(24 days)
Not Found
No
The summary describes a software-controlled digital flexible ureteroscope system for visualization and procedures, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
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."
Yes
The indications for use state that the device "can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract." Therefore, it explicitly includes diagnostic procedures as part of its intended use.
No
The device description explicitly states that the LithoVue System consists of both a software-controlled workstation and a single-use digital flexible ureteroscope, which is a hardware component.
Based on the provided information, the LithoVue System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to visualize organs, cavities, and canals in the urinary tract and to perform diagnostic and therapeutic procedures within the urinary tract. This involves direct visualization and intervention within the body.
- Device Description: The description confirms it's a digital flexible ureteroscope system used for accessing, visualizing, and performing procedures. This is an endoscopic device used for internal examination and treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The LithoVue System does not perform any analysis on specimens.
Therefore, the LithoVue System falls under the category of an endoscopic device used for direct visualization and intervention within the body, not an IVD.
N/A
Intended Use / Indications for Use
The LithoVue 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.
Product codes
FGB
Device Description
The LithoVue™ System is a software-controlled digital flexible ureteroscope system that consists of the LithoVue System Workstation (Touch PC with installed Interface Box and Cart) and the Litho Vue Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).
The LithoVue System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, forceps).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract (urethra, bladder, ureter, calyces and renal papillae)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians / 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)
Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with LithoVue Flexscope samples aged at T=0 and T=3 months accelerated aged.
The following testing was completed to demonstrate the LithoVue System functions as intended:
- Working Distance Resolution in Air -Near, Typical and Far
- Field of View in Air
- Direction of View
- Image Orientation
- Contrast Sensitivity
- Image Signal to Noise
- Uniformity of Image Brightness
- Total Flux Available at Tip
- Image Latency
- Automatic Light Control (ALC)
- ALC Response Time
- Width of Insertion Portion Distal Tip
- Maximum Width of Insertion Portion (Overall Shaft Diameter and Size Designation)
- Working Length (Shaft Length)
- Minimum Instrument Channel Width
- Tortuous Path Ability
- Surface and Edges
- SUD Working Channel Freedom from Leakage
- SUD Shaft Leakage
- Torsional Resistance of Tip
- Tip Column Strength
- Shaft Flexural Resistance
- Maximum Angle of Deflection
- Bend Radius
- Secondary Deflection
- Deflection Life Cycling
- Shaft to Handle Tensile Strength
- Tip to Shaft Tensile Strength
- Handle to Active Deflection Torque Angle at Break
- Umbilicus to Handle Tensile Strength
- Umbilicus to Connector Tensile Strength
- Critical Shaft Bend Radius
- Shaft Bend Fatigue
- SUD Durability (Procedure Duration)
- SUD Mechanical Durability
- Neutral Position Marking
- Deflection Direction Marking
- Lever Force
- Connector Retention Strength
- Laser Aiming Beam Compatibility
- Laser Lithotripsy Compatibility
- Radiopacity
- Working Channel Connection Compatibility
- Maximum Endotherapy Tool Blind Insertion Distance
- Working Channel Length
- Monitor and Switcher Compatibility
- SUD Packaging Integrity
- SUD Package Seal Strength
- Photobiologic Safety per IEC 62471
- Software verification and validation
Biocompatibility of the LithoVue Single-Use Digital Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (, and Latex. All evaluation acceptance criteria were met.
Electrical safety testing of the System was evaluated in accordance with IEC 60601-1 (2005) Edition 3, IEC 60601-1-2 (2007) Edition 3, IEC 60601-1-4 (2000), Edition 1.1 Consolidated Edition, and IEC 60601-2-18 (2009), Edition 3. All evaluation acceptance criteria were met.
The results of the performance testing demonstrate that the LithoVue System is considered safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ACMI, K060269, Olympus, K033651
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 13, 2015
Boston Scientific Corporation % Dave Yungvirt CEO Third Party Review Group, LLC 45 Rockefeller Plaza, Suite 2000 New York, NY 10111
Re: K153049
Trade/Device Name: LithoVue System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: November 5, 2015 Received: November 9, 2015
Dear Dave Yungvirt,
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. 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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153049
Device Name LithoVue System
Indications for Use (Describe)
The LithoVue 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over-The-Counter Use (21 C.FR 801 Subnart 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
SECTION 6
510K SUMMARY
510(k) Summary for LithoVue™ System
A. Date Prepared
August 12, 2015
B. Sponsor
Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756
C. Contact
Jeanne O'Toole Senior Specialist, Regulatory Affairs 508-683-4271 jeanne.otoole@bsci.com or Nichole Riek
Manager, Regulatory Affairs 508-683-4175 nichole.riek@bsci.com
D. Device Name
| Trade name: | LithoVue System |
|---|---|
| Common usual/name: | Digital Flexible Ureteroscope |
| Classification: | FGB – Ureteroscope and accessories, flexible/rigid |
| 21 CFR 876.1500, Class II |
E. Predicate Device(s)
| Trade name: | DUR-Digital Ureteroscope and Choledochoscope
(DUR-D) |
|-------------------------|----------------------------------------------------------------------|
| Common usual/name: | Ureteroscope and Accessories, Flexible/Rigid |
| Classification: | FGB – Endoscope, associated accessories
21 CFR 876.1500, Class II |
| Premarket Notification: | ACMI, K060269 |
and
| Trade name: | Olympus URF-V (cleared as the Video Ureteroscope
NTSC) |
|--------------------|----------------------------------------------------------------------|
| Common usual/name: | Ureteroscope and Accessories, Flexible/Rigid |
| Classification: | FGB – Endoscope, associated accessories
21 CFR 876.1500. Class II |
4
Premarket Notification: Olympus, K033651
F. Device Description
The LithoVue™ System is a software-controlled digital flexible ureteroscope system that consists of the LithoVue System Workstation (Touch PC with installed Interface Box and Cart) and the Litho Vue Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).
The LithoVue System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, forceps).
G. Intended Use
The LithoVue 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.
This Intended Use is equivalent to that for the predicates, which are also used to perform various diagnostic and therapeutic procedures in the urinary tract using additional accessories.
H. Technological Characteristics
The LithoVue System has the same technological characteristics and fundamental design as the predicate devices. The LithoVue System and the predicate devices are all designed to provide real-time images to the physician in order to facilitate diagnostic and therapeutic procedures in the urinary tract.
The main difference between the LithoVue System and the predicate devices is reusability. The LithoVue Single-Use Digital Flexible Ureteroscope is single-use, while the predicate devices are reusable.
I. Substantial Equivalence
A direct comparison of key characteristics demonstrates that the LithoVue System is substantially equivalent to the predicate devices in terms of intended use, technological characteristics, and performance characteristics. The differences between the LithoVue System and predicate devices do not alter suitability of the proposed device for its intended use.
J. Performance Testing (Bench Evaluation)
Boston Scientific has conducted performance testing with LithoVue Flexscope samples aged at T=0 and T=3 months accelerated aged.
5
The following testing was completed to demonstrate the LithoVue System functions as intended:
- · Working Distance Resolution in Air -Near, Typical and Far
- Field of View in Air
- · Direction of View
- · Image Orientation
- · Contrast Sensitivity
- · Image Signal to Noise
- · Uniformity of Image Brightness
- Total Flux Available at Tip
- · Image Latency
- Automatic Light Control (ALC)
- · ALC Response Time
- Width of Insertion Portion Distal Tip
- Maximum Width of Insertion Portion (Overall Shaft Diameter and Size Designation)
- Working Length (Shaft Length)
- Minimum Instrument Channel Width
- Tortuous Path Ability
- · Surface and Edges
- · SUD Working Channel Freedom from Leakage
- · SUD Shaft Leakage
- · Torsional Resistance of Tip
- · Tip Column Strength
- Shaft Flexural Resistance
- · Maximum Angle of Deflection
- Bend Radius
- · Secondary Deflection
- · Deflection Life Cycling
- · Shaft to Handle Tensile Strength
- Tip to Shaft Tensile Strength
- · Handle to Active Deflection Torque Angle at Break
- Umbilicus to Handle Tensile Strength
- Umbilicus to Connector Tensile Strength
- Critical Shaft Bend Radius
- · Shaft Bend Fatigue
- · SUD Durability (Procedure Duration)
- SUD Mechanical Durability
- · Neutral Position Marking
- · Deflection Direction Marking
- · Lever Force
- · Connector Retention Strength
- · Laser Aiming Beam Compatibility
- · Laser Lithotripsy Compatibility
- · Radiopacity
- · Working Channel Connection Compatibility
- Maximum Endotherapy Tool Blind Insertion Distance
- · Working Channel Length
- · Monitor and Switcher Compatibility
- SUD Packaging Integrity
- SUD Package Seal Strength
- · Photobiologic Safety per IEC 62471
- Software verification and validation
Biocompatibility of the LithoVue Single-Use Digital Flexible Ureteroscope was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (, and Latex. All evaluation acceptance criteria were met.
Electrical safety testing of the System was evaluated in accordance with IEC 60601-1 (2005) Edition 3, IEC 60601-1-2 (2007) Edition 3, IEC 60601-1-4 (2000), Edition 1.1 Consolidated Edition, and IEC 60601-2-18 (2009), Edition 3. All evaluation acceptance criteria were met.
The results of the performance testing demonstrate that the LithoVue System is considered safe and effective for its intended use.