Neo-Bronchoscope -Digital Video Bronchoscopy System(Rigid/Flexible)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 19, 2016 Prosurg, Inc Ashvin Desai Manager. Regulatory Affairs 2193 Trade Zone Blvd San Jose, California 95131 Re: K152466 Trade/Device Name: Neo-bronchoscope Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: April 26, 2016 Received: April 28, 2016 Dear Ashvin Desai: 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. 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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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Sincerely yours, Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ਜਾ #### Indications for Use 310(k) Number (if known) K152466 Device Name Neo- Bronchoscope ™ - Digital Video Bronchoscopy System (Rigid / Flexible) Indications for Use (Describe) The Prosurg's Neo-Bronchoscope™ - Digital Video Bronchoscopy System -Rigid & Flexible (which includes Digital Video Bronchoscope, Single view (Volto Sheath) is intended for use for use for use for use for use for use for use for use for use for use for use for use for use for examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices and accessories. The Neo-Bronchoscope achieves its purpose by providing the user with a visual confirmation of where the tip of the endoscope is in the human anatomy. The NeoFlex – Bronchscope allows user to guide the tip of desired location with ease & safety. 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) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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The overall design is simple and clean, with a focus on the text itself. # 510K Summary # K152466 (Traditional 510K) ## Neo- Bronchoscope™ -Digital Video Bronchoscopy System (Rigid / Flexible) | Submitter : | Prosurg, Inc<br>2193 Trade Zone Blvd<br>San Jose CA 95131<br>Tel: 408 945 4044 Fax: 408 945 1390 | | | |------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------| | Contact person: | Ashvin Desai<br>Manager, Regulatory Affairs<br>Prosurg, Inc<br>2193 Trade Zone Blvd San Jose CA 95131<br>Tel: 408 945 4044<br>Fax : 408 945 1390 | | | | Date Summary prepared : | March 30, 2016 | | | | Device Trade Name: | Neo- BronchoscopeTM - Digital Video<br>Bronchoscopy System (Rigid / Flexible) | | | | Device Common Name: | Bronchoscope (Flexible/ Rigid) | | | | Device Classification: | 21CFR 874.4680 (Class II) | | | | Product Code: | Endoscope & Accessories - EOQ | | | | Legally Marketed Devices<br>to which the substantially<br>Equivalency is claimed : | Manufacturer:<br>Ambu A/S | Trade Name:<br>Ambu aScope<br>Ambu Monitor<br>(21 CFR 874.4680) | 510K #<br>K130845<br>EOQ | ### Device Description : The Single Use Digital Video Bronchoscope design incorporates a CMOS imaging sensor and built-in LEDs (Light Emitting Diodes) or fiber optic mounted at the distal end, connecting wires along the length of the hollow tubular structure and a USB Connector at the proximal end. The distal end of the Bronchoscope containing CMOS sensor and LEDs / Fiber optic is protected by sealed, clear optical window. The NeoFlex™ - Bronchoscope , Flexible Video Bronchoscope {4}------------------------------------------------ device with an Articulating Tip is designed with built-in fluid suction / irrigation and working channel for Micro Instrument delivery. ## Indications For Use: The Prosurg's, Neo-Bronchoscope™ -Digital Video Bronchoscopy System -Rigid & Flexible (which includes Digital Video Bronchoscope, Single use Diagnostic / Operating Outer Sheath) is intended for use for endoscopic examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices & accessories. The, Neo- Bronchoscope achieves its purpose by providing the user with a visual confirmation of where the tip of the endoscope is in the human anatomy. The Neoflex- Bronchoscope allows user to guide the Bronchoscope in the desired location with ease and safety. ## Technological Characteristics: The Neo- Bronchoscope ™ Video Bronchoscopy System consists of four main components: - (a) Digital Video Bronchoscope (Rigid / Flexible) with CMOS Sensor & Built-in LEDs / Fiber optic. - (b) Single Use. Rigid Diagnostic / Operating Outer Sheath with Suction / Irrigation / Instrument channel and a separate, dedicated channel for video Bronchoscope insertion. Or a flexible Bronchoscope with suction / Irrigation & Instrument channel with Articulating tip deflection. - (c ) )Laptop /Tablet computer with windows Operating System, Video Module and Video processing Software. (Commercially Available, Not supplied by Prosurg, Inc) - (d) USB 2.0 / HD / S-Video Connecting Cables. (Commercially Available, Not supplied by Prosurg, Inc) ## Substantial Equivalence: The Neo -Bronchoscope™ Digital Video Bronchoscopy System -(Rigid & Flexible) and Predicate device Ambu ascope and Ambu Monitor (Ref: K130845 ) are similar in design, Components, including CMOS Imaging Sensor, LED, Outer tube Handle materials & USB 2.0 Connectors. The Manufacturing & Assembly process, Product Packaging, Sterilization method & Recommended for Single use are also identical. The proposed Indications for Use for Neo-Bronchoscope is based on Predicate device Ambu aScope & aScope Monitor (K130845). The Neo - Bronchoscope - Digital Video System is substantially equivalent to Ambu aScope. For details, please refer to Substantial Equivalence Comparison chart summary outlining Physical, functional characteristics and Indications for use. ## Performance Testing : (Bench Testing) Prosurg has conducted performance testing (Bench Evaluation- As per FDA Guidance Document) of Neo- Bronchoscope ™ device to demonstrate Safety & effectiveness and its intended use. The {5}------------------------------------------------ Following Testing was completed to demonstrate safety & effectiveness of the proposed device for its intended use. - Dimensional Measurements (Outer Diameter, Working Length) . - Field of View (in air) - Image Resolution (Number of Pixels) ● - Direction of View - LED Brightness, Voltage & Current measurement. - Tip Deflection Control Mechanism (flex) & Angle of Tip deflection - . USB Connection compatibility with Laptop / Tablet / Monitor - Electrical Safety Test (IEC 601-1) - Electromagnetic Compatibility (IEC 601-1-2) - Thermal (Heat) Temperature at the Distal Tip (LED) - Maximum Safe amount of Suction (Vacuum) testing - Product Labeling & IFU Requirements & Accuracy - . Packaging Integrity & Sterility Assurance Test - Accelerated Aging Test (one Year) - . Sterilization Assurance Level (ISO 11135-1:2007) - . ETO Residual Levels (ISO 10993-7:2008) - . Biocompatibility (ISO 10993-1:2009) ### Conclusion: The results of the performance testing demonstrate that proposed Neo -Bronchoscope™ Digital Video Bronchoscopy System -(Rigid & Flexible), performs as well as predicate device for its intended use and is considered safe and effective for its intended use.