WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System
Device Facts
| Record ID | K220399 |
|---|---|
| Device Name | WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System |
| Applicant | OTU Medical, Inc. |
| Product Code | EOQ · Ear, Nose, Throat |
| Decision Date | Jun 16, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 874.4680 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.
Device Story
The WiScope Digital Bronchoscope System is a single-use, flexible digital bronchoscope used by physicians in hospital environments to visualize and perform endotherapy in the airways and tracheobronchial tree. The system consists of a single-use bronchoscope (control body with articulation lever, suction button, working channel port, and flexible insertion tube with a distal CMOS camera and LED light source) and the OTU-A image system. The device captures visual data via the distal camera, which is processed and displayed for the physician to guide endoscopic procedures and the use of endotherapy accessories. The system provides real-time visualization to assist in clinical decision-making during airway procedures. It is intended to provide a sterile, single-use alternative to reusable bronchoscopes, reducing cross-contamination risks.
Clinical Evidence
No clinical data was provided. Substantial equivalence is supported by bench testing only, including electrical safety (IEC 60601-1, IEC 60601-2-18), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-5, ISO 10993-10), sterilization validation (ISO 11135), and functional performance testing (ISO 8600).
Technological Characteristics
Single-use flexible bronchoscope with CMOS camera and LED illumination. Three models (OTU-BR01, OTU-BR02, OTU-BR03) with varying insertion tube diameters (2.85mm to 5.9mm) and working channels (1.2mm to 2.8mm). Connectivity via USB/AV/HDMI. Sterilized via Ethylene Oxide (EO) to SAL 10^-6. Complies with AAMI/ANSI ES60601-1, IEC 60601-2-18, ISO 10993, and ISO 8600 series standards.
Indications for Use
Indicated for use by physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree in adult patients.
Regulatory Classification
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.
Predicate Devices
- Ambu® aScope™ 4 Broncho Slim 3.8/1.2 (K173727)
- Ambu® aScope™ 4 Broncho Regular 5.0/2.2 (K173727)
- Ambu® aScope™ 4 Broncho Large 5.8/2.8 (K173727)
- Ambu® aView™ Monitor (K173727)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 16, 2022
OTU Medical Inc. % Mingzi Hussey Regulatory Consultant Zi-medical 93 Springs Rd Bedford, Massachusetts 01730
Re: K220399
Trade/Device Name: WiScope Digital Bronchoscope System Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: May 11, 2022 Received: May 11, 2022
Dear Mingzi Hussey:
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
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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,
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K220399
Device Name WiScope® Digital Bronchoscope System
Indications for Use (Describe)
WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.
Type of Use (Select one or both, as applicable)
| <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/>Registration Use (Part 21 CFR 601 Subpart E)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/>Same-Tissue Controls Use (21 CFR 601 Subpart E)</div> |
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
> Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary
[As required by 21 CFR 807.92]
## 1. Submission Sponsor
OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131 Phone: (408) 797-7313 Contact: Geping Liu Email: info@@otumed.com
# 2. Submission Correspondent
Mingzi Hussey Zi-medical, Inc. Address: 93 Springs Rd, Bedford, MA 01730 US Phone: 206-981-0675 Email: mingzi@zi-medical.com
## 3. Date Prepared
June 16th, 2022
## 4. Device Identification
Trade Name: WiScope® Digital Bronchoscope System Common Name/Classification Name: Bronchoscope (Flexible or Rigid) and accessories Product Code: EOQ Regulation Number: 21 CFR 874.4680 Regulation Class: Class II Review Panel: Ear Nose & Throat 510(k) Number: K220399
## 5. Predicate Devices
The proposed devices are substantially equivalent to the following predicate devices:
| Applicant | Device name | 510(k) Number | Product code |
|-----------|-----------------------------------------|---------------|--------------|
| Ambu Inc. | Ambu® aScope™ 4 Broncho Slim 3.8/1.2 | K173727 | EOQ |
| | Ambu® aScope™ 4 Broncho Regular 5.0/2.2 | | |
| | Ambu® aScope™ 4 Broncho Large 5.8/2.8 | | |
| | Ambu® aView™ Monitor | | |
## 6. Device Description
WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree. This
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system includes a single-use digital bronchoscope and an image system.
- The image system OTU-A is the currently marketed in the United States by OTU Medical Inc. under 510(k) # K181977.
- The single-use bronchoscope is comprised of a control body with an articulation lever, a suction connector, a suction button, and a working channel port, and a flexible insertion tube with an on-tip camera module and LED lighting source.
# 7. Indication for Use Statement
The subject device: WiScope® Digital Bronchoscope System is designed for physicians to access, visualize, and perform endoscopy and endotherapy in the airways and tracheobronchial tree.
The predicate device: 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 are single-use devices designed for use in adults. They have been evaluated for the following endotracheal tubes (ETT), double lumen tubes (DLT) and endoscopic accessories (EA) sizes:
| | Minimum<br>ETT inner<br>diameter | Minimum<br>DLT size | EA minimum<br>working<br>channel width |
|--------------------------------|----------------------------------|---------------------|----------------------------------------|
| aScope 4<br>Broncho<br>Slim | 5.0mm | 35Fr | Up to 1.2 mm |
| aScope 4<br>Broncho<br>Regular | 6.0mm | 41Fr | Up to 2.0 mm |
| aScope 4<br>Broncho<br>Large | 7.0 mm | - | Up to 2.6mm |
WiScope® Digital Bronchoscope System and the primary predicate device are similar in terms of indication for use. WiScope® Digital Bronchoscope System is used in the airways and tracheobronchial tree, while predicate device is used within the airways and tracheobronchial tree. They are all for endoscopy and endotherapy procedures with endoscopic accessories.
## 8. Comparison of Technological Characteristics
The following table compares the proposed device with the predicate devices in terms of intended use, technological characteristics and principles of operation, and it provides detailed information for determining substantial equivalences.
Table 5A – General Comparison
| ITEM | Proposed Device | Predicate Device |
|------|-----------------|------------------|
|------|-----------------|------------------|
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## OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131
| Trade name | WiScope® Digital<br>Bronchoscope System,<br>OTU-BR01,<br>OTU- BR02,<br>OTU-BR03,<br>OTU-A image system. | Ambu® aScope™ 4 Broncho Slim 3.8/1.2<br>Ambu® aScope™ 4 Broncho Regular 5.0/2.2<br>Ambu® aScope™ 4 Broncho Large 5.8/2.8<br>Ambu® aView™ Monitor | | | | | | | | | | | | | | | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| 510(K)<br>Submitter | OTU Medical Inc. | Ambu Inc. | | | | | | | | | | | | | | | | |
| 510(K) Number | K220399 | K173727 | | | | | | | | | | | | | | | | |
| Classification<br>Regulation | 21 CFR 874.4680 | 21 CFR 874.4680 | | | | | | | | | | | | | | | | |
| Classification<br>and Code | Class II,<br>EOQ | Class II,<br>EOQ | | | | | | | | | | | | | | | | |
| Common name | Bronchoscope (Flexible or<br>Rigid) and Accessories | Bronchoscope (Flexible or Rigid) and Accessories | | | | | | | | | | | | | | | | |
| Bronchoscope | Single-Use | Single-Use | | | | | | | | | | | | | | | | |
| Indications for<br>Use | WiScope® Digital<br>Bronchoscope System is<br>designed for physicians to<br>access, visualize, and perform<br>endoscopy and endotherapy<br>in the airways and<br>tracheobronchial tree. | The aScope 4 Broncho endoscopes have been designed<br>to be used with the aView monitor, endotherapy<br>accessories and other ancillary equipment for<br>endoscopy within the airways and tracheobronchial<br>tree.<br>The aScope 4 Broncho system are for use in a hospital<br>environment.<br>The aScope 4 Broncho are single-use devices designed<br>for use in adults. They have been evaluated for the<br>following endotracheal tubes (ETT), double lumen<br>tubes (DLT) and endoscopic accessories (EA) sizes:<br>Minimum<br>ETT inner<br>diameter Minimum<br>DLT size EA minimum<br>working<br>channel width aScope 4<br>Broncho<br>Slim 5.0mm 35Fr Up to 1.2 mm aScope 4<br>Broncho<br>Regular 6.0mm 41Fr Up to 2.0 mm aScope 4<br>Broncho<br>Large 7.0 mm - Up to 2.6mm | | | | | | | | | | | | | | | | |
| Digital video<br>technology | CMOS | CMOS | | | | | | | | | | | | | | | | |
| Illumination | LED | LED | | | | | | | | | | | | | | | | |
| Field of View<br>(Diagonal) | 100° | 85° | | | | | | | | | | | | | | | | |
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## OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131
| Working Length<br>(mm) | 600mm | 600mm |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Maximum<br>diameter of<br>insertion<br>portion | OTU-BR01: 9.5Fr(3.25mm)<br>OTU-BR02: 16Fr(5.4mm)<br>OTU-BR03: 18.6Fr(6.2mm) | 1. aScope 4 Broncho Slim:4.3mm<br>2.aScope 4 Broncho Regular:5.5mm<br>3.aScope 4 Broncho Large:6.3mm |
| Insertion tube<br>outer diameter | OTU-BR01: 2.85mm (8.6Fr)<br>OTU-BR02: 5.1mm(15.3Fr)<br>OTU-BR03: 5.9mm(17.7Fr) | 1. aScope 4 Broncho Slim:3.8mm<br>2.aScope 4 Broncho Regular:5.0mm<br>3.aScope 4 Broncho Large:5.8mm |
| Working<br>Channel<br>Diameter | OTU-BR01: 3.6Fr(1.2mm)<br>OTU-BR02: 6.6Fr(2.2mm)<br>OTU-BR03: 8.4Fr(2.8mm) | 1.aScope 4 Broncho Slim:1.2mm<br>2.aScope 4 Broncho Regular:2.0 mm<br>3.aScope 4 Broncho Large:2.6 mm |
| Up/Down<br>Deflection | UP: 180°<br>DOWN: 180° | 1.aScope 4 Broncho Slim and aScope 4 Broncho Regular: UP: 180°DOWN: 180°<br>2.aScope 4 Broncho Large: UP: 180°DOWN: 160° |
| Direction of<br>View | 0° | 0° |
| Brightness<br>Control | Yes | Yes |
| White Balance | Yes | Yes |
| Output Formats | USB/AV/HDMI | USB/HDMI |
| Image/Video<br>Capture | No | Yes |
| Sterilization | EO<br>SAL: 10-6 | EO<br>SAL: 10-6 |
| Packaging | WiScope® Single-Use Digital<br>Flexible Bronchoscope is<br>packaged by paper-plastic<br>bag. | Ambu® aScope™ 4 Broncho is packaged by<br>paper-plastic bag. |
| Label and<br>Labeling | Meet FDA's Requirements | Meet FDA's Requirements |
| Safety Testing | *AAMI / ANSI ES60601-1:2012<br>*AAMI / ANSI / IEC 60601-1-2:2014<br>*IEC 60601-2-18:2009<br>*AAMI / ANSI / ISO 10993-5:2009<br>*ISO 10993-10:2010<br>*ISO 11135:2014<br>*ISO 10993-7:2008<br>*ISO 11607-1:2019<br>*ASTM F1980-16<br>*ISO 11737-2:2019<br>*ASTM D3078-2013<br>*ASTM F1929-15<br>*DIN 58953-6:2016 | *IEC 60601-1:2012<br>*IEC 60601-2-18:2009<br>*ISO 8600-1-2015<br>*ISO 8600-3-1997<br>*ISO 8600-4-2014<br>*IEC 60601-1-2:2014<br>*ISO 10993-1:2009<br>*ISO 594-1:1986 |
| | | |
| | *ASTM F88/F88M-15<br>*ISO 8600-1-2015<br>*ISO 8600-3-2019<br>*ISO 8600-4-2014<br>*ISO 8600-6-2005<br>*ISO 594-1:1986 | |
| Cytotoxicity | Comply with ISO 10993-5, no cytotoxicity effect | |
| Irritation | Comply with ISO 10993-10, not an irritant | Comply with ISO 10993-1. |
| Sensitization | Comply with ISO 10993-10, not a sensitizer. | |
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WiScope® Single-Use Digital Flexible Bronchoscope has three models:
OTU-BR01, with slim size insertion tube (8.6Fr),
OTU-BR02, with regular size insertion tube(15.3Fr),
OTU-BR03, with large size insertion tube(17.7Fr).
The proposed device shares the similar indications for use, same device operation, and overall technical and functional capabilities as the predicate device. It also has the same standards and requirements as the predicate device.
# 9. Description of Non-clinical Testing
The non-clinical tests of the subject device and predicate device are in compliance with the following standards and guidance.
| ITEM | Proposed Device | Primary Predicate Device |
|----------------|------------------------------------------|---------------------------------|
| Trade name | WiScope® Digital Bronchoscope<br>System, | Ambu® aScope™ 4 Broncho Slim |
| | OTU-BR01, | 3.8/1.2 |
| | OTU-BR02, | Ambu® aScope™ 4 Broncho Regular |
| | OTU-BR03, | 5.0/2.2 |
| | OTU-A image system. | Ambu® aScope™ 4 Broncho Large |
| | | 5.8/2.8 |
| | | Ambu® aView™ Monitor |
| Safety Testing | *AAMI / ANSI ES60601-1:2012 | *IEC 60601-1:2012 |
| | *AAMI / ANSI / IEC 60601-1-2:2014 | *IEC 60601-2-18:2009 |
| | *IEC 60601-2-18:2009 | *ISO 8600-1-2015 |
| | *AAMI / ANSI / ISO 10993-5:2009 | *ISO 8600-3-1997 |
| | *ISO 10993-10:2010 | *ISO 8600-4-2014 |
| | *ISO 11135:2014 | *IEC 60601-1-2:2014 |
| | *ISO 10993-7:2008 | *ISO 10993-1:2009 |
| | *ISO 11607-1:2019 | *ISO 594-1:1986 |
| | *ASTM F1980-16 | |
| | *ISO 11737-2:2019 | |
| | *ASTM D3078-2013 | |
| | *ASTM F1929-15 | |
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| *DIN 58953-6:2016 | |
|-------------------|--|
| *ASTM F88/F88M-15 | |
| *ISO 8600-1-2015 | |
| *ISO 8600-3-2019 | |
| *ISO 8600-4-2014 | |
| *ISO 8600-6-2005 | |
| *ISO 594-1:1986 | |
WiScope® Digital Bronchoscope System has been verified for its safety and effectivity based on the following performance data. These tests only used to evaluate non-clinical testing of the subject device.
Electrical safety of the system was evaluated in accordance with IEC 60601-1and IEC 60601-2-18. Electromagnetic compatibility was evaluated in accordance with IEC 60601-1-2. All evaluation acceptance criteria were met.
The biocompatibility evaluation for WiScope® Single-Use Digital Flexible Bronchoscope was conducted in accordance with ISO 10993-1.
- · Cytotoxicity (ISO 10993-5)
- · Sensitization (ISO 10993-10)
- Intracutaneous reactivity test (ISO 10993-10)
Result: All tests were passed.
Shelf life for WiScope® Single-Use Digital Flexible Bronchoscope test is conducted based on ASTM F1980:
- Performance test
- · Sterile Packaging Integrity
Result: All tests were passed.
Sterile barrier systems for WiScope® Single-Use Digital Flexible Bronchoscope were evaluated in accordance with ISO 11607-1:2019.
Sterilization Process has been validated accordance with ISO 11135:2014.
Result: The WiScope® Single-Use Digital Flexible Bronchoscope is sterile with a determination of lethal rate of the sterilization process to demonstrate achievement of the required SAL of 10° is in accordance to half cycle overkill approach.
Technological characteristics for WiScope® Single-Use Digital Flexible Bronchoscope have been tested for its functions as intended including verification of performance characteristics per ISO 8600 and performances characteristics relevant to functions as intended:
- Appearance
- Working length of the shaft,
- · Minimum bending radius
- Working channel diameter
- Outer Shaft Diameter
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OTU Medical Inc. 2231A Fortune Drive, San Jose, CA 95131
- Depth of field
- Field of view
- Direction of view
- Rigid Distal Tip Temperature
- · Tensile Force Testing
- Resolution
- Illumination
- · Angulation range
- Working channel free from leakage
- Water proof
- Suction
Result: All tests were passed.
Simulated shipping distribution on aged devices test were conducted based on ASTM D4169-16. Result: All tests were passed.
Software is developed according to ISO 13485 standard. It is verified and validated according to IEC 62304:2006. Cybersecurity Assessment is completed according to FDA Cybersecurity Guidance.
The results of Non-Clinical Performance testing demonstrate that the WiScope® Digital Bronchoscope System is considered safe and effective for its intended use.
#### 10. Performance Data-Clinical
No clinical study is included in this submission.
#### 11. Conclusion
lt has been shown in this 510(k) submission that the differences between the proposed device and the predicate device do not raise different questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use.
