(27 days)
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.
The LithoVue Elite Digital Flexible Ureteroscope System (cleared under K221515 on 02-FEB-2023 and K233645 on 12-DEC-2023) consists of the StoneSmart Connect Console, LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring, and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring). The proposed devices within the scope of this Special 510(k) premarket notification are the LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).
The proposed ureteroscope with pressure monitoring contains a redesigned distal tip to improve its durability during a ureteroscopy procedure. To maintain congruence between the two marketed configurations of the ureteroscope, the distal tip of the ureteroscope (without pressure monitoring) is also modified to match the one used in the ureteroscope with pressure monitoring, with the exception that it does not contain the specific modifications intended for pressure monitoring. Furthermore, test methods are also modified to be more representative of "challenging" working conditions as well as for better alignment with the intent of the specifications.
This document is a 510(k) summary for the LithoVue Elite Single-Use Digital Flexible Ureteroscope. It details the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument for regulatory clearance. Since this is a submission for the clearance of a device (a ureteroscope), and not for an AI/ML algorithm or a diagnostic test, the typical acceptance criteria and study designs that would apply to software are not present. The document focuses on the physical and functional aspects of the hardware.
Therefore, many of the questions regarding AI/ML-specific details, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set ground truth, are not applicable to this document. The "device" in question is a physical endoscope.
However, I can extract the relevant performance testing information provided:
1. Table of acceptance criteria and the reported device performance:
The document implicitly defines acceptance criteria by stating that the proposed devices have the "Same" or "Identical" performance to the predicate devices across various characteristics. The specific numerical criteria mentioned are for "Pressure Measurement Accuracy" which applies to the ureteroscope with pressure monitoring.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Mechanical Specifications | Identical to Predicate | |
| Shaft Working Length | 68 cm | 68 cm |
| Shaft OD | 9.5F | 9.5F |
| Insertion Portion Width (Distal Face) | 7.7 F | 7.7 F |
| Working Channel Size | 3.6 F (1.15mm MIN ABS) | 3.6 F (1.15mm MIN ABS) |
| Working Length | 82 cm | 82 cm |
| Deflection | Active and Passive | Active and Passive |
| Degree of Active Deflection | 270° in both directions | 270° in both directions |
| Optical Specifications | Identical to Predicate | |
| Field of View (in air) | 120° (diagonal) | 120° (diagonal) |
| Working Distance | 2 - 50 mm | 2 - 50 mm |
| Direction of View | 0° (forward viewing) | 0° (forward viewing) |
| Resolution (Typical, 5mm Distance) | >9.81 lp/mm | >9.81 lp/mm |
| Pressure Measurement Accuracy (Pressure Monitoring version only) | Same as Predicate | |
| 0-60 minutes: 0-100 mmHg | +/- 10 mmHg | +/- 10 mmHg |
| 0-60 minutes: 100-300 mmHg | +/- 5 mmHg + 5 % of reading | +/- 5 mmHg + 5 % of reading |
| 60-120 minutes: 0-100 mmHg | +/- 13 mmHg | +/- 13 mmHg |
| 60-120 minutes: 100-300 mmHg | +/- 8 mmHg + 5 % of reading | +/- 8 mmHg + 5 % of reading |
Description of the Study:
The study performed was a "subset of the mechanical performance and durability testing (including pressure sensor durability testing) along with the 'Image Rotation Offset' testing." The purpose was to evaluate the "design changes" to the ureteroscopes, specifically a redesigned distal tip to improve durability. The document asserts that the proposed devices maintained the same performance characteristics as the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not explicitly state the sample size for the mechanical performance and durability testing. It indicates that testing was performed on the "proposed ureteroscopes" to evaluate the design changes. The data provenance is not specified, but given it's for a medical device cleared in the US, it would generally be expected to be internal laboratory testing. It is a prospective evaluation of the new design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and therefore not provided. The testing relates to the physical and functional performance of the device, not the interpretation of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical or image-based studies where expert consensus is needed. The testing described is physical performance testing against engineering specifications.
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 applicable. The device is a ureteroscope (hardware), not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical ureteroscope, not a standalone AI algorithm. It's a tool used by a human clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device would be its adherence to established engineering specifications and performance benchmarks for mechanical durability, optical clarity, and pressure measurement accuracy. This is based on objective measurements rather than expert consensus or pathology in a clinical sense.
8. The sample size for the training set:
This information is not applicable. The device is hardware; there is no AI/ML training set.
9. How the ground truth for the training set was established:
This information is not applicable. There is no AI/ML training set.
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July 1, 2024
Boston Scientific Corporation Matthew Minks Senior Regulatory Affairs Specialist Boston Scientific Corporation-Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K241598
Trade/Device Name: LithoVue Elite Single-Use Digital Flexible Ureteroscope -Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope -Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -Reverse (without pressure monitoring) (M0067941500) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: June 3, 2024 Received: June 4, 2024
Dear Matthew Minks:
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.
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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" (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.
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
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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
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Indications for Use
Submission Number (if known)
Device Name
LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000): LithoVue Elite Single-Use Digital Flexible Ureteroscope -- Reverse (with pressure monitoring) (M0067940500): LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (without pressure monitoring) (M0067941000): LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (without pressure monitoring) (M0067941500) 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)
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510(k) Summary for LithoVue™ Elite Single-Use Digital Flexible Ureteroscope
Date Prepared: June 03, 2024
A. Submitter
Boston Scientific Corporation Urology and Pelvic Health Division 100 Boston Scientific Way Marlborough, MA 01752
B. Contacts
Matthew Minks Sr. Regulatory Affairs Specialist 508-683-6522 Matthew.Minks@bsci.com
C. Device Names
| Trade Names: | LithoVue™ Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000) |
|---|---|
| LithoVue™ Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500) | |
| LithoVue™ Elite Single-Use Digital Flexible Ureteroscope - Standard (without pressure monitoring) (M0067941000) | |
| LithoVue™ Elite Single-Use Digital Flexible Ureteroscope - Reverse (without pressure monitoring) (M0067941500) | |
| 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 the purpose of establishing 'substantial equivalence', the designs and technological characteristics of the proposed LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring and LithoVue Elite Single-Use Digital Flexible Ureteroscope without pressure monitoring were compared to the following 510(k)-cleared devices device.
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| Predicates | ||
|---|---|---|
| Device TradeName: | LithoVue Elite Single-UseDigital Flexible Ureteroscopewith pressure monitoring | LithoVue Elite Single-UseDigital Flexible Ureteroscope |
| Regulation Name: | Endoscope and accessories | Endoscope and accessories |
| RegulationNumber: | 21 CFR §876.1500 | 21 CFR §876.1500 |
| Classification: | Class II | Class II |
| Product Code: | FGB | FGB |
| 510(k)Submitter/Holder: | Boston Scientific Corporation,Marlborough, MA | Boston ScientificCorporation, Marlborough,MA |
| 510(k) #/ | K221515 | K233645 |
| Clearance Date | February 2, 2023 | December 12, 2023 |
Predicate Device for Establishing 'Substantial Equivalence'
E. Device Description
The LithoVue Elite Digital Flexible Ureteroscope System (cleared under K221515 on 02-FEB-2023 and K233645 on 12-DEC-2023) consists of the StoneSmart Connect Console, LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring, and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring). The proposed devices within the scope of this Special 510(k) premarket notification are the LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).
The proposed ureteroscope with pressure monitoring contains a redesigned distal tip to improve its durability during a ureteroscopy procedure. To maintain congruence between the two marketed configurations of the ureteroscope, the distal tip of the ureteroscope (without pressure monitoring) is also modified to match the one used in the ureteroscope with pressure monitoring, with the exception that it does not contain the specific modifications intended for pressure monitoring. Furthermore, test methods are also modified to be more representative of "challenging" working conditions as well as for better alignment with the intent of the specifications.
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.
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G. Operating Principle
The operating principle for the illumination and intraluminal pressure monitoring (submitted under K221515 and K233645) remains unchanged. 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 console for processing and output to an external display.
The LithoVue Elite ureteroscope with pressure monitoring contains the 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 console for real-time display of the pressure value on an external display.
H. Comparison of Key Technological/Performance Characteristics
The proposed ureteroscope have the same technological characteristics and fundamental design as the predicate ureteroscopes.
| Proposedureteroscopes | Predicateureteroscopes(K221515 and K233645) | SubstantialEquivalenceDiscussion | |
|---|---|---|---|
| Reusability | Single Use | Single Use | Identical |
| UreteroscopeType | Flexible | Flexible | Identical |
| Ureteroscopeis Provided | Sterile | Sterile | Identical |
| SterilizationAgent | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Identical |
| Imager Type | CMOS | CMOS | Identical |
| ImagerLocation | Distal | Distal | Identical |
| IlluminationSource | LED | LED | Identical |
| Ureteroscope Mechanical Specifications | |||
| ShaftWorkingLength | 68 cm | 68 cm | Identical |
| Shaft OD | 9.5F | 9.5F | Identical |
| InsertionPortion Width(Distal Face) | 7.7 F | 7.7 F | Identical |
| Proposedureteroscopes | Predicateureteroscopes(K221515 and K233645) | SubstantialEquivalenceDiscussion | |
| WorkingChannel Size | 3.6 F (1.15mm MINABS) | 3.6 F (1.15mm MIN ABS) | Identical |
| WorkingLength | 82 cm | 82 cm | Identical |
| Deflection | Active and Passive | Active and Passive | Identical |
| Degree ofActiveDeflection | 270° in both directions | 270° in both directions | Identical |
| Optical Specifications | 120° (diagonal) | 120° (diagonal) | Identical. |
| (in air) | |||
| WorkingDistance | 2 - 50 mm | 2 - 50 mm | Identical |
| Direction ofView | 0° (forward viewing) | 0° (forward viewing) | Identical |
| Resolution | Typical (5mm Distance):>9.81 lp/mm | Typical (5mm Distance):>9.81 lp/mm | Identical. |
| PressureMeasurement(Applies to ureteroscope with pressure monitoring only) | Procedure Duration PostInitialization: | Procedure Duration PostInitialization: | Same |
| PressureMeasurementAccuracy | 0 minutes to60 minutes: | 0 minutes to60 minutes: | |
| (Applies toureteroscopewith pressuremonitoringonly) | 0 mmHg - 100 mmHg:(+/- 10 mmHg) | 0 mmHg - 100 mmHg:(+/- 10 mmHg) | |
| 100 mmHg - 300 mmHg:(+/- 5 mmHg+ 5 % of reading) | 100 mmHg - 300 mmHg:(+/- 5 mmHg+ 5 % of reading) | ||
| 60 minutes to120 minutes: | 60 minutes to120 minutes: | ||
| 0 mmHg - 100 mmHg:(+/- 13 mmHg) | 0 mmHg - 100 mmHg:(+/- 13 mmHg) | ||
| 100 mmHg - 300 mmHg:(+/- 8 mmHg+ 5 % of reading) | 100 mmHg - 300 mmHg:(+/- 8 mmHg+ 5 % of reading) |
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Substantial Equivalence l.
A direct comparison of key characteristics demonstrates that the proposed ureteroscopes are substantially equivalent to the predicate ureteroscopes in terms of intended use, technological characteristics, and performance characteristics. The
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differences between the proposed and the predicate devices do not alter suitability of the proposed devices for their intended use.
J. Performance Testing
To evaluate the design changes introduced with the proposed ureteroscopes, a subset of the mechanical performance and durability testing (including pressure sensor durability testing) along with the "Image Rotation Offset" testing was executed to support the safe and effective use of the proposed ureteroscopes.
There are no differences between the proposed and the predicate ureteroscopes that could affect the shelf life or sterility; therefore, sterilization and shelf-life evaluations were not required. From a biocompatibility standpoint, the contact classification of the proposed ureteroscopes is the same as that of the predicate ureteroscopes (cleared under K221515 and K233645). A biocompatibility assessment for the proposed devices was conducted and it was concluded that no additional biocompatibility testing was required.
Basic safety and EMC compatibility were not affected by the modifications made for the proposed devices as there were no changes to the electrical components, and the mechanical updates do not introduce sharp edges or corners.
The ureteroscopes do not contain software. So, software testing is not applicable.
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 proposed ureteroscopes are substantially equivalent to the predicate ureteroscopes (cleared under K221515 and K233645).
§ 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.