(28 days)
Not Found
No
The document describes software changes for image processing and user control features ("Aiming Beam Mode") but does not mention AI, ML, or related concepts like training/test sets for algorithms.
Yes
The device is described as being used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract."
No
The device is a system that includes both a software-controlled console and a physical, single-use ureteroscope, which is a hardware component. While software changes are part of the submission, the overall system is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize organs, cavities and canals in the urinary tract" and to "perform various diagnostic and therapeutic procedures in the urinary tract." This describes a device used directly on or within the patient for visualization and intervention.
- Device Description: The description details a "software-controlled digital flexible ureteroscope system" consisting of a console and a ureteroscope. This is a medical device used for endoscopy, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis based on laboratory testing
The device is clearly an endoscopic system used for direct visualization and procedures within the urinary tract, which falls under the category of a medical device used in vivo.
N/A
Intended Use / Indications for Use
The LithoVue Elite Digital Flexible Ureteroscope System is intended to by used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
Product codes
FGB
Device Description
The LithoVue Elite Digital Flexible Ureteroscope System is a software-controlled digital flexible ureteroscope system that consists of the StoneSmart Connect Console and the Single-Use Digital Flexible Ureteroscope. The LithoVue Elite Digital Flexible Ureteroscope System is designed to allow the physician to access, visualize and perform procedures in the urinary tract.
The proposed devices within the scope of this Special 510(k) premarket notification are the StoneSmart Connect Console and the LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).
Changes to the StoneSmart Connect Console (cleared under K221515 on 02-FEB-2023) include software changes to introduce a new user control feature (referred to as "Aiming Beam Mode") that is designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system and implement software bug fixes and enhancements.
The proposed LithoVue Elite Single-Use Digital Flexible Ureteroscope is the same as the predicate LithoVue Elite Sinqle-Use Digital Flexible Ureteroscope with pressure monitoring (K221515) with respect to its design, performance, intended use, operating principle, and fundamental technology, except that it does not possess the pressure monitoring capability.
Mentions image processing
A digital CMOS imager located in the distal tip of the ureteroscope provides the raw image data from the surgical field. The raw image data is transferred from the CMOS imager through the ureteroscope handle, via the umbilicus, to the console for processing and output to an external display.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CMOS imager
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
Design verification (bench) testing for visualization, mechanical performance, and durability, conducted by utilizing the predicate ureteroscope (K221515), remains valid for the proposed ureteroscope. Changes to the cleared console (K221515) are limited to software changes only. The existing bench testing information/data reviewed by the FDA for the predicate console (reference K221515) remains valid for the proposed console.
Software testing was completed. The software documentation stipulated in FDA guidance document, Content of Premarket Submissions for Device Software Functions (issued June 14, 2023) was included in this premarket submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
December 12, 2023
Boston Scientific Corporation Urology and Pelvic Health Division Alexandra Skinner Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K233645
Trade/Device Name: StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: November 13, 2023 Received: November 14, 2023
Dear Alexandra Skinner:
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.
1
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" (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 QS 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.
2
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 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,
Mark J. Antonino -S
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
510(k) Number (if known) K233645
Device Name StoneSmart Connect Console LithoVue Elite Standard Deflection LithoVue Elite Reverse Deflection
Indications for Use (Describe)
The LithoVue Elite Digital Flexible Ureteroscope System is intended to by used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
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 for LithoVue Elite Digital Flexible Ureteroscope System
Date Prepared: 13-NOV-2023
A. Submitter
Boston Scientific Corporation Urology Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contacts
Alexandra Skinner Regulatory Affairs Specialist II 508-382-9492 Alexandra.Skinner@bsci.com
C. Device Names
| Trade Name(s): | StoneSmart Connect Console
LithoVue Elite Standard Deflection
LithoVue Elite Reverse Deflection |
|--------------------|-------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Ureteroscope and Accessories,
Flexible/Rigid |
| Regulation Number: | 21 CFR §876.1500 |
| Regulation Name: | Endoscope and accessories |
| Classification: | Class II |
| Product Code: | FGB |
D. Predicate and Reference Devices
For the purpose of establishing 'substantial equivalence', the design and technological characteristics of the proposed StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope were compared to the following 510(k)-cleared devices.
| Predicate Device | |
|---|---|
| Device Trade Name(s): | StoneSmart™ Connect Console and LithoVue™ |
| Elite Single-Use Digital Flexible Ureteroscope with | |
| Pressure Monitoring | |
| Regulation Name: | Endoscope and accessories |
| Regulation Number: | 21 CFR §876.1500 |
| Classification: | Class II |
Predicate Device for Establishing 'Substantial Equivalence'
5
| Product Code: | FGB |
|---|---|
| 510(k) Submitter/Holder: | Boston Scientific Corporation, Marlborough, MA |
| 510(k) #/ | K221515 |
| Clearance Date | February 2, 2023 |
E. Device Description
The LithoVue Elite Digital Flexible Ureteroscope System is a software-controlled digital flexible ureteroscope system that consists of the StoneSmart Connect Console and the Single-Use Digital Flexible Ureteroscope. The LithoVue Elite Digital Flexible Ureteroscope System is designed to allow the physician to access, visualize and perform procedures in the urinary tract.
The proposed devices within the scope of this Special 510(k) premarket notification are the StoneSmart Connect Console and the LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).
Changes to the StoneSmart Connect Console (cleared under K221515 on 02-FEB-2023) include software changes to introduce a new user control feature (referred to as "Aiming Beam Mode") that is designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system and implement software bug fixes and enhancements.
The proposed LithoVue Elite Single-Use Digital Flexible Ureteroscope is the same as the predicate LithoVue Elite Sinqle-Use Digital Flexible Ureteroscope with pressure monitoring (K221515) with respect to its design, performance, intended use, operating principle, and fundamental technology, except that it does not possess the pressure monitoring capability.
F. Intended Use/Indications for Use
The indications for use of the LithoVue Elite Digital Flexible Ureteroscope System (cleared under K221515, on 02-FEB-2023) remains valid; therefore, no change to the cleared indications for use (presented below) is being proposed in the current submission.
The LithoVue Elite Digital Flexible Ureteroscope System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
G. Operating Principle
The operating principle for the illumination and intraluminal pressure monitoring of the predicate ureteroscope system (submitted under K221515) is unchanged and therefore applies to the proposed ureteroscope system. The illumination is generated by an LED located in the ureteroscope handle and transmitted to the distal tip lens via a fiber-optic
6
illumination fiber. A digital CMOS imager located in the distal tip of the ureteroscope provides the raw image data from the surgical field. The raw image data is transferred from the CMOS imager through the ureteroscope handle, via the umbilicus, to the console for processing and output to an external display.
The console supports real-time intraluminal pressure monitoring when used with a LithoVue Elite ureteroscope with pressure monitoring capability, which contains the piezoresistive MEMS absolute pressure sensor located at the distal tip. The proposed ureteroscope, submitted as part of the current application, does not have pressure measuring/monitoring capability.
H. Comparison of Key Technological/Performance Characteristics
The proposed StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring) have the same technological characteristics and fundamental design as the predicate devices.
| | Proposed StoneSmart
Connect Console and
LithoVue Elite Single-
Use Digital Flexible
Ureteroscope (without
Pressure Monitoring) | Predicate StoneSmart
Connect Console and
LithoVue Elite Single-
Use Digital Flexible
Ureteroscope (with
Pressure Monitoring)
(K221515) | Substantial
Equivalence
Discussion |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reusability | Ureteroscope (without
pressure monitoring):
Single Use
Console: Reusable | Ureteroscope (with
pressure monitoring):
Single Use
Console: Reusable | Same |
| Ureteroscope
Type | Flexible | Flexible | Same |
| Ureteroscope is
Provided | Sterile | Sterile | Same |
| Sterilization
Agent | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Power Input
(Workstation) | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Same |
| Imager Type | CMOS | CMOS | Same |
| Imager Location | Distal | Distal | Same |
| Illumination
Source | LED | LED | Same |
| Ureteroscope
supports real-
time intraluminal | No | Yes | The proposed
ureteroscope does
not support real- |
| | Proposed StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without Pressure Monitoring) | Predicate StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope (with Pressure Monitoring) (K221515) | Substantial Equivalence Discussion |
| pressure monitoring | | | time intraluminal pressure monitoring. |
| Aiming Beam Mode | Yes | No | Aiming beam mode is a new feature introduced with the proposed console. It is an optional (user-activated) feature that is designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system. |
| Ureteroscope Mechanical Specifications | | | |
| Shaft Working Length | 68 cm | 68 cm | Same |
| Shaft OD | 9.5F | 9.5F | Same |
| Insertion Portion Width (Distal Face) | 7.7 F | 7.7 F | Same |
| Working Channel Size | 3.6 F (1.15mm MIN ABS) | 3.6 F (1.15mm MIN ABS) | Same |
| Working Length | 82 cm | 82 cm | Same |
| Deflection | Active and Passive | Active and Passive | Same |
| Degree of Active Deflection | 270° in both directions | 270° in both directions | Same |
| Optical Specifications | | | |
| | Proposed StoneSmart
Connect Console and
LithoVue Elite Single-
Use Digital Flexible
Ureteroscope (without
Pressure Monitoring) | Predicate StoneSmart
Connect Console and
LithoVue Elite Single-
Use Digital Flexible
Ureteroscope (with
Pressure Monitoring)
(K221515) | Substantial
Equivalence
Discussion |
| Field of View (in
air) | 120° (diagonal) | 120° (diagonal) | Same |
| Working
Distance | 2 - 50 mm | 2 - 50 mm | Same |
| Direction of View | 0° (forward viewing) | 0° (forward viewing) | Same |
| Resolution | Typical (5mm Distance):
9.81 lp/mm | Typical (5mm
Distance): >9.81 lp/mm | Same |
| Video Latency
(Max.) | 155 ms | 155 ms | Same |
7
8
-Substantial Equivalence
A direct comparison of key characteristics demonstrates that the proposed StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring) are substantially equivalent to the predicate devices with respect to intended use, technological characteristics, and performance characteristics. The differences between the proposed and predicate devices do not alter the suitability of the proposed devices for their intended use.
J. Performance Testing
Design verification (bench) testing for visualization, mechanical performance, and durability, conducted by utilizing the predicate ureteroscope (K221515), remains valid for the proposed ureteroscope. Changes to the cleared console (K221515) are limited to software changes only. The existing bench testing information/data reviewed by the FDA for the predicate console (reference K221515) remains valid for the proposed console.
Software testing was completed. The software documentation stipulated in FDA guidance document, Content of Premarket Submissions for Device Software Functions (issued June 14, 2023) was included in this premarket submission.
The proposed ureteroscope does not introduce any new direct or indirect patientcontacting materials, as compared to the predicate ureteroscope. Furthermore, the predicate ureteroscope with its additional patient-contacting components to support its pressure monitoring capability is considered a worst-case device for biocompatibility testing purposes. Therefore, the biocompatibility test results reviewed by the FDA for the predicate ureteroscope (reference K221515) also support the proposed ureteroscope (without pressure monitoring). Thus, additional biocompatibility testing was not required for the proposed device. The console is non-patient contacting; therefore, no biocompatibility testing is required.
9
There are no differences between the predicate ureteroscope (with pressure monitoring) and the proposed ureteroscope (without pressure monitoring) that could affect the shelf life or sterility; therefore, sterilization and shelf-life evaluations were not required. The console is a durable medical device that will be supplied non-sterile and is not intended to be sterilized by the user. Handling and storage conditions, as described in the console user's manual, are not expected to affect the safety or effectiveness of the console. Therefore, sterilization and shelf-life testing are not required for the console.
Changes to the cleared console (K221515) are limited to software changes only and the predicate ureteroscope with active pressure monitoring is considered a worstcase device for electrical safety and EMC testing purposes. Therefore, the previously reviewed electrical safety and EMC test results for the predicate ureteroscope and console (reference K221515) also support the proposed ureteroscope and console.
K. Conclusion
Based on the intended use/indications for use, comparison of key technological characteristics, and performance testing presented in this premarket notification, it is concluded that the proposed StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope are substantially equivalent to the predicate devices (cleared under K221515).