(30 days)
No
The description focuses on standard digital image processing techniques (amplification, digital conversion, post-processing) and software features for image enhancement and exposure management. There is no mention of AI, ML, or related concepts like training data or algorithms that learn from data.
No
The device is used for generating radiographic images, which is a diagnostic purpose, not a therapeutic one.
Yes.
The device is intended for use in generating radiographic images of human anatomy and the images are sent to a PACS server for reading. The "Intended Use" section explicitly states "The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy". The "Device Description" also mentions that the "S-station" is the "Operation Software (OS) of Samsung Digital Diagnostic X-ray System," directly linking this system to diagnostic purposes. Furthermore, the system is designed to "capture images by transmitting X-ray to a patient's body," and these images are then "sent to the Picture Archiving & Communication System (PACS) sever for reading images," which is a key step in diagnosis.
No
The device is described as a "digital X-ray imaging system" which includes hardware components like an X-ray generator and detector, in addition to software for image processing and operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "generating radiographic images of human anatomy". This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
- Device Description: The description details how the device captures X-ray images of a patient's body and processes those images. This aligns with the function of a medical imaging system, not an IVD.
- Input Imaging Modality: The input is X-ray, which is a form of medical imaging, not a method used for in vitro diagnostics.
- Anatomical Site: The device is used on "human anatomy" and specific body parts like the chest, abdomen, and L-spine. IVDs are used on samples taken from the body.
In summary, the GC85A Digital X-ray Imaging System is a medical imaging device used for generating radiographic images of the human body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Product codes
KPR
Device Description
The GC85A digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
The GC85A digital X-ray imaging system was previously cleared with K172229, and through this premarket notification, we would like to add more configurations in the previously cleared GC85A as three High Voltage Generators and two detectors are newly added, and three software features are newly added as stated below.
S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Pediatric Exposure Management (PEM), which was cleared before with the predicate device GM85 at K171119, is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols, and Remote View to enable the images on the device is being displayed on the remote monitor. It was determined that the level of concern for the software contained in the GC85A digital X-ray imaging system was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
Mentions image processing
Yes, "The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-ray
Anatomical Site
human anatomy, chest, abdomen, and L-spine
Indicated Patient Age Range
Not Found. Pediatric patients are mentioned in the context of exposure management, but no specific age range is provided.
Intended User / Care Setting
qualified/trained doctor or technician
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
Phantom image evaluations for the new detector and S-Enhance were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. Anthropomorphic phantom images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray flat-panel detector similar to the predicate detector) but they provide further evidence in addition to the performance data to show that the complete system works as intended. They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score considering the standard deviation of image quality evaluation between the proposed device and the predicate device and it is confirmed that S-Enhance is able to generate a companion image which provide clear visibility for foreign bodies such as lines, tubes, and needles, and urinary stones in chest, abdomen, and L-spine protocol in addition to the original images. Therefore, these changes do not affect either the safety or the effectiveness, compared to the predicated device.
Key Metrics
Not Found
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
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July 20, 2018
Samsung Electronics Co., Ltd. % Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA
Re: K181629
Trade/Device Name: GC85A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 15, 2018 Received: June 20, 2018
Dear Jaesang Noh:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Nils
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name GC85A
Indications for Use (Describe)
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services
Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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510(k) Premarket Notification - Traditional
Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: June 15, 2018
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea
3. Primary Contact Person
- A. Name: JAESANG NOH & CHUNSIN KIM
- B. Title: Regulatory Affairs, Senior Professional
- C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437
- D. FAX Number: +82-31-200-6401
- E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com ய்
4. Secondary Contact Person
- A. Name: Genci Omari
- B. Title: Manager, Regulatory Affairs
- C. Phone Number: 978-564-8602
- D. FAX Number: 978-560-0602
- E. E-Mail: gomari@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GC85A
- B. Device Name: GC85A
- C. Common Name: Digital Diagnostic X-ray System
- D. Regulation Name: Stationary X-ray system
- E. Product Code: KPR
- ட் Regulation: 21 CFR 892.1680
6. Predicate Devices
| Predicate Device #1 | Predicate Device #2 | |
|---|---|---|
| Device Name | GC85A | GM85 |
| Classification Name | Stationary X-ray | |
| System | Mobile X-ray System | |
| Product Code | KPR | IZL |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1720 |
| 510(K)# | K172229 | K171119 |
| 510(K) Decision Date | Nov., 22, 2017 | May, 12, 2017 |
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Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, rounded, rectangular background.
510(k) Premarket Notification - Traditional
7. Device Description
The GC85A digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images.
The GC85A digital X-ray imaging system was previously cleared with K172229, and through this premarket notification, we would like to add more configurations in the previously cleared GC85A as three High Voltage Generators and two detectors are newly added, and three software features are newly added as stated below.
S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Pediatric Exposure Management (PEM), which was cleared before with the predicate device GM85 at K171119, is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols, and Remote View to enable the images on the device is being displayed on the remote monitor. It was determined that the level of concern for the software contained in the GC85A digital X-ray imaging system was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".
8. Intended Use
The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The proposed device GC85A apply software features as S-Enhance and Pediatric Exposure, which were cleared with K171119, and Remote View to GC85A product which was cleared with K172229 without changes in technical characteristics, materials, energy sources and biocompatibility such as X-ray Tube Assembly except of high voltage generator and detector. Optional high voltage generators and detectors which were improved durability and dust/water-resistance are added to GC85A.
Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicate.
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Image /page/5/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, oval shape.
510(k) Premarket Notification - Traditional
| Specification | Predicate
Device #1 | Proposed
Device | Predicate
Device #2 | Discussion |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name | GC85A | GC85A | GM85 | |
| Manufacturer | SAMSUNG
ELECTRONICS
Co., Ltd. | SAMSUNG
ELECTRONICS
Co., Ltd. | SAMSUNG
ELECTRONICS
Co., Ltd. | |
| 510(k) Number | K172229 | None | K171119 | |
| Appearances | Image: GC85A X-ray system | Image: GC85A X-ray system | Image: GM85 Mobile X-ray system | Same as PD#1 |
| Intended Use | The GC85A
digital X-ray
imaging system
is intended for
use in
generating
radiographic
images of
human anatomy
by a
qualified/trained
doctor or
technician. This
device is not
intended for
mammographic
applications. | The GC85A
Digital X-ray
Imaging System
is intended for
use in
generating
radiographic
images of
human anatomy
by a
qualified/trained
doctor or
technician. This
device is not
intended for
mammographic
applications. | The GM85
Digital Mobile X-
ray imaging
System is
intended for use
in generating
radiographic
images of
human anatomy
by a
qualified/trained
doctor or
technician. This
device is not
intended for
mammographic
applications. | Same as PD#1 |
| t | Comparing with Predicate Device | |||
|---|---|---|---|---|
| --- | --------------------------------- | -- | -- | -- |
| Manufacturer
Contents | GC85A
(K172229) | GC85A | GM85
(K171119) | Discussion |
|---------------------------|--------------------|------------|-------------------|---------------|
| (1)High Voltage Generator | | | | |
| Max. Power | 82kW | 82kW
| 32kW / 40kW | Difference(1) |
| Output
RANGE | 40-150kV | 40 - 150kV | 40-150kV | Same |
| | Tube
Voltage |
| | |
| | Tube
Curr | 10-1000mA | 10 - 500mA | 10 - 500mA |
6
Image /page/6/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.
510(k) Premarket Notification - Traditional
| Manufacturer
Contents | | GC85A
(K172229) | GC85A | | | GM85
(K171119) | Discussion |
|----------------------------------------------------|--------------------------|--------------------|-------------------------------------|-------------------------------------|-------------------------------------|-------------------|--------------|
| | ent | | m
A | m
A | A
A | | |
| | Exp
osur
e
Time | 1msec-10sec | 1
ms
ec
10
se
c | 1
ms
ec
10
se
c | 1
ms
ec
10
se
c | 1msec-10sec | Same |
| AEC
(Automatic
Exposure
Control) | | Yes | Yes | | | - | Same as PD#1 |
| APR
(Anatomically
Programmed
Radiography) | | Yes | Yes | | | - | Same as PD#1 |
| Manufacturer
Contents | GC85A (K172229) | GC85A | GM85
(K171119) | Discussion |
|----------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------|
| (2) Detector | | | | |
| Name | S4335-W
S4343-W
S3025-W | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW | S4335-W
S4343-W
S3025-W | Difference(3) |
| | S4335-W | S4335-AW | S4335-W | |
| | S4343-W | S4343-AW | S4343-W | |
| Detector Type | Csl | Csl | Csl | Same |
| | Indirect | Indirect | Indirect | Same |
| Detector Area | 14"X17"
(345mm
X425m
m) | 17"X17"
(425mm
X425m
m) | 14"X17"
(345mm
X425m
m) | Same |
| | 17"X17"
(425mm
X425m
m) | 14"X17"
(345mm
X425m
m) | 17"X17"
(425mm
X425m
m) | Same |
| Number of pixels | 2466X3
040 | 3036X3
040 | 2466X3
040 | Same |
| | 3036X3
040 | 2466X3
040 | 3036X3
040 | Same |
| Pixel Pitch(um) | 140 | 140 | 140 | Same |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.57 | 3.57 | 3.57 | Same |
| Communication | Wired /
Wireless | Wired /
Wireless | Wired /
Wireless | Same |
| Dust/Water-
resistance | IPx1 | IP54 | IPx1 | Difference(3)
-1 |
| Max.load
capacity | 150 kg for uniform
load,
100 kg for local
load (40 mm in
diameter disk at | 400 kg for uniform
load,
200 kg for local
load (40 mm in
diameter disk at | 150 kg for uniform
load,
100 kg for local
load (40 mm in
diameter disk at | Difference(3)
-2 |
7
Image /page/7/Picture/1 description: The image shows the SAMSUNG logo. The logo is white text on a blue background. The text is in a bold, sans-serif font.
510(k) Premarket Notification - Traditional
| Manufacturer
Contents | GC85A (K172229) | GC85A | GM85
(K171119) | Discussion |
|--------------------------|-----------------|-------------|-------------------|------------|
| | the center) | the center) | the center) | |
| Manufacturer
Contents | GC85A (K172229) | GC85A | GM85
(K171119) | Discussion |
|--------------------------|-----------------|-------------|-------------------|-----------------|
| (3) Software Features | | | | |
| Feature
Names | SimGrid | SimGrid | SimGrid | Same |
| | S-Guide | S-Guide | - | Same as
PD#1 |
| | - | S-Enhance | TLE | Difference(4) |
| | - | PEM | PEM | Same as
PD#2 |
| | S-DAP | S-DAP | S-DAP | Same |
| | S-Align | S-Align | S-Align | Same |
| | S-Share | S-Share | S-Share | Same |
| | BSI | BSI | BSI | Same |
| | - | Remote View | - | Difference(5) |
| No | Differences | Explanation |
|---|---|---|
| (1) | HVG Power rating | Optional HVGs which are added to the GC85A device have lower max power than the predicate device's max power and these changes do not contribute any adverse impact to the device's safety and effectiveness. |
| (2) | HVG mA range | Optional HVGs which are added to the GC85A device have lower max current than the predicate's max current and these changes do not contribute any adverse impact to the device's safety and effectiveness. |
| (3)-1 | Dust/Water-resistance | The new detectors which are added to the GC85A device have better dust/water-resistance than the predicate device's dust/water-resistance and this change does not contribute any adverse impact to the device's safety and effectiveness. |
| (3)-2 | Max.load capacity | The new detectors which are added to the GC85A device have higher max load capacity than the predicate device's |
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Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is placed inside a blue, rounded, oval shape. The logo is simple and modern.
510(k) Premarket Notification - Traditional
| | | max load capacity and this change does not contribute any
adverse impact to the device's safety and effectiveness. |
|-----|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (4) | S-Enhance | S-Enhance is renamed from Tube & Line Enhancement
(TLE), which was cleared with K171119, is to enhance
visibility of tubes and lines and provide enhanced images
separately from original images. This software feature is
applied to the GC85A with the scope of application for S-
Enhance, which is expanded from tubes and lines on chest
images to foreign body (e.g. tubes, lines and needles) and
urinary stones on chest, abdomen and L-spine images.
This change is considered low risk and does not contribute
any adverse impact to the device's safety and
effectiveness. |
| (5) | Remote View | The function of Remote View, which allows remote access
to view the current image on the workstation through a web
browser, is applied to the GC85A and this change does not
contribute any adverse impact to the device's safety and
effectiveness. |
B. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1,IEC 60601-1-2,IEC 60601-1-3,IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
C. Non-clinical data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements form the predicate device.
D. Clinical data
Phantom image evaluations for the new detector and S-Enhance were performed in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. Anthropomorphic phantom images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note X-ray flat-panel detector similar to the predicate detector) but they provide further evidence in addition to the performance data to show that the complete system works as intended. They were evaluated by professional radiologists and found to be equivalent to the predicate devices. There is no significant difference in the average score considering the standard deviation of image quality evaluation between the proposed device and the predicate device and it is confirmed that S-Enhance is able to generate a companion image which provide clear visibility for foreign bodies such as lines, tubes, and
9
Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background. The oval is tilted slightly upward from left to right.
510(k) Premarket Notification - Traditional
needles, and urinary stones in chest, abdomen, and L-spine protocol in addition to the original images. Therefore, these changes do not affect either the safety or the effectiveness, compared to the predicated device.
E. Conclusions
The non-clinical and clinical data demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed device.