(217 days)
Not Found
No
The description focuses on standard video processing and hardware components without mentioning any AI/ML algorithms or capabilities.
No
The device is described as a Single-Use Video Bronchoscope System, primarily used for endoscopy within the airways for diagnostic and visual inspection purposes, not for providing therapy.
Yes
Explanation: The device is a bronchoscope system designed for "endoscopy within the airways and tracheobronchial tree" and it "receives, processes, and outputs images" which are then displayed for the user. These capabilities allow physicians to visually inspect the internal anatomy and identify abnormalities, which is a diagnostic function.
No
The device description clearly outlines both hardware components (Single-Use Video Bronchoscopes with physical characteristics like maneuverable tip, working channel, camera, LED light source, etc.) and a Digital Controller which is also a physical, reusable device. While there is software involved in image processing and display, the system is 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 device is for "endoscopy within the airways and tracheobronchial tree." This is a procedure performed in vivo (within the living body) to visualize internal structures.
- Device Description: The description details a bronchoscope with a camera and light source for imaging the airways. This aligns with an in vivo imaging device.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro.
The device is a medical device used for direct visualization of internal body structures, which falls under the category of endoscopic equipment, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Single-Use Video Bronchoscopes have been designed to be used with the Digital Controller, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Single-Use Video Bronchoscope is only designed for use in hospitals.
The Single-Use Video Bronchoscope is a disposable medical device for use on adults.
The Digital Controller can be used in conjunction with Micro-Tech scope products to provide illumination brightness adjustment ability and receive, process and output images from them for endoscopy.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The Video Bronchoscope System consists of:
Single-Use Video Bronchoscope:
- SVB11001
- SVB22001
- SVB33001
Digital Controller: - DC00001
The Single-Use Video Bronchoscopes are all sterile single use flexible bronchoscope and Digital Controller is a reusable device.
The Single-Use Video Bronchoscopes have the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Working channel
- Camera and LED light source at the distal tip.
The light emitted by the LED cold light source of the Single-Use Video Bronchoscopes lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS. The CMOS acquisition image is controlled by the circuit, and the standard color video signal is output to the digital video processor via the encoding circuit. The digital video processor adjusts the brightness of the light source and outputs the standard color video signal. The imaging sensor pixel count is 400× 400 and the pixel size is 1.75 µm × 1.75 µm.
The optical components and their arrangement at the distal tip for all models of Single-Use Video Bronchoscopes are identical.
The Single-Use Video Bronchoscopes have different size as follows:
- Maximum insertion portion width
- Deflection angle
- Minimum instrument channel width
The Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Bronchoscope on the screen
- Can record screenshots or video of image from the Single-Use Video Bronchoscope
- Can connect to an external monitor
- Reusable device
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
airways and tracheobronchial tree
Indicated Patient Age Range
adults
Intended User / Care Setting
hospitals
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)
Performance testing was conducted to demonstrate the essential performance of the proposed device Video Bronchoscope System and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
- Dimension
- Deflection angle
- Bending radius
- Endurance test
- Control lever rotation torque
- Connection strength
- Suction at full bend condition
- Liquid injection
- Matching test with Digital Controller
The optical tests below were tested and evaluated as substantially equivalent to the predicate device.
- Field of view
- Direction of View
- Dynamic Range
- Signal-to-noise ratio (SNR)
- Resolution
- Depth of Field
- Photobiological Safety
- Geometric Distortion
- Image Intensity Uniformity
- Color Performance
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. One-year aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed 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".
Electrical performance was performed in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-2-18:2009 "Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment", IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
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
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
July 8, 2022
Micro-Tech (Nanjing) Co., Lts Sally He RA Engineer No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone Nanjing, Jiangsu Province 210032 China
Re: K213782
Trade/Device Name: 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: June 2, 2022 Received: June 6, 2022
Dear Sally He:
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.
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
1
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 (OS) 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 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).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K213782
Device Name Video Bronchoscope System
Indications for Use (Describe)
The Single-Use Video Bronchoscopes have been designed to be used with the Digital Controller, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Single-Use Video Bronchoscope is only designed for use in hospitals.
The Single-Use Video Bronchoscope is a disposable medical device for use on adults.
The Digital Controller can be used in conjunction with Micro-Tech scope products to provide illumination brightness adjustment ability and receive, process and output images from them for endoscopy.
× Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are blocky and appear to be constructed from multiple layers, giving them a sense of depth. A registered trademark symbol (®) is positioned in the upper right corner of the logo. The logo is simple, bold, and uses a single color, which makes it easily recognizable.
510K Summary
This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K213782
Date of Preparation: 2022-07-08 1.
2. Sponsor Identification
Micro-Tech (Nanjing) Co., Ltd.
No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing, Jiangsu Province, PRC
Establishment Registration Number: 3004837686
Contact Person: Sally He
Position: RA Engineer
Tel: +86-25-58646395
Fax: +86-25-58350006
Email: RA.Micro-Tech@outlook.com
3. Identification of Proposed Device
Trade Name: Single-Use Video Bronchoscope, Digital Controller
Common Name: Video Bronchoscope System
Regulatory Information
Device Classification Name: Bronchoscope (Flexible)
Classification: 2
Product Code: EOQ
Regulation Number: 21 CFR 874.4680
Review Panel: Ear Nose & Throat
4
Image /page/4/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are blocky and appear to be connected, with the "M" on the left and the "T" on the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.
Identification of Predicate Device 4.
510(k) Number: K173727
Product Name: Ambu® aScope™ 3, Ambu® aView™ Monitor
Manufacturer: Ambu Inc.
ട. Indications for Use
The Single-Use Video Bronchoscopes have been designed to be used with the Digital Controller, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Single-Use Video Bronchoscope is only designed for use in hospitals.
The Single-Use Video Bronchoscope is a disposable medical device for use on adults.
The Digital Controller can be used in conjunction with Micro-Tech scope products to provide illumination brightness adjustment ability and receive, process and output images from them for endoscopy.
Device Description 6.
The Video Bronchoscope System consists of:
Single-Use Video Bronchoscope:
- SVB11001
- SVB22001
- SVB33001
Digital Controller:
- DC00001
The Single-Use Video Bronchoscopes are all sterile single use flexible bronchoscope and Digital Controller is a reusable device.
The Single-Use Video Bronchoscopes have the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Working channel
- Camera and LED light source at the distal tip.
5
Image /page/5/Picture/0 description: The image shows a logo with the letters "MT" in a stylized, three-dimensional block font. The letters are in a dark blue color, and the "M" is positioned to the left of the "T". The logo has a registered trademark symbol, the letter R inside a circle, in the upper right corner.
The light emitted by the LED cold light source of the Single-Use Video Bronchoscopes lens is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is imaged on the CMOS. The CMOS acquisition image is controlled by the circuit, and the standard color video signal is output to the digital video processor via the encoding circuit. The digital video processor adjusts the brightness of the light source and outputs the standard color video signal. The imaging sensor pixel count is 400× 400 and the pixel size is 1.75 µm × 1.75 µm.
The optical components and their arrangement at the distal tip for all models of Single-Use Video Bronchoscopes are identical.
The Single-Use Video Bronchoscopes have different size as follows:
- Maximum insertion portion width
- Deflection angle
- Minimum instrument channel width
The Digital Controller has the following physical and performance characteristics:
- Displays the image from The Single-Use Video Bronchoscope on the screen
- Can record screenshots or video of image from the Single-Use Video Bronchoscope
- Can connect to an external monitor
- Reusable device
Comparison of Technological Characteristics 7.
The Video Bronchoscope System substantially equivalent device materials, design, configuration,
packaging, sterilization process and intended use as those featured in the predicate device Ambu ®
aScope™ 3, Ambu® aView™M Monitor (K173727).
Comparison to predicate Devices:
| Characteristics | Proposed Device
Single-Use Video Bronchoscope,
Digital Controller | Predicated Device
Ambu® aScope™ 3,
Ambu® aView™ Monitor (K173727) | Remark |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | EOQ | EOQ | Same |
| Class | II | II | Same |
| Regulation Description | Bronchoscopes (flexible or rigid) and accessories | Bronchoscopes (flexible or rigid) and accessories | Same |
| | Proposed Device | Predicated Device | |
| Characteristics | Single-Use Video Bronchoscope,
Digital Controller | Ambu® aScope™ 3,
Ambu® aView™ Monitor (K173727) | Remark |
| Regulation number | 874.4680 | 874.4680 | Same |
| Indications for Use | The Single-Use Video Bronchoscopes have been designed to be used with the Digital Controller, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Single-Use Video Bronchoscope is only designed for use in hospitals.
The Single-Use Video Bronchoscope is a disposable medical device for use on adults.
The Digital Controller can be used in conjunction with Micro-Tech scope products to provide illumination brightness adjustment ability and receive, process and output images from them for endoscopy. | 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
The aScope 3™ system is for use in a hospital environment
The aScope 3™ is single-use devices designed for use in adults. | Same |
| Compatible device specification | They have been evaluated for used with the endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA). | They have been evaluated for used with the endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA). | Same |
| 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 |
| Performance | Complies with ISO 8600 | Complies with ISO 8600 | Same |
| Light source | LED | LED | Same |
| Separate monitor | Yes | Yes | Same |
| Energy used/Power source | Yes | Yes | Same |
6
Image /page/6/Picture/0 description: The image shows a blue and white logo with the letters "MT" in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, suggesting depth and solidity. A small registered trademark symbol is visible in the upper right corner of the logo.
7
Image /page/7/Picture/0 description: The image shows a logo with the letters 'MT' in a stylized, three-dimensional font. The letters are white and stand out against a blue background. A registered trademark symbol is located in the upper right corner of the image.
| Characteristics | Proposed Device
Single-Use Video Bronchoscope,
Digital Controller | | Predicated Device
Ambu® aScope™ 3,
Ambu® aView™ Monitor (K173727) | | Remark |
|----------------------------------------------------------------------|-------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------|-------------------------|-----------|
| Images by camera
technology | Yes | | Yes | | Same |
| Components in
contact with the
patient is delivered
sterile | Yes | | Yes | | Same |
| Disposable after
use | Single-Use Video
Bronchoscope | Yes | aScope 3™ | Yes | Same |
| | Digital Controller | Reusable | aView™ Monitor | Reusable | |
| Connect to devices | Monitor | | Monitor | | Same |
| Anatomic sites | Airways and tracheobronchial tree | | Airways and tracheobronchial tree | | Same |
| Target population | Adults | | Adults | | Same |
| Rx-only | Yes | | Yes | | Same |
| Design concept | Portable | | Portable | | Same |
| Working length | 600mm | | 600mm | | Same |
| Maximum
insertion portion
width | SVB11001
SVB22001
SVB33001 | 4.4mm
5.5mm
6.3mm | aScope™ 3 Slim
aScope™ 3 Regular
aScope™ 3 Large | 4.3mm
5.5mm
6.3mm | Similar |
| Minimum
instrument channel
width | SVB11001
SVB22001
SVB33001 | 1.2mm
2.2mm
2.8mm | aScope™ 3 Slim
aScope™ 3 Regular
aScope™ 3 Large | 1.2mm
2.2mm
2.8mm | Same |
| Luer/Luer lock
connection to
working channel | No | | Yes | | Different |
| Deflection angle | SVB11001 | 180 °up
180 °down | aScope™ 3 Slim | 130 °up
130 °down | Different |
| | SVB22001 | | aScope™ 3
Regular | 150 °up
130 °down | |
| | SVB33001 | | aScope™ 3
Large | 140 °up
110 °down | |
| Field of view | 120° | | 85° | | Different |
8
Image /page/8/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, with the "M" on the left and the "T" on the right. A registered trademark symbol (®) is located in the upper right corner of the logo.
| Characteristics | Proposed Device
Single-Use Video Bronchoscope,
Digital Controller | Predicated Device
Ambu® aScope™ 3,
Ambu® aView™ Monitor (K173727) | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Depth of view | 5mm-50mm | 8mm-19mm | Different |
| Suction possible | Yes | Yes | Same |
| Biocompatibility | Comply with ISO 10993-1 | Comply with ISO 10993-1 | Same |
| Shelf Life | Single-Use Video Bronchoscope:
1 Year
Comply with ASTM F1980-16 | aScope™ 3: 3 Years
Comply with ASTM F1980-16 | Different |
| Electrical
Performance | Comply with
ANSI AAMI ES60601-1:2005/(R)2012
and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012
IEC60601-1-2:2014
IEC 60601-2-18:2009 | Comply with
ANSI AAMI ES60601-1:2005/(R)2012
and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012
IEC60601-1-2:2014
IEC 60601-2-18:2009 | Same |
| Software | Comply with IEC 62304:2015 | Comply with IEC 62304:2015 | Same |
| Labeling | Conforms to 21 CFR part 801 | Conforms to 21 CFR part 801 | Same |
Performance Data 8.
Performance testing was conducted to demonstrate the essential performance of the proposed device Video Bronchoscope System and confirmed that the proposed device works as intended with the compatible devices.
The bench tests below were tested and evaluated as substantially equivalent to the predicate device.
-
Dimension
-
Deflection angle
-
Bending radius
-
Endurance test
- Control lever rotation torque >
-
Connection strength
-
Suction at full bend condition
- ア Liquid injection
-
Matching test with Digital Controller
9
Image /page/9/Picture/0 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional block font. The letters are connected and appear to be angled slightly to the left, giving a sense of depth. In the upper right corner of the logo, there is a small circle with the "R" symbol inside, indicating a registered trademark.
The optical tests below were tested and evaluated as substantially equivalent to the predicate
device.
-
Field of view
-
Direction of View
-
Dynamic Range
-
Signal-to-noise ratio (SNR)
-
Resolution
-
Depth of Field
-
Photobiological Safety
-
Geometric Distortion
-
Image Intensity Uniformity
-
Color Performance
Shelf-life testing was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. One-year aging test was performed to demonstrate longer stability and support the results of the accelerated aging test.
Sterilization validation was carried out in accordance with ISO 11135:2014 "Sterilization of Health Care products - Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices".
Biocompatibility testing was performed 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".
Electrical performance was performed in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-2-18:2009 "Medical
10
Image /page/10/Picture/0 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional font. The letters are interconnected, with the 'M' appearing to be in front of the 'T'. The logo has a registered trademark symbol, a circled 'R', in the upper right corner. The logo is simple and modern.
electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment", IEC 60601-1-2:2014 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
9. Animal Study
No animal study is included in this submission.
10. Clinical Study
No clinical study is included in this submission.
11. Substantially Equivalent (SE) Conclusion
Based on the indications for use, technological characteristics, and safety and performance testing, the Video Bronchoscope System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device under K173727.