Broncho Videoscope System

K210379 · Scivita Medical Technology Co., Ltd. · EOQ · Jul 28, 2021 · Ear, Nose, Throat

Device Facts

• Record ID: K210379
• Device Name: Broncho Videoscope System
• Applicant: Scivita Medical Technology Co., Ltd.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jul 28, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 Story

System comprises single-use flexible bronchoscope and reusable endoscopic image processor. Bronchoscope captures visual data via distal CMOS sensor; transmits signal to processor. Processor (models HDVS-S100A/D) handles image enhancement (A-model only), auto-white balance, and signal output (DVI/SDI) to external monitor. Used by physicians in hospital settings for observation, diagnosis, photography, and treatment of respiratory tract. Provides real-time visualization to guide clinical decision-making and therapeutic interventions. Benefits include sterile, single-use design reducing cross-contamination risk and improved visualization via integrated LED illumination and CMOS imaging.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via optical testing (color reproduction, resolution, depth of view, distortion, frame frequency), suction/irrigation function, and use-life testing (accelerated aging). Biocompatibility (cytotoxicity, sensitization, intracutaneous) and electrical safety (IEC 60601-1, 60601-1-2, 60601-2-18) confirmed.

Technological Characteristics

Flexible single-use bronchoscope (Nylon/PEEK) and reusable image processor. CMOS sensor; LED illumination. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: DVI/SDI video output. Standards: ISO 10993, ISO 8600, IEC 60601 series, ASTM F88/F1929/D4169.

Indications for Use

Indicated for endoscopic diagnosis and therapy of the respiratory system (trachea, bronchi, lungs) in a hospital environment.

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

• Vathin Video Bronchoscope System (K191828)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 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

- 1. Date of Preparation: 06/21/2021
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 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<br>Videoscope<br>System | Single-use Broncho Videoscope | SBV-1A-B, SBV-1A-P, SBV-1B-B,<br>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

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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.

- 5. Identification of Predicate Device
510(k) Number: K191828 Product Name: Vathin Video Bronchoscope System

- 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

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- 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 (<24 hours). The proposed endoscope was evaluated for the following tests. The results ofthe biocompatibility testing showed that there are no negative impacts from the materials that are used in the proposed device.

- > 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.

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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.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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#### 8. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device | Predicate Device<br>K191828 | Remark | |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|------|
| Product Code | EOQ | EOQ | Same | |
| Regulation No. | 874.4680 | 874.4680 | Same | |
| Class | II | II | Same | |
| Indication<br>for<br>Use | The Broncho videoscope system is designed<br>to be used for endoscopic diagnosis and<br>therapies within the respiratory system such<br>as trachea, bronchi, and lungs. The Broncho<br>videoscope System is for use in a hospital<br>environment.<br>This Endoscopic Image Processor is used for<br>endoscopic diagnosis and therapies. It<br>connects to the electronic endoscopes,<br>displaying the images on the monitor detected<br>within the field of view from the body cavity.<br>This Single-use Broncho Videoscope is<br>intended to to use in conjunction with<br>endoscopic image processor (HDVS-S100A<br>and HDVS-S100D) to provide images<br>through the video monitor for observation,<br>diagnosis, photography and treatment of the<br>respiratory system such as trachea, bronchi,<br>and lungs. | The Vathin® H-SteriScope™ I<br>Single-use flexible Video<br>Bronchoscope have been designed to<br>be used with the VathinⓇ<br>VisionCenter™ I Digital Video<br>Processor, endotherapy accessories<br>and other ancillary equipment for<br>endoscopy within the airways and<br>tracheobronchial tree.<br>The Vathin® Video Bronchoscope<br>System is for use in a hospital<br>environment. | Different | |
| Single<br>use/<br>Reuse | Endoscope: Single use<br>Image Processor: Reuse | Endoscope: Single use<br>Image Processor: Reuse | Same | |
| Sterile | Yes for disposable endoscope | Yes for disposable endoscope | Same | |
| Anatomical<br>Site | Respiratory system such as trachea, bronchi,<br>and lungs | Airways and tracheobronchial tree | Different | |
| Where used | Hospitals | Hospital | Same | |
| Main | Single-use Broncho Videoscope | Vathin® H-SteriScope™ I Single-use<br>flexible Video Bronchoscope | Same | |
| Configuration | Endoscopic Image Processor | Vathin® VisionCenter™ I Digital<br>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<br>of<br>view | 0° | 0° | Same | |
| Depth of field | 0.5~120mm | 3~30mm | Different | |
| Sensor type | CMOS | CMOS | Same | |
| Max.<br>outer<br>diameter<br>of<br>insertion<br>section | 3.2mm (SBV-1A-B; SBV-1A-P);<br>4.9mm (SBV-1B-B; SBV-1B-P);<br>6.2mm (SBV-1C-B; SBV-1C-P); | 2.2 mm, 3.2mm,<br>4.1mm, 4.7mm, 4.9mm, 5.2mm,<br>5.8mm, 6.0mm, 6.2mm | Different | |
| Up/down | Up: 220° | Up:210° | Different | |
| deflection | Down: 220° | Down: 210° | Different | |
| Work length | 600mm | 600mm,<br>700mm | Different | |
| Minimum<br>instrument<br>channel width | 1.15mm (SBV-1A-B; SBV-1A-P);<br>1.95mm (SBV-1B-B; SBV-1B-P);<br>2.75mm (SBV-1C-B; SBV-1C-P); | 0mm, 1.2mm,<br>1.7mm, 2.0mm, 2.2mm,<br>2.4mm, 2.8mm, 3.0mm, 3.2mm | Different | |
| Illumination<br>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<br>signal<br>output | DVI:1<br>SDI: 2 | DVI | Different | |
| Auto<br>white<br>balance | Automatically adjusted | Manually adjusted | Different | |
| Communication<br>with endoscope | Provided | Provided | Same | |
| Electrical<br>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<br>requirements | Comply with IEC 60601-2-18 | Comply with IEC 60601-2-18 | Same | |
| Product<br>Performance | Comply with ISO 8600 | Comply with ISO 8600 | Same | |
| Patient-contact component and material | | | | |
| Bending<br>section | Pebax | Unknown | Different | |
| Insertion<br>section | Nylon PA12/PEEK | | | |
| Connecting<br>section | PET | | | |
| Distal<br>end<br>section | CMOS front end | Glass | | |
| | Injection head | Sulfone polymer | | |
| | Distal end<br>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 |…