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 Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor 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 subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "Broncho Videoscope System." It details the device's technical specifications and compares it to a predicate device to establish substantial equivalence. However, the document explicitly states that "No clinical study is included in this submission" (page 6, section 7).

This means there is no information available in this document regarding acceptance criteria, reported device performance against those criteria, or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information based on the provided input.

However, I can extract information related to non-clinical testing and general device characteristics as described in the summary:

Section 1-7: No information available as no clinical study was conducted.

Section 8: Sample size for the training set - Not applicable, as no clinical study for AI model training is mentioned.

Section 9: How the ground truth for the training set was established - Not applicable, as no clinical study for AI model training is mentioned.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 14, 2023

Scivita Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.box 120-119 Shanghai, 200120, China

Re: K231521

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: October 11, 2023 Received: October 11, 2023

Dear Diana Hong:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Joyce C. Lin -S

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

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Indications for Use

Submission Number (if known)

K231521

Device Name

Broncho Videoscope System

Indications for Use (Describe)

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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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: K231521

1. Date of Preparation: 11/10/2023
1. Sponsor Identification

Scivita Medical Technology Co., Ltd. No. 2, Qingqiu Street, Suzhou Industrial Park, 215000 Suzhou, Jiangsu Prov., P.R.CHINA.

Establishment Registration Number: 3020746799

Contact Person: Ruqin Wu Position: Quality Manager Tel: +86-512-81877788 Fax: +86-512-85187285 Email: wuruqin@scivitamedical.com

1. 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: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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4. Identification of Subject Device

Trade Name: Broncho Videoscope System Common Name: BronchoscopeSystem

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:

Device Description:

System name	Component name	Model
BronchoVideoscopeSystem	Single-use Broncho Videoscope	SBV-1A-B, SBV-1A-P, SBV-1B-B,SBV-1B-P, SBV-1C-B, SBV-1C-P
	Full HD Visualization Endoscopic Image Processor	HDVS-S300A, HDVS-S300B,HDVS-S300C, HDVS-S300D

System Configuration

The Single-use Broncho Videoscope, which has been cleared in K210379, is a single use device. It is intended to use in conjunction with Full HD Visualization Endoscopic Image Processor to provide

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images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi and lungs. The Single-use Broncho Videoscope has six modes, 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 section (Nylon and PEEK). All these six models are included inK210379.

The single-use Broncho Videoscope is a single-channel endoscope. There is 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 (EO) Gas to achieve a SAL of 10° and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.

The Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the Single-use Broncho Videoscope, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity. The Full HD Visualization Endoscopic Image Processor has four models, which are different in image adjustment functions.

1. Identification of Predicate Device
  510(k) Number: K210379

Product Name: Broncho Videoscope System

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to demonstrate substantial equivalence (SE) to the predicate. The test

results demonstrated that the subject device complies with the following standards:

ISO 10993-7:2008 Biological evaluation of medical devices-Part 7: Ethylene oxide sterilization residuals
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 Medical Electrical Equipment-Part 1: General Requirements for basic safety and essential performance
IEC 60601-2-18:2009, Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 62133-2:2017, Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems

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ア ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
ア ASTM F88/F88M -21, 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
1. Clinical Test Conclusion
  No clinical study is included in this submission.
1. Summary of Technological Characteristics

ITEM	Subject Device K231521	Predicate Device K201379	Remark
Product Code	EOQ	EOQ	Same
Regulation No.	874.4680	874.4680	Same
Class	II	II	Same
Manufacturer	Scivita Medical Technology Co., Ltd.	Scivita Medical Technology Co., Ltd.	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	The Broncho videoscopesystem 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	Similar Analysis 1
	hospital environment.	a hospital environment.
	This Full HD VisualizationEndoscopic Image Processor isused for endoscopic diagnosis andtherapies. It connects to theelectronic endoscopes, displayingthe images on its LCD displayand/or external monitor within thefield of view from the bodycavity.	This Endoscopic ImageProcessor is used for endoscopicdiagnosis and therapies. Itconnects to the electronicendoscopes, displaying theimages on the monitor detectedwithin the field of view from thebody cavity.
	This Single-use BronchoVideoscope is intended to use inconjunction with endoscopicimage processor to provideimages through the video monitorfor observation, diagnosis,photography and treatment of therespiratory system such astrachea, bronchi, and lungs.	This Single-use BronchoVideoscope is intended to use inconjunction with endoscopicimage processor (HDVS-S100Aand HDVS-S100D) to provideimages through the videomonitor for observation,diagnosis, photography andtreatment of the respiratorysystem such as trachea, bronchi,and lungs.
Main Configuration	Single-use Broncho Videoscopewith square plug and round plug(SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P,SBV-1C-B, SBV-1C-P)Full HD Visualization EndoscopicImage Processor	Single-use Broncho Videoscopewith square plug.(SBV-1A-B, SBV-1A-P,SBV-1B-B, SBV-1B-P,SBV-1C-B, SBV-1C-P)Endoscopic Image Processor	SimilarAnalysis 2
Single use/ Reuse	Endoscope: Single useImage Processor: Reuse	Endoscope: Single useImage Processor: Reuse	Same
Sterile	Yes, for disposable endoscope	Yes, for disposable endoscope	Same
Anatomical Site	Respiratory system such astrachea, bronchi, and lungs	Respiratory system such astrachea, bronchi, and lungs	Same
Where used	Hospitals	Hospital	Same
Label/Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same
ITEM	FullHD VisualizationEndoscopic ImageProcessor	Endoscopic ImageProcessorK201379	Remark
Model	HDVS-S300A,HDVS-S300B,HDVS-S300C,HDVS-S300D	HDVS-S100AHDVS-S100D	/
Dimension	332mm (W)×241.9mm (D)×56.5mm (H)	300(W)×57(H)×225(D) mm	SimilarAnalysis 3
Weight	About 2.5Kg	About 2.5Kg	Same
Is there an integratedLCD display?	Yes	No	DifferentAnalysis 4
Freeze	Create staticpicture ofdynamic image	Create static picture of dynamicimage	Same
Zoom	Magnification of image is1 times, 1.5 times and 2times (full screen), threestages cycling adjustment.	By pressing the ZOOM button,the original(74%contrasting to vertical screen) canbe enlarged to 89% and 100% ofthe vertical screen, respectively.	DifferentAnalysis 5
510(k) Summary
LEDBrightnessAdjustment	Adjust LED brightness bythree models (L, M, H).L: low Led light intensityM: moderate Led lightintensityH: high Led light intensity	Three modes of Ledlightintensity can be chosen whenpressing the LED (L M H) buttonin order.L: low Led light intensityM: moderate Led light intensityH: high Led light intensity	Same
RECORD (PHOTO)	Pressthe RECORD(PHOTO) button on thetouchscreen, the imageswill be captured by theelectronic endoscope andstored to the storagedevice.	Once pressed the RECORD(PHOTO) button, the photo willbe taken and stored in the storagedevice.	Same
RECORD (VIDEO)	Press the RECORD(VIDEO) button on thetouchscreen, the equipmentstarts to record. Press thebutton again to end therecording.The videorecorded willautomatically store to thestorage device(photographing functioncan be performed whenrecording video).	After pressing the RECORD(VIDEO) button, the endoscopicimage processor starts to recordthe video, and it will keeprecording until the RECORD(VIDEO) button is pressed for thesecond time.	Same
Auto white balance	Automatically adjusted	Automatically adjusted	Same
Video Signal Output	SDI, HDMI video signaloutput port	SDI, DVI video signal outputport	DifferentAnalysis 6
Foot switch	There is no Foot switch.	The foot switch can control thefunctions of gain, image freezing,electronic magnification, contouremphasis and image recording.	DifferentAnalysis 7
Power Supply	It has a rechargeablelithium-ion battery. It hastwo power supply modes,which are internal andexternal power supply. Theexternal power supply isAC100V-240V 50/60Hz.	It has only an external powersupply, 100-240V±10% AC,50/60Hz.	DifferentAnalysis 8
Disinfection method	75% ethanol	75% ethanol	Same
Communication withendoscope	Provided	Provided	Same

Table 1. General Comparison

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Analysis 1- Indication for Use (IFU)

The IFU of the subject device is expressed in three parts including the whole system's IFU, the Image Processor' s IFU and the Broncho Videoscope's IFU. The IFU of the predicate device is also expressed in

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three parts including the whole system's IFU, the Image Processor's IFU and the Broncho Videoscope's IFU. The IFU statements of the whole system and Broncho Videoscope of subject are same as those of the predicate device. Compared with the predicate device, the image resolution of the subject device can reach full HD. The Full HD Visualization Endoscopic Image Processor has a LCD display. The Full HD Visualization Endoscopic Image Processor of the subject device can display the images on its LCD display and/or external monitor. The Endoscopic Image Processor of the predicate device can display the images on the external monitor. The image quality testing of the subject device demonstrate that the image quality of the integratiy LCD display is acceptable.

Based on above analysis, the indication for use of the subject device and the predicate device is only different in expression. The difference will not affect the safety and effectiveness of the subject device.

Analysis 2- Main Configuration

The Broncho Videoscope of subject device has extra round plug comparing with the predicate device. The image quality testing of the subject device The image quality testing of the proposed device include intensity uniformity test , depth of field test, resolution test, color reproduction test, geometric distortion test, image frame frequency and system delay test and noise and dynamic range test demonstrate that the image quality of the device does not affected by the different plug.

Table 2. Specifications Comparison of Endoscopic Image Processor

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510(k) Summary

Analysis 3-Dimension

The dimension for the subject image processor is different form the predicate device. The dimension are just in physical specification and this difference will not raise any issues in safety and effectiveness.

Analysis 4-Is there an integrated LCD display?

The subject image processor has extra integrated LCD display comparing with the predicate device. However, the color reproduction performance of the integrated LCD display has been tested in the Tab 57 Color Reproduction Test Report, the test results demonstrated the performance of the integrated LCD display is acceptable.

Analysis 5-ZOOM

The ZOOM function of the subject image processor is different from predicate image processor. The ZOOM function is used to adjust the image size without changing the image content; this difference will not raise any issues in safety and effectiveness.

Analysis 6-Video Signal Output

The types of video signal output are different between subject image processor and predicate image processor. The subject device has HDMI and SDI interface, the predicate device has SDI and DVI interface. The image quality of the subject device and predicative device have been tested in the quantitative image quality testing.. The test results demonstrate that the image quality of the subject device was equivalent to that of the predicate device. The difference on video signal output will not affect the safety and effectiveness of the subject device.

Analysis 7- Foot switch

The foot switch of the subject device is different between subject image processor and predicate device. There is no foot switch for subject device. The subject device has a LCD display. The main unit function control can be realized by clicking the LCD display. The main unit function of the predicate device is located in the front panel, and the main unit function can be controlled by the foot switch. The LCD display of the subject device is 13.3 inches, and the area of touchscreen is large, and the function icon is clear. Therefore, the difference will not affect the safety and effectiveness of the subject device.

Analysis 8- Power Supply

There are two power supplies for subject device, which are internal power supply. The external power supply for subject device is same as predicate device. So the subject device has extra internal power supply comparing with the predicate device. The internal power supply for subject device is an embedded rechargeable lithium-ion battery, the electrical safety and electromagnetic compatibility has been test in, the

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510(k) Summary

test results demonstrated the internal power supply is safety.

ITEM	Subject Device	Predicate DeviceK210379	Remark
Model	SBV-1A-B, SBV-1A-PSBV-1B-B, SBV-1B-PSBV-1C-B, SBV-1C-P	SBV-1A-B, SBV-1A-PSBV-1B-B, SBV-1B-PSBV-1C-B, SBV-1C-P	Same
Maximum OuterDiameterofInsertion 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);	3.2mm (SBV-1A-B; SBV-1A-P);4.9mm(SBV-1B-B; SBV-1B-P);6.2mm(SBV-1C-B; SBV-1C-P);	Same
MinimumInstrumentChannel 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);	1.15mm(SBV-1A-B; SBV-1A-P);1.95mm(SBV-1B-B;SBV-1B-P);2.75mm(SBV-1C-B;SBV-1C-P);	Same
Working Channel	Φ1.2mm (SBV-1A-B; SBV-1A-P);Φ2.0mm(SBV-1B-B; SBV-1B-P);Φ2.8mm (SBV-1C-B; SBV-1C-P);	Ф1.2mm(SBV-1A-B; SBV-1A-P);Φ2.0mm(SBV-1B-B; SBV-1B-P);Ф2.8mm(SBV-1C-B; SBV-1C-P);	Same
Working Length	600mm	600mm	Same
Total Length	920mm	920mm	Same
Bending angle	Up:220°,Down:220°	Up:220°,Down:220°	Same
Field of View	120°	120°	Same
Direction of View	0°	0°	Same
Depth of Field	0.5~120mm	0.5~120mm	Same
EndoscopeIllumination	LED light is placed at the distal endof the endoscope	LED light is placed at the distalend of the endoscope	Same
MethodofSterilization	EO	EO	Same
	Square plug	Square plug	Similar

Table 3. Specifications Comparison of Broncho Videoscope

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ITEM	Subject Device	Predicate DeviceK210379	Remark
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1	Same
EMC	Comply with IEC60601-1-2	Comply with IEC60601-1-2	Same
Particular requirements	Comply with IEC60601-2-18	Comply with IEC60601-2-18	Same
Bending section	Pebax	Pebax	Same
Insertion section	Nylon PA12/PEEK	Nylon PA12/PEEK	Same
Connecting section	PET	PET	Same
Distalendsection	CMOS front end	Glass	Glass	Same
	Injection head	Sulfone polymer	Sulfone polymer	Same
	Distal endconnecting ring	304 SUS	304 SUS	Same
	WorkingChannel	Pebax	Pebax	Same
Drainage tube	PC	PC	Same
Irrigation valve	PC; silicone rubber	PC; silicone rubber	Same
Suctiondevice	Suction nozzle	PC	PC	Same
	Suction button	Silicone rubber	Silicone rubber	Same
	Suction access	Pebax	Pebax	Same
Biocompatibility	No Cytotoxicity	No Cytotoxicity	Same
	No Sensitization	No Sensitization
	No Irritation	No Irritation
Sterilization (Single-use Broncho Videoscope)
Method	EO sterilization	EO sterilization	Same
SAL	10-6	10-6	Same

Table 4. Safety Comparison

9. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device, Broncho Videoscope System is as safe, as effective, and performs as well and is substantially equivalent to the legally marketed predicate device cleared under K210379.

Regulation Number and Section

§ 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.