | General Radiography | |
| Power Supply | 100 | 100 | |
| Component | PoE Adaptor | ||
| Lan cables(2 ea) | |||
| AC Power Cable | |||
| Ethernet Connector Bracket | PoE Adaptor | ||
| Lan cables(2 ea) | |||
| AC Power Cable | |||
| Ethernet Connector Bracket | |||
| Communication | |||
| Interface | Wired: Ethernet | Wired: Ethernet | |
| Parameter | Modified Device | Predicate Device | Remark |
| DQE | EXPD 4343P: 50.0% at 1.0 lp/mm | EVS 4343A: 52.9% at 1.0 lp/mm | |
| EXPD 3643P: 52.3 % at 1.0 lp/mm | EVS 4343AG: 27.2 % at 1.0 lp/mm | ||
| MTF | EXPD 4343P: 52.3 % at 2.0 lp/mm | EVS 4343A: 44.1 % at 2.0 lp/mm | |
| EXPD 3643P: 46.8 % at 2.0 lp/mm | EVS 4343AG: 49.2 % at 2.0 lp/mm | ||
| EVS 3643A: 44.5 % at 2.0 lp/mm | |||
| EVS 3643AG: 46.3 % at 2.0 lp/mm |
8. Substantial Equivalence [21 CFR 807.92(b)]
6
DRTECH
When compared to the predicate devices (K192400), the EXPD 4343P / EXPD 3643P presented in this submission have similar:
- . Intended Use
- Technological characteristics •
- Operating principle •
- Performance (Resolution) •
- Communication Method
- . Components
7
-
Size
A few differences are as follows -
. Performance (DQE and MTF)
-
. TFT Panel
There are no significant differences between the EXPD 4343P / EXPD 3643P and the predicate device(s) that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.
According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device.
9. Summary of Non-Clinical Data [21 CFR 807.92(b)(1)]
The non-clinical performance testing constrains that the main physical values for comparison of Xray devices like DQE and MTF are basically equal or worth than the predicate device as following table:
8
DRTECH
The EXPD 4343P / EXPD 3643P detector complies with the following international and FDArecognized consensus standards:
| Recognition No. | Standard No. | Title of Standard | Remark |
|---|---|---|---|
| 19-4 | ANSI AAMI ES60601- | ||
| 1:2005/(R)2012 and | |||
| A1:2012 | Medical electrical equipment - | ||
| Part 1: General requirements for | |||
| basic safety and essential | |||
| performance (IEC 60601- | |||
| 1:2005, MOD) | |||
| 12-289 | IEC 62220-1 Edition 1.0 | ||
| 2015-03 | Medical electrical equipment- | ||
| Characteristics of digital X-ray | |||
| imaging devices Part 1-1: | |||
| Determination of the detective | |||
| quantum efficiency Detectors | |||
| used in radiographic imaging | |||
| 5-40 | ISO 14971 Second edition | ||
| 2007-03-01 | Medical devices - Application | ||
| of risk management to medical | |||
| devices | |||
| 5-89 | IEC 60601-1-6 Edition 3.1 | Medical electrical equipment - | |
| Part 1-6: General requirements | |||
| for basic safety and essential | |||
| performance - Collateral | |||
| standard: Usability | |||
| 12-300 | PS 3.1 - 3.20 (2016) | Digital Imaging and | |
| Communications in Medicine | |||
| (DICOM) Set | |||
| 19-8 | IEC 60601-1-2 Edition 4.0 | Medical electrical equipment - | |
| Part 1-2: General requirements | |||
| for basic safety and essential | |||
| performance - Collateral | |||
| Standard: Electromagnetic | |||
| disturbances - Requirements | |||
| and tests | |||
| 13-32 | ANSI AAMI IEC | ||
| 62304:2006 | Medical device software - | ||
| Software life cycle processes |
9
10. Conclusion [21 CFR 807.92(b)(3)]
The modified EXPD 4343P / EXPD 3643P detector is substantially equivalent to the currently marketed and predicate device (EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG - K192400) in terms of fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recogmized consensus standards, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2:2014, ANSI AAMI IEC 62304:2006 and IEC 6220-1-1 which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.
The results of these tests demonstrate that The EXPD 4343P / EXPD 3643P meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, nonclinical performance data and safety testing demonstrates that the device is as safe, as effective, and performs as well or better than the predicate devices.