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 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 (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.

Device Description

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

The Single-use Broncho Videoscope is a single use device. The Single-use Broncho Videoscope has six models 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 (Nylon and PEEK). The single-use Broncho Videoscope is a single-channel endoscope. 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 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 Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the Broncho Videoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are broad, based on compliance with various international standards and demonstrating equivalence to a predicate device. The performance is reported as meeting these standards and being comparable to or better than the predicate.

Acceptance Criteria Category	Specific Acceptance Criteria (Standards/Tests)	Reported Device Performance
Biocompatibility	ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Complies; no negative impacts from materials
	ISO 10993-5:2009 (In vitro cytotoxicity)	Complies; no negative impacts from materials
	ISO 10993-10:2010 (Irritation and skin sensitization)	Complies; no negative impacts from materials
	Intracutaneous (Biocompatibility test)	Complies; no negative impacts from materials
Material/Packaging Sterility	ASTM F88/F88M-15 (Seal strength of flexible barrier materials)	Complies
	ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Complies
Endoscope Design/Optics	ISO 8600-1:2015 (General requirements for endoscopes)	Complies
	ISO 8600-3:1997/Amd1:2003 (Field of view and direction of view)	Complies
	ISO 8600-4:2014 (Maximum width of insertion portion)	Complies
Software	FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern)	Software verification and validation testing conducted and documentation provided as recommended.
Electrical Safety/EMC	IEC 60601-1-2005+ (General requirements for basic safety and essential performance)	Complies
	IEC 60601-1-2:2014 (Electromagnetic compatibility)	Complies
	IEC 60601-2-18:2009 (Particular requirements for endoscopic equipment)	Complies
Shipping Performance	ASTM D4169-16 (Performance Testing of Shipping Containers and Systems)	Complies
Photobiological Safety	IEC 62471:2006 (Photobiological Safety of Lamps and Lamp Systems)	Complies
Risk Management	ISO 14971:2007 (Application of Risk Management to Medical Devices)	Complies
Bench Performance (Optical)	Photobiological safety test according to IEC 62471: 2006	Passes
	Color reproduction, Resolution, Depth of view, Geometric distortion, Image intensity uniformity, Image frame frequency and system delay testing	Compared with predicate device; results demonstrated equivalence or improvement (e.g., color reproduction better than predicate).
Bench Performance (Physical/Functional)	Suction system function test	Performed and compared with predicate device.
	Irrigation valve leakage test	Performed.
Use-Life Testing	Optical performance comparison (un-aged vs. aged Single-use Broncho Videoscope)	Optical performance of aged endoscope similar to un-aged.
	Use-life verification of image system (accelerated aging/running)	Performance of system doesn't reduce after accelerated aging/running; use-life of six years accepted. Optical performance of aged image processor similar to new.
Substantial Equivalence (General)	Comparison to predicate device (Vathin Video Bronchoscope System, K191828)	Determined to be Substantially Equivalent (SE), with differences in expression of indications, anatomical sites, field of view, depth of field, outer diameter, deflection, work length, instrument channel, dimension, weight, input power, video output, white balance, and patient-contact materials addressed and deemed not to affect safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated as a number of devices or "cases" for human studies. The testing appears to be primarily bench/laboratory-based on the device components. For the use-life testing, "un-aged" and "aged" single-use bronchoscopes were compared, and "new" and "accelerated aged and running" image processors were compared, implying at least two samples for these comparisons.
Data Provenance: The studies are non-clinical (bench performance, testing against standards). The country of origin for the data is not specified, but the applicant is "Scivita Medical Technology Co., Ltd." in "Suzhou, Jiangsu, China," suggesting the testing may have occurred there. The studies are prospective in nature, as they are conducted specifically to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this submission. The ground truth for the non-clinical tests is established by compliance with international standards and direct objective measurements, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

Not applicable. This was a non-clinical submission relying on objective measurements against predefined standards and comparative bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance assessment was conducted for the device itself. The entire non-clinical testing section (bench performance, biocompatibility, electrical safety, etc.) is a standalone assessment of the device's technical specifications and performance against established standards and a predicate device. This is primarily a hardware device with associated software, not an AI algorithm in the typical sense that would necessitate a "human-in-the-loop" study for algorithm performance.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical tests includes:

International Standards: Compliance with various ISO, ASTM, and IEC standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 8600 for endoscope performance).
Predicate Device Performance: Direct comparison of objective measurements (e.g., optical parameters, suction function) against a legally marketed predicate device (Vathin Video Bronchoscope System K191828).
Objective Measurements: Laboratory measurements of device specifications (e.g., field of view, depth of field, dimensions, weight, power).

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning or AI algorithm in the common sense that would require a "training set" of data for learning purposes. The "software" mentioned is for device control and image processing, not for diagnostic AI interpretation.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.

July 28, 2021

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

Re: K210379

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: June 21, 2021 Received: June 28, 2021

Dear Diana Hong:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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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,

for Shu-Chen Peng, Ph.D. Assistant Director DHT1C: 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

Enclosure

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Indications for Use

510(k) Number (if known) K201379

Device Name Broncho Videoscope System

Indications for Use (Describe)

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: __K210379

1. Date of Preparation: 06/21/2021
1. Sponsor Identification

Scivita Medical Technology Co., Ltd.

No.8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China.

Establishment Registration Number: Not yet registered.

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 Proposed Device

Trade Name: Broncho Videoscope System Common Name: Bronchoscope Systen

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:

Device Description:

System name	Component name	Model
BronchoVideoscopeSystem	Single-use Broncho Videoscope	SBV-1A-B, SBV-1A-P, SBV-1B-B,SBV-1B-P, SBV-1C-B, SBV-1C-P
	Endoscopic Image Procesosr	HDVS-S100A, HDVS-S100D

	Table 1 Product Model

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PEEK). The single-use Broncho Videoscope is a single-channel endoscope. 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 Gas to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

1. Identification of Predicate Device
  510(k) Number: K191828 Product Name: Vathin Video Bronchoscope System
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
A ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
A ASTM F88/F88M-15 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
A ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices-part 1: General requirements
A ISO 8600-3:1997/Amd1:2003 Optics and optical instruments-Medical endoscopes and endoscopic accessories-Part 3: Determination of field of view and direction of view of endoscopes with optics
ISO 8600-4:2014 Endoscopes-Medical endoscopes and endotherapy devices-Part 4: Determination of maximum width of insertion portion
A ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance, including the US National Differences

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IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety > and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
A IEC 60601-2-18:2009 Medical electrical equipment-Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
IEC 62471:2006 Photobiological Safety of Lamps and Lamp Systems.
ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices

Biocompatibility testing

The contact level of the proposed device is mucosal membrance, and the contact duration is limited contact (<24 hours). The proposed endoscope was evaluated for the following tests. The results ofthe biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

Cytotoxicity,
Sensitization,
A Intracutaneous,

Software verification and validation testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Bench performance testing

Optical performance testing

Photobiological safety test according to IEC 62471: 2006;
Color reproduction, Resolution, Depth of view, Geometric distortion, Image intensity uniformity), > Image frame frequency and system delay testing compared with the predicate device.

Physical/functional performance testing

Suction system function test was performed compared with the predicate device, and irrigation valve leakage test was performed on the proposed device;

Endoscope and image processor use-life testing

The optical performance comparison test was conducted on the un-aged Single-use Broncho Videoscope and aged Single-use Broncho Videoscope. The test results demonstrate that the optical performance of the aged endoscope is similar as those of the un-aged endoscope.

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A use-life verification was conducted to determine the image system's use life. After accelerating aging and running, the qualitative was conducted on the image processor. The test results demonstrate that the performance of the proposed system doesn't reduced after accelerating aging and running, and the use-life statement of six years are accepted. In addition, the quantitative optical performance comparison testing was conducted on the new image processor and the image processor after accelerating aged and running. The test results demonstrate that the optical performance of the image process after accelerating aged and running is similar as those of the new one.

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

ITEM	Proposed Device	Predicate DeviceK191828	Remark
Product Code	EOQ	EOQ	Same
Regulation No.	874.4680	874.4680	Same
Class	II	II	Same
IndicationforUse	The Broncho videoscope system is designedto be used for endoscopic diagnosis andtherapies within the respiratory system suchas trachea, bronchi, and lungs. The Bronchovideoscope System is for use in a hospitalenvironment.This Endoscopic Image Processor is used forendoscopic diagnosis and therapies. Itconnects to the electronic endoscopes,displaying the images on the monitor detectedwithin the field of view from the body cavity.This Single-use Broncho Videoscope isintended to to use in conjunction withendoscopic image processor (HDVS-S100Aand HDVS-S100D) to provide imagesthrough the video monitor for observation,diagnosis, photography and treatment of therespiratory system such as trachea, bronchi,and lungs.	The Vathin® H-SteriScope™ ISingle-use flexible VideoBronchoscope have been designed tobe used with the VathinⓇVisionCenter™ I Digital VideoProcessor, endotherapy accessoriesand other ancillary equipment forendoscopy within the airways andtracheobronchial tree.The Vathin® Video BronchoscopeSystem is for use in a hospitalenvironment.	Different
Singleuse/Reuse	Endoscope: Single useImage Processor: Reuse	Endoscope: Single useImage Processor: Reuse	Same
Sterile	Yes for disposable endoscope	Yes for disposable endoscope	Same
AnatomicalSite	Respiratory system such as trachea, bronchi,and lungs	Airways and tracheobronchial tree	Different
Where used	Hospitals	Hospital	Same
Main	Single-use Broncho Videoscope	Vathin® H-SteriScope™ I Single-useflexible Video Bronchoscope	Same
Configuration	Endoscopic Image Processor	Vathin® VisionCenter™ I DigitalVideo Processor
Label/Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
Scope type	Flexible	Flexible	Same
Field of view	120°	110°	Different
Directionofview	0°	0°	Same
Depth of field	0.5~120mm	3~30mm	Different
Sensor type	CMOS	CMOS	Same
Max.outerdiameterofinsertionsection	3.2mm (SBV-1A-B; SBV-1A-P);4.9mm (SBV-1B-B; SBV-1B-P);6.2mm (SBV-1C-B; SBV-1C-P);	2.2 mm, 3.2mm,4.1mm, 4.7mm, 4.9mm, 5.2mm,5.8mm, 6.0mm, 6.2mm	Different
Up/down	Up: 220°	Up:210°	Different
deflection	Down: 220°	Down: 210°	Different
Work length	600mm	600mm,700mm	Different
Minimuminstrumentchannel 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);	0mm, 1.2mm,1.7mm, 2.0mm, 2.2mm,2.4mm, 2.8mm, 3.0mm, 3.2mm	Different
Illuminationsource	LED	LED	Same
Power supply	AC: 100-240V±10% 50/60 Hz	AC 100-240V 50-60Hz	Same
Dimension	300(W)×57(H)×225(D) mm	235(W) ×210(H) ×70(D)mm	Different
Weight	About 2.5Kg	Unknown	Different
Input power	100VA	Unknown	Different
Videosignaloutput	DVI:1SDI: 2	DVI	Different
Autowhitebalance	Automatically adjusted	Manually adjusted	Different
Communicationwith endoscope	Provided	Provided	Same
ElectricalSafety	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
Particularrequirements	Comply with IEC 60601-2-18	Comply with IEC 60601-2-18	Same
ProductPerformance	Comply with ISO 8600	Comply with ISO 8600	Same
Patient-contact component and material
Bendingsection	Pebax	Unknown	Different
Insertionsection	Nylon PA12/PEEK
Connectingsection	PET
Distalendsection	CMOS front end	Glass
	Injection head	Sulfone polymer
	Distal endconnecting ring	304 SUS
	Working Channel	Pebax
Drainage tube	PC
Irrigation valve	PC; silicone rubber
Suction device	Suction nozzle	PC
	Suction button	Silicone rubber
	Suction access	Pebax
Sterilization (Single-use Broncho Videoscope)
Method	EO sterilization		EO sterilization	Same
SAL	10-6		10-6	Same

Table 1 SE Comparison

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Different- Indication for Use

Firstly, the indication for use of the proposed device is different from that of the predicate device in expression. The indications for use of the proposed device is provided in the form of system's indications for use, image processor's indications for use and disposable endoscope's indications for use. The predicate device doesn't provide the whole system's indications for use. Many cleared endoscope system adopted this expression form of indications for use. Therefore, the difference on expression form of indications for use will not raise new questions on safety and effectiveness of the propose device.

Second, the endo-therapy accessories and ancillary equipment are included in the predicate device's indications for use statement. While the proposed device does not include these in the indications for use statement. The proposed device also can be used with the accessories and ancillary equipment during clinical, and the information of accessories and ancillary equipment is listed in the section 3.5 of User Manual of Single-use Broncho Videoscope. Therefore, this difference will not raise new questions on safety and effectiveness of the propose device.

Thirdly, the intended clinical anatomic sites of the predicate device including airways and tracheobronchial tree; the intended clinical anatomic site of the proposed device including trachea, bronchi, and lungs. However, the trachea, bronchi, and lungs are collectively called the respiratory system or the airways and tracheobronchial tree. Therefore, the proposed device and predicate device are applicable to the same clinical anatomic sites. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.

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Finally, the intended working place is included in the predicate device's indications for use, which is hospital environment. Although, the intended working place of the proposed device isn't included in its indications for use, the proposed device also will be used in the hospital environment. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.

Both devices are used for endoscopic diagnosis and therapies within the respiratory system. Based on above analysis, the indication for use of the proposed device and the predicate device is only different in expression. The difference will not affect the safety and effectiveness of the proposed device.

Different- Anatomical Site

The anatomical site of the proposed device is different from the predicate device. However, the difference is only in expression. The trachea, bronchi, and lungs are collectively called the respiratory system or the airways and tracheobronchial tree as expressed in Analysis 1-Indication for Use. Therefore, the proposed device and predicate device are applicable to the same clinical anatomic sites. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.

Different- Field of view

The proposed device has a wider range of field of view than the predicate device to give physicians more options for diagnosis and treatment based on the patient's condition. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.

Different- Depth of field

The proposed device has a wider range of depth of field than the predicate device to give physicians more options for diagnosis and treatment based on the patient's condition. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.

Different- Max. outer diameter of insertion section

The Max. outer diameter of insertion of the proposed device is different from the predicate device. However, the Max. outer diameter of insertion of the proposed device is available in only three specifications, 3.2mm, 4.9mm and 6.2mm. The Max. outer diameter of insertion section of the predicate device has more specifications than the proposed device, but it also includes 3.2mm, 4.9mm and 6.2mm. Therefore, the difference will not affect the safety and effectiveness of the proposed device

Different- Up/down deflection

The up/down deflection of the proposed device is different with the predicate device. However, the

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up/down deflection of the proposed device is similar to those of the predicate device. All of the specification of the proposed device has been included in the user manual, including bend angle. The surgeon will select the proper endoscope based on her/his experiences and clinical conditions.

This slight difference on up/down deflection between the proposed device and predicate devices does not affect the safety and effectiveness of the proposed device

Different- Work length

The work length of the proposed device is different from the predicate device. However, the working length of the proposed device is available in 600mm. The working length of the predicate device has more specifications than the proposed device, but it also includes 600mm. In addition, all of the specification of the proposed device has been included in the user manual, including working length. The surgeon will select the proper endoscope based on her/his experience and clinical conditions. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Different- Min. inner diameter instrument channel

The Min. inner diameter instrument channel of the proposed device is different from the predicate device. However, the range of the Min. inner diameter instrument channel of the proposed device is within the range of the Min. inner diameter instrument channel of the predicate device. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Different-Dimension and weight

The dimension for the proposed image processor is different from predicate image processor and the weight of the predicate device is unknown. However, the dimension and weight is just in physical specification and this difference will not raise any issues in safety and effectiveness.

Different- Input power

The input power for the predicate image processor is unknown. However, the input power of proposed image processor complies with IEC 60601-1 standard, the difference in input power is just the difference in device design. Therefore, this difference on input power is considered not affect the safety and effectiveness of the proposed device.

Different-Video Signal Output

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

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Different- Auto white balance

The type of auto white balance of the proposed device is different between proposed image processor and predicate device. Automatic white balance is more convenient and does not require the user to adjust manually. The proposed device is automatically adjusted and the predicate device is manually adjusted. However, the color reproduction test has been tested on the proposed device and predicate device and the test results demonstrate that the image quality of the proposed device was better to the predicate device. In addition, there are a lot of image processors already on the market use automatic white balance. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Different- Patient-contact component and material

The patient-contact material of the predicate device is unknown. However, the biocompatibility tests were conducted on the material consisted of the proposed device and the test result shows that the material does not raise the adverse effect on the material. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Substantially Equivalent (SE) Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.

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.