(220 days)
No reference devices were used in this submission.
No
The description focuses on standard image processing and hardware components without mentioning AI/ML algorithms or capabilities.
No
This device is described as a video bronchoscope system used for endoscopy within the airways and tracheobronchial tree, primarily for imaging and observation, not for delivering therapeutic treatment.
Yes
The device, a Vathin®H-SteriScope™ I Single-use flexible Video Bronchoscope, is used with a Vathin®VisionCenter™ I Digital Video Processor to provide images of the airways and tracheobronchial tree. The Intended Use/Indications for Use states it's for endoscopy, which is a method of visual examination for diagnostic purposes. While it might also be used for interventional procedures (presence of a working channel), its primary role as described involves imaging for observation and assessment (e.g., "Provide image ... for observation"), making it a diagnostic device.
No
The device description clearly outlines both a physical bronchoscope (Vathin®H-SteriScope™ I) and a digital video processor (Vathin®VisionCenter™ I), indicating it is a system with both hardware and software components.
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 device is for "endoscopy within the airways and tracheobronchial tree" and for "clinical image processing." This describes a procedure performed directly on the patient's body for visualization and potential intervention, not for testing samples taken from the body.
- Device Description: The description details a bronchoscope and a video processor used for inserting into the airways and capturing images. This aligns with an endoscopic device, not an IVD.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or performing tests on them outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device is a tool for direct visualization and potential intervention within the body.
N/A
Intended Use / Indications for Use
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.
Product codes
EOQ
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.
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
Bronchoscope large 5.2/2.4 BCV1-O1/BCV1-O2
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.
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
Adults
Intended User / Care Setting
Use in a hospital environment by trained surgical physicians who are familiar with endoscopic 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: Tests performed include Cytotoxicity, Irritation, Pyrogen, and Sensitization. The device is considered surface – mucosal membrane contacting for a duration of less than 24 hours.
- Sterilization and shelf life testing: Validated to ISO11135 and shelf life confirmed.
- Electrical safety and electromagnetic compatibility (EMC): Complies with IEC 60601-1, IEC60601-2-18 for safety, and IEC 60601-1-2 for EMC.
- Software Verification and Validation Testing: Conducted in accordance with FDA guidance, classified as a "moderate" level of concern.
- Bench performance testing:
- Optical performance testing according to ISO8600 series.
- Performance test of 6% (Luer) taper according ISO 80369-7.
- Mechanical characteristics: Tests for 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.
- Color feature separation and photobiological safety test.
- 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: No clinical studies were needed due to similarities in specifications, intended use, and indications for use with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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.
1
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
2
Indications for Use
510(k) Number (if known) K191828
Device Name Vathin® Video Bronchoscope System
Indications for Use (Describe)
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.
| 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 Video |
| Bronchoscope | |
| BCV1-01 BCV1-02 BCV1-C1 BCV1-C2 BCV1-H1 BCV1- | |
| H2 BCV1-K1 BCV1-K2 BCV1-M1 BCV1-M2 BCV1-O1 | |
| BCV1-O2 BCV1-S1 BCV1-S2 BCV1-U1 BCV1-U2 | |
| BCV1-W1 BCV1-W2 | |
| Vathin®VisionCenter™ I Digital Video Processor | |
| Common or Usual Name: | DVP-A1 |
| Bronchoscope (flexible or rigid) and accessories |
4
| Classification Names: | Bronchoscope (flexible or rigid) and accessories (21
CFR 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
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.
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 |
5
| 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.
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
6
-
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 Medical | ||
| Instrument Co., Ltd. | Ambu A/S | ||
| Specification | Subject device | Predicate device | Remark |
| Model | Vathin®H-SteriScope™ I | ||
| Single-use flexible Video | |||
| Bronchoscope | |||
| BCV1-01 BCV1-02 BCV1-C1 | |||
| BCV1-C2 BCV1-H1 BCV1-H2 | |||
| BCV1-K1 BCV1-K2 BCV1-M1 | |||
| BCV1-M2 BCV1-O1 BCV1-O2 | |||
| BCV1-S1 BCV1-S2 BCV1-U1 | |||
| BCV1-U2 BCV1-W1 BCV1-W2 | |||
| Vathin®VisionCenter™ I Digital | |||
| Video Processor | |||
| DVP-A1 | 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 | |||
| Device Trade | |||
| name | Vathin® Video Bronchoscope | ||
| System | Ambu® aScope™ 3 System | ||
| Intended Use | 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. | 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. | Same | ||
| 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. | Same | ||
| Population | Adults | Adults | Same |
| Specification | Subject device | Predicate device | Remark |
| 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. | 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 predicate |
| device. | |||
| Direction of | |||
| view (degree) | 0 | 0 | Same |
| Depth of view | 3-30mm | 8 – 19mm | Larger range than the |
| predicate device. | |||
| Bending angle | |||
| (degree) | Up: 210 | ||
| Down: 210 | Slime and Regular: | ||
| Up: 130 | |||
| Down: 130 | |||
| Large: | |||
| Up: 140 | |||
| Down: 110 | Larger range than the | ||
| predicate device. | |||
| Endurance of | |||
| the bending | |||
| section | More than 2000 times, the | ||
| maximum of 5000 times | More than 1000 times, the | ||
| maximum of 1700 times | More endurance of | ||
| bending times than the | |||
| predicted device. | |||
| Radius of the | |||
| bending section | Outer diameter about 2.2cm | ||
| (Vathin® Video Bronchoscope | |||
| BCV1-C1 3.2/1.2) | Outer diameter about 2.7cm | ||
| (Ambu® aScope™ 3 Slim | |||
| 3.8/1.2) | Thinner than the | ||
| predicate device. | |||
| Distal end | |||
| diameter(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 than | |
| predicted device. | |||
| Maximum | |||
| insertion portion | |||
| width(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 |
| Minimum | |||
| insertion channel | |||
| width(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 | |
| Digital | |||
| video | |||
| technology | CMOS | CMOS | Same |
| Illumination | |||
| source | LED | LED | Same |
| Shutter speed | 1/30 sec~1/12000 sec | 1/60 sec- 1/10000 sec | Faster than the predicate |
| device. | |||
| White balance | Manual | Automatic | Different |
| Video format | |||
| inputs (Camera) | RAW | analog signal RGB Bayer | |
| pattern | Different | ||
| Output formats | DVI/USB | Composite video | Different |
| Enhancement | |||
| control | |||
| (contrast and | |||
| definition) | Yes | Yes | Same |
| Image/Video | |||
| capture | Yes | Yes | Same |
| Storage | Yes | ||
| SD Card | Yes | ||
| SD 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 of | |||
| sensitization | No significant evidence of | ||
| sensitization | Same | ||
| No pyrogen | No pyrogen | Same | |
| Sterilization | EO | EO | Same |
products.
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8
9
VII. PERFORMANCE DATA
10
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
11
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:
-
- Optical performance testing according to ISO8600 series.
-
- The performance test of 6% (Luer) taper according ISO 80369-7.
-
- 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.
-
- Color feature separation and photobiological safety test
-
- 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.