(154 days)
Not Found
No
The description focuses on the physical components and basic image display functionality, with no mention of AI/ML terms or capabilities.
Yes
The device is described as being used for "treatment" in the intended use section and by enabling "aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung" by sucking fluid out of the patient's body in the device description.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Digital Video Monitor is designed for "endoscopic diagnosis." The "Device Description" also mentions displaying a "live image" from the bronchoscope. Both phrases directly support the conclusion that the device is used for diagnostic purposes.
No
The device description explicitly states the system consists of a flexible bronchoscope, sampler, and digital video monitor, which are hardware components. While software verification and validation were performed, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The primary intended use is for endoscopic diagnosis, treatment, and video observation within the airways and tracheobronchial tree. While it includes a sampler for collecting fluid samples, the device itself is not performing a diagnostic test on those samples. The collection of the sample is a procedure, not the diagnostic test itself.
- Device Description: The description focuses on the physical components and their function in visualizing and collecting samples during a procedure. It doesn't describe any components or processes that analyze biological samples to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other elements typically associated with in vitro diagnostic devices that analyze samples outside the body.
- Performance Studies: The performance studies described are related to the physical and optical performance of the bronchoscope system, not the analytical performance of a diagnostic test on a biological sample.
The sampler component facilitates the collection of a sample, which could then be used for an in vitro diagnostic test performed separately in a laboratory. However, the bronchoscope system itself is a medical device used for visualization and sample collection during a procedure, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airways and tracheobronchial tree, bronchial or alveolar part of the lung
Indicated Patient Age Range
Adults
Intended User / Care Setting
professional Healthcare Facility Environment.
The device is only to be used by skilled medical staff trained in clinical endoscopic techniques and procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (
§ 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.
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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
1
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
2
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
3
Indications for Use
Submission Number (if known)
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 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.
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 Jing | ||
| Title: Regulatory Affairs Manager | |||
| Phone: +86-731-5558558 | |||
| E-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 Sampler
Set 5.0/2.2
aScope 4 Broncho Large Sampler
Set 5.8/2.8 | Ambu aView 2 Advance |
|--------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Regulation number: | 21 CFR 874.4680 | 21 CFR 874.4680 |
| Regulation name: | Bronchoscope (flexible or rigid) and
accessories | Bronchoscope (flexible or rigid) and
accessories |
| 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
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.
V Indications for use
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
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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 Sampler | |
| Set 5.0/2.2, | ||
| aScope 4 Broncho Large Sampler | ||
| Set 5.8/2.8 | ||
| Ambu aView 2 Advance | ||
| Classification | ||
| Name | Bronchoscope (flexible or rigid) and | |
| accessories | Bronchoscope (flexible or rigid) and | |
| accessories | ||
| Product Code | EOQ | EOQ |
| Regulation | ||
| Number | 21 CFR 874.4680 | 21 CFR 874.4680 |
| Device feature | Proposed Device | Predicate Device |
| Intended use | 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. | aScope 4 Broncho Sampler Set | |
| consists of sterile, single use, flexible | ||
| endoscope with sample containers | ||
| (aScope BronchoSampler), intended | ||
| for endoscopic procedures and | ||
| examination within the airways and | ||
| tracheobronchial tree. aScope | ||
| BronchoSampler is designed as an | ||
| add-on to aScope 4 Broncho during | ||
| Bronchial Alveolar Lavage (BAL) or | ||
| part of the lung. Bronchial Wash | ||
| (BW) procedure which enables | ||
| aspiration and collection of fluid | ||
| sample(s) from the bronchial or | ||
| alveolarIt is designed for use in | ||
| adults and intended for use in a | ||
| hospital environment.It is intended to | ||
| provide visualization via Ambu | ||
| Displaying Unit. | ||
| Application | ||
| field | The device is for use in a hospital or | |
| qualified medical institution. | The device is for use in a hospital | |
| environment. | ||
| Intended user | The device is only to be used by skilled | |
| medical staff trained in clinical | ||
| endoscopic techniques and procedures. | Only to be used by skilled physicians | |
| trained in clinical endoscopic | ||
| techniques and procedures. | ||
| Patient | ||
| population | Adults | Adults |
| Scope type | Flexible | Flexible |
| Field of view | ||
| (degree) | 95° | 85° |
| Direction of | ||
| view (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 video | ||
| technology | CMOS | CMOS |
| Illumination | ||
| source | LED | LED |
| Device feature | Proposed Device | Predicate Device |
| Single-use | ||
| Sampler | 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 |
| USB | ||
| connection | Type A | Type A |
| Video output | HDMI/SDI | HDMI/SDI |
| Image/Video | ||
| capture | 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 (