(146 days)
Not Found
No
The document describes standard image processing for display and observation, and there is no mention of AI, ML, or related concepts like deep learning or algorithms for automated analysis or interpretation.
Yes
The "Intended Use / Indications for Use" section states: "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 mention of "treatment" indicates a therapeutic purpose.
Yes
The "Digital Video Monitor" component of the Video Bronchoscope System is explicitly stated to be used "for the purposes of endoscopic diagnosis." This indicates that the overall system facilitates diagnostic procedures.
No
The device description clearly states the system consists of a "Single-use Flexible Bronchoscope" (hardware) and a "Digital Video Monitor" (hardware with software). The performance studies also include hardware-specific testing like biocompatibility, sterilization, electrical safety, and mechanical tests.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for direct visualization within the airways and tracheobronchial tree for endoscopic diagnosis, treatment, and video observation. This is a direct examination of the body, not an analysis of samples taken from the body.
- Device Description: The device is a bronchoscope system that is inserted into the body to capture images. It does not involve the analysis of biological samples like blood, urine, or tissue in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, assays, sample preparation, or analysis of biological markers.
IVD devices are designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This bronchoscope system is a medical device used for direct visualization and intervention within the body.
N/A
Intended Use / Indications for Use
The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
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
E00, EOQ
Device Description
The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen.
The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Endoscopy
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional Healthcare Facility Environment.
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)
Non-clinical tests performed:
- Biocompatibility testing: evaluated according to ISO 10993-1:2018 for "Surface – Mucosal Membrane" contact 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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October 29, 2024
Hunan Vathin Medical Instrument Co., Ltd Charlene Du RA manager 1/F, Building 12, Innovation and Entrepreneurship Service Center No 9 Chuangi West Road, Jiuhua Economic Development Zone Xiangtan, Hunan 411100 China
Re: K241612
Trade/Device Name: Video Bronchoscope System: Single-use Flexible Bronchoscope (BC-S1E00-L. BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00.); Digital Video Monitor (DVM-D1, DVM-D2) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: September 27, 2024 Received: September 27, 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 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"
1
(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 OS 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 Rue"). 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Image /page/2/Picture/3 description: The image shows the name "Joyce C. Lin -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible and well-defined. There is a faint watermark in the background.
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
Video Bronchoscope System:
Single-use Flexible Bronchoscope (BC-S1E00-L,BC-S1J00-L,BC-S1J00-L,BC-S1E00,BC-S1H00, BC-S1J00)
Digital Video Monitor (DVM-D1,DVM-D2)
Indications for Use (Describe)
The Single-use Flexible Bronchoscope has been designed to used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
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)
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 word "VATHIN" in blue font. The "VA" portion of the word is stylized with three parallel lines that form the letters. The "THIN" portion of the word is in a solid blue font, and there is a blue circle above the "I".
510(k) summary
l Submitter
| Device submitter: | Hunan Vathin Medical Instrument Co., Ltd. |
|---|---|
| 1/F, Building 12, Innovation and Entrepreneurship Service | |
| Address: | 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
| Trade Name of Device: | Video Bronchoscope System |
|---|---|
| Single-use Flexible Bronchoscope | |
| BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. | |
| Model: | 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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Image /page/5/Picture/0 description: The image shows the word "VATHIN" in blue. The "VA" portion of the word is stylized with three parallel lines that form the shape of the letters. The "THIN" portion of the word is in a solid blue font. There is a small blue circle above the "I" in "THIN".
Premarket Notification 510(k) Submission
III Predicate Device
| 510 (k) Number | K210883 | K223299 |
|---|---|---|
| Device 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 | ||
| Common Name: | Flexible Bronchoscope | Flexible Bronchoscope |
| Classification | ||
| Name: | Bronchoscope (flexible or rigid) | |
| and accessories | Bronchoscope (flexible or | |
| rigid) and accessories | ||
| Regulation | ||
| Number: | 21 CFR 874.4680 | 21 CFR 874.4680 |
| Regulatory | ||
| Class: | II | II |
| Product Code: | EOQ | EOQ |
IV Device description
The Video Bronchoscope System consists of a Single-use Flexible Bronchoscope to be introduced within the airways or tracheobronchial tree and a Digital Video Monitor for endoscopic image processing and displaying. The flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Digital Video Monitor receives, processes the real-time image signal from the endoscope and displays the live image on the screen.
The Single-use Flexible Bronchoscope has six models: BC-S1E00-L, BC-S1H00-L, BC-S1J00-L, BC-S1E00, BC-S1H00, BC-S1J00. The main differences between product models are the size of the device channel, the color of the rotating sleeve, and whether it is self-locking.
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Image /page/6/Picture/1 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 made up of three parallel lines, while the "THIN" is in a solid, blocky font. There is a small blue circle above the "I" in "VATHIN".
V Indications f
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.
The Digital Video Monitor is specially designed to be used with compatible Vathin 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 | |
| Digital Video Monitor | aScope 4 Broncho Regular | |
| Sampler Set 5.0/2.2 | ||
| aScope 4 Broncho Large | ||
| Sampler Set 5.8/2.8 | ||
| Ambu® aView 2 Advance | ||
| Field of view | ||
| (degree) | 110° | 85° |
| Direction of | ||
| view (degree) | 0° | 0° |
| Depth of view | 3-100mm | 6-50mm |
| Bending angle | ||
| (degree) | Up: 210° | |
| Down: 210° | aScope 4 Broncho Regular: | |
| Up: 180°, Down: 180° | ||
| aScope 4 Broncho Large: | ||
| Up: 180°, Down: 160° | ||
| Working length | ||
| (mm) | 600 | 600 |
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Image /page/7/Picture/0 description: The image shows the logo for Vathin. The logo is blue and white. The word "Vathin" is written in a stylized font, with the "V" and "A" being made up of three parallel lines.
Premarket Notification 510(k) Submission
| Device feature | Proposed Device | Predicate Device |
|---|---|---|
| Trade Name | Single-use Flexible Bronchoscope | |
| Digital Video Monitor | aScope 4 Broncho Regular | |
| Sampler Set 5.0/2.2 | ||
| aScope 4 Broncho Large | ||
| Sampler Set 5.8/2.8 | ||
| Ambu® aView 2 Advance | ||
| Digital video | ||
| technology | CMOS | CMOS |
| Illumination | ||
| source | LED | LED |
| Single-use | Yes | Yes |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity |
| No Irritation to Skin | No Irritation to Skin | |
| No significant evidence of | ||
| sensitization | No significant evidence of | |
| sensitization | ||
| 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 | A-type | Type A |
| Video output | HDMI/SDI | HDMI/SDI |
| Image/Video | ||
| capture | Yes | Yes |
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 (