K Number

Device Name

XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

Manufacturer

Gemss Healthcare Co., Ltd.

Date Cleared

2023-11-16

(49 days)

Product Code

OWB JAA OXO

Regulation Number

892.1650

Intended Use

XPlus 35 Series (XPLUS 35. XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and interventions inside and outside the operating room.

Device Description

XPLUS 35 Series (XPLUS 35, XPLUS 35FD), C-arm mobile, is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. XPLUS 35 Series (XPLUS 35, XPLUS 35FD) consist of X-ray tube, X-ray generator, C-arm including image receptor, monitor cart, medical monitor and accessories such as foot switch and hand switch.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K091918

Reference Devices

K222080

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies. The focus is on standard fluoroscopic and radiographic imaging capabilities.

Therapeutic

No
The device is a C-arm designed for imaging patients during diagnostic, surgical, and interventional procedures, not for providing therapy.

Diagnostic

Yes
The device is described as "designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures," and is used for "providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures." The "Intended Use / Indications for Use" section explicitly states its use for "diagnostic" procedures.

SaMD (Software as a Medical Device)

The device description explicitly lists hardware components such as an X-ray tube, X-ray generator, C-arm, monitor cart, medical monitor, foot switch, and hand switch. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The XPlus 35 Series is a mobile digital C-arm that uses X-rays to produce images of the patient's internal anatomy during procedures. It is a medical imaging device, not a device that analyzes samples taken from the body.
Intended Use: The intended use clearly states it provides "fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures." This involves imaging the patient directly, not analyzing samples.

Therefore, the XPlus 35 Series falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

XPlus 35 Series (XPLUS 35. XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures.
i.e. surgical interventions needing X-ray imaging and interventions inside and outside the operating room.

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

OWB, JAA, OXO

Device Description

1. C-arm
- X-ray tube: It converts high voltage currents into an X-ray through a generator. -
- -Image receptors: It translates the x-ray, which penetrates the patient's body, into the image signals.
1. Monitor cart

Main C-arm units and monitor cart are connected to each other with a cable. There is a main power cable to supply power to the monitor cart and main unit, which is not a battery type.

Software: The displayed images can be edited and saved, and the images can also be sent to PACS server. Moreover, the patient information and database can be managed through the monitor cart
Medical montor: It displays the images by the monitor through visualizing the image signals. It displays live image on the left, and reference image on the right.
1. Accessories
- Foot switch: It is used for fluoroscopy and can save images. -
- Hand switch: It is used in both radiographic and fluoroscopic modes. It controls X-ray generation.

Mentions image processing

The displayed images can be edited and saved, and the images can also be sent to PACS server.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopic X-ray, Radiographic X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.

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 validation testing has been performed to validate that XPLUS 35 Series (XPLUS 35, XPLUS 35FD) conforms to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.
As a results, all test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.

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.

K091918

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.

K222080

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

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

November 16, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Gemss Healthcare Co., Ltd. % Mr. Dave Kim RA Consultant Mtech Group LLC 7505 Fannin St. Suite 610 HOUSTON TX 77054

Re: K233200

Trade/Device Name: XPLUS 35 Series (XPLUS 35, XPLUS 35FD) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: September 22, 2023 Received: September 28, 2023

Dear Mr. Kim:

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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 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,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Indications for Use

510(k) Number (if known) K233200

Device Name XPLUS 35 Series (XPLUS 35, XPLUS 35FD)

Indications for Use (Describe)

i.e. surgical interventions needing X-ray imaging and interventions inside and outside the operating room.

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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Image /page/3/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is written in orange, with each letter connected to the next. Below the word "GEMSS" is the word "HEALTHCARE" in gray. The logo is simple and modern.

1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952 South Korea Tel. +82 31-906-9017 Fax. +82 31-906-9019 sales@gemss-healthcare.com

510(k) Summary K233200

This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: November 15, 2023

1. Applicant / Submitter

GEMSS HEALTHCARE CO., LTD. ।
Address: 1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952, Republic of Korea ।
Tel: +82-31-906-9017 | Fax: +82-31-906-9019 | Email:olivia@gemss.co.kr -
Official Correspondent (U.S): Dave Kim / Mtech Group LLC । 7505 Fannin St. Suite 610, Houston, TX 77054 / Tel) 1-713-467-2607 / davekim@mtechgroupllc.com

2. Device Information

Trade/Device Name: XPLUS 35 Series (XPLUS 35, XPLUS 35FD) -
Regulation Number: 21CFR 892.1650 -
Regulation Name: Image-Intensified Fluoroscopic X-ray System -
Device Class: Class II -
। Product Code: OWB
-Subsequence product code: JAA, OXO

3. Predicate Device

K Number: K091918
Manufacturer: GENORAY Co., Ltd. -
Trade Name: ZEN-2090 Pro -
Regulation Number: 21CFR 892.1650 -
Regulation Name: Image-Intensified Fluoroscopic X-ray System -
-Device Class: Class II
Product Code: OWB ।
Subsequence product code: JAA, OXO -

4. Reference Device

K Number: K222080 -
-Manufacturer: SG HealthCare Co. Ltd.
-Trade Name: Garion
Requlation Number: 21CFR 892.1650 -

Image /page/4/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is in orange, and the word "HEALTHCARE" is in gray. The logo is simple and modern.

Regulation Name: Image-Intensified Fluoroscopic X-ray System
Device Class: Class II
Product Code: OWB ।

5. General Description

1. C-arm
- X-ray tube: It converts high voltage currents into an X-ray through a generator. -
- -Image receptors: It translates the x-ray, which penetrates the patient's body, into the image signals.
1. Monitor cart

Main C-arm units and monitor cart are connected to each other with a cable. There is a main power cable to supply power to the monitor cart and main unit, which is not a battery type.

Software: The displayed images can be edited and saved, and the images can also be sent to PACS server. Moreover, the patient information and database can be managed through the monitor cart
Medical montor: It displays the images by the monitor through visualizing the image signals. It displays live image on the left, and reference image on the right.
1. Accessories
- Foot switch: It is used for fluoroscopy and can save images. -
- Hand switch: It is used in both radiographic and fluoroscopic modes. It controls X-ray generation.

6. Indication for use

XPlus 35 Series (XPLUS 35, XPLUS 35FD) are mobile digital C-arms designed to provide fluoroscopic and radiographic images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include endoscopy, orthopedic, neurologic, critical care and emergency room procedures. i.e. surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the operating room.

Image /page/5/Picture/0 description: The image contains the logo for GEMSS Healthcare. The word "GEMSS" is written in orange, and the word "HEALTHCARE" is written in gray below it. The font is sans-serif and the text is left-aligned.

Comparison of the subject device to the predicate device.

Descriptive Information	Subject Device	Predicate Device	Reference Device	Note
Manufacturer	GEMSS
HEALTHCARE CO.,
LTD.	GENORAY Co.,
Ltd.	SG HealthCare Co.
Ltd.
Device Name	XPLUS 35,
XPLUS 35 FD	ZEN-2090 Pro	Garion
510(k) number	K233200	K091918	K222080	-
Regulatory Number	21CFR 892.1650	21 CFR 892.1650	21 CFR 892.1650	Same
Product Code	OWB, JAA, OXO	OWB, JAA, OXO	OWB	Same
Regulatory Class	2	2	2	Same
Indications for Use	XPLUS 35 series
(XPLUS 35, XPLUS
35FD) are mobile
digital C-arms
designed to provide
fluoroscopic and
radiographic images
of the patient during
diagnostic, surgical
and interventional
procedures.
Examples of clinical
application may
include orthopedic,
neurologic, vascular,
cardiac,
angiography,
endoscopy, urologic,
critical care and
emergency room
procedures. i.e.
surgical interventions
needing X-ray
imaging and/or
guidance and
interventions inside
and outside the
operating room.	ZEN-2090 Pro is
a mobile digital
C-arm designed
to provide
fluoroscopic and
radiographic
images of the
patient during
diagnostic,
surgical and
interventional
procedures.
Examples of
clinical
application may
include
cholangiography,
endoscopy,
orthopedic,
neurologic, stone
location, critical
care and
emergency room
procedures
i.e. surgical
interventions
needing X-ray
imaging and/or
guidance and
interventions
inside and
outside the
operating room.	The Garion is
intended to be
used and
operated by:
adequately
trained, qualified
and authorized
health care
professionals who
have full
understanding of
the safety
information and
emergency
procedures as well
as the capabilities
and functions of
the device. The
device is used for
radiological
guidance and
visualization
during diagnostic,
interventional and
surgical
procedures on all
patients, except
neonates (birth to
one month),
within the limits of
the device. The
device is to be
used in healthcare
facilities both
inside and outside
the operating
room, sterile as
well as non-sterile
environment in a
variety of
procedures.	Similar
Radiogra	kV range	40 to 110 kV	40 to 110 kV	40 to 125 kV	Same
phic	mA Range	30 to 45 mA	20 mA	0.3~ 32 mA	Similar
Mode	mAs Range	1.0 to 200 mAs	0.4 to 100 mAs	0.2 ~ 100 mAs	Similar
Fluorosco
pic Mode	kV range	40 to 110 kV	40 to 110 kV	40 to 110 kV	Same
	mA range	0.2 to 8 mA
10 mA (Boost Mode)	0.2 to 6 mA
10 mA (Boost
mode)	0.3 ~ 6.3 mA	Similar
	Pulse
Fluoro	Yes	Yes	Yes	Same
C-arm	Range of
C-arm Rail
Rotation	I.I Type: 135 ° (90
° / 45 °)
FPD Type: 165°
(120° / 45°)	120 °
(90 ° / 30 °)	150 °	Similar
	Range of
the
Horizontal
C-arm
Movement	200 mm	200 mm	200 mm	Same
	Range of
the Vertical
C-arm
Movement	500 mm	400 mm	400 mm	Similar
	Range of
Swing-arm
Movement	+ 12.5 °	+ 12.5 °	+ 15 o	Same
	Range of
Stay-arm
Rotation	225 °	180 °	180 °	Similar
Image
Receptor	Image
Intensifier	E5830SD-P4A
(Manufactured by
TOSHIBA)
9″ / 6″ / 4.5″	E5830SD-P4A
(Manufactured
by TOSHIBA)
9″ / 6″ / 4.5″	-	Same
	Flat Panel
Detector	Mercu 0909F
(Manufactured by
IRay) 9″		Mercu 0909F
(Manufactured by
IRay) 9″
	Pixel Pitch	205µm	N/A	205um	Same
	DQE @ 0
lp/mm	77% at 0lp/mm	65% at 0lp/mm	77% at 0lp/mm	Same
	MTF @
1lp/mm	61%	N/A	61%	Same
	Frame
rates (fps
values)	N/A for I.I.
Up to 60fps for FPD	N/A	Up to 60fps	Same
Collimators		Iris and Leaf	Iris and Leaf	Motor
control/rotation	Same
Laser Guide		Yes	Yes	Yes	Same
	Model	DF-151SBR
(Manufactured by
Canon)	DF-151SBR
(Manufactured
by Canon)	Rotating Anode
(200kHU)	Same
X-ray
Tube	Anode
Type	Stationary Anode	Stationary Anode	Rotating anode	Same
Focal size		0.5/1.5 mm	0.5/1.5 mm	0.3/0.6 mm	Same

Image /page/6/Picture/0 description: The image shows the logo for GEMSS Healthcare. The logo consists of the word "GEMSS" in orange, with the word "Healthcare" in gray underneath. The font is sans-serif and the letters are bold.

1F, 822, Bogwang-ro, Gwangtan-myeon, Paju-si, Gyeonggi-do, 10952 South Korea

Image /page/7/Picture/0 description: The image shows the logo for GEMSS Healthcare. The word "GEMSS" is in orange, and the word "HEALTHCARE" is in gray. The logo is simple and modern.

XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is substantially equivalent to the predicate device ZEN-2090 Pro (K091918) and Garion (K222080) These devices are very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, different X-ray generators, the appearance, and the user interfaces are different. The Xray generator capacity of the subject device has higher maximum power output compared with the predicate devices. The subject device utilized both solid state X-ray imager (FPD) and image intensifier which are the same as the predicate devices. All detectors used for the subject devices have been already cleared by FDA and do not raise new concerns for safety and effectiveness. However, these small and minor differences do not raise any new questions of safety and effectiveness.

8. Safety, EMC and Performance data comparison to Predicate

IEC60601-1 (ed3.1, 2012), Medical electrical equipment Part 1: General requirements for basic safety and essential performance (Recognition No: 19-4)
-IEC60601-1-2: 2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances -Requirements and tests (Recognition No: 19-8)
IEC60601-1-3 (ed 2.1, 2013), Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment (Recognition No: 12-269)
-IEC60601-2-28 (ed 3, 2017) Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis (Recognition No: 12-309)
IEC60601-2-43 (ed 2.2, 2019) Medical electrical equipment Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures (Recognition No: 12-329)

In addition, the device complies with the FDA Radiation Safety Performance Standard Performance Standard for Diagnostic X-Ray Systems and Their Major Components (21CFR 1020.30, 1020.31, 1020.32); Small Entity Compliance Guide. In addition, labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Drug Administration Staff. Labeling also includes reference to the Image Gently website (http://www.imagegently.org/). Also we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff.

Image /page/8/Picture/0 description: The image shows the logo for GEMSS Healthcare. The logo consists of the word "GEMSS" in orange, with the word "HEALTHCARE" in gray underneath. The font is sans-serif and the letters are bold.

Software verification testing of the functional requirements as well as performance and safety has been performed to verify that all the requirements of System Requirements Specification as well as the safety risk control measures from the Detailed Risk Management Matrix and the Privacy and Security requirements and mitigations have been implemented. FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices" to ensure substantial equivalence.

Results demonstrated that all executed verification tests were passed.

As a results, all test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.

9. Conclusion

In reference to the comparison provided in substantial equivalence chart, and the most of functions and electronic features are similar with predicate device. We believe that the XPLUS 35 Series (XPLUS 35, XPLUS 35FD) is safe and effective as predicate device, and has no new indication for use. Therefore, XPLUS 35 Series (XPLUS 35FD) is substantially equivalent to predicate device.