(262 days)
Not Found
No
The summary mentions "Video processing Software" but provides no details suggesting AI/ML capabilities. The performance studies focus on basic device functionality and safety, not algorithmic performance. There is no mention of AI, DNN, or ML in the text.
Yes
The device is intended for "examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices and accessories," which includes therapeutic applications.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use for examination, diagnosis and treatment of Airways and Tracheobronchial tree". The inclusion of "diagnosis" clearly indicates its function as a diagnostic tool.
No
The device description explicitly lists hardware components such as a CMOS imaging sensor, LEDs, connecting wires, a USB connector, and a hollow tubular structure. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "examination, diagnosis and treatment of Airways and Tracheobronchial tree, using surgical devices and accessories." This describes a device used directly on or within the patient for visualization and intervention.
- Device Description: The description details a bronchoscope with a camera, light, and channels for instruments and suction. This is a medical device used for internal examination and procedures.
- Lack of In Vitro Activity: An IVD is a device intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic purposes. This device does not perform any tests on biological samples.
- Performance Studies: The performance studies focus on the physical and functional aspects of the bronchoscope itself (dimensions, image quality, tip deflection, electrical safety, etc.), not on the analysis of biological specimens.
- Predicate Device: The predicate device is also a bronchoscope, which is a medical device used for in-vivo procedures.
In summary, the Prosurg's Neo-Bronchoscope™ is a medical device used for direct visualization and intervention within the human body, not for testing biological samples in vitro. Therefore, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 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.
Product codes
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 device with an Articulating Tip is designed with built-in fluid suction / irrigation and working channel for Micro Instrument delivery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Airways and Tracheobronchial tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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.
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
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)
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.
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-13-
FORM FDA 3881 (1/14)
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510K Summary # K152466 (Traditional 510K)
Neo- Bronchoscope™ -Digital Video Bronchoscopy System (Rigid / Flexible)
| Submitter : | Prosurg, Inc
2193 Trade Zone Blvd
San Jose CA 95131
Tel: 408 945 4044 Fax: 408 945 1390 | | |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|--------------------------|
| Contact person: | Ashvin Desai
Manager, Regulatory Affairs
Prosurg, Inc
2193 Trade Zone Blvd San Jose CA 95131
Tel: 408 945 4044
Fax : 408 945 1390 | | |
| Date Summary prepared : | March 30, 2016 | | |
| Device Trade Name: | Neo- BronchoscopeTM - Digital Video
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
to which the substantially
Equivalency is claimed : | Manufacturer:
Ambu A/S | Trade Name:
Ambu aScope
Ambu Monitor
(21 CFR 874.4680) | 510K #
K130845
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.