(169 days)
Not Found
No
The summary describes a standard bronchoscope system with image processing capabilities but makes no mention of AI or ML algorithms for image analysis, diagnosis, or any other function. The "Enhance function" on one model of the image processor is a common feature in medical imaging and does not necessarily imply AI/ML.
Yes
The device is explicitly stated to be for "endoscopic diagnosis and therapies" and for "observation, diagnosis, photography and treatment of the respiratory system." The inclusion of "therapies" and "treatment" indicates its use extends beyond just diagnostic purposes to therapeutic interventions.
Yes
The device is explicitly stated to be used for "endoscopic diagnosis" and "observation, diagnosis" within the respiratory system.
No
The device description explicitly states that the Broncho Videoscope System consists of a Single-use Broncho Videoscope (a physical endoscope) and an Endoscopic Image Processor (a hardware component). While there is software involved in the image processing, the system includes significant hardware 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 "endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs." This involves directly visualizing and potentially treating structures within the body.
- Device Description: The description details a bronchoscope system used for internal examination and procedures.
- Lack of In Vitro Activity: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) outside the body to provide information about a person's health. This device does not perform such tests on samples. It is used for direct visualization and intervention within the body.
The device is an endoscopic system used for internal examination and procedures, which falls under a different regulatory category than IVDs.
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.
This 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.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor (HDVS-S100A and HDVS-S100D) to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
Product codes (comma separated list FDA assigned to the subject device)
EOQ
Device Description
The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.
Single-use Broncho Videoscope: SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P
Endoscopic Image Processor: HDVS-S100A, HDVS-S100D
The Single-use Broncho Videoscope is a single use device. The Single-use Broncho Videoscope has six models which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion (Nylon and PEEK). The single-use Broncho Videoscope is a single-channel endoscope. Only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.
The Single-use Broncho Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
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
Not Found
Anatomical Site
respiratory system such as 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)
Non-Clinical Test Conclusion: Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with standards including ISO 10993-7:2008, ASTM F88/F88M-15, ASTM F1929-15, ISO 8600-1:2015, ISO 8600-3:1997/Amd1:2003, ISO 8600-4:2014, ISO 10993-5:2009, ISO 10993-10:2010, IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, IEC 60601-1-2:2014, IEC 60601-2-18:2009, ASTM D4169-16, IEC 62471:2006, ISO 14971:2007.
Biocompatibility testing: The contact level of the proposed device is mucosal membrance, and the contact duration is limited contact (
§ 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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
July 28, 2021
Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai. 200120 China
Re: K210379
Trade/Device Name: Broncho Videoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 21, 2021 Received: June 28, 2021
Dear Diana Hong:
We have reviewed vour 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
1
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 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,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1C: 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) K201379
Device Name Broncho Videoscope System
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.
This 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.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor (HDVS-S100A and HDVS-S100D) to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
| 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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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: __K210379
-
- Date of Preparation: 06/21/2021
-
- Sponsor Identification
Scivita Medical Technology Co., Ltd.
No.8, Zhong Tian Xiang, Suzhou Industrial Park, Suzhou, Jiangsu, 215000, China.
Establishment Registration Number: Not yet registered.
Contact Person: Ruqin Wu Position: Quality Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Broncho Videoscope System Common Name: Bronchoscope Systen
Regulatory Information Classification Name: Bronchoscope (Flexible or Rigid) Classification: II; Product Code: EOQ Regulation Number: 21 CFR 874.4680 Review Panel: Ear Nose & Throat
Indication 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.
This 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.
This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor (HDVS-S100A and HDVS-S100D) to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.
Device Description:
The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.
| System name | Component name | Model |
|---|---|---|
| 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 | ||
| Endoscopic Image Procesosr | HDVS-S100A, HDVS-S100D |
| Table 1 Product Model | ||
|---|---|---|
The Single-use Broncho Videoscope is a single use device. The Single-use Broncho Videoscope has six models which are available in three kinds of outer diameter of insertion (Φ2.8mm, Φ4.2mm and Φ5.6mm), one working length (600mm) and two different material of the insertion (Nylon and
5
PEEK). The single-use Broncho Videoscope is a single-channel endoscope. Only one working channel is in the distal end of the endoscope, and it bifurcates to two channels leading to the irrigation valve and suction section.
The Single-use Broncho Videoscope is sterilized by Ethylene Oxide Gas to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
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.
-
- Identification of Predicate Device
510(k) Number: K191828 Product Name: Vathin Video Bronchoscope System
- Identification of Predicate Device
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
A ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
-
A ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
A ISO 8600-1:2015 Endoscopes-Medical endoscopes and endotherapy devices-part 1: General requirements
-
A ISO 8600-3:1997/Amd1:2003 Optics and optical instruments-Medical endoscopes and endoscopic accessories-Part 3: Determination of field of view and direction of view of endoscopes with optics
-
ISO 8600-4:2014 Endoscopes-Medical endoscopes and endotherapy devices-Part 4: Determination of maximum width of insertion portion
-
A ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization
-
IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+AM1:2012, Medical Electrical Equipment-Part 1: General requirements for basic safety and essential performance, including the US National Differences
6
- IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2: General requirements for basic safety > and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- A IEC 60601-2-18:2009 Medical electrical equipment-Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
-
ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
-
IEC 62471:2006 Photobiological Safety of Lamps and Lamp Systems.
-
ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices
Biocompatibility testing
The contact level of the proposed device is mucosal membrance, and the contact duration is limited contact ( Cytotoxicity,
-
Sensitization,
- A Intracutaneous,
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
Optical performance testing
-
Photobiological safety test according to IEC 62471: 2006;
Color reproduction, Resolution, Depth of view, Geometric distortion, Image intensity uniformity), > Image frame frequency and system delay testing compared with the predicate device.
Physical/functional performance testing
Suction system function test was performed compared with the predicate device, and irrigation valve leakage test was performed on the proposed device;
Endoscope and image processor use-life testing
The optical performance comparison test was conducted on the un-aged Single-use Broncho Videoscope and aged Single-use Broncho Videoscope. The test results demonstrate that the optical performance of the aged endoscope is similar as those of the un-aged endoscope.
7
A use-life verification was conducted to determine the image system's use life. After accelerating aging and running, the qualitative was conducted on the image processor. The test results demonstrate that the performance of the proposed system doesn't reduced after accelerating aging and running, and the use-life statement of six years are accepted. In addition, the quantitative optical performance comparison testing was conducted on the new image processor and the image processor after accelerating aged and running. The test results demonstrate that the optical performance of the image process after accelerating aged and running is similar as those of the new one.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
8
8. Substantially Equivalent (SE) Comparison
| ITEM | Proposed Device | Predicate Device
K191828 | Remark | |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------|
| Product Code | EOQ | EOQ | Same | |
| Regulation No. | 874.4680 | 874.4680 | Same | |
| Class | II | II | Same | |
| Indication
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.
This 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.
This Single-use Broncho Videoscope is
intended to to use in conjunction with
endoscopic image processor (HDVS-S100A
and HDVS-S100D) to provide images
through the video monitor for observation,
diagnosis, photography and treatment of the
respiratory system such as trachea, bronchi,
and lungs. | 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. | Different | |
| Single
use/
Reuse | Endoscope: Single use
Image Processor: Reuse | Endoscope: Single use
Image Processor: Reuse | Same | |
| Sterile | Yes for disposable endoscope | Yes for disposable endoscope | Same | |
| Anatomical
Site | Respiratory system such as trachea, bronchi,
and lungs | Airways and tracheobronchial tree | Different | |
| Where used | Hospitals | Hospital | Same | |
| Main | Single-use Broncho Videoscope | Vathin® H-SteriScope™ I Single-use
flexible Video Bronchoscope | Same | |
| Configuration | Endoscopic Image Processor | Vathin® VisionCenter™ I Digital
Video Processor | | |
| Label/Labeling | Conform with 21CFR Part 801 | Conform with 21CFR Part 801 | Same | |
| Scope type | Flexible | Flexible | Same | |
| Field of view | 120° | 110° | Different | |
| Direction
of
view | 0° | 0° | Same | |
| Depth of field | 0.5120mm | 330mm | Different | |
| Sensor type | CMOS | CMOS | Same | |
| Max.
outer
diameter
of
insertion
section | 3.2mm (SBV-1A-B; SBV-1A-P);
4.9mm (SBV-1B-B; SBV-1B-P);
6.2mm (SBV-1C-B; SBV-1C-P); | 2.2 mm, 3.2mm,
4.1mm, 4.7mm, 4.9mm, 5.2mm,
5.8mm, 6.0mm, 6.2mm | Different | |
| Up/down | Up: 220° | Up:210° | Different | |
| deflection | Down: 220° | Down: 210° | Different | |
| Work length | 600mm | 600mm,
700mm | Different | |
| Minimum
instrument
channel width | 1.15mm (SBV-1A-B; SBV-1A-P);
1.95mm (SBV-1B-B; SBV-1B-P);
2.75mm (SBV-1C-B; SBV-1C-P); | 0mm, 1.2mm,
1.7mm, 2.0mm, 2.2mm,
2.4mm, 2.8mm, 3.0mm, 3.2mm | Different | |
| Illumination
source | LED | LED | Same | |
| Power supply | AC: 100-240V±10% 50/60 Hz | AC 100-240V 50-60Hz | Same | |
| Dimension | 300(W)×57(H)×225(D) mm | 235(W) ×210(H) ×70(D)mm | Different | |
| Weight | About 2.5Kg | Unknown | Different | |
| Input power | 100VA | Unknown | Different | |
| Video
signal
output | DVI:1
SDI: 2 | DVI | Different | |
| Auto
white
balance | Automatically adjusted | Manually adjusted | Different | |
| Communication
with endoscope | Provided | Provided | Same | |
| Electrical
Safety | Comply with IEC 60601-1 | Comply with IEC 60601-1 | Same | |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | Same | |
| Particular
requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | Same | |
| Product
Performance | Comply with ISO 8600 | Comply with ISO 8600 | Same | |
| Patient-contact component and material | | | | |
| Bending
section | Pebax | Unknown | Different | |
| Insertion
section | Nylon PA12/PEEK | | | |
| Connecting
section | PET | | | |
| Distal
end
section | CMOS front end | Glass | | |
| | Injection head | Sulfone polymer | | |
| | Distal end
connecting ring | 304 SUS | | |
| | Working Channel | Pebax | | |
| Drainage tube | PC | | | |
| Irrigation valve | PC; silicone rubber | | | |
| Suction device | Suction nozzle | PC | | |
| | Suction button | Silicone rubber | | |
| | Suction access | Pebax | | |
| Sterilization (Single-use Broncho Videoscope) | | | | |
| Method | EO sterilization | | EO sterilization | Same |
| SAL | 10-6 | | 10-6 | Same |
Table 1 SE Comparison
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9
10
Different- Indication for Use
Firstly, the indication for use of the proposed device is different from that of the predicate device in expression. The indications for use of the proposed device is provided in the form of system's indications for use, image processor's indications for use and disposable endoscope's indications for use. The predicate device doesn't provide the whole system's indications for use. Many cleared endoscope system adopted this expression form of indications for use. Therefore, the difference on expression form of indications for use will not raise new questions on safety and effectiveness of the propose device.
Second, the endo-therapy accessories and ancillary equipment are included in the predicate device's indications for use statement. While the proposed device does not include these in the indications for use statement. The proposed device also can be used with the accessories and ancillary equipment during clinical, and the information of accessories and ancillary equipment is listed in the section 3.5 of User Manual of Single-use Broncho Videoscope. Therefore, this difference will not raise new questions on safety and effectiveness of the propose device.
Thirdly, the intended clinical anatomic sites of the predicate device including airways and tracheobronchial tree; the intended clinical anatomic site of the proposed device including trachea, bronchi, and lungs. However, the trachea, bronchi, and lungs are collectively called the respiratory system or the airways and tracheobronchial tree. Therefore, the proposed device and predicate device are applicable to the same clinical anatomic sites. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.
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Finally, the intended working place is included in the predicate device's indications for use, which is hospital environment. Although, the intended working place of the proposed device isn't included in its indications for use, the proposed device also will be used in the hospital environment. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.
Both devices are used for endoscopic diagnosis and therapies within the respiratory system. Based on above analysis, the indication for use of the proposed device and the predicate device is only different in expression. The difference will not affect the safety and effectiveness of the proposed device.
Different- Anatomical Site
The anatomical site of the proposed device is different from the predicate device. However, the difference is only in expression. The trachea, bronchi, and lungs are collectively called the respiratory system or the airways and tracheobronchial tree as expressed in Analysis 1-Indication for Use. Therefore, the proposed device and predicate device are applicable to the same clinical anatomic sites. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.
Different- Field of view
The proposed device has a wider range of field of view than the predicate device to give physicians more options for diagnosis and treatment based on the patient's condition. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.
Different- Depth of field
The proposed device has a wider range of depth of field than the predicate device to give physicians more options for diagnosis and treatment based on the patient's condition. Therefore, this difference will not raise new question on safety and effectiveness of the proposed device.
Different- Max. outer diameter of insertion section
The Max. outer diameter of insertion of the proposed device is different from the predicate device. However, the Max. outer diameter of insertion of the proposed device is available in only three specifications, 3.2mm, 4.9mm and 6.2mm. The Max. outer diameter of insertion section of the predicate device has more specifications than the proposed device, but it also includes 3.2mm, 4.9mm and 6.2mm. Therefore, the difference will not affect the safety and effectiveness of the proposed device
Different- Up/down deflection
The up/down deflection of the proposed device is different with the predicate device. However, the
12
up/down deflection of the proposed device is similar to those of the predicate device. All of the specification of the proposed device has been included in the user manual, including bend angle. The surgeon will select the proper endoscope based on her/his experiences and clinical conditions.
This slight difference on up/down deflection between the proposed device and predicate devices does not affect the safety and effectiveness of the proposed device
Different- Work length
The work length of the proposed device is different from the predicate device. However, the working length of the proposed device is available in 600mm. The working length of the predicate device has more specifications than the proposed device, but it also includes 600mm. In addition, all of the specification of the proposed device has been included in the user manual, including working length. The surgeon will select the proper endoscope based on her/his experience and clinical conditions. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Different- Min. inner diameter instrument channel
The Min. inner diameter instrument channel of the proposed device is different from the predicate device. However, the range of the Min. inner diameter instrument channel of the proposed device is within the range of the Min. inner diameter instrument channel of the predicate device. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Different-Dimension and weight
The dimension for the proposed image processor is different from predicate image processor and the weight of the predicate device is unknown. However, the dimension and weight is just in physical specification and this difference will not raise any issues in safety and effectiveness.
Different- Input power
The input power for the predicate image processor is unknown. However, the input power of proposed image processor complies with IEC 60601-1 standard, the difference in input power is just the difference in device design. Therefore, this difference on input power is considered not affect the safety and effectiveness of the proposed device.
Different-Video Signal Output
The types of video signal output are different between proposed image processor and predicate image processor. The proposed device has DVI and SDI interface, the predicate device has DVI interface. The image quality of the proposed device and predicative device have been tested in the quantitative image quality testing. The test results demonstrate that the image quality of the proposed device was equivalent to that of the predicate device. Therefore, the difference on video signal output will not affect the safety and effectiveness of the proposed device.
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Different- Auto white balance
The type of auto white balance of the proposed device is different between proposed image processor and predicate device. Automatic white balance is more convenient and does not require the user to adjust manually. The proposed device is automatically adjusted and the predicate device is manually adjusted. However, the color reproduction test has been tested on the proposed device and predicate device and the test results demonstrate that the image quality of the proposed device was better to the predicate device. In addition, there are a lot of image processors already on the market use automatic white balance. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Different- Patient-contact component and material
The patient-contact material of the predicate device is unknown. However, the biocompatibility tests were conducted on the material consisted of the proposed device and the test result shows that the material does not raise the adverse effect on the material. Therefore, the difference will not affect the safety and effectiveness of the proposed device.
Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.