← Product Code [FAJ](/productcode/FAJ) · K253905

# PrimeSight UltraView System (K253905)

_Cogentix Medical, Inc. · FAJ · Apr 7, 2026 · Gastroenterology, Urology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K253905

## Device Facts

- **Applicant:** Cogentix Medical, Inc.
- **Product Code:** [FAJ](/productcode/FAJ.md)
- **Decision Date:** Apr 7, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 876.1500
- **Device Class:** Class 2
- **Review Panel:** Gastroenterology, Urology
- **Attributes:** Therapeutic

## Indications for Use

PrimeSight UltraView® Hybrid Flexible Video Cystoscope: Indications for Cystoscopy: - Endoscopic access of the lower urinary tract, including the bladder. - When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures. Indications for Hysteroscopy: For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures. PrimeSight UltraView® All-in-One Video Processor Unit: The PrimeSight UltraView® All-in-One Video Processor Unit, when used in conjunction with a Laborie flexible videoscope (i.e., UV-6000 or UV-6000i) with Slide-On® EndoSheath® Technology, is indicated for the display and management of video and images during cystoscopy and hysteroscopy procedures.

## Device Story

System comprises PrimeSight UltraView All-in-One Video Processor (UVP-1000) and Hybrid Flexible Video Cystoscope (UV-6000/6000i) with Slide-On EndoSheath technology. Device captures video/images of lower urinary tract or uterine cavity via CMOS sensor; transmits electronic signal to processor for display/management. Used in clinical settings by physicians for diagnostic and therapeutic procedures. Output allows real-time visualization to guide surgical instruments; aids clinical decision-making by enabling direct inspection of anatomy. Benefits include improved visualization over fiberoptic predecessors and sterile barrier protection via EndoSheath.

## Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via reliability, usability, functional optical equivalency (ISO 8600-1, 8600-3, 8600-5, ISO 12233), environmental stability (ISO 9022-2), packaging (ISTA 3A/3B), biocompatibility (ISO 10993-1), and reprocessing (ISO 17664-1, ISO 11135). Electrical safety/EMC verified per IEC 60601 series.

## Technological Characteristics

Video endoscopic system; CMOS image sensor; In-Plane Switching (IPS) display. Components: UVP-1000 processor, UV-6000/6000i cystoscope, Slide-On EndoSheath. Connectivity: Standalone AIO processor. Sterilization: Ethylene Oxide (EndoSheath). Software: UNITY 3.0. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18, ISO 10993-1, ISO 8600 series.

## Regulatory Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

## Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

## Predicate Devices

- Vision-Sciences Flexible Cystoscope with EndoSheath System ([K071127](/device/K071127.md))

## Reference Devices

- CST-5000/5000i Cystoscopes/Hysteroscopes with Slide-On EndoSheath Technology ([K072180](/device/K072180.md))
- PrimeSight UNITY 9000 Series Video Processor ([K181292](/device/K181292.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 7, 2026

Cogentix Medical, Inc.
Chanrasmey White
Senior Regulatory Affairs Specialist
40 Ramland Rd. S.
Orangeburg, New York 10962

Re: K253905
Trade/Device Name: PrimeSight UltraView System
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FAJ, HIH
Dated: March 20, 2026
Received: March 20, 2026

Dear Chanrasmey White:

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 (the 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 available 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: The Center for Devices and Radiological Health (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, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253905 - Chanrasmey White
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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K253905 - Chanrasmey White
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the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark R. Kreitz -S

for Mark J. Antonino, M.S.
Assistant Director
DHT3B: Division of Reproductive, Gynecology, and Urology Devices
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

|  DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.  |
| --- | --- |
|  510(k) Number (if known) K253905  |   |
|  Device Name PrimeSight UltraView System  |   |
|  Indications for Use (Describe) PrimeSight UltraView® Hybrid Flexible Video Cystoscope: Indications for Cystoscopy: - Endoscopic access of the lower urinary tract, including the bladder. - When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures. Indications for Hysteroscopy: For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures. PrimeSight UltraView® All-in-One Video Processor Unit: The PrimeSight UltraView® All-in-One Video Processor Unit, when used in conjunction with a Laborie flexible videoscope (i.e., UV-6000 or UV-6000i) with Slide-On® EndoSheath® Technology, is indicated for the display and management of video and images during cystoscopy and hysteroscopy 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)  |   |
|  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."  |   |

{4}

Laborie
FOR DIGNITY. FOR LIFE.
Traditional 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

# 510(k) Summary

This summary is submitted in accordance with 21 CFR § 807.92(a)(1).

Date Prepared: March 31, 2026

## Submitter

|  Manufacturer Name and Address | Cogentix Medical, Inc.
40 Ramland Road South,
Orangeburg, NY 10962  |
| --- | --- |
|  Contact Information | Chanrasmey White
Senior Regulatory Affairs Specialist
Laborie Medical Technologies
180 International Drive
Portsmouth, NH 03820 USA
cwhite@laborie.com  |
|  Secondary Contact | Garrett Ahlborg
Senior Manager Regulatory Affairs
Laborie Medical Technologies
180 International Drive
Portsmouth, NH 03820 USA
gahlborg@laborie.com  |

## Device

|  Proprietary Name | PrimeSight UltraView® System  |
| --- | --- |
|  Common Name | Endoscope and accessories  |
|  Classification Name | Cystoscope and accessories, flexible/rigid  |
|  Product Code Associated | FAJ, HIH  |
|  Product Code Regulation | Endoscope and accessories  |
|  Description Regulation | 876.1500  |
|  Number Device Class | Class II  |
|  Review Panel | Gastroenterology/Urology
K071127  |
|  Primary Predicate Device | K072180  |
|  Reference Device | K181292  |
|  Reference Device | The predicate and reference devices have not been subject to any design-related recalls.  |

Laborie Medical Technologies Corp.
Page 1 of 11

{5}

Laborie
FOR DIGNITY. FOR LIFE.
Traditional 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

# Device Description

The PrimeSight UltraView® System consists of the PrimeSight UltraView® All-in-One Video Processor Unit (UVP-1000) and PrimeSight UltraView® Hybrid Flexible Video Cystoscope (UV-6000 and UV-6000i) with Slide-On® EndoSheath® Technology. The PrimeSight UltraView System forms an endoscopy system utilized for the display and management of video and images during endoscopic access and examination of the lower urinary tract, including the bladder, and for accessing the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures. When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures. The subject PrimeSight UltraView System maintains the same intended use and indications for use of its primary predicate device, the CST-2000A Flexible Hysteroscope with EndoSheath System (K071127). In addition, the subject PrimeSight UltraView System is a modification to the currently marketed PrimeSight System which includes the reference devices, the CST-5000/5000i Cystoscopes/Hysteroscopes with Slide-On® EndoSheath® Technology (K072180) and the PrimeSight UNITY 9000 Series Video Processor (K181292). Therefore, the subject device is substantially equivalent to the identified predicate and reference devices.

# Indication for Use

## PrimeSight UltraView® Hybrid Flexible Video Cystoscope

### Indications for Cystoscopy:

- Endoscopic access of the lower urinary tract, including the bladder.
- When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures.

### Indications for Hysteroscopy:

For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures.

## PrimeSight UltraView® All-in-One Video Processor Unit

The PrimeSight UltraView® All-in-One Video Processor Unit, when used in conjunction with a Laborie flexible videoscope (i.e., UV-6000 or UV-6000i) with Slide-On® EndoSheath® Technology, is indicated for the display and management of video and images during cystoscopy and hysteroscopy procedures.

Laborie Medical Technologies Corp.
Page 2 of 11

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Laborie

FOR DIGNITY. FOR LIFE.

Special 510(k) Premarket Notification

PrimeSight UltraView® System

510(k) Summary

510(k): K253905

Comparison of Technological Characteristics with the Predicate Devices
Table 1: Comparison of Technological Characteristics with the Predicate Devices

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|  Indications for Use | PrimeSight UltraView® Hybrid Flexible Video Cystoscope
Indications for Cystoscopy:
• Endoscopic access of the lower urinary tract, including the bladder.
• When combined with accessory instruments, the endoscopic system allows the user to perform various diagnostic and therapeutic procedures.

Indications for Hysteroscopy:
For accessing the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic surgical procedures.

PrimeSight UltraView® All-in-One Video Processor Unit
The PrimeSight UltraView® All-in-One Video Processor Unit, when used in conjunction with a Laborie flexible videoscope (i.e., UV-6000 or UV-6000i) with Slide-On® EndoSheath® Technology, is indicated for the display and management of video and images during cystoscopy and hysteroscopy procedures. | The CST-2000A and Slide-On® EndoSheath® System provides for endoscopic access and examination of the lower urinary tract including the bladder, and using additional accessories, to perform various diagnostic and therapeutic procedures.

The CST-2000A and Slide-On® EndoSheath® System is used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and therapeutic/surgical procedures. | The PrimeSight UltraView System maintains the same intended use and indications for use as its primary predicate device (K071127), which is intended for cystoscopy and hysteroscopy procedures.  |

Laborie Medical Technologies Corp.

{7}

Laborie
FOR DIGNITY. FOR LIFE.
Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|  Contraindications | The UltraView Cystoscope and EndoSheath should not be used to perform cystoscopy if any one of the following conditions exists:
• Patients with acute infection (acute urethritis, acute prostatitis, acute epididymitis)
• Patients with untreated urinary tract infection

The UltraView Cystoscope and EndoSheath should not be used to perform hysteroscopy if any one of the following conditions exists:
• The patient is pregnant or suspected to be pregnant
• The patient’s cervix cannot be properly dilated
• The patient’s uterus cannot be distended
• The patient has acute pelvic inflammatory disease (PID)
• The patient has invasive carcinoma of the cervix
• The patient has had a recent uterine perforation | The CST-2000A and Slide-On EndoSheath System should not be used to perform hysteroscopy if any one of the following conditions exists. Do not perform hysteroscopy using this equipment if:
• The patient is pregnant or suspected to be pregnant
• The patient’s cervix cannot be properly dilated
• The patient’s uterus cannot be distended
• The patient has acute pelvic inflammatory disease (PID)
• The patient has invasive carcinoma of the cervix
• The patient has had a recent uterine perforation | The PrimeSight UltraView System maintains the same contraindications as its primary predicate device (K071127) for hysteroscopy. Contraindications for cystoscopy have been added, however the addition of these contraindications does not raise new questions of safety or effectiveness.  |

Laborie Medical Technologies Corp.
Page 4 of 11

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Laborie
FOR DIGNITY. FOR LIFE.
Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|   | The digital video processors are not contraindicated for any patient population. |  |   |
|  System Components | UVP-1000 – Video Processor
UV-6000/6000i
Slide-On EndoSheath Technology
Cart, Table Top, Wall Mounted | CST-2000A
C2 Slide On EndoSheath System
Fiberoptic light source | The primary predicate device is a fiberoptic system, whereas the subject device is a video endoscopic system that uses an electronic image transmission system to achieve its intended use. The design and performance of the subject device have been demonstrated to be equivalent to the reference devices K181292 and K072180 through bench testing. The differences in system components compared to the primary predicate device do not raise questions on safety and effectiveness.  |
|  Workflow | Cystoscopy and Hysteroscopy Procedures with a Video Processor System | Cystoscopy and Hysteroscopy Procedures with a Fiberoptic System | The primary predicate device is a fiberoptic system, whereas the subject device is a video endoscopic system that uses an electronic image transmission system to achieve its intended use. The PrimeSight UltraView System continues to support standard procedural steps and user interactions consistent with the predicate and reference devices. The design and performance of the subject device have been demonstrated to be equivalent to the reference devices K181292 and K072180 through bench testing. The differences compared to the primary predicate device  |

Laborie Medical Technologies Corp.
Page 5 of 11

{9}

Laborie
FOR DIGNITY. FOR LIFE.

Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary

510(k): K253905

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|   |  |  | do not raise questions on safety and effectiveness.  |
|  Endoscope Design | UV-6000/UV-6000i Videoscope | CST-2000A Fiberscope | The design of the subject endoscopes as part of the PrimeSight UltraView System is a design change to reference device (K072180). The overall usability and handling of the endoscope have not changed. The design and performance of the subject device have demonstrated to be equivalent to the reference device (K072180) through performance testing and does not raise questions on safety and effectiveness compared to the predicate device.  |
|  Video Processor Design | UVP-1000 Video Processor:
All-in-One Computer (AIO)
Camera Control Unit (CCU) | N/A | The primary predicate device is a fiberoptic system, whereas the subject device is a video endoscopic system that uses an electronic image transmission system to achieve its intended use. The subject video processor and reference device (K181292) include an All-in-One (AIO) Computer and Camera Control Unit (CCU). The design and performance of the subject device have been demonstrated to be equivalent to the reference device (K181292) through bench testing. The differences compared to the primary predicate device do not raise questions on safety and effectiveness.  |

Laborie Medical Technologies Corp.
Page 6 of 11

{10}

Laborie
FOR DIGNITY. FOR LIFE.

Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary

510(k): K253905

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|  Video Processor Display Technology | Utilizes In-Plane Switching (IPS)
Display Technology | N/A | The primary predicate device is a fiberoptic system, whereas the subject device is a video endoscopic system that uses an electronic image transmission system to achieve its intended use. The design and performance of the subject device have been demonstrated to be equivalent to the reference device (K181292) through bench testing. The differences compared to the primary predicate device do not raise questions on safety and effectiveness.  |
|  System Image | System allows for images to be displayed during endoscopic procedures utilizing Complementary Metal-Oxide-Semiconductor (CMOS)
Image Sensor. | The optical system consists of a fiberoptic glass bundle, which transmits the image from the distal end of the scope to the eyepiece, and two fiberoptic glass illumination bundles. The scope is intended for use with a standard fiberoptic light source. | The primary predicate device is a fiberoptic system, whereas the subject device is a video endoscopic system that uses an electronic image transmission system to achieve its intended use. The design and performance of the subject device have been demonstrated to be equivalent to the reference device (K181292) through bench testing. The differences compared to the primary predicate device do not raise questions on safety and effectiveness.  |
|  System Software | Unity 3.0
Developed in accordance with IEC 62304 | N/A | The UNITY 3.0 software used in the PrimeSight UltraView System was developed in accordance with IEC 62304. UNITY 3.0 is based on the currently marketed UNITY 2.0 software incorporated in the reference devices K181292 and K072180. The differences compared to the  |

Laborie Medical Technologies Corp.
Page 7 of 11

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Laborie

FOR DIGNITY. FOR LIFE.

Special 510(k) Premarket Notification

PrimeSight UltraView® System

510(k) Summary

510(k): K253905

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|   |  |  | primary predicate device do not raise questions on safety and effectiveness.  |
|  Electrical Safety and EMC | Electrical safety and EMC testing performed per:
IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC-60601-2-18 | N/A | Testing for Electrical Safety and Electromagnetic Compatibility (EMC) was performed in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC-60601-2-18 identical to the Electrical Safety and EMC performed for the reference device (K181292). The differences compared to the primary predicate device do not raise questions on safety and effectiveness.  |
|  Biocompatibility | Biocompatibility testing performed per ISO 10993-1 on EndoSheath System | Biocompatibility testing performed per ISO 10993-1 on EndoSheath System | Biocompatibility of the EndoSheath System was performed according to ISO 10993-1, identical to reference device (K072180). The differences compared to the primary predicate device do not raise questions on safety and effectiveness.  |
|  Reprocessing | Endoscope:
High Level Disinfection
Sterilization | Endoscope:
High Level Disinfection
Ethylene Oxide Sterilization | The reprocessing of the subject endoscope is equivalent to the primary predicate device, utilizing validated high-level disinfection and sterilization procedures. The validated reprocessing procedures of the subject endoscope are identical to the reference device (K072180). The differences compared to the primary predicate device do not raise questions on safety and effectiveness.  |

Laborie Medical Technologies Corp.
Page 8 of 11

{12}

Laborie
FOR DIGNITY. FOR LIFE.
Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

|  Element of Comparison | PrimeSight UltraView® System | Primary Predicate
Vision-Sciences Flexible Cystoscope
with EndoSheath® System
K071127 | Evaluation  |
| --- | --- | --- | --- |
|  Sterility | CV EndoSheath – Ethylene Oxide
Sterilized validated to SAL 10⁻⁵ | C2 EndoSheath – Ethylene Oxide
Sterilized validated to SAL 10⁻⁵ | The sterility of the compatible EndoSheath is achieved using an Ethylene Oxide sterilization process validated to a sterility assurance level (SAL) of 10⁻⁶, identical with the sterilization method and performance of the primary predicate and reference devices.  |

Laborie Medical Technologies Corp.
Page 9 of 11

{13}

Laborie
FOR DIGNITY. FOR LIFE.
Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

# Non-Clinical Performance Data

The proposed device has been evaluated against the predicate and reference devices listed in the table above. Performance testing was conducted to support the determination of substantial equivalence, including assessments of reliability, usability, functional performance (including optical equivalency), packaging, and environmental stability. All testing met the predefined acceptance criteria.

The software update from UNITY 2.0 to UNITY 3.0 was developed and validated in accordance with IEC 62304. Based on the results of this validation and supporting performance testing, the software changes do not raise any questions regarding the safety or effectiveness of the subject device.

Additionally, the PrimeSight UltraView System successfully passed all testing and demonstrates compliance with applicable electrical safety and electromagnetic compatibility (EMC) standards.

Below is a summary of the non-clinical performance testing conducted, along with the corresponding standards to which the testing demonstrates compliance:

- Software
- IEC 62304: Medical device software - Software life cycle processes
- Electrical Safety & EMC
- IEC 60601-1: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests
- IEC 60601-1-6: Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 60601-2-18: Medical electrical equipment – Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment
- Photobiological Safety
- IEC 62471: Photobiological safety of lamps and lamp systems
- Environmental Stability
- ISO 9022-2: Optics and photonics — Environmental test methods
- Packaging Verification
- ISTA 3A: Package Integrity Testing of Product Packaging Less Than 150 lb
- ISTA 3B: Package Testing of Packaged-Products for Less-Than-Truckload (LTL) Shipment
- Optical Equivalency
- ISO 8600-1: Endoscopes — Medical endoscopes and endotherapy devices – Part 1: General requirements
- ISO 8600-3: Endoscopes — Medical endoscopes and endotherapy devices – Part 3: Determination of field of view and direction of view of endoscopes with optics
- ISO 8600-5: Optics and photonics — Medical endoscopes and endotherapy devices – Part 5: Determination of optical resolution of rigid endoscopes with optics
- ISO 12233: Digital cameras — Resolution and spatial frequency responses
- Human Factors

Laborie Medical Technologies Corp.
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{14}

Laborie
FOR DIGNITY. FOR LIFE.
Special 510(k) Premarket Notification
PrimeSight UltraView® System
510(k) Summary
510(k): K253905

○ ISO 62366-1: Medical devices – Part 1: Application of usability engineering to medical devices

- Biocompatibility Assessment
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

- Reprocessing Assessment
- ISO 17664-1: Sterilization of medical devices – Information to be provided by the manufacturer for the processing of resterilizable medical devices – Part 1: Critical and semi-critical devices
- ISO 11135: Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices

- In addition, functional, reliability, and usability testing were performed to verify that the design outputs meet the design inputs for the PrimeSight UltraView System. All testing was completed and met the predefined acceptance criteria.

Based on this comprehensive evaluation, the subject PrimeSight UltraView System has been determined to be substantially equivalent to the primary predicate device, the CST-2000A Flexible Hysteroscope with EndoSheath System (K071127) as well as the reference devices, the CST-5000/5000i Cystoscopes/Hysteroscopes with Slide-On® EndoSheath® Technology (K072180) and the PrimeSight UNITY 9000 Series Video Processor (K181292).

# Conclusion

A comprehensive evaluation of functionality, operation, user interface, and design of the PrimeSight UltraView System has been determined to be substantially equivalent to the primary predicate device, the CST-2000A Flexible Hysteroscope with EndoSheath System (K071127), as well as the reference devices, the CST-5000/5000i Cystoscopes/Hysteroscopes with Slide-On® EndoSheath® Technology (K072180) and the PrimeSight UNITY 9000 Series Video Processor (K181292). The subject device shares the same intended use and fundamental scientific technology as the predicate and reference devices. The minor differences in technological characteristics do not introduce new or different issues of safety or effectiveness, and performance testing confirms that the subject device is at least as safe and effective as the predicates. Therefore, the subject device is substantially equivalent with respect to safety and effectiveness.

Laborie Medical Technologies Corp.
Page 11 of 11

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**Source:** [https://fda.innolitics.com/device/K253905](https://fda.innolitics.com/device/K253905)

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