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.

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.

AI/ML Overview

The provided document, a 510(k) summary for the PrimeSight™ UNITY 9000 Series Video Processors, describes the device's functional performance and compliance with various standards. However, it explicitly states that clinical data was not used to demonstrate substantial equivalence because the subject device and predicate device are considered very similar in design and functionality. This means the study did not involve human readers, ground truth establishment, or multi-reader multi-case comparative effectiveness.

Therefore, many of the requested details about acceptance criteria related to clinical performance metrics and associated study parameters (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies) are not applicable or provided in this document.

The acceptance criteria mentioned are primarily focused on functional performance, compliance with electrical safety and electromagnetic compatibility standards, software requirements, environmental testing, and usability.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

Since the document focuses on demonstrating substantial equivalence through non-clinical testing, specific quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) are not stated, nor is there reported clinical device performance in terms of these metrics.

Instead, the "acceptance criteria" are implied by the successful completion and positive results of the various engineering and regulatory compliance tests. The "reported device performance" is that the device meets these criteria and is "safe and effective and performs in a manner making it substantially equivalent to its predicate device."

Category	Acceptance Criteria (Implied by Standards & Test Reports)	Reported Device Performance
Functional Performance	Compliance with product requirements (RPT-175-0020-VER), Camera Interface Module requirements (RPT-175-0021-VER), mechanical requirements (RPT-175-0023-VER), usability standards (IEC 62366-1:2015), gap verification (TR 006-18), and image quality standards (ISO 12233:2017). Application of risk management (EN ISO 14971:2012).	Testing confirms the device is safe and effective and performs in a manner making it substantially equivalent to its predicate device. All specified functional tests were successfully completed.
Software	Compliance with user interface software requirements (RPT-175-0022-VER), Camera Interface Module requirements (RPT-175-0021-VER), and medical device software life cycle processes standard (IEC 62304:2006+A1:2015).	Testing confirms the device is safe and effective and performs in a manner making it substantially equivalent to its predicate device. All specified software tests were successfully completed.
Environmental, Shipping, Transportation	Compliance with environmental test methods (ISO 9022-1:2012, ISO 9022-2:2015) and general stimulation performance tests (ISTA 3A:2008) for PrimeSight UNITY 9000 (TR 032-17).	Testing confirms the device is safe and effective and performs in a manner making it substantially equivalent to its predicate device. All specified environmental and transportation tests were successfully completed.
Electrical Safety & Electromagnetic Compatibility	Compliance with general requirements for basic safety and essential performance (IEC 60601-1:2005 + A1:2012), particular requirements for endoscopic equipment (IEC 60601-2-18:2009), electromagnetic disturbances (IEC 60601-1-2:2014), usability (IEC 60601-1-6:2010 + A1:2013), and medical device software life cycle processes (IEC 62304:2006+A1:2015). Application of risk management (EN ISO 14971:2012). Specific EMC and electrical safety test reports are cited (e.g., 103144900BOX-002, 103480453BOX-001 to -005).	Testing confirms the device is safe and effective and performs in a manner making it substantially equivalent to its predicate device. All specified electrical safety and EMC tests were successfully completed.

2. Sample size used for the test set and the data provenance:
Not applicable for this type of non-clinical testing. The "test set" consisted of the physical device and its components undergoing various engineering, software, and regulatory compliance tests. There is no mention of a "data provenance" in the clinical sense (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of clinical studies, refers to definitive diagnoses or findings. This document describes engineering and regulatory compliance testing. Usability evaluation (TR 013-18) was performed, which likely involved human users, but details on the number or qualifications of "experts" to establish a clinical ground truth are not provided because it's not a clinical study.

4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve disagreements among human readers or evaluators when establishing ground truth. This document does not describe such a study.

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:
No, a MRMC comparative effectiveness study was not done. The device is a video processor for endoscopes, not an AI-powered diagnostic tool, and the document explicitly states that "Clinical data was not used to demonstrate substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a video processor, which is inherently a "standalone" piece of hardware and software designed to display and manage images from endoscopes for human interpretation, not an algorithm providing diagnostic output on its own.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the clinical sense. The "ground truth" for the various engineering and regulatory compliance tests would be the established specifications, standards, and documented requirements that the device needed to meet.

8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device requiring a dataset for model training.

9. How the ground truth for the training set was established:
Not applicable, as there was no training set.

Summary

{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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 EndoSheathSystem (K072180)
	Vision Sciences BRS-5000 Video Bronchoscope withEndoSheath System, DPU-5000/DPU-5050 Video Processor andAccessories (K091768)
	Vision-Sciences ENT-5000 Video ENT Scope with EndoSheathTechnology, Vision-Sciences DPU-5000/DPU-5050 VideoProcessor (K102733)

Device Description

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 MedicalFlexible Videoscope	Flexible VideoscopeModel Number	Endoscopy System Indication
Trans-nasalesophagoscope	TNE-5000	For the display and management of video andimages during endoscopic examination of thelarynx, esophagus, and gastro-esophageal junction
Cystoscope	CST-5000CST-5000i	For the display and management of video andimages during endoscopic examination of the lowerurinary 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 MedicalFlexible Videoscope	Flexible VideoscopeModel Number	Endoscopy System Indication
Bronchoscope	BRS-5100	For the display and management of video andimages during airway management of the tracheaand other major passages of the lungs andendoscopic diagnosis of the airways
Nasopharyngoscope	ENT-5000	For the display and management of video andimages during endoscopic examination of the upperairway, 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
FunctionalPerformance	RPT-175-0020-VER – PrimeSightProduct Requirements VerificationReport
	RPT-175-0021-VER – PrimeSightCamera Interface Module VerificationReport
	RPT-175-0023-VER – PrimeSightMechanical Requirements VerificationReport	EN ISO 14971:2012 – Medical devices.Application of risk management to medicaldevices
	TR 013-18 – Usability Evaluation ofUNITY 9000 Video Processor	IEC 62366-1:2015 – Medical devices - Part 1:Application of usability engineering to medicaldevices
	TR 006-18 – PrimeSight UNITY 9000Gap Verification	IEC 62304:2006+A1:2015 – Medical devicesoftware – Software life cycle processes
	TR 020-18 – Video Processor ImageQuality Performance	ISO 12233:2017 – Resolution and spatialfrequency responses
Software	RPT-175-0022-VER – PrimeSight UserInterface Software RequirementsVerification Report
	RPT-175-0021-VER – PrimeSightCamera Interface Module VerificationReport
Environmental,Shipping andTransportation		ISO 9022-1:2012 – Optics and photonics –Environmental test methods - Part 1:Definitions, extent of testing
	TR 032-17 – Environment and TransportTesting of PrimeSight UNITY 9000	ISO 9022-2:2015 – Optics and photonics –Environmental test methods - Part 2: Cold,heat and humidity
		ISTA 3A:2008 – General StimulationPerformance Tests
Category	Evaluation Test Reports	Associated Standards
Electrical Safety andElectromagneticCompatibility	Report Number 103144900BOX-002 –Cogentix Medical, Inc. Test Report –EMC Testing – UVP-9100Report Number 103480453BOX-001 –Test Report – IEC 60601-1 Testing –Endoscopic Video ProcessorReport Number 103480453BOX-002 –Test Report – IEC 60601-1-6 Testing –Endoscopic Video ProcessorReport Number 103480453BOX-003 –Test Report – IEC 62304 Testing –Endoscopic Video ProcessorReport Number 103480453BOX-004 –Test Report – IEC 60601-2-18 Testing –Endoscopic Video ProcessorReport Number 103480453BOX-005 –Listing Constructional Data Report	IEC 60601-1:2005 + A1:2012 – Medicalelectrical equipment. General requirements forbasic safety and essential performanceIEC 60601-2-18:2009 – Medical electricalequipment – Part 2-18: Particular requirementsfor the basic safety and essential performanceof endoscopic equipmentIEC 60601-1-2:2014 – Medical electricalequipment. General requirements for basicsafety and essential performance. CollateralStandard. Electromagnetic disturbances.Requirements and testsIEC 60601-1-6:2010 + A1:2013 – Medicalelectrical equipment – Part 1-6: Generalrequirements for basic safety and essentialperformance – Collateral standard: UsabilityIEC 62304:2006+A1:2015 – Medical devicesoftware – Software life cycle processesEN ISO 14971:2012 – Medical devices.Application of risk management to medicaldevices

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.

Regulation Number and Section

§ 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.

Srinivas Nandkumar -S

Indications for Use

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) Summary

General Information

2242464

Alternate Contact:

Device Information

Device Description

Indications for Use

Intended Use

Contraindications

Comparison to Predicate Device

Summary of Testing

Table 1.1 – Summary of Testing

Conclusion

§ 874.4710 Esophagoscope (flexible or rigid) and accessories.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW