The LiNA CystoVu HD is intended for use in visualization via LiNA displaying unit of adult male and female urethra and bladder cavity during diagnostic and therapeutic cystoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

Device Description

The LiNA CystoVu™ HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by LiNA Scope Vu™ full HD display and light source. The LiNA Cysto Vu™ HD is intended to be used with a reusable LiNA ScopeVu™ to visualize the urethra and the bladder. The LiNA CystoVu™ HD can be operated by the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

AI/ML Overview

The provided text describes the LiNA CystoVu HD and LiNA ScopeVu, single-use flexible cystoscopes, and their substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study that proves the device meets those criteria with detailed device performance metrics, MRMC comparative effectiveness studies, standalone algorithm performance, or training set details as requested in your prompt.

The document focuses on demonstrating substantial equivalence to a predicate device (Ambu aScope 4 Cysto) through non-clinical performance testing.

Here's a breakdown of what can be extracted from the provided text based on your request, and what is missing:

1. Table of acceptance criteria and the reported device performance

This information is not explicitly provided in the document. The text states: "Non-clinical performance testing was conducted in order to demonstrate that the LiNA CystoVu HD and LiNA ScopeVu perform according to their requirements and specifications." It then lists the types of tests conducted:

Test Type	Reported Performance/Outcome
Functional and Performance Testing (mechanical instrumentation)	Satisfies functional performance requirements including force/bending/tensile stress and stress cracking and irrigation flow testing.
Optical Performance Testing (ISO 8600 series)	Complies with ISO 8600 series.
Optical Performance (various metrics)	Color performance, geometric distortion, field of view, resolution, depth of field, image intensity uniformity, SNR, dynamic range, image frame frequency, and system delay were compared with the predicate device. (Specific measurements/thresholds are not provided, only that a comparison was done and implied to be acceptable for substantial equivalence)
Electrical Safety and EMC Testing	Complies with IEC 60601-1 and IEC 60601-2-18 for safety and IEC 60601-1-2 for EMC.
Software Verification and Validation	Conducted as required by IEC 62304 and documented per FDA Guidance.
Biocompatibility Testing	All tests indicated patient contact materials were biocompatible (in accordance with ISO 10993 series).
Sterilization	Validated in accordance with ISO 11135 to an SAL of 10⁻⁶.
Human Factors Testing	Confirmed that the design of the device is safe and effective for intended users, uses, and use environments.

2. Sample size used for the test set and the data provenance

This information is not provided. The non-clinical performance testing description does not specify sample sizes for individual tests or the provenance of any data used for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The testing described is primarily non-clinical and technical performance testing, not involving expert interpretation of medical images or diagnoses. Human factors testing included "Test participants representing the intended users," but their qualifications for establishing ground truth (in the diagnostic sense) are not relevant or mentioned.

4. Adjudication method for the test set

This information is not provided. Given the nature of the non-clinical performance tests conducted, an adjudication method as typically understood for clinical or image interpretation studies is not applicable or described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided. The document makes no mention of AI or an MRMC study. It describes a medical device (endoscope components) and its direct performance, not an AI-assisted diagnostic tool.

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

This information is not provided. There is no mention of an algorithm or standalone performance testing for AI components.

7. The type of ground truth used

For the technical and performance tests, the "ground truth" would be the engineering specifications, relevant ISO/IEC standards, and expected functional outcomes. For biocompatibility, it's the established safety profiles within ISO 10993. For sterilization, it's the validated SAL (Sterility Assurance Level).
The document explicitly states: "Clinical data was not used to support substantial equivalence of the subject device to the predicate device." This means there was no ground truth derived from pathology, expert consensus on clinical cases, or outcomes data in a clinical setting for substantial equivalence.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

9. How the ground truth for the training set was established

This information is not applicable and not provided. There is no mention of an AI algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on demonstrating substantial equivalence of a medical device (endoscope components) to a predicate device through non-clinical performance testing and technological comparison. It does not involve AI, clinical data for determining substantial equivalence, or detailed studies with the specific metrics the prompt is asking for related to AI performance, expert ground truth, or training sets.

Summary

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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.

August 22, 2024

LiNA Medical Aps % Richelle Helman Senior Director. Regulatory MEDIcept, Inc. 200 Homer Avenue Ashland, Massachusetts 01721

Re: K240227

Trade/Device Name: LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ Received: July 26, 2024

Dear Richelle Helman:

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: 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.

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"

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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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 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-reportingcombination-products); 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 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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/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,

Sharon M. Andrews -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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K240227

Device Name

LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)

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.

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

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510(k) SUMMARY

I. SUBMITTER

510(k) Holder:	LiNA Medical ApSFormervangen 5DK-2600 GlostrupDenmark
Contact Person:	Richelle HelmanSenior Director, RegulatoryMEDIcept, Inc.rhelman@medicept.com603-765-8184
Secondary Contact:	Katarzyna BarczakRegulatory OfficerLiNA Medical ApSkbr@lina-medical.com(+45) 43 29 66 66

Date Prepared: August 20, 2024

II. DEVICE

Name of Device:	LiNA CystoVu™ HD (CYV-100-5, CYV-101-5) and
	LiNA ScopeVu™ (SCP-100-1)
Common Name:	Cystoscope And Accessories, Flexible/Rigid
Classification Name:	Endoscope and accessories (21 CFR 876.1500)
Regulatory Class:	Class II
Product Code:	FAJ

PREDICATE DEVICE III.

K193095 Ambu® aScope™ 4 Cysto The predicate device has not been subject to a design-related recall.

DEVICE DESCRIPTION IV.

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V. INTENDED USE/INDICATIONS FOR USE

The LINA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

In accordance with the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued July 28, 2014, the comparison between the predicate Ambu aScope 4 Cysto and the subject LiNA CystoVu HD and the LiNA Scope Vu is shown to be substantially equivalent by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences. (Table 1) The technological characteristic similarities and differences rationale demonstrates that the LiNA Cysto Vu HD and the LiNA ScopeVu are safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness than the predicate Ambu aScope 4 Cysto.

Characteristic	Subject DeviceLiNA CystoVu HDLiNA Medical	Predicate DeviceAmbu aScope 4 CystoAmbu Inc.(K193095)	EquivalenceComparison
Regulatory Class	Class II	Class II	Same
Regulatory Number	876.1500	876.1500	Same
Regulation Name	Endoscope andAccessories	Endoscope andAccessories	Same
Product Code	FAJ	FAJ	Same
Device Definition	Cystoscope andAccessories,Flexible/Rigid	Cystoscope andAccessories,Flexible/Rigid	Same
Intended Use/Indications for Use	The LiNA CystoVu HDis intended for use invisualization via LiNAdisplaying unit of adultmale and female urethraand bladder cavityduring diagnostic andtherapeutic cystoscopyprocedures It is	Ambu® aScope™ 4Cysto is a sterile, single-use, flexible cystoscopeintended to be used forendoscopic access toand examination of thelower urinary tract. TheAmbu® aScope™ 4Cysto is intended to	Same
Characteristic	Subject DeviceLiNA CystoVu HDLiNA Medical	Predicate DeviceAmbu aScope 4 CystoAmbu Inc.(K193095)	EquivalenceComparison
	intended for hospital- ormedical officeenvironment use and isoperated by medicalprofessionals.	provide visualization viaAmbu® displaying unitand can be used withendoscopic accessories.Ambu® aScope™ 4Cysto is intended for usein a hospitalenvironment or medicaloffice environment.Ambu® aScope™ 4Cysto is designed foruse in adults.
Use Population	Adults	Adults	Same
Use Environment	Professional HealthcareFacility Environment	Professional HealthcareFacility Environment	Same
Operating Principle	The camera is placed atthe distal tip of theflexible catheter. Theworking channel (usedfor irrigation and routefor surgicalinstruments), the wiresfrom the camera and theoptical fibers (for theillumination of theorgans) are all runninginside the flexiblecatheter. The active tipcan be articulated by theuser by using the leveron the handle.	The camera is placed atthe distal tip of theflexible catheter. Theworking channel (usedfor irrigation and routefor surgicalinstruments), the wiresfrom the camera and forthe LED's (for theillumination of theorgans) are all runninginside the flexiblecatheter. The active tipcan be articulated by theuser by using the leveron the handle.	Same
Endoscope feature	Flexible with amaneuverable tip.	Flexible with amaneuverable tip.	Same
Handle	It has a control buttongiving the operator theability to maneuver theendoscope tip up anddown.	It has a control buttongiving the operator theability to maneuver theendoscope tip up anddown.	Same
Characteristic	Subject DeviceLiNA CystoVu HDLiNA Medical	Predicate DeviceAmbu aScope 4 CystoAmbu Inc.(K193095)	EquivalenceComparison
Articulation angle	210° up and 210° down	210° up and 120° down	Up articulation,same. Downarticulation,different
IP Diameter	5.0 mm	5.4 mm	Same
Distal EndDiameter	2.3 mm	5.4 mm	Different
Max. Diameter	5.6 mm	6.0 mm	Same
Working Length	390 mm	390 mm	Same
Working Channel	Width: 2.5mm	Width: 2.2 mm	Same
Working ChannelAccess	Graspers and otherinstrumentation.	Graspers and otherinstrumentation.	Same
Irrigation	Yes	Yes	Same
Camera location	At the distal tip toprovide an image on amonitor.	At the distal tip toprovide an image on amonitor.	Same
Illumination	Provided at the distaltip.	Provided at the distaltip.	Same
Light Source	LED	LED	Same
Connection	It is connected to amonitor by a cable.	It is connected to amonitor by a cable.	Same
Distal Tip Diameter	5.4 mm	5.4mm	Same
Insertion Cord	Flexible	Flexible	Same
Use Frequency	CystoVu: single use	Cysto: single use	Same
Sterilization	Ethylene Oxide	Ethylene Oxide	Same

Table 1. Substantial Equivalence for the Subject LiNA CystoVu HD and Predicate Ambu aScope 4 Cysto

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PERFORMANCE DATA VII.

Non-clinical performance testing was conducted in order to demonstrate that the LiNA CystoVu HD and LiNA ScopeVu perform according to their requirements and specifications.

Functional and performance testing were conducted to provide confirmation that . mechanical instrumentation satisfies the functional performance requirements including force/bending/tensile stress and stress cracking and irrigation flow testing.
Optical performance testing was conducted in accordance with the ISO 8600 series.
Color performance, geometric distortion, optical performance (field of view, resolution, ● depth of field and image intensity uniformity), SNR and dynamic range, image frame frequency and system delay test compared with the predicate device.
Electrical safety and EMC testing were conducted. The system complies with IEC 60601-● 1 and IEC 60601-2-18 for safety and IEC 60601-1-2 for EMC.

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Software verification and validation were conducted as required by IEC 62304 and ● documentation was provided as recommended by FDA Guidance "Content of Premarket Submissions for Device Software Functions".
. Biocompatibility testing was conducted in accordance with the ISO 10993 series. All tests indicated the patient contact materials were biocompatible.
Sterilization process has been validated in accordance with ISO 11135 to an SAL of 10°. ●
Human factors testing was conducted in compliance with the requirements of IEC 62366, IEC 60601-1-6 and FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices". Test participants representing the intended users of the device were included in the human factors validation testing. Observational data as well as interview data were recorded. The observation of participant performance and the assessment of their understanding of essential information through the interview confirmed that the design of the device is safe and effective for the intended users, uses and use environments.

The results demonstrated that the LiNA CystoVu™ HD and LiNA ScopeVu™ perform according to their specifications and function as intended.

Clinical data was not used to support substantial equivalence of the subject device to the predicate device.

VIII. CONCLUSIONS

Based on the indications for use, technological characteristics, performance data and comparison to the predicate device it was shown that the LiNA CystoVu™ HD and LiNA ScopeVu™ is substantial equivalent to the predicate Ambu® aScope™ 4 Cysto.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.