The Vathin®H-SteriScopeTM I Single-use flexible Video Bronchoscope have been designed to be used with the Vathin@VisionCenterTM I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

Device Description

The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScope™ I Singleuse flexible Video Bronchoscope (eighteen models shown in below) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenter™ I Digital Video Processor (model: DVP-A1) for clinical image processing. The Vathin®H-SteriScope™ I Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCenter™ I Digital Video Processor provides power and processes the images for medical electronic endoscope.

Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope is a sterile single used flexible bronchoscope. Vathin®VisionCenter™ I Digital Video Processor is a reusable monitor.

The light emitted by the LED cold light source of the Vathin®H-SteriScope™ I Singleuse flexible Video Bronchoscope lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS (complementary metal oxide semiconductor). The CMOS acquisition image is controlled by the CMOS drive circuit, and the standard color video signal is output to the Vathin®VisionCenter™ I Digital Video Processor via the encoding circuit. The Vathin®VisionCenter™ I Digital Video Processor adjusts the brightness of the light source or corrects the image according to the video signal output from the CMOS, and outputs the corrected standard color video signal.

Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord
Camera and LED light source at the distal tip
Sterilized by Ethylene Oxide
For single use

The differences between the Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope models are as follow:

Presence or absence of working channel
Working channel inner diameter
Insertion tube outer diameter
The length of insertion tube

Vathin®VisionCenter™ I Digital Video Processor has the following physical and performance characteristics:

Provide image from Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope for observation
Can connect to an external monitor
Reusable device

AI/ML Overview

This document describes the regulatory approval for the Vathin® Video Bronchoscope System. However, it does not contain a study that establishes acceptance criteria for direct device performance in a clinical context, nor does it provide details of a study specifically designed to prove the device meets such criteria.
The provided text focuses on demonstrating substantial equivalence to a predicate device (Ambu® aScope™ 3 System) through non-clinical performance data and adherence to recognized standards.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison table (Page 6-7) of technological characteristics between the subject device (Vathin® Video Bronchoscope System) and the predicate device (Ambu® aScope™ 3 System). While these are not explicitly termed "acceptance criteria" in the context of a clinical performance study, they represent the design and performance specifications against which the device was evaluated for substantial equivalence. The "Remark" column indicates how the subject device's performance compares to the predicate.

Specification	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Subject Device)
K Number	K173727	K191828
Manufacturer	Ambu A/S	Hunan Vathin Medical Instrument Co., Ltd.
Model	Ambu® aScope™ 3 Slim 3.8/1.2; Ambu® aScope™ 3 Regular 5.0/2.2; Ambu® aScope™ 3 Large 5.8/2.8; Ambu® aView™ Monitor; Ambu® aScope™ 4 Broncho Slim 3.8/1.2; Ambu® aScope™ 4 Broncho Regular 5.0/2.2; Ambu® aScope™ 4 Broncho Large 5.8/2.8	Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope (18 models); Vathin®VisionCenter™ I Digital Video Processor DVP-A1
Device Trade name	Ambu® aScope™ 3 System	Vathin® Video Bronchoscope System
Intended Use	The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.	The Vathin™ Single-use video endoscope have been designed to be used with the Vathin®VisionCenterTM I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
Working place/User	Use in a hospital environment by trained surgical physicians who are familiar with endoscopic procedures.	Use in a hospital environment by trained surgical physicians who are familiar with endoscopic procedures.
Population	Adults	Adults
Technology	The Flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor.	The Flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. Anatomical images are transmitted to the user by the video processor with a CMOS chip at the distal end of the endoscope and the images showing on a monitor.
Conical lock	6 % (Luer) taper	6 % (Luer) taper
Performance	Complies with: ISO 8600	Complies with: ISO 8600
Field of view (degree)	85°	110° ± 5%
Direction of view (degree)	0	0
Depth of view	8 – 19mm	3-30mm
Bending angle (degree)	Slim and Regular: Up: 130, Down: 130; Large: Up: 140, Down: 110	Up: 210, Down: 210
Endurance of the bending section	More than 1000 times, the maximum of 1700 times	More than 2000 times, the maximum of 5000 times
Radius of the bending section	Outer diameter about 2.7cm (Ambu® aScope™ 3 Slim 3.8/1.2)	Outer diameter about 2.2cm (Vathin® Video Bronchoscope BCV1-C1 3.2/1.2)
Distal end diameter (mm)	4.3/5.5/6.3	2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2
Maximum insertion portion width (mm)	4.2/5.4/6.2	2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2
Minimum insertion channel width (mm)	1.2/2.0/2.6	0/1.2/1.7/2.0/2.2/2.4/2.8/3.0/3.2
Working length (mm)	600	600/700
Digital video technology	CMOS	CMOS
Illumination source	LED	LED
Shutter speed	1/60 sec - 1/10000 sec	1/30 sec - 1/12000 sec
White balance	Automatic	Manual
Video format inputs (Camera)	analog signal RGB Bayer pattern	RAW
Output formats	Composite video	DVI/USB
Enhancement control	Yes	Yes
Image/Video capture	Yes	Yes
Storage	Yes, SD Card	Yes, SD Card
Single-use	Yes	Yes
Biocompatibility	No Cytotoxicity; No Irritation to Skin; No significant evidence of sensitization; No pyrogen	No Cytotoxicity; No Irritation to Skin; No significant evidence of sensitization; No pyrogen
Sterilization	EO	EO

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "no clinical studies were needed to support this 510(k) Premarket Notification." This means there was no designated "test set" in the context of a clinical trial or performance study involving human patients. The evaluation was based on non-clinical bench testing and comparison to the predicate device's specifications. Thus, there is no sample size for a test set, nor a data provenance in terms of country or retrospective/prospective nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were performed, there was no "ground truth" established by experts in a clinical setting for the purpose of validating the device's diagnostic or procedural effectiveness on human patients. The assessment relied on engineering and performance criteria established through bench testing and comparative analysis against the predicate device and relevant standards.

4. Adjudication method (e.g. 2+1, 3+1, none) 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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a bronchoscope system, not an AI-powered diagnostic tool, and no MRMC studies were conducted.

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

Not applicable. This is a medical instrument, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical bench testing, the "ground truth" was established by engineering specifications, recognized international standards (e.g., ISO 8600, ISO 80369-7, IEC 60601 series, ISO 11135), and the performance characteristics of the legally marketed predicate device. The product's compliance with these standards and equivalence to the predicate serve as the basis for its safety and effectiveness claims.

8. The sample size for the training set

Not applicable. This device does not have an AI component that undergoes a training phase with a dataset.

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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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 and Human Services logo on the left and the FDA logo 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.

February 13, 2020

Hunan Vathin Medical Instrument Co., Ltd. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, N0., 26 Oinglan Street Panyu District Guangzhou, 510006 China

Re: K191828

Trade/Device Name: Vathin Video Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOQ Dated: January 14, 2020 Received: January 16, 2020

Dear Mike Gu:

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

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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-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 Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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) K191828

Device Name Vathin® Video Bronchoscope System

Indications for Use (Describe)

The Vathin® Video Bronchoscope System is for use in a hospital environment.

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

In accordance with 21 CFR 807.92 the following summary of information is provided:

I. SUBMITTER

Hunan Vathin Medical Instrument Co., Ltd.

1/F, Building 12, Innovation and Entrepreneurship Service Center, No 9 Chuanqi west road, Jiuhua Economic Development Zone, Xiangtan, Hunan, China Phone: +86 18017856052

Fax: +86 731 5555 8558

Contact Person:	Yun Feng
	RA
	Hunan Vathin Medical Instrument Co., Ltd.
	Tel: +86 18017856052
	Fax: +86 731 5555 8558
Date Prepared:	Feb 13, 2020

II. DEVICE

Name of Device:	Vathin® Video Bronchoscope System
Model:	Vathin®H-SteriScope™ I Single-use flexible VideoBronchoscope
	BCV1-01 BCV1-02 BCV1-C1 BCV1-C2 BCV1-H1 BCV1-H2 BCV1-K1 BCV1-K2 BCV1-M1 BCV1-M2 BCV1-O1BCV1-O2 BCV1-S1 BCV1-S2 BCV1-U1 BCV1-U2BCV1-W1 BCV1-W2
	Vathin®VisionCenter™ I Digital Video Processor
Common or Usual Name:	DVP-A1Bronchoscope (flexible or rigid) and accessories

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Classification Names:	Bronchoscope (flexible or rigid) and accessories (21CFR 874.4680)
Regulation Class:	II
Product Code:	EOQ

III. PREDICATE DEVICE

Predicate device	K173727:
	Ambu® aScope™ 3 Slim 3.8/1.2
	Ambu® aScope™ 3 Regular 5.0/2.2
	Ambu® aScope™ 3 Large 5.8/2.8
	Ambu® aScope™ 4 Broncho Slim 3.8/1.2
	Ambu® aScope™ 4 Broncho Regular 5.0/2.2
	Ambu® aScope™ 4 Broncho Large 5.8/2.8
	Ambu® aView™ Monitor

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

Models of Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope

Bronchoscope zero:	BCV1-01/BCV1-02
Bronchoscope slim 3.2/1.2:	BCV1-C1/BCV1-C2
Bronchoscope slim 4.1/1.7	BCV1-H1/BCV1-H2
Bronchoscope normal 4.7/2.0	BCV1-K1/BCV1-K2
Bronchoscope normal 4.9/2.2	BCV1-M1/BCV1-M2

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Bronchoscope large 5.2/2.4	BCV1-01/BCV1-02
Bronchoscope large 5.8/2.8	BCV1-S1/BCV1-S2
Bronchoscope extra 6.0/3.0	BCV1-U1/BCV1-U2
Bronchoscope extra 6.2/3.2	BCV1-W1/BCV1-W2

Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope is a sterile single used flexible bronchoscope. Vathin®VisionCenter™ I Digital Video Processor is a reusable monitor.

Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope has the following physical and performance characteristics:

Maneuverable tip controlled by the user
Flexible insertion cord
Camera and LED light source at the distal tip
Sterilized by Ethylene Oxide
For single use

The differences between the Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope models are as follow:

Presence or absence of working channel
Working channel inner diameter
Insertion tube outer diameter

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The length of insertion tube
Vathin®VisionCenter™ I Digital Video Processor has the following physical and performance characteristics:
· Provide image from Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope for observation
Can connect to an external monitor
Reusable device

V. INDICATION FOR USE

The Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope have been designed to be used with the Vathin®VisionCenter™ I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.

The Vathin® Video Bronchoscope System is for use in a hospital environment.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

This comparison of the specifications demonstrates the functional equivalence of the

Specification	Subject device	Predicate device	Remark
K Number	K191828	K173727
Manufacturer	Hunan Vathin MedicalInstrument Co., Ltd.	Ambu A/S
Specification	Subject device	Predicate device	Remark
Model	Vathin®H-SteriScope™ ISingle-use flexible VideoBronchoscopeBCV1-01 BCV1-02 BCV1-C1BCV1-C2 BCV1-H1 BCV1-H2BCV1-K1 BCV1-K2 BCV1-M1BCV1-M2 BCV1-O1 BCV1-O2BCV1-S1 BCV1-S2 BCV1-U1BCV1-U2 BCV1-W1 BCV1-W2Vathin®VisionCenter™ I DigitalVideo ProcessorDVP-A1	Ambu® aScope™ 3 Slim3.8/1.2Ambu® aScope™ 3 Regular5.0/2.2Ambu® aScope™ 3 Large5.8/2.8Ambu® aView™ Monitor
Device Tradename	Vathin® Video BronchoscopeSystem	Ambu® aScope™ 3 System
Intended Use	The Vathin™ Single-use videoendoscope have beendesigned to be used with theVathin®VisionCenterTM IDigital Video Processor,endotherapy accessories andother ancillary equipment forendoscopy within the airwaysand tracheobronchial tree.	The aScope 3 endoscopes havebeen designed to be used withthe aView monitor,endotherapy accessories andother ancillary equipment forendoscopy within the airwaysand tracheobronchial tree.	Same
Workingplace/User	Use in a hospital environmentby trained surgical physicianswho are familiar withendoscopic procedures.	Use in a hospital environmentby trained surgical physicianswho are familiar withendoscopic procedures.	Same
Population	Adults	Adults	Same
Specification	Subject device	Predicate device	Remark
Technology	The Flexible bronchoscope isinserted through the airwaysand tracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user by thevideo processor with a CMOSchip at the distal end of theendoscope and the imagesshowing on a monitor.	The Flexible bronchoscope isinserted through the airwaysand tracheobronchial treeduring Bronchoscopy.Anatomical images aretransmitted to the user by thevideo processor with a CMOSchip at the distal end of theendoscope and the imagesshowing on a monitor.	Same
Conical lock	6 % (Luer) taper	6 % (Luer) taper	Same
Performance	Complies with:ISO 8600	Complies with:ISO 8600	Same
Field of view(degree)	$110°±5%$	$85°$	Larger than the predicatedevice.
Direction ofview (degree)	0	0	Same
Depth of view	3-30mm	8 – 19mm	Larger range than thepredicate device.
Bending angle(degree)	Up: 210Down: 210	Slime and Regular:Up: 130Down: 130Large:Up: 140Down: 110	Larger range than thepredicate device.
Endurance ofthe bendingsection	More than 2000 times, themaximum of 5000 times	More than 1000 times, themaximum of 1700 times	More endurance ofbending times than thepredicted device.
Radius of thebending section	Outer diameter about 2.2cm(Vathin® Video BronchoscopeBCV1-C1 3.2/1.2)	Outer diameter about 2.7cm(Ambu® aScope™ 3 Slim3.8/1.2)	Thinner than thepredicate device.
Distal enddiameter(mm)	2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2	4.3/5.5/6.3	More specifications thanpredicted device.
Maximuminsertion portionwidth(mm)	2.2/3.2/4.1/4.7/4.9/5.2/5.8/6.0/6.2	4.2/5.4/6.2
Specification	Subject device	Predicate device	Remark
Minimuminsertion channelwidth(mm)	0/1.2/1.7/2.0/2.2/2.4/2.8/3.0/3.2	1.2/2.0/2.6
Working length(mm)	600/700	600
Digitalvideotechnology	CMOS	CMOS	Same
Illuminationsource	LED	LED	Same
Shutter speed	1/30 sec~1/12000 sec	1/60 sec- 1/10000 sec	Faster than the predicatedevice.
White balance	Manual	Automatic	Different
Video formatinputs (Camera)	RAW	analog signal RGB Bayerpattern	Different
Output formats	DVI/USB	Composite video	Different
Enhancementcontrol(contrast anddefinition)	Yes	Yes	Same
Image/Videocapture	Yes	Yes	Same
Storage	YesSD Card	YesSD Card	Same
Single-use	Yes	Yes	Same
Biocompatibility	No Cytotoxicity	No Cytotoxicity	Same
	No Irritation to Skin	No Irritation to Skin	Same
	No significant evidence ofsensitization	No significant evidence ofsensitization	Same
	No pyrogen	No pyrogen	Same
Sterilization	EO	EO	Same

products.

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VII. PERFORMANCE DATA

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The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

Biocompatibility of the Vathin® Video Bronchoscope System was evaluated in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were performed, as recommended:

Cytotoxicity
Irritation
Pyrogen
Sensitization

The Vathin® Video Bronchoscope Systems is considered surface – mucosal membrane contacting for a duration of less than 24 hours.

Sterilization and shelf life testing

The sterilization method has been validated to ISO11135, which has thereby determined the routine control and monitoring parameters. The shelf life of the Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope is validated.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Vathin® Video Bronchoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC 60601-1-2 for EMC.

Software Verification and Validation Testing

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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

The following bench tests were performed:

1. Optical performance testing according to ISO8600 series.
1. The performance test of 6% (Luer) taper according ISO 80369-7.
1. Mechanical characteristics including the test leaking, bending, articulating bending angle, endurance of the bending section, radius of the bending section and irrigation tests were performed compared with the predicate device.
1. Color feature separation and photobiological safety test
1. Color performance (color reproduction), optical performance (resolution, depth of view and image intensity uniformity), SNR and dynamic test compared with the predicate device.

Clinical Testing

Based on the similarities of the device specifications, intended use, indications for use between the Vathin® Video Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.

VIII. CONCLUSION

The Vathin® Video Bronchoscope System is substantially equivalent to the predicate device. The non-clinical testing demonstrates that the subject device is as safe, as effective and performs as well as 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.