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.

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 device with an Articulating Tip is designed with built-in fluid suction / irrigation and working channel for Micro Instrument delivery.

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)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Neo-Bronchoscope Digital Video Bronchoscopy System:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily describes bench testing performed to demonstrate safety and effectiveness, rather than specific performance metrics against pre-defined acceptance criteria with numerical targets. It lists the types of tests conducted.

Acceptance Criteria Category	Reported Device Performance / Test Conducted
Physical Performance	Dimensional Measurements (Outer Diameter, Working Length), Field of View (in air), Image Resolution (Number of Pixels), Direction of View
Electrical / Optical	LED Brightness, Voltage & Current measurement, USB Connection compatibility with Laptop / Tablet / Monitor
Mechanical (Flexible)	Tip Deflection Control Mechanism (flex) & Angle of Tip deflection
Safety	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
Material / Process	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)

Missing Information: The document states that these tests were "completed to demonstrate safety & effectiveness," but it does not provide the specific acceptance criteria (e.g., "Field of View must be > X degrees") nor the quantitative results from these tests. It only lists the types of tests performed.

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that "Prosurg has conducted performance testing (Bench Evaluation - As per FDA Guidance Document) of Neo- Bronchoscope™ device." This indicates that the testing was performed on physical devices in a laboratory setting.

Sample Size: The document does not specify the sample size of devices used for the bench tests.
Data Provenance: The data provenance is from bench testing conducted by Prosurg, Inc. The document does not mention human subject data, therefore, the concepts of "country of origin of the data," "retrospective or prospective" do not apply in the context of this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable as the study described is a series of bench tests on the device's physical and functional properties, not a clinical study involving diagnosis or interpretation by experts. Therefore, no ground truth established by experts is mentioned in this context.

4. Adjudication Method for the Test Set:

This information is not applicable as the described study is a series of bench tests and does not involve human interpretation or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable. The document describes the premarket notification for a bronchoscope, which is a medical device for direct visualization. There is no mention of AI or human reader improvement with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable. The device is an endoscope, which is directly operated by a human. It does not involve any algorithms functioning in a standalone capacity (without human-in-the-loop performance) that would be assessed.

7. The Type of Ground Truth Used:

As noted above, the study involved bench testing of device specifications and safety parameters. The "ground truth" for such tests would be the engineering specifications and regulatory standards (e.g., IEC 601-1, ISO 11135-1, ISO 10993-7, ISO 10993-1) that the device must meet.

8. The Sample Size for the Training Set:

This information is not applicable. The document describes the premarket notification for a medical device that does not appear to involve machine learning or AI, and therefore would not have a "training set" in the computational sense. The "training" here refers to the manufacturing and design process.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

Summary

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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. 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 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

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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 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)

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FORM FDA 3881 (1/14)

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Image /page/3/Picture/0 description: The image shows the word "ProSurg" in a stylized font. The "Pro" part of the word is in pink, while the "Surg" part is in blue with horizontal lines running through it, giving it a textured appearance. 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, Inc2193 Trade Zone BlvdSan Jose CA 95131Tel: 408 945 4044 Fax: 408 945 1390
Contact person:	Ashvin DesaiManager, Regulatory AffairsProsurg, Inc2193 Trade Zone Blvd San Jose CA 95131Tel: 408 945 4044Fax : 408 945 1390
Date Summary prepared :	March 30, 2016
Device Trade Name:	Neo- BronchoscopeTM - Digital VideoBronchoscopy System (Rigid / Flexible)
Device Common Name:	Bronchoscope (Flexible/ Rigid)
Device Classification:	21CFR 874.4680 (Class II)
Product Code:	Endoscope & Accessories - EOQ
Legally Marketed Devicesto which the substantiallyEquivalency is claimed :	Manufacturer:Ambu A/S	Trade Name:Ambu aScopeAmbu Monitor(21 CFR 874.4680)	510K #K130845EOQ

Device Description :

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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

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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.

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.