The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.

Device Description

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor.

The light emitted by the LED cold light source at the distal tip of the Single-use Bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output of the Electronic Endoscope Imaging Processor via the encoding circuit. The Electronic Endoscope Imaging Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the monitor. The Electronic Endoscope Imaging Processor also controls the brightness of the LEDs on the endoscope.

The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical.

The Single-use Bronchoscope is single-use medical devices that are sterilized with ethylene oxide and intended for use in adults. This product is accompanied by an electronic endoscopic image processor, which supports the use of medical monitors. The electronic bronchoscope system is used for endoscopic diagnosis or treatment, and the processor collects, processes, stores, and transmits images of the human body cavity to the monitor.

AI/ML Overview

This FDA 510(k) summary describes the Bronchoscope System (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1). The submission indicates that no clinical studies were performed to demonstrate substantial equivalence. Instead, a series of non-clinical (bench) tests were conducted to verify that the proposed device met all design specifications and was substantially equivalent to the predicate devices (K231107 and K191828).

Therefore, I will provide the acceptance criteria and performance as reported for the non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission relies on non-clinical testing for substantial equivalence, the "acceptance criteria" are typically compliance with recognized standards or meeting specific performance benchmarks defined in the device's design specifications. The "reported device performance" refers to the results of these tests confirming that the device meets those standards/specifications.

Acceptance Criteria (from recognized standards or design specifications)	Reported Device Performance (Test Results)
Electrical Safety: Compliance with IEC 60601-1:2005+A1:2012+A2:2020	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2:2014 + A1:2020 / ANSI AAMI IEC 60601-1-2:2014 + A1:2021	Complies with IEC 60601-1-2
Basic Safety and Essential Performance (Endoscopic Equipment): Compliance with IEC 60601-2-18:2009	Complies with IEC 60601-2-18
Usability Engineering: Compliance with IEC 60601-1-6:2010 + A1:2020 + A2:2020	Complies with IEC 60601-1-6
Photobiological Safety: Compliance with IEC 62471:2006	Complies with IEC 62471
Biocompatibility:
ISO 10993-1:2018 (Evaluation and testing)	Complies with ISO 10993-1
ISO 10993-5:2009 (In vitro cytotoxicity)	Complies with ISO 10993-5
ISO 10993-10:2021 (Skin sensitization)	Complies with ISO 10993-10
ISO 10993-11:2017 (Systemic toxicity)	Complies with ISO 10993-11
ISO 10993-23:2021 (Irritation)	Complies with ISO 10993-23
Sterilization & Shelf Life & Packaging:
ISO 11607-1:2019 (Packaging)	Complies with ISO 11607-1
ISO 11135:2014 (EO Sterilization)	Complies with ISO 11135
ISO 10993-7:2019 (EO Sterilization Residuals)	Complies with ISO 10993-7
System Performance Tests:
Validation of up/down deflection	Tested, results met standard requirements
Repeated flexing	Tested, results met standard requirements
Water supply system	Tested, results met standard requirements
Sealing performance	Tested, results met standard requirements
Normal working condition	Tested, results met standard requirements
Field of View	Tested, results met standard requirements
Direction of View (DOV)	Tested, results met standard requirements
Geometric distortion	Tested, results met standard requirements
Signal-To-Noise Ratio (SNR)	Tested, results met standard requirements
Image Intensity Uniformity (IIU)	Tested, results met standard requirements
Color performance	Tested, results met standard requirements

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

Sample Size: The document does not specify the exact sample sizes for each non-clinical test performed. However, these tests are typically performed on a statistically representative number of manufactured units according to the applicable standard requirements (e.g., a certain number of devices for electrical safety, biocompatibility batches, etc.).
Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory or simulated environment, not on human subjects. The manufacturer is Shenzhen Sanping Image Technology Co., Ltd. located in Shenzhen, Guangdong, China. The data would therefore originate from testing facilities associated with the manufacturer or their designated testing laboratories. The data is prospective in the sense that it was generated specifically to support this 510(k) submission.

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

Not applicable. Since no clinical studies were performed, there was no test set requiring expert ground truth establishment for diagnostic or clinical performance. The non-clinical tests relied on validated reference methods and calibrated equipment to assess various physical and performance characteristics against established international standards.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical test data was used to support the decision of substantial equivalence." Therefore, there is no reported effect size regarding human reader improvement with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI/algorithm-only device. It is a Bronchoscope System, which functions as a direct visualization tool for medical professionals. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

For the non-clinical performance tests, the "ground truth" implicitly refers to the specifications defined by the international consensus standards (e.g., IEC, ISO) and the device's own design specifications. The tests verify that the device's physical, electrical, mechanical, and imaging properties meet these predefined engineering and safety benchmarks.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/machine learning device that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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March 14, 2025

Image /page/0/Picture/1 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Shenzhen Sanping Image Technology Co., Ltd. Vincent Pan General Manager Room 203, No.634, Shajing Road, Buchong Community, Shajing Street, Bao'an District Shenzhen, Guangdong 518104 China

Re: K242010

Trade/Device Name: Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCL012.1) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: July 10, 2024 Received: July 10, 2024

Dear Pan Vincent:

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.

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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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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

Enclosure

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Indications for Use

Submission Number (if known)

K242010

Device Name

Bronchoscope System、The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8、SP-Y-ZQGJ3.8、SP-Y-ZQGJ4.2、SP-Y-ZQGJ4.8、SP-Y-ZQGJ5.2、SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

Indications for Use (Describe)

The Bronchoscope System is for use in a hospital environment. The Single-use is a single-use device designed for use in adults.

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

1. Sponsor Identification:

Company Name: Shenzhen Sanping Image Technology Co., Ltd. >
Address: Room 203, No.634, Shajing Road, Buchong Community, Shajing Street, > Bao'an District, Shenzhen, China
Phone: +86-755-23223975 >
Fax: +86-755-23223975 >
Contact Person (Title): Vincent Pan (General Manager)
E-mail: 99020278@qq.com
Date of Preparation: December 26, 2024

2. Name of the Device:

Trade Name	BronchoscopeSystem、TheSingle-useBronchoscope	ModelNumber/Name	Single-use Bronchoscope:SP-Y-ZQGJ2.8、SP-Y-ZQGJ3.8、SP-Y-ZQGJ4.2、SP-Y-ZQGJ4.8、SP-Y-ZQGJ5.2、SP-Y-ZQGJ5.8
	ModelNumber/Name	Electronic Endoscope ImagingProcessor: SP-TXCLQ12.1

3. Common Name and Classification:

Device Classification Name: Bronchoscope (Flexible Or Rigid)
Classification Product Code: EOQ

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Regulation Number: 21 CFR 874.4680
Class: 2
Review Panel: Ear Nose & Throat
Trade/Proprietary Name: The Single-use Bronchoscopes、Bronchoscope System >
Common Name: Bronchoscope (flexible or rigid) and accessories

Predicate Device Information1: 4.

510(k) Number: K231107
Device Classification Name: Bronchoscope (Flexible Or Rigid) >
Sponsor: Hunan Endoso Life Technology Co., Ltd.
Classification Product Code: EOQ >
Regulation Number: 21 CFR 874.4680
Class: 2
Review Panel: Ear Nose & Throat
Trade/Proprietary Name: Single-use Bronchoscope, Monitor for Single-Use Endoscopy, > Bronchoscope System
Common Name: Bronchoscope (flexible or rigid) and accessories

Predicate Device Information2: 5.

510(k) Number: K191828
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Sponsor: Hunan Vathin Medical Instrument Co., Ltd. >
Classification Product Code: EOQ
Regulation Number: 21 CFR 874.4680
Class: 2
Review Panel: Ear Nose & Throat
Trade/Proprietary Name: Vathin® Video Bronchoscope System
Common Name: Bronchoscope (flexible or rigid) and accessories

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6. Device Description

The Single-use Bronchoscope is a sterile single used flexible bronchoscope. The Electronic Endoscope Imaging Processor is a reusable monitor.

The optical components and their arrangement at the distal tip for all models of the Single-use Bronchoscope are identical.

7. Indications for Use

The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.

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8. Comparison to the predicate device

Table 1 General Comparison

Elements ofComparison	Proposed Device	Predicate Device 1K231107	Predicate Device 2K191828	Judgment	Review Panel	Ear Nose & Throat	Ear Nose & Throat	Ear Nose & Throat	SE
CompanyName	Shenzhen Sanping ImageTechnology Co., Ltd.	Hunan Endoso LifeTechnology Co., Ltd.	Hunan Endoso LifeTechnology Co., Ltd.	/	Class	2	2	2	SE
Model	Single-use Bronchoscope:SP-Y-ZQGJ2.8、SP-Y-ZQGJ3.8、SP-Y-ZQGJ4.2、SP-Y-ZQGJ4.8、SP-Y-ZQGJ5.2、SP-Y-ZQGJ5.8Electronic EndoscopeImaging Processor:SP-TXCLQ12.1	Single-use Bronchoscope:BC12-1, BC12-2, BC20-1,BC20-2, BC22-1, BC22-2,BC22-3, BC28-1, BC28-2,BC28-3Monitor for Single-UseEndoscopy: P1-A, P1-B,P1-C, P1-D, P1-E, P2-A,P2-B, P2-C, P2-D, P2-E	Vathin®H-SteriScope™Single-use flexible VideoBronchoscopeBCV1-01 BCV1-02BCV1-C1BCV1-C2 BCV1-H1BCV1-H2BCV1-K1 BCV1-K2BCV1-M1BCV1-M2 BCV1-01BCV1-02BCV1-S1 BCV1-S2BCV1-U1BCV1-U2 BCV1-W1BCV1-W2Vathin®VisionCenter™ DigitalVideo ProcessorDVP-A1	/	Prescriptionor OTC	Prescription Use	Prescription Use	Prescription Use	SE
Device Name	Bronchoscope System	Bronchoscope System	Vathin® VideoBronchoscopeSystem	/	Anatomicsites	airways andtracheobronchial tree	airways andtracheobronchial tree	airways andtracheobronchial tree	SE
ClassificationProduct Code	EOQ	EOQ	EOQ	SE	TargetPopulation	Adults	Adults	Adults	SE
Regulation	874.4680	874.4680	874.4680	SE	Where used	Hospital	Hospital	Hospital	SE
ClassificationName	Bronchoscope (Flexible OrRigid)	Bronchoscope (FlexibleOr Rigid)	Bronchoscope (Flexible OrRigid)	SE

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Workingplace/User	Use in a hospitalenvironment by trainedsurgical physicians who arefamiliar with endoscopicprocedures.	Use in a hospitalenvironment by trainedsurgical physicians who arefamiliar with endoscopicprocedures.	Use in a hospitalenvironment by trainedsurgical physicians whoare familiar withendoscopicprocedures.	SE
Technology	The Single-usebronchoscope is insertedthrough the airways andtracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user bythe Monitor for Single-UseEndoscopy with a CMOSchip at the distal end of theendoscope and the imagesshowing on the monitor.	The Single-usebronchoscope is insertedthrough the airways andtracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user bythe Monitor for Single-UseEndoscopy with a CMOSchip at the distal end of theendoscope and the imagesshowing on the monitor.	The Single-usebronchoscope is insertedthrough the airways andtracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user bythe Monitor for Single-UseEndoscopy with a CMOSchip at the distal end of theendoscope and theimages showing on themonitor.	SE

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			TheVathin®H-SteriScopeTM I
	The Single-useBronchoscopes have been	The Single-useBronchoscopes have been	Single-use flexible VideoBronchoscope have been
	designed to be used with	designed to be used withthe Monitor for Single-Use	designed to be used with
	the Electronic Endoscope	Endoscopy, endotherapy	the
	Imaging Processor,	accessories and other	Vathin®VisionCenterTM I
	endotherapy accessories	ancillary equipment for	Digital Video Processor,
	and other ancillary	endoscopy within the	endotherapy accessories	SE
Intended Use	equipment for endoscopywithin the airways and	airways and	and other ancillary
	tracheobronchial tree.	tracheobronchial tree.	equipment for endoscopywithin the airways and
	The Bronchoscope System	The Bronchoscope System	tracheobronchial tree.
	is for use in a hospitalenvironment. The	is for use in a hospitalenvironment. The	The Vathin® Video
	Single-use Bronchoscopeis a single-use device	Single-use Bronchoscopeis a disposable device	Bronchoscope System is
	designed for use in adults.	designed for use in adults.	for use in a hospitalenvironment.

Table 2 Safety factor & Performance Comparison

Safety factor &Performance	Proposed Device	Predicate Device1	Predicate Device2	Judgment
Electrical Safety	Compliance with IEC60601-1	Compliance withIEC 60601-1	Compliance with IEC60601-1	SE
EMC	Compliance with IEC60601-1-2	Compliance withIEC 60601-1-2	Compliance with IEC60601-1-2	SE
UsabilityEngineering	Compliance with IEC62366-1	Compliance withIEC 62366-1	Compliance with IEC62366-1	SE
Biocompatiblity	Compliance with ISO10993-1	Compliance withISO 10993-1	Compliance with ISO10993-1	SE
Safety factor &Performance	Proposed Device	Predicate Device1	Predicate Device2	Judgment
Connect todevices	Monitor	Monitor	Monitor	SE
Type of Imager	CMOS	CMOS	CMOS	SE
Light Source	Internal LED	Internal LED	Internal LED	SE
Direction ofView (°)	forward	forward	forward	SE
Working Length(mm)	650	600mm	600/700mm	Note 1
Depth of Field (mm)	3 - 50	3 - 50	3mm~30mm	SE
Type of Scope	Flexible	Flexible	Flexible	SE
Distal endouter diameter	<2.9mm (8.7 Fr)	<2.9mm (8.7 Fr)	<3.1mm (9.3 Fr)	SE
Deflection Angle	Up & Down 180°, tolerance±10%	Up & Down 180°,tolerance ±10%	Up: 210Down: 210	SE
Distal enddiameter(mm)	3.00/4.05/4.40/4.80/5.20/6.10	/	2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2	Note 2
Maximuminsertion portionwidth(mm)	3.20/4.25/4.55/5.40/5.70/6.35	/	2.2/3.2/4.1/4.7/4.9/52/5.8/6.0/6.2	Note 2
Minimuminsertion channelwidth(mm)	1.20/1.60/2.20/2.60/3.00/3.20	/	0/1.2/1.7/2.0/2.2/2.4/2.8/3.0/3.2	Note 2
General materialtype of mainpatient-contact	Compliance with ISO10993- 1	Compliance withISO10993 - 1	Compliance withISO10993 - 1	SE
Generalmaterial typeof mainpatient-contactpart	Pebax, polyamide,StainlessSteel, Epoxy glue, glass,Polycarbonate, PTFE, PET	Pebax, polyamide,StainlessSteel, Epoxy glue,glass,Polycarbonate,PTFE, PET	Pebax, PTFE, LCP,TPU,Fluoro elastomers,Epoxy glue, glass	SE
Safety factor &Performance	Proposed Device	Predicate Device1	Predicate Device2	Judgment
Duration and typeof contact	"Surface - MucosalMembrane" with a contactduration of "Limited (< 24hours)"	"Surface - MucosalMembrane" with acontact duration of"Limited (< 24hours)"	"Surface - MucosalMembrane" with acontact duration of"Limited (< 24hours)"	SE
Number of Users	Single-Use	Single-Use	Single-Use	SE
Sterilization	EO Sterilized,SAL 10-6	EO Sterilized, SAL10-6	EO Sterilized, SAL10-6	SE

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8.1 Review of Differences :

Note1:

There is slight difference in the working length as compared to the predicate. However, the working length of the device is utilized by many similar devices in clinical practice. Therefore, this variance does not raise different questions of its safety and effectiveness.

Note 2:

The difference lies in the mechanical specifications, there may be slight size differences within the same specification and all within the tolerance range. All the performance was tested, and the results met the standard requirements, these differences will not raise any issues in safety and effectiveness.

8.2 Discussion of Non-clinical Tests Performed for Determination of Substantial Equivalence are as follows:

A series of 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:

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1) Electrical safety

IEC6060-1:2005+A1:2012+A2:2020, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.

2) Electromagnetic compatibility (EMC)

IEC 60601-1-2:2014 + A1:2020 / ANSI AAMI IEC 60601-1-2:2014 + A1:2021], Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests.

IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

3) Basic Safety and Essential Performance

IEC 60601-1-6:2010 + A1:2020 + A2:2020, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.

4) Photobiological safety

IEC 62471:2006, Medical electrical equipment, Photobiological safety of lamps and lamp systems.

5) Biocompatibility testing

ISO 10993-1:2018 Biological evaluation of medical devices-Parts 1: Evaluation and testing.

ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

ISO 10993-10:2021 Biological evaluation of medical devices - Parts 10: Tests for skin sensitization

ISO 10993-11:2017 Biological evaluation of medical devices, Part 11: Tests for

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systemic toxicity

ISO 10993-23:2021 Biological evaluation of medical devices-Parts 10: Tests for irritation

6) Sterilization and Shelf Life & Packaging testing

ISO 11607-1:2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.

ISO 11135:2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

ISO 10993-7: 2019, Biological evaluation of medical devices: Part 7-Ehylene oxide Sterilization Residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019).

The system performance tests were performed including validation of up/down deflection、repeated flexing,water supply system,sealing performance,normal working condition, field of View, direction of view (DOV)、geometric distortion, Signal-To-Noise Ratio, Image Intensity Uniformity (IIU)、and color performance.

All the test results demonstrate Bronchoscope System meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate device.

9. Clinical Tests Performed

No clinical test data was used to support the decision of substantial equivalence.

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10. Conclusion

The subject devices have all features of the predicate devices. The few differences were evaluated and do not affect the safety and effectiveness of the subject devices compared to the predicate.

Thus, the subject devices are substantially equivalent to the predicate devices.

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.