Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard bronchoscope system with an image processor and does not mention any AI or ML capabilities. The performance studies focus on image quality and safety, not algorithmic performance.

Therapeutic

Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state that the device is "designed to be used for endoscopic diagnosis and therapies." This direct mention of "therapies" indicates its therapeutic function.

Diagnostic

Yes

The 'Intended Use / Indications for Use' section explicitly states that the system is "designed to be used for endoscopic diagnosis" and "used for endoscopic diagnosis and therapies" and "for observation, diagnosis, photography and treatment."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor," indicating the presence of both hardware components (videoscope and processor) in addition to any potential software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use/Indications for Use: The intended use is for "endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs." This involves direct visualization and intervention within the body, not the examination of specimens in vitro (outside the body).
Device Description: The device is a "Broncho Videoscope System" consisting of a videoscope and an image processor. This is a system for visualizing internal body structures.
Input Imaging Modality: The input is "Endoscopic images," which are images captured from inside the body.
Anatomical Site: The anatomical site is the "Respiratory system such as trachea, bronchi, and lungs," which are internal body parts.

IVD devices are used to examine specimens such as blood, urine, tissue, etc., in vitro to provide information for diagnosis, monitoring, or screening. This device is used for direct visualization and intervention in vivo (within the body).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.
This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

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

EOQ

Device Description

The subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

System name	Component name	Model
Broncho Videoscope System	Single-use Broncho Videoscope	SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P
	Full HD Visualization Endoscopic Image Processor	HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D

The Single-use Broncho Videoscope, which has been cleared in K210379, is a single use device. It is intended to use in conjunction with Full HD Visualization Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six modes, which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion section (Nylon and PEEK). All these six models are included in K210379.
The single-use Broncho Videoscope is a single-channel endoscope. There is only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.
The Single-use Broncho Videoscope is sterilized by Ethylene Oxide (EO) Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, which are different in image adjustment functions.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Endoscopic video/images

Anatomical Site

respiratory system such as trachea, bronchi, and lungs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospital environment

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 tests were conducted to demonstrate substantial equivalence (SE) to the predicate. The test results demonstrated that the subject device complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical Electrical Equipment-Part 1: General Requirements for basic safety and essential performance
IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ASTM F88/F88M -21, Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
No clinical study is included in this submission.
The image quality testing of the subject device demonstrate that the image quality of the integratiy LCD display is acceptable.
The image quality testing of the proposed device include intensity uniformity test , depth of field test, resolution test, color reproduction test, geometric distortion test, image frame frequency and system delay test and noise and dynamic range test demonstrate that the image quality of the device does not affected by the different plug.
The color reproduction performance of the integrated LCD display has been tested in the Tab 57 Color Reproduction Test Report, the test results demonstrated the performance of the integrated LCD display is acceptable.
The image quality of the subject device and predicative device have been tested in the quantitative image quality testing.. The test results demonstrate that the image quality of the subject device was equivalent to that of the predicate device.
The internal power supply for subject device is an embedded rechargeable lithium-ion battery, the electrical safety and electromagnetic compatibility has been test in, the test results demonstrated the internal power supply is safety.

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.

K210379

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.

Not Found

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

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2023

Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120, China

Re: K231521

Trade/Device Name: Broncho Videoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: October 11, 2023 Received: October 11, 2023

Dear Diana Hong:

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 (the 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 available 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).

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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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Joyce C. Lin -S

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

Submission Number (if known)

K231521

Device Name

Broncho Videoscope System

Indications for Use (Describe)

The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

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) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K231521

1. Date of Preparation: 11/10/2023
1. Sponsor Identification

Scivita Medical Technology Co., Ltd. No. 2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA.

Establishment Registration Number: 3020746799

Contact Person: Ruqin Wu Position: Quality Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Subject Device

Trade Name: Broncho Videoscope System Common Name: BronchoscopeSystem

Regulatory Information Classification Name: Bronchoscope (Flexible or Rigid); Classification: II; Product Code: EOQ; Regulation Number: 21 CFR 874.4680; Review Panel: Ear Nose & Throat;

Indication for use:

The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

Device Description:

The subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

System name	Component name	Model
Broncho
Videoscope
System	Single-use Broncho Videoscope	SBV-1A-B, SBV-1A-P, SBV-1B-B,
SBV-1B-P, SBV-1C-B, SBV-1C-P
	Full HD Visualization Endoscopic Image Processor	HDVS-S300A, HDVS-S300B,
HDVS-S300C, HDVS-S300D

System Configuration

The Single-use Broncho Videoscope, which has been cleared in K210379, is a single use device. It is intended to use in conjunction with Full HD Visualization Endoscopic Image Processor to provide

5

images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six modes, which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion section (Nylon and PEEK). All these six models are included inK210379.

The single-use Broncho Videoscope is a single-channel endoscope. There is only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.

The Single-use Broncho Videoscope is sterilized by Ethylene Oxide (EO) Gas to achieve a SAL of 10° and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, which are different in image adjustment functions.

1. Identification of Predicate Device
  510(k) Number: K210379

Product Name: Broncho Videoscope System

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to demonstrate substantial equivalence (SE) to the predicate. The test

results demonstrated that the subject device complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical Electrical Equipment-Part 1: General Requirements for basic safety and essential performance
IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems

6

ア ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ア ASTM F88/F88M -21, Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1929-15, Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Summary of Technological Characteristics

ITEM	Subject Device K231521	Predicate Device K201379	Remark
Product Code	EOQ	EOQ	Same
Regulation No.	874.4680	874.4680	Same
Class	II	II	Same
Manufacturer	Scivita Medical Technology Co., Ltd.	Scivita Medical Technology Co., Ltd.	Same
Indication for Use	The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a	The Broncho videoscopesystem is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in	Similar Analysis 1
	hospital environment.	a hospital environment.
	This Full HD Visualization
Endoscopic Image Processor is
used for endoscopic diagnosis and
therapies. It connects to the
electronic endoscopes, displaying
the images on its LCD display
and/or external monitor within the
field of view from the body
cavity.	This Endoscopic Image
Processor is used for endoscopic
diagnosis and therapies. It
connects to the electronic
endoscopes, displaying the
images on the monitor detected
within the field of view from the
body cavity.
	This Single-use Broncho
Videoscope is intended to use in
conjunction with endoscopic
image processor to provide
images through the video monitor
for observation, diagnosis,
photography and treatment of the
respiratory system such as
trachea, bronchi, and lungs.	This Single-use Broncho
Videoscope is intended to use in
conjunction with endoscopic
image processor (HDVS-S100A
and HDVS-S100D) to provide
images through the video
monitor for observation,
diagnosis, photography and
treatment of the respiratory
system such as trachea, bronchi,
and lungs.
Main Configuration	Single-use Broncho Videoscope
with square plug and round plug
(SBV-1A-B, SBV-1A-P,
SBV-1B-B, SBV-1B-P,
SBV-1C-B, SBV-1C-P)
Full HD Visualization Endoscopic
Image Processor	Single-use Broncho Videoscope
with square plug.
(SBV-1A-B, SBV-1A-P,
SBV-1B-B, SBV-1B-P,
SBV-1C-B, SBV-1C-P)
Endoscopic Image Processor	Similar
Analysis 2
Single use/ Reuse	Endoscope: Single use
Image Processor: Reuse	Endoscope: Single use
Image Processor: Reuse	Same
Sterile	Yes, for disposable endoscope	Yes, for disposable endoscope	Same
Anatomical Site	Respiratory system such as
trachea, bronchi, and lungs	Respiratory system such as
trachea, bronchi, and lungs	Same
Where used	Hospitals	Hospital	Same
Label/Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
ITEM	Full
HD Visualization
Endoscopic Image
Processor	Endoscopic Image
Processor
K201379	Remark
Model	HDVS-S300A,
HDVS-S300B,
HDVS-S300C,
HDVS-S300D	HDVS-S100A
HDVS-S100D	/
Dimension	332mm (W)×241.9mm (D)
×56.5mm (H)	300(W)×57(H)×225(D) mm	Similar
Analysis 3
Weight	About 2.5Kg	About 2.5Kg	Same
Is there an integrated
LCD display?	Yes	No	Different
Analysis 4
Freeze	Create static
picture of
dynamic image	Create static picture of dynamic
image	Same
Zoom	Magnification of image is
1 times, 1.5 times and 2
times (full screen), three
stages cycling adjustment.	By pressing the ZOOM button,
the original
(74%
contrasting to vertical screen) can
be enlarged to 89% and 100% of
the vertical screen, respectively.	Different
Analysis 5
510(k) Summary
LED
Brightness
Adjustment	Adjust LED brightness by
three models (L, M, H).
L: low Led light intensity
M: moderate Led light
intensity
H: high Led light intensity	Three modes of Led
light
intensity can be chosen when
pressing the LED (L M H) button
in order.
L: low Led light intensity
M: moderate Led light intensity
H: high Led light intensity	Same
RECORD (PHOTO)	Press
the RECORD
(PHOTO) button on the
touchscreen, the images
will be captured by the
electronic endoscope and
stored to the storage
device.	Once pressed the RECORD
(PHOTO) button, the photo will
be taken and stored in the storage
device.	Same
RECORD (VIDEO)	Press the RECORD
(VIDEO) button on the
touchscreen, the equipment
starts to record. Press the
button again to end the
recording.
The video
recorded will
automatically store to the
storage device
(photographing function
can be performed when
recording video).	After pressing the RECORD
(VIDEO) button, the endoscopic
image processor starts to record
the video, and it will keep
recording until the RECORD
(VIDEO) button is pressed for the
second time.	Same
Auto white balance	Automatically adjusted	Automatically adjusted	Same
Video Signal Output	SDI, HDMI video signal
output port	SDI, DVI video signal output
port	Different
Analysis 6
Foot switch	There is no Foot switch.	The foot switch can control the
functions of gain, image freezing,
electronic magnification, contour
emphasis and image recording.	Different
Analysis 7
Power Supply	It has a rechargeable
lithium-ion battery. It has
two power supply modes,
which are internal and
external power supply. The
external power supply is
AC100V-240V 50/60Hz.	It has only an external power
supply, 100-240V±10% AC,
50/60Hz.	Different
Analysis 8
Disinfection method	75% ethanol	75% ethanol	Same
Communication with
endoscope	Provided	Provided	Same

Table 1. General Comparison

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Analysis 1- Indication for Use (IFU)

The IFU of the subject device is expressed in three parts including the whole system's IFU, the Image Processor' s IFU and the Broncho Videoscope's IFU. The IFU of the predicate device is also expressed in

8

three parts including the whole system's IFU, the Image Processor's IFU and the Broncho Videoscope's IFU. The IFU statements of the whole system and Broncho Videoscope of subject are same as those of the predicate device. Compared with the predicate device, the image resolution of the subject device can reach full HD. The Full HD Visualization Endoscopic Image Processor has a LCD display. The Full HD Visualization Endoscopic Image Processor of the subject device can display the images on its LCD display and/or external monitor. The Endoscopic Image Processor of the predicate device can display the images on the external monitor. The image quality testing of the subject device demonstrate that the image quality of the integratiy LCD display is acceptable.

Based on above analysis, the indication for use of the subject device and the predicate device is only different in expression. The difference will not affect the safety and effectiveness of the subject device.

Analysis 2- Main Configuration

The Broncho Videoscope of subject device has extra round plug comparing with the predicate device. The image quality testing of the subject device The image quality testing of the proposed device include intensity uniformity test , depth of field test, resolution test, color reproduction test, geometric distortion test, image frame frequency and system delay test and noise and dynamic range test demonstrate that the image quality of the device does not affected by the different plug.

Table 2. Specifications Comparison of Endoscopic Image Processor

9

10

510(k) Summary

Analysis 3-Dimension

The dimension for the subject image processor is different form the predicate device. The dimension are just in physical specification and this difference will not raise any issues in safety and effectiveness.

Analysis 4-Is there an integrated LCD display?

The subject image processor has extra integrated LCD display comparing with the predicate device. However, the color reproduction performance of the integrated LCD display has been tested in the Tab 57 Color Reproduction Test Report, the test results demonstrated the performance of the integrated LCD display is acceptable.

Analysis 5-ZOOM

The ZOOM function of the subject image processor is different from predicate image processor. The ZOOM function is used to adjust the image size without changing the image content; this difference will not raise any issues in safety and effectiveness.

Analysis 6-Video Signal Output

The types of video signal output are different between subject image processor and predicate image processor. The subject device has HDMI and SDI interface, the predicate device has SDI and DVI interface. The image quality of the subject device and predicative device have been tested in the quantitative image quality testing.. The test results demonstrate that the image quality of the subject device was equivalent to that of the predicate device. The difference on video signal output will not affect the safety and effectiveness of the subject device.

Analysis 7- Foot switch

The foot switch of the subject device is different between subject image processor and predicate device. There is no foot switch for subject device. The subject device has a LCD display. The main unit function control can be realized by clicking the LCD display. The main unit function of the predicate device is located in the front panel, and the main unit function can be controlled by the foot switch. The LCD display of the subject device is 13.3 inches, and the area of touchscreen is large, and the function icon is clear. Therefore, the difference will not affect the safety and effectiveness of the subject device.

Analysis 8- Power Supply

There are two power supplies for subject device, which are internal power supply. The external power supply for subject device is same as predicate device. So the subject device has extra internal power supply comparing with the predicate device. The internal power supply for subject device is an embedded rechargeable lithium-ion battery, the electrical safety and electromagnetic compatibility has been test in, the

11

510(k) Summary

test results demonstrated the internal power supply is safety.

| ITEM | Subject Device | Predicate Device
K210379 | Remark |
|------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------|
| Model | SBV-1A-B, SBV-1A-P
SBV-1B-B, SBV-1B-P
SBV-1C-B, SBV-1C-P | SBV-1A-B, SBV-1A-P
SBV-1B-B, SBV-1B-P
SBV-1C-B, SBV-1C-P | Same |
| Maximum Outer
Diameter
of
Insertion Section | 3.2mm(SBV-1A-B; SBV-1A-P);
4.9mm (SBV-1B-B; SBV-1B-P);
6.2mm(SBV-1C-B; SBV-1C-P); | 3.2mm (SBV-1A-B; SBV-1A-P);
4.9mm(SBV-1B-B; SBV-1B-P);
6.2mm(SBV-1C-B; SBV-1C-P); | Same |
| Minimum
Instrument
Channel Width | 1.15mm(SBV-1A-B; SBV-1A-P);
1.95mm (SBV-1B-B; SBV-1B-P);
2.75mm(SBV-1C-B; SBV-1C-P); | 1.15mm(SBV-1A-B; SBV-1A-P);
1.95mm(SBV-1B-B;SBV-1B-P);
2.75mm(SBV-1C-B;SBV-1C-P); | Same |
| Working Channel | Φ1.2mm (SBV-1A-B; SBV-1A-P);
Φ2.0mm(SBV-1B-B; SBV-1B-P);
Φ2.8mm (SBV-1C-B; SBV-1C-P); | Ф1.2mm(SBV-1A-B; SBV-1A-P);
Φ2.0mm(SBV-1B-B; SBV-1B-P);
Ф2.8mm(SBV-1C-B; SBV-1C-P); | Same |
| Working Length | 600mm | 600mm | Same |
| Total Length | 920mm | 920mm | Same |
| Bending angle | Up:220°,Down:220° | Up:220°,Down:220° | Same |
| Field of View | 120° | 120° | Same |
| Direction of View | 0° | 0° | Same |
| Depth of Field | 0.5~~120mm | 0.5~~120mm | Same |
| Endoscope
Illumination | LED light is placed at the distal end
of the endoscope | LED light is placed at the distal
end of the endoscope | Same |
| Method
of
Sterilization | EO | EO | Same |
| | Square plug | Square plug | Similar |

Table 3. Specifications Comparison of Broncho Videoscope

12

| ITEM | Subject Device | Predicate Device
K210379 | Remark | |
|-----------------------------------------------|-------------------------------|-------------------------------|-----------------|------|
| Electrical Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | |
| EMC | Comply with IEC
60601-1-2 | Comply with IEC
60601-1-2 | Same | |
| Particular requirements | Comply with IEC
60601-2-18 | Comply with IEC
60601-2-18 | Same | |
| Bending section | Pebax | Pebax | Same | |
| Insertion section | Nylon PA12/PEEK | Nylon PA12/PEEK | Same | |
| Connecting section | PET | PET | Same | |
| Distal
end
section | CMOS front end | Glass | Glass | Same |
| | Injection head | Sulfone polymer | Sulfone polymer | Same |
| | Distal end
connecting ring | 304 SUS | 304 SUS | Same |
| | Working
Channel | Pebax | Pebax | Same |
| Drainage tube | PC | PC | Same | |
| Irrigation valve | PC; silicone rubber | PC; silicone rubber | Same | |
| Suction
device | Suction nozzle | PC | PC | Same |
| | Suction button | Silicone rubber | Silicone rubber | Same |
| | Suction access | Pebax | Pebax | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | Same | |
| | No Sensitization | No Sensitization | | |
| | No Irritation | No Irritation | | |
| Sterilization (Single-use Broncho Videoscope) | | | | |
| Method | EO sterilization | EO sterilization | Same | |
| SAL | 10-6 | 10-6 | Same | |

Table 4. Safety Comparison

9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device, Broncho Videoscope System is as safe, as effective, and performs as well and is substantially equivalent to the legally marketed predicate device cleared under K210379.