The Single-use Flexible Bronchoscope has been designed to be used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. Single-use Sampler is designed as an add-on for use during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedures which enable aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Video Bronchoscope System is for use in professional Healthcare Facility Environment.

Device Description

The Video Bronchoscope System consists of Single-use Flexible Bronchoscope, Single-use sampler and digital video monitor. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The video monitor receives the real-time image signal from Bronchoscope and displays the live image. During the bronchoscope sputum aspiration and collection, the fluid in the patient's body can be sucked out by pressing the suction button on the bronchoscope. The sampler control switch can collect liquid into the sampler.

AI/ML Overview

The provided text is a Premarket Notification 510(k) Submission for the Hunan Vathin Medical Instrument Co. Ltd.'s Video Bronchoscope System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain specific acceptance criteria, reported device performance metrics in a tabular format, details about a clinical study (sample size, data provenance, expert qualifications, adjudication methods), information on multi-reader multi-case (MRMC) studies, standalone algorithm performance, or details about training set ground truth.

The submission focuses on non-clinical tests to demonstrate safety and performance. Here's a summary of the information that is available based on your request, and what is missing:

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

Not provided in the document. The document lists the performance tests conducted but does not provide specific numerical acceptance criteria or the measured performance values.

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

Not provided in the document. The document details non-clinical tests (biocompatibility, sterilization, electrical safety, software verification, performance testing) but does not describe a clinical test set with human subjects or data provenance.

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)

Not provided in the document. This information would typically be relevant for a clinical study involving interpretation of images or data, which is not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided in the document. This is relevant for clinical studies with expert reviewers, which are not described.

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 mentioned in the document. The device is a physical bronchoscope system; there is no indication of it incorporating AI or being subject to an MRMC study.

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

Not applicable/Not mentioned in the document. The device is a bronchoscope system, not an AI algorithm. While it has software, standalone algorithm performance is not a focus here.

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

Not provided in the document. For non-clinical tests, "ground truth" often refers to engineering specifications or validated test methods. The document states that "All evaluation acceptance criteria were met" for biocompatibility and that electrical safety and EMC tests comply with relevant IEC standards. Performance tests were conducted based on engineering specifications.

8. The sample size for the training set

Not applicable/Not mentioned in the document. This device is hardware with integrated software, not a machine learning model that requires a "training set" in the typical sense. Software verification and validation were conducted.

9. How the ground truth for the training set was established

Not applicable/Not mentioned in the document. See point 8.

Summary of Conducted Studies (from the document):

The document primarily describes non-clinical tests to demonstrate the safety and effectiveness of the Video Bronchoscope System, ensuring its substantial equivalence to predicate devices. These tests include:

Biocompatibility testing: Evaluated according to ISO 10993-1:2018 for "Surface – Mucosal Membrane" body contact for "Limited (< 24 hours)" duration. Tests performed and met acceptance criteria: Cytotoxicity, Irritation, Sensitization, Pyrogenicity, and Acute systemic toxicity.
Sterilization and shelf life testing: Sterilization validated per ISO 11135. Shelf life and package validated.
Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1 and IEC 60601-2-18 for safety, and IEC 60601-1-2 for EMC.
Software Verification and Validation Testing: Conducted in accordance with FDA guidance documents "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."
Performance testing:
- Optical tests: Color rendering index, illuminance, correlated color temperature, geometric distortion, color restoration, resolution, depth of field, field of view, direction of view, signal-to-noise ratio, dynamic range, geometric distortion, image brightness uniformity, and field of view.
- Mechanical tests: Working length, minimum instrument channel width, outer diameter of main hose, max outer diameter, bending angle, water delivery, attractive volume, insertion end tension, and passively bent part reliability test.
- Shelf-life verification test.
- Packaging verification test.
- Electromagnetic Compatibility according to IEC 60601-1-2.
- Electrical Safety according to IEC 60601-1 and IEC 60601-2-18.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right, there is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font, also in blue.

January 16, 2025

Hunan Vathin Medical Instrument Co.Ltd Charlene Du RA Manager 1/F, Building 12, Innovation and Entrepreneurship Service Ctr No 9 Chuanqi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 China

Re: K242416

Trade/Device Name: Single-use Flexible Bronchoscope (BC-E1C10,BC-E1C11,BC-E1C12,BC-E1E10,BC-E1E11,BC-E1E12, BC-E1H10,BC-E1H11,BC-E1H12.); Digital Video Monitor (DVM-D1, DVM-D2.); Single-use sampler (S-20mL, S-30mL, S-50mL.) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: December 20, 2024 Received: December 20, 2024

Dear Charlene Du:

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

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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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

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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

Enclosure

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Indications for Use

Submission Number (if known)

K242416

Device Name

Single-use Flexible Bronchoscope:BC-E1C10,BC-E1C12,BC-E1C12,BC-E1E10,BC-E1E11,BC-E1E12,BC-E1H10,BC-E1H11,BC-E1H12

Digital Video Monitor:DVM-D1,DVM-D2

Single-use sampler:S-20mL,S-30mL,S-50mL,S-50mL

Indications for Use (Describe)

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Video Bronchoscope System is for use in professional Healthcare Facility Environment.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for Vathin. The logo is blue and features the word "Vathin" in a stylized font. The "V" and "A" are connected and have three lines running through them. There is a blue dot above the "i" in "Vathin."

510(k) summary

l Submitter

Device submitter:	Hunan Vathin Medical Instrument Co., Ltd.
Address:	1/F, Building 12, Innovation and Entrepreneurship Service Center,No 9 Chuanqi west road, Jiuhua Economic Development Zone,411100 Xiangtan, Hunan, China
Contact person:	Du JingTitle: Regulatory Affairs Manager
	Phone: +86-731-5558558E-mail: charlene@vathin.com
II Device
	Single-use flexible Bronchoscope: BC-E1C10,BC-E1C11,
	BC-E1C12,BC-E1E10,BC-E1E11,BC-E1E12,
Device Name:	BC-E1H10,BC-E1H11,BC-E1H12.
	Single-use sampler: S-20mL, S-30mL, S-50mL.
	Digital Video Monitor: DVM-D1, DVM-D2.
Regulation number:	21 CFR 874.4680
Regulation name:	Bronchoscope (flexible or rigid) and accessories
Regulation Class:	II
Product Code:	EOQ
Review Panel:	Ear Nose & Throat

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Premarket Notification 510(k) Submission

Image /page/5/Picture/1 description: The image shows the word "VATHIN" in a stylized font. The letters "VA" are blue and made of three parallel lines. The letters "THIN" are solid blue. There is a blue dot above the "I".

III Predicate Device

Trade name:	aScope 4 Broncho Regular SamplerSet 5.0/2.2aScope 4 Broncho Large SamplerSet 5.8/2.8	Ambu aView 2 Advance
Regulation number:	21 CFR 874.4680	21 CFR 874.4680
Regulation name:	Bronchoscope (flexible or rigid) andaccessories	Bronchoscope (flexible or rigid) andaccessories
Regulatory class:	Class II	Class II
Product code:	EOQ	EOQ
Submitter:	Ambu A/S	Ambu A/S
510(k) number:	K210883	K223299

IV Device description

V Indications for use

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Image /page/6/Picture/0 description: The image shows the word "VATHIN" in a stylized font. The letters "VA" are in a lighter blue color and are made up of three parallel lines. The letters "THIN" are in a darker blue color and are solid. There is a light blue circle above the letter "I".

collection of fluid sample(s) from the bronchial or alveolar part of the lung.

The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation.

The Video Bronchoscope System is for use in professional Healthcare Facility Environment.

VI Comparison of technological characteristics with the predicate devices

Intended use and principal operation, the technology, design and performance specifications of Video Bronchoscope system are either identical or substantially equivalent to existing legally marketed predicate devices. Any differences in various attributes as listed below between the Video Bronchoscope System and predicate device do not alter suitability of the proposed device for its intended use nor impact substantial equivalence with the predicate.

Device feature	Proposed Device	Predicate Device
Trade Name	Single-use flexible Bronchoscope:BC-E1C10, BC-E1C11, BC-E1C12,BC-E1E10, BC-E1E11, BC-E1E12,BC-E1H10, BC-E1H11, BC-E1H12.Single-use sampler: S-20mL, S-30mL,S-50mL.Digital Video Monitor: DVM-D1, DVM-D2.	aScope 4 Broncho Regular SamplerSet 5.0/2.2,aScope 4 Broncho Large SamplerSet 5.8/2.8Ambu aView 2 Advance
ClassificationName	Bronchoscope (flexible or rigid) andaccessories	Bronchoscope (flexible or rigid) andaccessories
Product Code	EOQ	EOQ
RegulationNumber	21 CFR 874.4680	21 CFR 874.4680
Device feature	Proposed Device	Predicate Device
Intended use	The Single-use Flexible Bronchoscopehas been designed to be used with VathinDisplay Units, endoscopic accessoriesand other ancillary equipment forendoscopy within the airways andtracheobronchial tree. Single-useSampler is designed as an add-on for useduring Bronchial Alveolar Lavage (BAL)or Bronchial Wash (BW) procedureswhich enable aspiration and collection offluid sample(s) from the bronchial oralveolar part of the lung.The Digital Video Monitor is speciallydesigned to be used with Vathin medicalendoscopes and other auxiliaryequipment for the purposes ofendoscopic diagnosis, treatment andvideo observation.The Video Bronchoscope System is foruse in professional Healthcare FacilityEnvironment.	aScope 4 Broncho Sampler Setconsists of sterile, single use, flexibleendoscope with sample containers(aScope BronchoSampler), intendedfor endoscopic procedures andexamination within the airways andtracheobronchial tree. aScopeBronchoSampler is designed as anadd-on to aScope 4 Broncho duringBronchial Alveolar Lavage (BAL) orpart of the lung. Bronchial Wash(BW) procedure which enablesaspiration and collection of fluidsample(s) from the bronchial oralveolarIt is designed for use inadults and intended for use in ahospital environment.It is intended toprovide visualization via AmbuDisplaying Unit.
Applicationfield	The device is for use in a hospital orqualified medical institution.	The device is for use in a hospitalenvironment.
Intended user	The device is only to be used by skilledmedical staff trained in clinicalendoscopic techniques and procedures.	Only to be used by skilled physicianstrained in clinical endoscopictechniques and procedures.
Patientpopulation	Adults	Adults
Scope type	Flexible	Flexible
Field of view(degree)	95°	85°
Direction ofview (degree)	0°	0°
Depth of view	3-100mm	6-50mm
Bending angle	Up: 180°	Regular: Up: 180°, Down: 180°
(degree)	Down: 150°	Large: Up: 180°, Down: 160°
Working length(mm)	560/580/600	600
Digital videotechnology	CMOS	CMOS
Illuminationsource	LED	LED
Device feature	Proposed Device	Predicate Device
Single-useSampler	20mL/30mL/50mL	30mL
Biocompatibility	No Cytotoxicity	No Cytotoxicity
	No Irritation to Skin	No Irritation to Skin
	No significant evidence of sensitization	No significant evidence of sensitization
	No Acute Systemic Toxicity	No Acute Systemic Toxicity
	No material-mediated pyrogenicity	No material-mediated pyrogenicity
	No Oral Mucosa Irritation	No Oral Mucosa Irritation
Sterilization	EO	EO
Single-use	Yes	Yes
Max. resolution	1920 * 1080	1920 * 1080
Display type	15.6"" touch screen	12.8" touch screen
USBconnection	Type A	Type A
Video output	HDMI/SDI	HDMI/SDI
Image/Videocapture	Yes	Yes

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Image /page/7/Picture/0 description: The image shows the logo for Vathin. The logo is blue and features the word "VATHIN" in a stylized font. The "V" is made up of three parallel lines, and there is a blue circle above the "I".

Premarket Notification 510(k) Submission

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Image /page/8/Picture/0 description: The image shows the word "VATHIN" in blue. The "VA" portion of the word is stylized with three parallel lines running through each letter. The "THIN" portion of the word is in a solid blue font. There is a small blue circle above the "I".

Premarket Notification 510(k) Submission

VII Summary of Non-clinical tests:

Biocompatibility testing

Biocompatibility of the Single-Use Flexible Bronchoscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Pyrogenicity and Acute systemic toxicity. All evaluation acceptance criteria were met.

Sterilization and shelf life testing

Sterilization process of Single-use Flexible Bronchoscope has been validated according to ISO11135, which thereby routine control and monitoring parameters of the process

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Image /page/9/Picture/1 description: The image shows the word "VATHIN" in blue lettering. The letters "VA" are stylized with three parallel lines each, in a lighter shade of blue. The letters "THIN" are in a darker shade of blue, with a small blue circle above the "I". The overall design is modern and clean.

has been determined. Shelf life and package of Single-use flexible Bronchoscope was validated.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the 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

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions ".

Performance testing

The following performance tests was conducted on the Video Bronchoscope System:

Optical tests: including color rendering index, illuminance, correlated color temperature, geometric distortion, color restoration, resolution, depth of field, field of view, direction of view, signal-to-noise ratio, dynamic range, geometric distortion, image brightness uniformity and field of view.

Mechanical tests: working length, minimum instrument channel width, outer diameter of main hose, max outer diameter, bending angle, water delivery, attractive volume , insertion end tension and passively bent part reliabitity test.

Shelf-life verification test.

Packaging verification test.

Electromagnetic Compatibility according to IEC 60601-1-2

Electrical Safety according to IEC 60601-1 and IEC 60601-2-18.

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Image /page/10/Picture/0 description: The image shows the text "Premarket Notification 510(k) Submission". The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be a title or heading, possibly indicating the subject of a document or presentation.

Image /page/10/Picture/1 description: The image shows the word "VATHIN" in blue. The "VA" portion of the word is stylized with three parallel lines that curve to form the letters. The rest of the word, "THIN", is in a solid, darker blue font. There is a small, light blue circle above the "I" in "THIN".

VIII Conclusion

Based on the indication for use, technological characteristics, performance data and comparison to predicate device it has been concluded that the functionality and intended use of Video Bronchoscope System is substantially equivalent to the predicate device. It is concluded that Video Bronchoscope System is as safe and 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.