(219 days)
No reference devices were used in this submission.
No
The document describes standard image processing for displaying video from an endoscope and does not mention any AI/ML specific terms or capabilities.
No.
The device is described as a bronchoscope system designed for endoscopy within the airways and tracheobronchial tree to capture images for clinical image processing, not for treating conditions.
Yes
The device is explicitly described as a "Bronchoscope System" used for endoscopy within the airways and tracheobronchial tree, which is a diagnostic procedure, even though it can also be used for therapy (endotherapy accessories). The primary function described is "clinical image processing" of images captured from within the body to be displayed on a monitor, enabling visual assessment.
No
The device description clearly outlines both a Flexible Bronchoscope (hardware) and a Video Processor (hardware) as components of the system. While software is mentioned for image processing and control, it is integral to the function of these hardware components and not a standalone software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a flexible bronchoscope system used for direct visualization within the airways and tracheobronchial tree. It captures images of the internal anatomy.
- Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. It is used for direct observation and potentially for facilitating procedures within the airways.
The information provided clearly describes a device used for in vivo (within the living body) visualization and intervention, not for analyzing samples in vitro (outside the living body).
N/A
Intended Use / Indications for Use
The flexible bronchoscope have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.
Product codes
EOQ
Device Description
The Bronchoscope System consists of Flexible Bronchoscope (twelve models shown in below) to be introduced within the airways or tracheobronchial tree and Video Processor (model: EOS-H-01) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope.
The Flexible Bronchoscope is a sterile single used flexible bronchoscope. The Video Processor is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.
Flexible 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
Video Processor has the following physical and performance characteristics:
- Provide image from Flexible 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 image sensor / RGB video signal
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: 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. Tests performed: Cytotoxicity, Sensitization, Intracutaneous reactivity, Material-Mediated Pyrogenicity, Acute systemic toxicity. The Flexible Bronchoscope 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. The shelf life of the Flexible Bronchoscope is validated.
Electrical safety and electromagnetic compatibility (EMC): 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: 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:
- Optical performance testing according to ISO 8600 series.
- Mechanical characteristics 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 Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
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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November 24, 2021
Shanghai AnQing Medical Instrument CO., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd 9th Floor, R&D Building, No. 26 Qinglan Street, Panyu District Guangzhou, 510006 China
Re: K211169
Trade/Device Name: Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: October 27, 2021 Received: October 29, 2021
Dear Olivia Meng:
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/cdrl/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.
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) K21169
Device Name Bronchoscope System
Indications for Use (Describe)
The flexible bronchoscope have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.
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/3/Picture/0 description: The image contains a logo for a company called "Innovex Anqing Medical". The logo features a stylized purple graphic on the left, resembling a folded piece of paper with leaf-like shapes. To the right of the graphic, the word "Innovex" is written in a bold, sans-serif font, with a curved line above it. Below "Innovex", the words "Anqing Medical" are written in a similar font, but slightly smaller in size.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
l. SUBMITTER
Shanghai AnQing Medical Instrument Co., Ltd. 3&4 Floor, No.2 Building, 366 Huiqing Road, Zhangjiang High-Tech Park, 201201 Shanghai, China Tel: +86-021-61117375 Fax: +86-021-61117374
| Primary contact person: | Olivia Meng
RA Manager
Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Tel: +86-18825133860
Fax: +86-020-86330253 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary contact person: | Shuwen Fan
RA Manager
Shanghai AnQing Medical Instrument Co., Ltd.
Tel: +86-021-61117375
Fax: +86-021-61117374 |
| Date Prepared: | April 6, 2021 |
- II. DEVICE
| Name of Device: | Bronchoscope System |
|---|---|
| Model: | Flexible Bronchoscope: |
| BS41H-12EU, BS41H-12US, BS46H-17EU, BS46H-17US, | |
| BS50H-20EU, BS50H-20US, BS53H-22EU, BS53H-22US, | |
| BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US | |
| Video Processor: | |
| EOS-H-01 | |
| Common or Usual Name: | Bronchoscope (flexible or rigid) and accessories |
4
Image /page/4/Picture/0 description: The image contains the logo for "Innovax Anqing Medical". The logo is purple and white. The word "Innovax" is in a larger font than "Anqing Medical". There is a purple graphic to the left of the text.
| 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 Bronchoscope System consists of Flexible Bronchoscope (twelve models shown in below) to be introduced within the airways or tracheobronchial tree and Video Processor (model: EOS-H-01) for clinical image processing. The Flexible Bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Video Processor provides power and processes the images for medical electronic endoscope.
| Models of Flexible Bronchoscope | |
|---|---|
| BS41H-12EU | BS41H-12US |
| BS46H-17EU | BS46H-17US |
| BS50H-20EU | BS50H-20US |
| BS53H-22EU | BS53H-22US |
| BS55H-24EU | BS55H-24US |
| BS59H-28EU | BS59H-28US |
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Image /page/5/Picture/0 description: The image contains the logo for Anqing Medical. The logo is purple and white. The logo has a purple graphic on the left side and the text "INNOVEX Anqing Medical" on the right side.
The Flexible Bronchoscope is a sterile single used flexible bronchoscope. The Video Processor is a reusable monitor.
The light emitted by the LED cold light source at the distal tip of the disposable video bronchoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LEDs on the endoscope.
Flexible 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
Video Processor has the following physical and performance characteristics:
- Provide image from Flexible Bronchoscope for observation
- Can connect to an external monitor
- Reusable device
V. INDICATION FOR USE
The flexible bronchoscope have been designed to be used with the video processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Bronchoscope System is for use in a hospital environment. The Flexible Bronchoscope is a single-use device designed for use in adults.
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Image /page/6/Picture/0 description: The image contains a logo for a company called "Innovex Anqing Medical". The logo features a stylized purple graphic on the left side, resembling a leaf or abstract shape. To the right of the graphic, the word "Innovex" is written in a bold, sans-serif font, with the words "Anqing Medical" appearing below in a similar font style. The color scheme is primarily purple and white.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
DEVICE
This comparison of the specifications demonstrates the functional equivalence of the products.
| Specification | Subject device | Predicate device | Remark |
|---|---|---|---|
| K Number | -- | K173727 | |
| Manufacturer | Shanghai AnQing Medical Instrument | ||
| Co., Ltd. | Ambu A/S | ||
| Model | Flexible Bronchoscope: | ||
| BS41H-12EU, BS41H-12US, | |||
| BS46H-17EU, BS46H-17US, | |||
| BS50H-20EU, BS50H-20US, | |||
| BS53H-22EU, BS53H-22US, | |||
| BS55H-24EU, BS55H-24US, | |||
| BS59H-28EU, BS59H-28US | |||
| Video Processor: | |||
| EOS-H-01 | Ambu® aScope™ 4 Broncho System: | ||
| 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 | |||
| Classification | |||
| Name | Bronchoscope (flexible or rigid) and | ||
| accessories | Bronchoscope (flexible or rigid) and | ||
| accessories | |||
| Device | |||
| Trade | |||
| name | Bronchoscope System | 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 | |||
| Product Code | EOQ | EOQ | Same |
| Intended Use | The flexible bronchoscopes have | ||
| been designed to be used with the | |||
| video processor, endotherapy | |||
| accessories and other ancillary | |||
| equipment for endoscopy within the | |||
| airways and tracheobronchial tree. | |||
| The Bronchoscope System is for use | |||
| in a hospital environment. The | |||
| Flexible Bronchoscope is a single-use | |||
| device designed for use in adults. | The aScope 4 Broncho 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 4 Broncho system are for | |||
| use in a | |||
| hospital environment. The aScope 4 | |||
| Broncho is a single-use device | |||
| designed for use in adults. | Same | ||
| Specification | Subject device | Predicate device | Remark |
| 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 |
| 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) | $110°±10%$ | $85°$ | Larger than the |
| predicate device. | |||
| Direction of | |||
| view (degree) | $0°±3°$ | $0°$ | Same |
| Depth of view | 5-100mm | 6 – 50mm | Larger range |
| than the | |||
| predicate device. | |||
| Working length | |||
| (mm) | 620 mm±3% | 600 | Longer than the |
| predicate device. | |||
| Digital video | |||
| technology | CMOS | CMOS | Same |
| Illumination | |||
| source | LED | LED | Same |
| Image/Video | |||
| capture | Yes | Yes | Same |
| Storage | Yes | ||
| USB storage | Yes | ||
| SD Card | Similar | ||
| Single-use | Yes | Yes | Same |
| Biocompatibility | No Cytotoxicity | No Cytotoxicity | Same |
| Specification | Subject device | Predicate device | Remark |
| 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 |
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Image /page/7/Picture/0 description: The image contains a logo for a medical company. The logo has a purple color scheme. The text "INNOVEX" and "ANQING MEDICAL" are present in the logo.
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Image /page/8/Picture/0 description: The image contains the logo for Innovex Anqing Medical. The logo features a stylized purple graphic on the left, resembling a folded piece of paper with a leaf design. To the right of the graphic, the word "INNOVEX" is displayed in a bold, sans-serif font, with a curved line above it. Below "INNOVEX", the words "Anqing Medical" are written in a similar font, with "Anqing" being larger than "Medical".
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Flexible Bronchoscope 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
- Sensitization
- Intracutaneous reactivity
- Material-Mediated Pyrogenicity
- Acute systemic toxicity
The Flexible Bronchoscope 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 Flexible Bronchoscope is validated.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Bronchoscope System. The system complies with the IEC 60601-1 and IEC60601-2-18 for safety and the IEC
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Image /page/9/Picture/0 description: The image shows a logo for a company called "Innovex Anqing Medical". The logo is purple and white. The word "Innovex" is in a larger font than the words "Anqing Medical". There is a purple graphic to the left of the company name. The graphic is a square with a curved line above the company name.
60601-1-2 for EMC.
Software Verification and Validation Testing
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 ISO 8600 series.
-
- Mechanical characteristics 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 Bronchoscope System and its predicate device, no clinical studies were needed to support this 510(k) Premarket Notification.
VIII. CONCLUSION
The 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.