(54 days)
Not Found
No
The document describes a standard bronchoscope system for visualization and diagnosis, with no mention of AI or ML capabilities in the intended use, device description, or performance studies. The image processing mentioned appears to be standard enhancement functions, not AI/ML-driven analysis.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to be used for endoscopic diagnosis and therapies within the respiratory system". The term "therapies" indicates a treatment function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "designed to be used for endoscopic diagnosis" and "for observation, diagnosis, photography and treatment" of the respiratory system.
No
The device description clearly outlines hardware components: a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or Endoscopic Image Processor. These are physical devices, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "endoscopic diagnosis and therapies within the respiratory system" and provides "images through the video monitor for observation, diagnosis, photography and treatment". This describes a system used directly on or within the patient's body to visualize internal structures.
- Device Description: The description reinforces this by detailing a "Broncho Videoscope" (an endoscope) and "Endoscopic Image Processors" that connect to it to display images from "within the field of view from the body cavity".
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside of the body to obtain information about a patient's health. This device does not process or analyze biological specimens in this manner.
The device is a medical device used for direct visualization and intervention within the respiratory system, which falls under the category of endoscopic equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Broncho Videoscope System is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho Videoscope System is for use in a hospital environment.
The Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or within the field of view from the body cavity.
The Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
Product codes
EOO, EOQ
Device Description
The subject device, Broncho Videoscope System, is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.
The Single-use Broncho Videoscope is a single use in conjunction with Full HD Visualization Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six models, which are available in three kinds of outer diameter of insertion section (02.8mm and 05.6mm), one working length (600mm), two different material of the insertion (Nylon and PEEK) and two plug types (Square type and round type). The six models with round type have been cleared in K210739.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, they have and the difference is only on the image adjustment functions.
The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Respiratory system (trachea, bronchi, and lungs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital 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)
The biocompatibility tests were re-conducted on the representative models per the requirements of ISO 1099-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-23) tests. The test results device complies with the requirements of the standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
March 19, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" in a larger font size and "ADMINISTRATION" underneath in a smaller font.
Scivita Medical Technology Co., Ltd. Jiang Dan Senior Regulatory Affairs Specialist No.2, Qingqiu Street, Suzhou Industrial Park Suzhou, Jiangsu 215000 China
Re: K250210
Trade/Device Name: Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: February 20, 2025 Received: February 20, 2025
Dear Jiang Dan:
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.
1
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-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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joyce C. Lin -S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K250210
Device Name
Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-P, SBV-1B-B, SBV-1C-B, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300B, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D))
Indications for Use (Describe)
The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.
The Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or within the field of view from the body cavity.
The Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
| 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) #: K250210 | 510(k) Summary | Prepared on: 2025-03-17 | ||
|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |||
| Applicant Name | Scivita Medical Technology Co.,Ltd. | |||
| Applicant Address | No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA Suzhou China | |||
| Applicant Contact Telephone | 86-512-81877788 | |||
| Applicant Contact | Mrs. Wu Ruqin | |||
| Applicant Contact Email | wuruqin@scivitamedical.com | |||
| Correspondent Name | Scivita Medical Technology Co.,Ltd. | |||
| Correspondent Address | No.2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA Suzhou China | |||
| Correspondent Contact Telephone | 86-512-81877788 | |||
| Correspondent Contact | Ms. Jiang Dan | |||
| Correspondent Contact Email | ra@scivitamedical.com | |||
| Device Name | ||||
| 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Broncho Videoscope System (Single-use Broncho Videoscope: SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-B, SBV-1C-P, Full HD Visualization Endoscopic Image Processor: HDVS-S300A, HDVS-S300B. HDVS-S300C. HDVS-S300D. Endoscopic Image Processor: HDVS-S100A, HDVS-S100D) | |||
| Common Name | Bronchoscope (flexible or rigid) and accessories | |||
| Classification Name | Bronchoscope (Flexible Or Rigid) | |||
| Regulation Number | 874.4680 | |||
| Product Code(s) | EOQ | |||
| Legally Marketed Predicate Devices | ||||
| 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | ||
| K231521 | Broncho Videoscope System | EOQ | ||
| K210379 | Broncho Videoscope System | EOQ | ||
| Device Description Summary | ||||
| 21 CFR 807.92(a)(4) |
The subject device, Broncho Videoscope System, is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor or Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis
5
and therapies within the respiratory system such as trachea, bronchi, and lungs.
The Single-use Broncho Videoscope is a single use in conjunction with Full HD Visualization Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six models, which are available in three kinds of outer diameter of insertion section (02.8mm and 05.6mm), one working length (600mm), two different material of the insertion (Nylon and PEEK) and two plug types (Square type and round type). The six models with round type have been cleared in K210739.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, they have and the difference is only on the image adjustment functions.
The Endoscopic Image Processor is a reusable device. The Endoscopic Image Processor has two models. The only difference between the two models is that the HDVS-S100A has Enhance function and the HDVS-S100D does not have the Enhance function.
Intended Use/Indications for Use
The Broncho videoscope system is designed to be used for endoscopic diagnosis within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.
The Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.
The Endoscopic Image Processor is used for endoscopic diagnosis and the electronic endoscopes, displaying the images on the monitor detected within the field of view from the body cavity.
Indications for Use Comparison
The indications for use of the subject device is the same as the predicate device.
Technological Comparison
The subject device has the same technical characteristics as the predicate device. They have the same specifications, designed structure and materials. This submission is intended to provide new biocompatibility data for FDA review to ensure the safety and effectiveness of Broncho Videoscope System.
Specifically, the North American Sciences (NAMSA) retested the biocompatibility tests (cytotoxicity, sensitization, irritation) of models with tail letter "-B", SBV-1C-B, and its scope of ASCA accreditation includes all three aforementioned test methods. The biocompatibility tests (cytotoxicity, sensitization, irritation) of the models with tail letter "-P", SBV-16-P, SBV-1C-P, were retested in WuXi Apptec Suzhou, where only the cytotoxicity)/ test method is within the scope of ASCA accreditation.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The biocompatibility tests were re-conducted on the representative models per the requirements of ISO 1099-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-23) tests. The test results device complies with the requirements of the standards.
The non-clinical tests provided in this subject Broncho Videoscope System is substantially equivalent to the predicate device.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)