(209 days)
K193095 Ambu® aScope™ 4 Cysto
Not Found
No
The summary describes a standard endoscopic visualization system and does not mention any AI/ML capabilities, image processing beyond basic visualization, or data training/testing related to AI/ML.
No
The device is described for visualization during diagnostic and therapeutic procedures, but its function is only visualization and does not involve applying therapy. While visualization is a component of therapeutic procedures, the device itself is not a therapeutic tool; it's a diagnostic imaging tool.
Yes
The "Intended Use / Indications for Use" states that the device is intended for use "during diagnostic and therapeutic cystoscopy procedures" and "during diagnostic and therapeutic endoscopy procedures". This explicitly includes diagnostic purposes.
No
The device description clearly states that the LiNA CystoVu HD is a sterile, single-use, flexible cystoscope with an optical module containing a camera and LED light sources. This indicates the presence of hardware components beyond just software. While software verification and validation are mentioned, the device 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 clearly states the device is for "visualization" of anatomical structures (urethra and bladder cavity) during diagnostic and therapeutic procedures. This is a direct visualization tool used in vivo (within the body).
- Device Description: The description reinforces that it's a flexible cystoscope with a camera and light source for visualization.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. IVDs typically involve analyzing biological samples.
The device is an endoscopic visualization system used for direct examination of internal body cavities.
N/A
Intended Use / Indications for Use
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.
Product codes
FAJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra and bladder cavity
Indicated Patient Age Range
Adult male and female (for LiNA CystoVu HD); female and male patients of all ages (for LiNA ScopeVu)
Intended User / Care Setting
hospital- or medical office environment use and is operated by medical professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- 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 10-6.
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K193095 Ambu® aScope™ 4 Cysto
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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"
1
(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
2
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)
Indications for Use (Describe)
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.
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
510(k) SUMMARY
I. SUBMITTER
| 510(k) Holder: | LiNA Medical ApS
Formervangen 5
DK-2600 Glostrup
Denmark |
|--------------------|----------------------------------------------------------------------------------------------------------|
| Contact Person: | Richelle Helman
Senior Director, Regulatory
MEDIcept, Inc.
rhelman@medicept.com
603-765-8184 |
| Secondary Contact: | Katarzyna Barczak
Regulatory Officer
LiNA Medical ApS
kbr@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.
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.
5
V. INTENDED USE/INDICATIONS FOR USE
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.
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 Device
LiNA CystoVu HD
LiNA Medical | Predicate Device
Ambu aScope 4 Cysto
Ambu Inc.
(K193095) | Equivalence
Comparison |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Regulatory Class | Class II | Class II | Same |
| Regulatory Number | 876.1500 | 876.1500 | Same |
| Regulation Name | Endoscope and
Accessories | Endoscope and
Accessories | Same |
| Product Code | FAJ | FAJ | Same |
| Device Definition | Cystoscope and
Accessories,
Flexible/Rigid | Cystoscope and
Accessories,
Flexible/Rigid | Same |
| Intended Use/
Indications for Use | 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 | Ambu® aScope™ 4
Cysto is a sterile, single-
use, flexible cystoscope
intended to be used for
endoscopic access to
and examination of the
lower urinary tract. The
Ambu® aScope™ 4
Cysto is intended to | Same |
| Characteristic | Subject Device
LiNA CystoVu HD
LiNA Medical | Predicate Device
Ambu aScope 4 Cysto
Ambu Inc.
(K193095) | Equivalence
Comparison |
| | intended for hospital- or
medical office
environment use and is
operated by medical
professionals. | provide visualization via
Ambu® displaying unit
and can be used with
endoscopic accessories.
Ambu® aScope™ 4
Cysto is intended for use
in a hospital
environment or medical
office environment.
Ambu® aScope™ 4
Cysto is designed for
use in adults. | |
| Use Population | Adults | Adults | Same |
| Use Environment | Professional Healthcare
Facility Environment | Professional Healthcare
Facility Environment | Same |
| Operating Principle | The camera is placed at
the distal tip of the
flexible catheter. The
working channel (used
for irrigation and route
for surgical
instruments), the wires
from the camera and the
optical fibers (for the
illumination of the
organs) are all running
inside the flexible
catheter. The active tip
can be articulated by the
user by using the lever
on the handle. | The camera is placed at
the distal tip of the
flexible catheter. The
working channel (used
for irrigation and route
for surgical
instruments), the wires
from the camera and for
the LED's (for the
illumination of the
organs) are all running
inside the flexible
catheter. The active tip
can be articulated by the
user by using the lever
on the handle. | Same |
| Endoscope feature | Flexible with a
maneuverable tip. | Flexible with a
maneuverable tip. | Same |
| Handle | It has a control button
giving the operator the
ability to maneuver the
endoscope tip up and
down. | It has a control button
giving the operator the
ability to maneuver the
endoscope tip up and
down. | Same |
| Characteristic | Subject Device
LiNA CystoVu HD
LiNA Medical | Predicate Device
Ambu aScope 4 Cysto
Ambu Inc.
(K193095) | Equivalence
Comparison |
| Articulation angle | 210° up and 210° down | 210° up and 120° down | Up articulation,
same. Down
articulation,
different |
| IP Diameter | 5.0 mm | 5.4 mm | Same |
| Distal End
Diameter | 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 Channel
Access | Graspers and other
instrumentation. | Graspers and other
instrumentation. | Same |
| Irrigation | Yes | Yes | Same |
| Camera location | At the distal tip to
provide an image on a
monitor. | At the distal tip to
provide an image on a
monitor. | Same |
| Illumination | Provided at the distal
tip. | Provided at the distal
tip. | Same |
| Light Source | LED | LED | Same |
| Connection | It is connected to a
monitor by a cable. | It is connected to a
monitor 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
6
7
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.
8
- 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.