(165 days)
No
The summary explicitly states "The devices do not contain software." and there is no mention of AI or ML in the device description or performance studies.
Yes
The device is explicitly intended for "therapy in conjunction with endoscopic accessories," and one model "has a second separate channel with 0.8 mm diameter for laser fibers or continuous irrigation" with a unique mechanism to help facilitate stone contact, which suggests its use in therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "For examination, diagnostics and/or therapy in conjunction with endoscopic accessories." This indicates that one of its intended purposes is diagnostic.
No
The device description clearly outlines physical hardware components including a handle, flexible shaft, CMOS imaging sensor, objective lens, integrated LED lights, working channels, and a laser adjustment unit. The summary also mentions biocompatibility, electrical safety, and mechanical testing, which are relevant to hardware devices, and explicitly states "The devices do not contain software" in the performance studies section.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for visualizing body cavities and organs for examination, diagnostics, and/or therapy. This is a direct visualization tool used in vivo (within the body).
- Device Description: The device is a flexible video endoscope with an imaging sensor at the tip to capture images inside the body.
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform tests on samples outside the body.
The device is clearly an endoscopic device used for direct visualization and intervention within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are used for visualizing body cavities and organs via natural and surgically created passages.
These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
For examination, diagnostics and/or therapy in conjunction with endoscopic accessories. The product is used in the following disciplines: Urology:
- Urogenital tract
- Nephroscopy
Product codes
FGB, FGA, ODC
Device Description
The Flexible Sensor-Ureterorenoscope BOA VISION EF (short name: BOA) and Flexible Sensor-Ureterorenoscopes COBRA VISION EF (short name: COBRA) are flexible video endoscopes used for visualizing body cavities and organs via natural and surgically created passages.
The Flexible Sensor-Ureterorenoscopes compromise a handle and a flexible shaft connected to the handle with an active controlled deflection section at the endoscope tip.
The video image of the Flexible Sensor-Ureterorenoscopes is produced by a CMOS imaging sensor located at the tip of the insertion shaft together with the objective lens. The imaging sensor with the electronics in the handle generates a signal that is transferred to the designated camera controller ENDOCAM Flex HD (cleared with K161204), which processes the signals to display them on a monitor (not part of this submission).
The Flexible Sensor-Ureterorenoscopes use integrated LED lights for illumination.
The Flexible Sensor-Ureterorenoscopes provide a working channel with 1.2 mm diameter and a working length of 680 mm length. A Luer sealing cap may be used to seal the provided Luer connectors if not used.
The Flexible Sensor-Ureterorenoscope COBRA VISION EF has a second separate channel with 0.8 mm diameter for laser fibers or continuous irrigation. The laser fiber channel is equipped with a laser adjustment unit for housing, clamping and aligning the laser fiber, which support to move the clamped laser fiber sensitively by turning an adjustment ring for contacting the stone.
Parts of the Flexible Sensor-Ureterorenoscopes have direct patient contact. When used as intended, the duration of tissue contact is limited (up to 24 hours). The used raw material with direct or indirect patient consist of Stainless steel, optical glass, Polyurethane, Perfluoroalkoxy (PFA) and adhesives (epoxy).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities and organs via natural and surgically created passages, Urogenital tract, Kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specialized medical personnel, medically qualified and adequately instructed persons.
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 data were provided for:
- Biocompatibility: Biological Risk Assessment performed according to FDA Guidance -Use of International Standard ISO 10993, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Tested endpoints include Cytotoxicity, Sensitization, Intracutaneous reactivity/irritation, acute systemic toxicity, material mediated pyrogenicity.
- Cleaning and Sterilization: Validation of reprocessing performed in accordance with FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
- Electrical safety and Electromagnetic Compatibility: Compliance with IEC 60601-1: 2005/AMD1:2012, IEC 60601-2-18:2009, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-1-2 :2014 / ANSI AAMI IEC 60601-1-2:2014.
- Photobiological safety: Tested according to IEC 62471:2006, modified + EN 62471:2008.
- Mechanical and Optical Performance: Designed to comply with applicable parts of ISO 8600. Optical measurements performed according to applicable part of ISO 8600 standard. Mechanical characteristics tested include leakage tightness, bending, deflection endurance, withstand of channel. Comparative testing related to image quality parameters was performed for submitted devices and the predicate device.
- Software Verification and Validation Testing: The submitted device does not contain software.
- Animal and Clinical Study: Not performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
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May 3, 2019
Richard Wolf Medical Instruments Corporation Mike Loiterman US Head of Regulatory - QA/QC 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K183188
Trade/Device Name: Flexible Sensor-Ureterorenoscopes BOA Vision EF Flexible Sensor-Ureterorenoscopes COBRA Vision EF Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB, FGA, ODC Dated: April 9, 2019 Received: April 11, 2019
Dear Mike Loiterman:
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.
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Glenn Bell, Ph.D. Assistant Division 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
510(k) Number (if known) K183188
Device Name
Flexible Sensor-Ureterorenoscopes BOA Vision EF Flexible Sensor-Ureterorenoscopes COBRA Vision EF
Indications for Use (Describe)
The Flexible Sensor-Ureterorenoscopes BOA Vision EF and Flexible Sensor-Ureterorenoscopes COBRA Vision EF are used for visualizing body cavities and organs via natural and surgically created passages.
These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
For examination, diagnostics and/or therapy in conjunction with endoscopic accessories. The product is used in the following disciplines: Urology:
-
Urogenital tract
-
Nephroscopy
Type of Use (Select one or both, as applicable):
| ☑ Registration Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) Summary
I. SUBMITTER
RICHARD WOLF MEDICAL INSTRUMENTS CORP. 353 Corporate Woods Parkway Vernon Hills, Illinois, USA, 60061
Phone: (847) 913 1113 Fax: (847) 913 0924
Contact Person: Mr. Michael G. Loiterman Date Prepared: May 02, 2019
II. DEVICES
Trade Name: Flexible Sensor-Ureterorenoscope BOA VISION EF Flexible Sensor-Ureterorenoscope COBRA VISION EF
| Model numbers: BOA: | 73551071, 73551076 |
|---|---|
| COBRA: | 73561071, 73561076 |
| Accessories: | 15369108, 15394144, 163914, 15023205 |
Common or Usual Name: Flexible Video Ureterorenoscope, Nephroscope, Endoscope Channel Accessories
Classification Name: Endoscope and Accessories (21 CFR 876.1500)
II Regulatory Class:
Product Code: FGB (Ureteroscope and Accessories, flexible/rigid) ODC (Endoscope Channel Accessory) FGA (Kit, Nephroscope)
III. PREDICATE DEVICE
Flexible Video Uretero Renoscope Flex XC (K131369)
This predicate has not been subject to a design-related recall.
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5.1 Description
The Flexible Sensor-Ureterorenoscope BOA VISION EF (short name: BOA) and Flexible Sensor-Ureterorenoscopes COBRA VISION EF (short name: COBRA) are flexible video endoscopes used for visualizing body cavities and organs via natural and surgically created passages.
The Flexible Sensor-Ureterorenoscopes compromise a handle and a flexible shaft connected to the handle with an active controlled deflection section at the endoscope tip.
The video image of the Flexible Sensor-Ureterorenoscopes is produced by a CMOS imaging sensor located at the tip of the insertion shaft together with the objective lens. The imaging sensor with the electronics in the handle generates a signal that is transferred to the designated camera controller ENDOCAM Flex HD (cleared with K161204), which processes the signals to display them on a monitor (not part of this submission).
The Flexible Sensor-Ureterorenoscopes use integrated LED lights for illumination.
The Flexible Sensor-Ureterorenoscopes provide a working channel with 1.2 mm diameter and a working length of 680 mm length. A Luer sealing cap may be used to seal the provided Luer connectors if not used.
The Flexible Sensor-Ureterorenoscope COBRA VISION EF has a second separate channel with 0.8 mm diameter for laser fibers or continuous irrigation. The laser fiber channel is equipped with a laser adjustment unit for housing, clamping and aligning the laser fiber, which support to move the clamped laser fiber sensitively by turning an adjustment ring for contacting the stone.
Parts of the Flexible Sensor-Ureterorenoscopes have direct patient contact. When used as intended, the duration of tissue contact is limited (up to 24 hours). The used raw material with direct or indirect patient consist of Stainless steel, optical glass, Polyurethane, Perfluoroalkoxy (PFA) and adhesives (epoxy).
5.2 Indications for Use
The Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF are used for visualizing body cavities and organs via natural and surgically created passages.
These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
For examination, diagnostics and/or therapy in conjunction with endoscopic accessories.
The product is used in the following disciplines:
Urology:
- Urogenital tract -
- Nephroscopy -
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5.3 Comparison with Predicate Device
The new Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF and the predicate device are optoelectronic devices used for visualizing body cavities and organs via natural and surgically created passages, for diagnostic and therapeutic use on human patients in the urogenital tract and kidney. Thus, the intended use can be declared as same.
The new Flexible Sensor-Ureterorenoscopes BOA VISION EF and Flexible Sensor-Ureterorenoscopes COBRA VISION EF have equivalent technical characteristics and fundamental design as the predicate device. The operating principle, mechanical design, dimensions and device materials are same or equivalent. The submitted devices and the predicate device are delivered non-sterile and must be reprocessed before and after each use.
The small differences between the new Flexible Sensor-Ureterorenoscopes and the predicate device are mainly related to the following aspects:
Design/Material:
The Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF with their working channel have similar diameter, length and deflection angle compared to the predicate device. Different material was used for the new Flexible Sensor-Ureterorenoscopes to improve kink characteristics and flexibility of the insertion part and deflectable distal tip tubing.
Laser fiber channel:
The Flexible Sensor-Ureterorenoscope COBRA VISION EF provides an additional channel for laser fibers or continuous irrigation. The use of laser fiber and irrigation are possible on the predicate device also through the working channel. The laser fiber channel is equipped with a laser adjustment unit for housing, clamping and aligning the laser fiber, which supports the clamped laser fiber to move sensitively by turning an adjustment ring for contacting the stone. Without the laser adjustment unit, the laser fiber still can be guided manually by the user the same way as it is done in the predicate device.
5.4 Performance Testing
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility
Biological Risk Assessment, considering FDA Guidance -Use of International Standard ISO 10993, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", Guidance for Industry and Food and Drug Administration Staff, issued June 16, 2016, was performed and necessary tests were conducted to ensure the biocompatibility of the product.
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Considering the categorization of the Flexible Sensor-Ureterorenoscopes as externally communicating devices in limited (≤24h) contact with tissue, the following endpoints were tested according to ISO 10993 standards: Cytotoxicity, Sensitization, Intracutaneous reactivity/irritation, acute systemic toxicity, material mediated pyrogenicity.
This demonstrates the biocompatibility of the Flexible Sensor-Ureterorenoscopes when used as intended.
Cleaning and Sterilization
Validation of reprocessing was performed in accordance with the FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", Guidance for Industry and Food and Drug Administration Staff, issued March 17, 2015.
Electrical safety and Electromagnetic Compatibility
Richard Wolf's Flexible Sensor-Ureterorenoscope BOA VISON EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF comply with the standards regarding electrical safety and electromagnetic compatibility:
- IEC 60601-1: 2005/AMD1:2012: Medical electrical equipment Part 1: General requirements for basic safety and essential performance; with US national differences according to ANSI/AAMI ES60601-1: 2005 / A2:2010.
- IEC 60601-2-18:2009: Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment
- IEC 60601-1-6:2010/AMD1:2013: Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usability
- IEC 60601-1-2 :2014 (Limit class: B); / ANSI AAMI IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic Disturbances - Requirements and test
Photobiological safety
The used LEDs in submitted Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF were tested according to the following standard:
- IEC 62471:2006, modified + EN 62471:2008: Medical electrical equipment, Photobiological safety of lamps and lamp systems
Mechanical and Optical Performance
The Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF were designed to comply with applicable parts of ISO 8600. Optical measurements were performed according to applicable part of ISO 8600 standard.
Mechanical characteristics were tested and include leakage tightness, bending, deflection endurance, withstand of channel.
In addition, comparative testing related to image quality parameters was performed for submitted Flexible Sensor-Ureterorenoscopes and the predicate device to support substantial equivalence.
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Software Verification and Validation Testing
The submitted Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF do not contain software.
Animal and Clinical Study
Animal Study and Clinical Study were not performed for submitted products.
5.5 Conclusion
Richard Wolf's Flexible Sensor-Ureterorenoscope BOA VISION EF, Flexible Sensor-Ureterorenoscope COBRA VISION EF and their accessories have the same intended use as the predicate device. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed device. For these reasons, Richard Wolf's Flexible Sensor-Ureterorenoscope BOA VISION EF and Flexible Sensor-Ureterorenoscope COBRA VISION EF and their accessories are substantially equivalent to the legally marketed device.