(183 days)
Not Found
No
The summary describes a video processor for displaying and managing images from endoscopes. While it mentions "image processing," there is no mention of AI, ML, or any related concepts like training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The focus is on hardware and basic image display/management.
No
The device is a video processor that displays and manages video and images during endoscopic procedures. It does not directly provide therapy or treatment to the patient.
No.
The device is described as a video processor and display unit for images from flexible videoscopes, primarily for visualization during procedures, not for making a diagnosis itself.
No
The device description clearly states it is a "video processing unit" consisting of physical modules (AIO PC unit and Camera Interface Module) with hardware components like a display, touchscreen, and connections for videoscopes and peripherals. 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 the display and management of video and images during endoscopic procedures. This is a real-time imaging and visualization tool for the physician performing the procedure.
- Device Description: The device processes and displays video and images from a videoscope. It also includes features like an integrated air pump and stroboscopy interface, which are related to the performance of the endoscopic procedure, not the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are specifically designed to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
The device is clearly intended for use in vivo (within the body) as part of a medical procedure, providing visual information to the clinician.
N/A
Intended Use / Indications for Use
The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.
Product codes
EOX, FAJ, EOB, OCS, EOQ
Device Description
The PrimeSight™ UNITY 9000 and PrimeSight™ UNITY 9100 Video Processors (herein referred to as "UNITY 9000", "UNITY 9000 Processor" or "UNITY 9000 Series Video Processors") are video processing units designed to work exclusively with the Cogentix Medical TNE-5000, CST-5000, CST-5000i. BRS-5100 and ENT-5000 models of flexible videoscopes (herein referred to as "5000 Series Videoscopes") to display images and videos during endoscopic procedures. The UNITY 9000 Processor consists of two modules which are physically connected with a hinge mechanism. The all-inone computer (AIO PC) unit is used for the presentation and display of images and includes a large 19'' wide screen display with an integrated touchscreen. The Camera Interface Module (CIM) base unit allows for the connection of a videoscope or camera to the Processor, as well as any endoscopic peripherals being used during the procedure, as well as image processing.
There are two different model configurations available for the UNITY 9000. These models are offered specific to the type of endoscopic procedure being performed. The Base Configuration model (UVP-9000) supports urology and bronchoscopy applications, while the Airway Configuration model (UVP-9100) offers an integrated air pump for trans-nasal esophagoscopy and a stroboscopy interface for use during Ear, Nose, and Throat (ENT) stroboscopy examinations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Esophagus, lower urinary tract (including bladder), trachea, major passages of the lungs, airways, upper airway, vocal cords, nasal passages.
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
Bench testing and ISO standard compliance testing were performed. The results confirmed that the UNITY 9000 Processor is safe and effective and performs substantially equivalent to its predicate device. Clinical data was not used.
Key Metrics
Not Found
Predicate Device(s)
K072088, K072180, K091768, K102733
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. 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 flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 15, 2018
Cogentix Medical, Inc. Christa Blaisdell Regulatory Affairs Specialist 40 Ramland Road South Orangeburg, NY 10962
Re: K181292
Trade/Device Name: PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOX, FAJ, EOB, OCS, EOQ Dated: October 15, 2018 Received: October 16, 2018
Dear Christa Blaisdell:
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. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours.
Srinivas Nandkumar -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181292
Device Name
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
Indications for Use (Describe)
The PrimeSight™ UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.
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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3
510(k) Summary
General Information
Date Prepared:
Submitter Information:
Registration Number: Contact:
September 11, 2018
Cogentix Medical, Inc. 40 Ramland Road South Orangeburg, New York, 10962
2242464
Christa Blaisdell Regulatory Affairs Specialist Cogentix Medical, Inc. Phone: 952-426-6161 Fax: 866-255-4522 Email: christa.blaisdell@cogentixmedical.com
Alternate Contact:
Nicole Boser Director, Quality and Regulatory Affairs Cogentix Medical, Inc. Phone: 952-426-6141 Fax: 866-255-4522 Email: nicole.boser@cogentixmedical.com
Device Information
Trade Name:
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor
Common Name: Video Processor Esophagoscope (flexible or rigid) and accessories Classification Name: 21 CFR 874.4710 Regulation Number: Product Classification: Class II Primary Product Code: EOX Secondary Product Code(s): FAJ, OCS, EOQ, EOB Primary Predicate Device Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable EndoSheath Systems (K072088)
4
| Secondary Predicate Device(s) | Vision-Sciences CST-5000 Video Cystoscope with EndoSheath
System (K072180) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | Vision Sciences BRS-5000 Video Bronchoscope with
EndoSheath System, DPU-5000/DPU-5050 Video Processor and
Accessories (K091768) |
| | Vision-Sciences ENT-5000 Video ENT Scope with EndoSheath
Technology, Vision-Sciences DPU-5000/DPU-5050 Video
Processor (K102733) |
Device Description
The PrimeSight™ UNITY 9000 and PrimeSight™ UNITY 9100 Video Processors (herein referred to as "UNITY 9000", "UNITY 9000 Processor" or "UNITY 9000 Series Video Processors") are video processing units designed to work exclusively with the Cogentix Medical TNE-5000, CST-5000, CST-5000i. BRS-5100 and ENT-5000 models of flexible videoscopes (herein referred to as "5000 Series Videoscopes") to display images and videos during endoscopic procedures. The UNITY 9000 Processor consists of two modules which are physically connected with a hinge mechanism. The all-inone computer (AIO PC) unit is used for the presentation and display of images and includes a large 19'' wide screen display with an integrated touchscreen. The Camera Interface Module (CIM) base unit allows for the connection of a videoscope or camera to the Processor, as well as any endoscopic peripherals being used during the procedure, as well as image processing.
There are two different model configurations available for the UNITY 9000. These models are offered specific to the type of endoscopic procedure being performed. The Base Configuration model (UVP-9000) supports urology and bronchoscopy applications, while the Airway Configuration model (UVP-9100) offers an integrated air pump for trans-nasal esophagoscopy and a stroboscopy interface for use during Ear, Nose, and Throat (ENT) stroboscopy examinations.
Indications for Use
The PrimeSight UNITY 9000 Series Video Processors, when used in conjunction with a Cogentix Medical flexible videoscope, are indicated for the display and management of video and images during trans-nasal esophagoscopy, cystoscopy, bronchoscopy and nasopharyngoscopy procedures.
Intended Use
| Cogentix Medical
Flexible Videoscope | Flexible Videoscope
Model Number | Endoscopy System Indication |
|-----------------------------------------|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Trans-nasal
esophagoscope | TNE-5000 | For the display and management of video and
images during endoscopic examination of the
larynx, esophagus, and gastro-esophageal junction |
| Cystoscope | CST-5000
CST-5000i | For the display and management of video and
images during endoscopic examination of the lower
urinary tract, including the bladder |
The PrimeSight UNITY 9000 Series Video Processors are intended to be used with a Cogentix Medical flexible videoscope to form an endoscopy system utilized for the following indications:
5
| Cogentix Medical
Flexible Videoscope | Flexible Videoscope
Model Number | Endoscopy System Indication |
|-----------------------------------------|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bronchoscope | BRS-5100 | For the display and management of video and
images during airway management of the trachea
and other major passages of the lungs and
endoscopic diagnosis of the airways |
| Nasopharyngoscope | ENT-5000 | For the display and management of video and
images during endoscopic examination of the upper
airway, vocal cords and/or nasal passages |
Additional information regarding the indication and intended use for each compatible flexible videoscope is contained within the User Manual specific to that device.
Contraindications
There are no patient populations for which the PrimeSight UNITY 9000 Series Video Processors are contraindicated for.
Comparison to Predicate Device
Cogentix Medical, Inc. (formerly Vision-Sciences, Inc.) holds the 510(k) clearances to market the current DPU-5000 Series Video Processor as part of its video endoscopy systems. These products were cleared for market through multiple 510(k) submissions, which include: the Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable EndoSheath Systems (K072088); the CST-5000 Video Cystoscope with EndoSheath System (K072180); the BRS-5000 Video Bronchoscope with EndoSheath System, DPU-5000/DPU-5050 Video Processor and Accessories (K091768); and, the ENT-5000 Video ENT Scope with EndoSheath Technology and DPU-5000/DPU-5050 Video Processor (K102733).
There are no significant differences in the intended use, mechanical and functional performance or the functional scientific technology between the UNITY 9000 Series Processors and the predicate device (DPU-5000). Both systems provide image presentation and capture and storage of pictures; provide the ability for the operator to store files under a patient centric directory; and allow controls on the endoscope to interface with the Processor for the purposes of zoom, white balance or other basic image functions of the system. The UNITY 9000 Processor simply provides an updated mechanical design which deals with parts obsolescence - and a new graphical interface when compared to its predicate. UNITY 9000 also introduces video capability and the ability to store images in a Digital Imaging and Communications in Medicine (DICOM) format for easier transposition to electronic medical records systems.
6
Summary of Testing
Bench testing and ISO standard compliance testing, as described below in Table 1.1 – Summary of Testing, was performed on the PrimeSight UNITY 9000 Series Video Processors. The results of this testing confirm that the UNITY 9000 Processor is safe and effective and performs in a manner making it substantially equivalent to its predicate device. Clinical data was not used to demonstrate substantial equivalence as the subject device and predicate device are so similar in design and functionality.
| Category | Evaluation Test Reports | Associated Standards |
|---|---|---|
| Functional | ||
| Performance | RPT-175-0020-VER – PrimeSight | |
| Product Requirements Verification | ||
| Report | ||
| RPT-175-0021-VER – PrimeSight | ||
| Camera Interface Module Verification | ||
| Report | ||
| RPT-175-0023-VER – PrimeSight | ||
| Mechanical Requirements Verification | ||
| Report | EN ISO 14971:2012 – Medical devices. | |
| Application of risk management to medical | ||
| devices | ||
| TR 013-18 – Usability Evaluation of | ||
| UNITY 9000 Video Processor | IEC 62366-1:2015 – Medical devices - Part 1: | |
| Application of usability engineering to medical | ||
| devices | ||
| TR 006-18 – PrimeSight UNITY 9000 | ||
| Gap Verification | IEC 62304:2006+A1:2015 – Medical device | |
| software – Software life cycle processes | ||
| TR 020-18 – Video Processor Image | ||
| Quality Performance | ISO 12233:2017 – Resolution and spatial | |
| frequency responses | ||
| Software | RPT-175-0022-VER – PrimeSight User | |
| Interface Software Requirements | ||
| Verification Report | ||
| RPT-175-0021-VER – PrimeSight | ||
| Camera Interface Module Verification | ||
| Report | ||
| Environmental, | ||
| Shipping and | ||
| Transportation | ISO 9022-1:2012 – Optics and photonics – | |
| Environmental test methods - Part 1: | ||
| Definitions, extent of testing | ||
| TR 032-17 – Environment and Transport | ||
| Testing of PrimeSight UNITY 9000 | ISO 9022-2:2015 – Optics and photonics – | |
| Environmental test methods - Part 2: Cold, | ||
| heat and humidity | ||
| ISTA 3A:2008 – General Stimulation | ||
| Performance Tests | ||
| Category | Evaluation Test Reports | Associated Standards |
| Electrical Safety and | ||
| Electromagnetic | ||
| Compatibility | Report Number 103144900BOX-002 – | |
| Cogentix Medical, Inc. Test Report – | ||
| EMC Testing – UVP-9100 | ||
| Report Number 103480453BOX-001 – | ||
| Test Report – IEC 60601-1 Testing – | ||
| Endoscopic Video Processor | ||
| Report Number 103480453BOX-002 – | ||
| Test Report – IEC 60601-1-6 Testing – | ||
| Endoscopic Video Processor | ||
| Report Number 103480453BOX-003 – | ||
| Test Report – IEC 62304 Testing – | ||
| Endoscopic Video Processor | ||
| Report Number 103480453BOX-004 – | ||
| Test Report – IEC 60601-2-18 Testing – | ||
| Endoscopic Video Processor | ||
| Report Number 103480453BOX-005 – | ||
| Listing Constructional Data Report | IEC 60601-1:2005 + A1:2012 – Medical | |
| electrical equipment. 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 60601-1-2:2014 – Medical electrical | ||
| equipment. General requirements for basic | ||
| safety and essential performance. Collateral | ||
| Standard. Electromagnetic disturbances. | ||
| Requirements and tests | ||
| IEC 60601-1-6:2010 + A1:2013 – Medical | ||
| electrical equipment – Part 1-6: General | ||
| requirements for basic safety and essential | ||
| performance – Collateral standard: Usability | ||
| IEC 62304:2006+A1:2015 – Medical device | ||
| software – Software life cycle processes | ||
| EN ISO 14971:2012 – Medical devices. | ||
| Application of risk management to medical | ||
| devices |
Table 1.1 – Summary of Testing
7
Conclusion
Cogentix Medical, Inc. believes that based on the data contained in this 510(k) related to the indications for use, technological characteristics, and performance testing, the PrimeSight UNITY 9000 Series Video Processors have demonstrated substantial equivalence to their predicate device and are considered to be safe and effective.