(253 days)
No
The summary describes a digital ureteroscope system with real-time pressure monitoring and image processing, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on standard medical device functionalities and testing.
Yes
The device is described as being used "to perform various diagnostic and therapeutic procedures in the urinary tract." It also states that it provides "real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy," which can be a therapeutic function.
Yes
The device is intended to visualize organs, cavities, and canals in the urinary tract, which is a diagnostic function, and can also be used to perform "various diagnostic and therapeutic procedures."
No
The device description explicitly states that the system consists of a Workstation (hardware) and a Single-Use Digital Flexible Ureteroscope (hardware), in addition to being software-controlled. This indicates it is a hardware system with integrated software, not a software-only device.
Based on the provided information, 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 diagnostic and therapeutic procedures within the body. This is an in vivo use, not in vitro (outside the body).
- Device Description: The device is a ureteroscope system designed for direct visualization and procedures within the urinary tract.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro to provide diagnostic information. The pressure monitoring is also performed in vivo.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly within the body for visualization and intervention.
N/A
Intended Use / Indications for Use
The LithoVue Elite Digital Flexible Ureteroscope System is intended 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 System is a software-controlled digital flexible ureteroscope system that consists of the Workstation (to be marketed as StoneSmart Connect Console) and the Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).
The LithoVue Elite System is designed to allow the physician to access, visualize and perform procedures in the urinary tract, and to provide real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy.
Mentions image processing
The raw image data is transferred from the CMOS imager through the ureteroscope handle, via the umbilicus, to the workstation for processing and output to an external display.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital CMOS imager
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing was performed to demonstrate that the device performs as intended under anticipated conditions of use, and that it meets its design specifications. Testing included Working Distance Resolution in Air, Field of View in Air, Direction of View, Image Signal-to-Noise Ratio, Total Flux Available at Tip, Uniformity of Image Brightness, Image Latency, and Photobiological Safety. Additional performance characteristics for the pressure measurement capability were evaluated: Gauge Pressure Accuracy in Water, Pressure Sensor Bandwidth, Pressure Measurement Durability, Pressure Measurement Zero Point Drift, Pressure Measurement Accuracy, and Pressure Measurement Latency.
Biocompatibility of the LithoVue Elite Single-Use Digital Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Externally Communicating - Tissue/Bone/Dentin" with a contact duration of "Limited (≤24 hours)". The following tests were performed: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, and Pyrogen. The results concluded that the ureteroscope is biocompatible.
EMC & Electrical Safety testing were conducted in accordance with ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and a. A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD); IEC 60601-2-18: Edition 3.0. 2009-08. Medical electrical equipment Part 2-18: b. Particular requirements for the basic safety and essential performance of endoscopic equipment; and IEC 60601-1-2: Edition 4.0, 2014-02, Medical electrical equipment Part 1-2: General C. requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. The results demonstrate that the device has met the applicable requirements.
Software verification and validation was completed.
A GLP Animal Study was conducted to demonstrate intraluminal pressure monitoring accuracy in vivo.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Resolution: Typical (5mm Distance): >9.81 lp/mm
Video Latency: 155 ms
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 2, 2023
Boston Scientific Corporation Tanmay Shukla Prin. Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, MA 01752
Re: K221515
Trade/Device Name: LithoVue Elite Digital Flexible Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: January 27, 2023 Received: January 31, 2023
Dear Tanmay Shukla:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K221515
Device Name
LithoVue Elite Digital Flexible Ureteroscope System
Indications for Use (Describe)
The LithoVue Elite Digital Flexible Ureteroscope System is intended 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."
3
510(k) Summary for LithoVue Elite System
Date Prepared: May 24, 2022
A. Submitter
Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contacts
Tanmay Shukla Prin. Regulatory Affairs Specialist 508-683-6522 Tanmay.Shukla@bsci.com
C. Device Names
| Trade Name: | LithoVue Elite Digital Flexible Ureteroscope System |
|---|---|
| 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 Devices
For purposes of establishing 'substantial equivalence', the LithoVue Elite System's design and technological characteristics were compared to the following 510(k)-cleared device.
| Predicate | |
|---|---|
| Device Trade Name: | LithoVue System |
| Regulation Name: | Endoscope and accessories |
| Regulation Number: | 21 CFR §876.1500 |
| Classification: | Class II |
| Product Code: | FGB |
| 510(k) Submitter/Holder: | Boston Scientific Corporation, Marlborough, MA |
| 510(k) #/ | K153049 |
| Clearance Date | November 13, 2015 |
Predicate Device for Establishing 'Substantial Equivalence'
4
E. Device Description
The LithoVue Elite System is a software-controlled digital flexible ureteroscope system that consists of the Workstation (to be marketed as StoneSmart Connect Console) and the Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).
The LithoVue Elite System is designed to allow the physician to access, visualize and perform procedures in the urinary tract, and to provide real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy.
F. Intended Use/Indications for Use
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, 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.
G. Operating Principle
Illumination is generated by an LED located in the single-use digital ureteroscope handle and transmitted to the distal tip lens via a fiber-optic 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 workstation for processing and output to an external display.
The LithoVue Elite System supports intraluminal pressure monitoring through a piezoresistive Micro-Electro-Mechanical Systems (MEMS) pressure sensor located at the distal tip of the ureteroscope. The pressure signals from the ureteroscope are transmitted to the workstation for real-time display of the pressure value on an external display.
H. Comparison of Key Technological/Performance Characteristics
The LithoVue Elite System has the same technological characteristics and fundamental design as the predicate device. The LithoVue Elite System and the predicate device are each designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract.
| | Proposed LithoVue Elite
System | Predicate LithoVue
System (K153049) | Substantial Equivalence
Discussion |
|---------------------------------------------|---------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reusability | Ureteroscope: Single Use
Workstation: Reusable | Ureteroscope: Single Use
Workstation: Reusable | Identical |
| Ureteroscope
Type | Flexible | Flexible | Identical |
| Ureteroscope
is Provided | Sterile | Sterile | Identical |
| | Proposed LithoVue Elite
System | Predicate LithoVue
System (K153049) | Substantial Equivalence
Discussion |
| Sterilization
Agent | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Identical |
| Power Input
(Workstation) | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Identical |
| Imager Type | CMOS | CMOS | Identical |
| Imager
Location | Distal | Distal | Identical |
| Illumination
Source | LED | LED | Identical |
| | Ureteroscope Mechanical Specifications | | |
| Shaft Working
Length | 68 cm | 68 cm | Identical |
| Shaft OD | 9.5F | 9.5F | Identical |
| Insertion
Portion Width
(Distal Face) | 7.7 F | 7.7 F | Identical |
| Working
Channel Size | 3.6 F (1.15mm MIN ABS) | 3.6 F (1.15mm MIN ABS) | Identical |
| Working
Length | 82 cm | 82 cm | Identical |
| Deflection | Active and Passive | Active and Passive | Identical |
| Degree of
Active
Deflection | 270° in both directions | 270° in both directions | Identical |
| Optical Specifications | | | |
| Field of View
(in air) | 120° (diagonal) | 85° (horizontal) | Identical. The predicate
device listed the field of
view as 85°, as measured in
the horizontal direction of a
square image. This equates
to 120°, as measured in the
diagonal direction for the
proposed device. |
| Working
Distance | 2 - 50 mm | 2 - 50 mm | Identical |
| Direction of
View | 0° (forward viewing) | 0° (forward viewing) | Identical |
| Resolution | Typical (5mm Distance):
9.81 lp/mm | Typical (5mm Distance):
5.04 lp/mm | Substantially equivalent.
The proposed device has
higher resolution compared
to the predicate device. |
| Video Latency | 155 ms | 155 ms | Identical |
5
6
The main difference between the LithoVue Elite System and the predicate (LithoVue System) is the LithoVue Elite System's intraluminal pressure monitoring capability in the kidney and ureter. Currently, an irrigation bag with a pressure cuff or an automated pressurized irrigation system is used with the predicate LithoVue System to estimate the pressure in the anatomy during flexible ureteroscopy (fURS) procedures. The LithoVue Elite System uses a piezoresistive MEMS absolute pressure sensor, located at the distal tip of the single-use, digital flexible ureteroscope, to measure the intraluminal pressure in the anatomy during ureteroscopy. The pressure sensor is incorporated within the distal tip without increasing the overall width of the insertion of the ureteroscope. Additionally, the fundamental technology for measuring of intraluminal pressure is the use of solid-state sensors in a bridge circuit, similar to that used for many years in various other medical devices.
I. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the Litho Vue Elite System is substantially equivalent to the predicate LithoVue System in terms of its intended use, technological characteristics, and performance characteristics. The differences between the LithoVue Elite System and the predicate device do not alter suitability of the proposed device for its intended use.
J. Performance Testing
There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. Bench testing was performed to demonstrate that the device performs as intended under anticipated conditions of use, and that it meets its design specifications. In addition to the performance testing typically associated with ureteroscopes (including, but not limited to. Working Distance Resolution in Air, Field of View in Air, Direction of View, Image Signal-to-Noise Ratio, Total Flux Available at Tip, Uniformity of Image Brightness, Image Latency, and Photobiological Safety), the following performance characteristics for the pressure measurement capability were evaluated during bench testing:
- Gauge Pressure Accuracy in Water
- Pressure Sensor Bandwidth
- . Pressure Measurement Durability
- . Pressure Measurement Zero Point Drift
- . Pressure Measurement Accuracy
- . Pressure Measurement Latency
Biocompatibility of the LithoVue Elite Single-Use Digital Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Externally Communicating - Tissue/Bone/Dentin" with a contact duration of "Limited (≤24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity, and Pyrogen. The results concluded that the ureteroscope is biocompatible.
EMC & Electrical Safety testing were conducted in accordance with the following FDArecognized standards, and the results of the testing demonstrate that the device has met the applicable requirements:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and a. A2:2010/(R)2012 (Consolidated Text), Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) (FR Recognition No. 19-4)
7
-
IEC 60601-2-18: Edition 3.0. 2009-08. Medical electrical equipment Part 2-18: b. Particular requirements for the basic safety and essential performance of endoscopic equipment
(FR Recognition No. 9-114) -
IEC 60601-1-2: Edition 4.0, 2014-02, Medical electrical equipment Part 1-2: General C. requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests (FR Recognition No. 19-8)
Software verification and validation was completed. The software documentation stipulated in FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 2005), was included in this premarket submission.
A GLP Animal Study was conducted to demonstrate intraluminal pressure monitoring accuracy in vivo. GLP animal study report was included in this premarket submission.
Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical testing was sufficient to establish substantial equivalence.
K. Conclusion
Based on the intended use/indications for use, comparison of key technological characteristics, and performance testing presented in this premarket submission, it is concluded that the LithoVue Elite System is substantially equivalent to the predicate device.