K Number
K181626
Device Name
Digital Diagnostic Mobile X-ray System
Date Cleared
2018-07-20

(30 days)

Product Code
Regulation Number
892.1720
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
The GM85 Digital Mobile X-ray imaging System is used to capture images by transmitting X-ray to a patient's body. The X-ray 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 send to the Picture Archiving & Communication System (PACS) sever for reading images. The GM85 Digital Mobile X-ray imaging System was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a fixed column type 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 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 Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GM85 Digital Mobile 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".
More Information

No
The document describes image processing techniques (S-Enhance, Manual Stitching, Remote View) but does not mention AI, ML, or related terms like neural networks or deep learning. The focus is on enhancing visibility and combining images, which are standard image processing functions.

No

Explanation: The device is an X-ray imaging system used to generate radiographic images for diagnostic purposes, not for treating conditions.

Yes

The "Intended Use / Indications for Use" section states: "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." While it generates images, the "Device Description" also mentions the "S-Station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System." This explicitly labels the system as "Diagnostic." Furthermore, the text states "The captured images ... send to the Picture Archiving & Communication System (PACS) sever for reading images," implying the images are used for diagnosis.

No

The device description explicitly states it is a "Digital Mobile X-ray imaging System" that transmits X-rays, uses a detector, and has hardware components like the S-Station. While it includes software features, it is fundamentally a hardware device with integrated software.

Based on the provided text, 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 an X-ray imaging system, not an IVD.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

The device is a digital mobile X-ray imaging system used for generating medical images, which falls under the category of medical imaging devices, not IVDs.

N/A

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

IZL

Device Description

The GM85 Digital Mobile X-ray imaging System is used to capture images by transmitting X-ray to a patient's body. The X-ray 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.

The GM85 Digital Mobile X-ray imaging System was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a fixed column type 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 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 Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GM85 Digital Mobile 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

The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-Station, and send to the Picture Archiving & Communication System (PACS) sever for reading images.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy, chest, abdomen, L-spine

Indicated Patient Age Range

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Non-clinical and clinical performance studies.
Key Results: The new types of detectors have equivalent image characteristics as the existing ones. S-Enhance shows no difference in non-clinical testing data such as TLC and CER measurements from TLE of the predicate device GM85 (K171119). Phantom image evaluations of the new types of detectors and S-Enhance were performed. Anthropomorphic phantom images were evaluated by a professional radiologist 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. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180543

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K171119

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 20, 2018

Samsung Electronics Co., Ltd. % Soeun Chang Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 16677 REPUBLIC OF KOREA

Re: K181626

Trade/Device Name: GM85 Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: June 18, 2018 Received: June 20, 2018

Dear Soeun Chang:

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,

Hsl 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

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Indications for Use

510(k) Number (if known) K181626

Device Name GM85

Indications for Use (Describe)

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.

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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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

    1. Date: June 18, 2018

2. Submitter

  • Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
  • Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, B. Republic of Korea

3. Primary Contact Person

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-Mail: gomari@samsungneurologica.com

5. Proposed Device

  • A. Trade Name: GM85
  • B. Device Name: GM85
  • C. Common Name: Digital Diagnostic Mobile X-ray System
  • D. Classification Name: Mobile X-ray System
  • E. Product Code: IZL
  • ட் Regulation: 21 CFR 892.1720

6. Predicate Devices

Predicate Device
Device NameGM85
Classification NameMobileX-ray system.
Product CodeIZL
Regulation21 CFR 892.1720
510(K)#K180543
510(K) Decision DateMay 24, 2018

4

510(k) Premarket Notification - Traditional

7. Device Description

The GM85 Digital Mobile X-ray imaging System is used to capture images by transmitting X-ray to a patient's body. The X-ray 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.

The GM85 Digital Mobile X-ray imaging System was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a fixed column type 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 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 Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GM85 Digital Mobile 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 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.

9. Summary of Technological characteristic of the proposed device compared with the predicate devices

The proposed device, GM85, has the same technological characteristics and hardware as its original predicate device. GM85 (K180543), and added a new fixed column type, new types of detectors and image processing technology(S-Enhance, Manual stitching, and Remote View). It does not have significant changes in materials, energy source or technological characteristics compared to the predicated device.

Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicates.

A. Comparing with Predicate Device

The proposed device is shown as its parts are identical or equivalent with predicate device while some differences are made as below, which does not show significant difference in safety and effectiveness.

5

SpecificationPredicate DeviceProposed DeviceDiscussion
Device NameGM85GM85-
ManufacturerSAMSUNG ELECTRONICSSAMSUNG ELECTRONICS-
510(k) NumberK180543--
AppearancesImage: Predicate Device AppearanceImage: Proposed Device Appearance
[C-Type*]
[F-Type**]
*Collapsible column type (C-Type)
**Fixed column type (F-Type)Difference(1)
Intended UseThe 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.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
Manufacturer ContentsPredicate DeviceGM85Discussion
(1)High Voltage Generator
TypeHigh FrequencyHigh Frequency-
Max. Power32kW / 40kW32kW / 40kWSame
Output
RANGEkVp Range40 to 150kVp40 to 150kVpSame
mA Range10 - 500mA10 - 500mASame
Exposure Time1msec-10sec1msec-10secSame

510(k) Premarket Notification - Traditional

Manufacturer ContentsPredicate DeviceGM85Discussion
C-typeF-type
(2)Tube assembly
Moving
RangeHorizontal793~1355mm793~1355mmSame
Vertical550~2030mm550~2030mm550~2030 or
1850mmDifference(2)
Rotation
RangeColumn$\pm$ 315°$\pm$ 315°Same
Tube (Arm axis)$\pm$ 180°$\pm$ 180°Same
Tube (Tube axis)-30°~90°-30°~90°Same
TubeModelLUC-13L,
XRR-3332XLUC-13L,
XRR-3332XSame
Focal spot0.6/1.2mm0.6/1.2mmSame
Target Angle14°14°Same

6

510(k) Premarket Notification - Traditional

Manufacturer ContentsPredicate DeviceGM85Discussion
C-typeF-type
Target MaterialRhenium-tungsten faced
molybdenumRhenium-tungsten faced
molybdenumSame
Nominal Tube
Voltage150kVp150kVpSame
Max.Anode HU300kHU300kHUSame
CollimatorAutomatic
SDR-OGCL40U
212 X 306 X 179mmAutomatic
SDR-
OGCL40U
212 X 306 X
179mmManual
SDR-
OGCL41U
222 X 271 X
140mmDifference(3)
Manufacturer ContentsPredicate DeviceGM85Discussion
(3) Detector
NameS4335-W
S4343-W
S3025-WS4335-W
S4343-W
S3025-W
S4335-AW
S4343-AWDifference(4)
S4335-WS4343-WS4335-AWS4343-AW
Detector TypeCslCslCslCslSame
IndirectIndirectIndirectIndirectSame
Detector Area14"X17"
(345mmX42
5mm)17"X17"
(425mmX42
5mm)14"X17"
(345mmX4
25mm)17"X17"
(425mmX4
25mm)Same
Number of pixels2466X30403036X30402466X30403036X3040Same
Pixel Pitch(um)140140140140Same
High Contrast Limiting
Resolution (LP/mm)3.573.573.573.57Same
CommunicationWired /
WirelessWired /
WirelessWired /
WirelessWired /
WirelessSame
Dust/Water-resistanceIPx1IP54Difference(4)-1
Max.load capacity150 kg for uniform load,
100 kg for local load (40
mm in diameter disk at the
center)400 kg for uniform load,
200 kg for local load (40
mm in diameter disk at the
center)Difference(4)-2
Manufacturer ContentsPredicate DeviceGM85Discussion
(4) Grid
Lines/cm84.684.6Same
Grid mechanismStationaryStationarySame
RemovabilityRemovableRemovableSame
(5) Weight Distribution Cap
Model NameSDR-OGWD80USDR-OGWD80USame
Size(mm)505x553x37.4505x553x37.4Same
(6) Software Features
SimGridSimGridSimGridSame

7

Manufacturer ContentsPredicate DeviceGM85Discussion
Tube & Line
Enhancement(TLE)
/ S-EnhanceTLE*
*FDA-cleared(K171119)S-EnhanceDifference(5)
Pediatric Exposure
Management(PEM)PEMPEMSame
S-DAP
(Dose Area Product)S-DAPS-DAPSame
S-AlignS-AlignS-AlignSame
S-ShareS-ShareS-ShareSame
Bone Suppression
Image(BSI)BSIBSISame
Remote ViewRemote ViewDifference(6)
Manual StitchingManual StitchingDifference(7)

510(k) Premarket Notification - Traditional

NoDifferencesExplanation
(1)AppearancesThe proposed device GM85 adds newly a fixed column type in comparison with the predicated device's one that has only collapsible column type. The fixed column type has two options about the column's height, 1,800mm and 1,980mm. It does not contribute any adverse impacts to the device's image quality. The variety of column's types can be more helpful to choose the right equipment for fitting user's needs.
(2)Moving Range
(Vertical)The vertical moving range of proposed device GM85 varies depending on the column type.
(3)CollimatorThe proposed device GM85 has different types of collimator depending on column type. The collapsible column type has the same collimator(automatic, SDR-OGCL40U) applied to the predicate device and the fixed column type has the new type of collimator(manual, SDR-OGCL41U) which does not contribute any adverse impacts to the device's image quality.
(4)-1Detector
Dust/Water-resistanceThe new detectors which are added to the GM85 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.
(4)-2Detector
Max.load capacityThe new detectors which are added to the GM85 device have higher max load capacity than the predicate device's max load capacity and this change does not contribute any adverse impact to the device's safety and effectiveness.
(5)Tube & Line
Enhancement(TLE) / S-EnhanceTube & Line Enhancement (TLE), which was cleared with K171119, is to enhance visibility of tubes and lines on chest images and provide enhanced images separately from original images. TLE is renamed as S-Enhance, expanding its coverage and scope in this proposed device. 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. This change is considered low risk and does not

8

| | | contribute any adverse impact to the device's safety and
effectiveness. |
|-----|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (6) | 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 GM85 and this change does not
contribute any adverse impact to the device's safety and
effectiveness. |
| (7) | Manual Stitching | Manual Stitching can capture a body part that is larger than the
detector's area by capturing multiple images. This function is
considered low risk and does not contribute any adverse impact
to the device's safety and effectiveness. |

510(k) Premarket Notification - Traditional

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 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 has new types of detectors that have equivalent image characteristics as the existing ones. Specific description is added to make it clear with the non-clinical data and phantom image evaluation report. And those detectors evaluated by Software System Test Case for verification and validation.

The S-Enhance is same image processing technology as TLE of predicate device GM85 (K171119) and extends the applicable body parts to chest, abdomen, and L-spine so it shows no difference in non-clinical testing data such as TLC and CER measurements from TLE of the predicate device GM85 (K171119).

Manual Stitching is optional software to capture a body part that is larger than the detector's area and evaluated Software System Test Case for verification and validation.

D. Clinical data

In clinical data, phantom image evaluations of the new types of detectors 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

9

510(k) Premarket Notification - Traditional

that the complete system works as intended. They were evaluated by a professional radiologist 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.

E. Conclusions

The non-clinical and clinical demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate devices.