(191 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical, optical, and electrical safety and performance, with no mention of AI or ML capabilities.
Yes
The device is described as being used "within the scope of therapeutic interventions" and specifically for "therapy of the upper urinary tract." It also features working channels for the insertion of auxiliary instruments like "laser fibers" or "stone-extraction basket," which are commonly used in therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract."
No
The device description clearly details a physical instrument (semi-rigid instrument sheath, flexible and actively deflectable tip, working channels, luer connectors, control wheel) and an accessory adapter for connecting to a camera controller. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Sensor-Ureterorenoscope is used for "visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid." It is used for "examination, diagnostics and/or therapy of the upper urinary tract." This describes a device used in vivo (within the living body) for direct visualization and intervention.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Description: The device description details a semi-rigid instrument sheath, flexible tip, working channels for instruments and irrigation, and a channel for return flow. This is consistent with an endoscopic device used for internal examination and procedures, not for testing samples outside the body.
- Lack of IVD-related activities: There is no mention of analyzing biological samples, reagents, or any processes typically associated with in vitro testing.
Therefore, the Sensor-Ureterorenoscope and its adapter are medical devices used for in vivo procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
SENSOR-URETERORENOSCOPE 9 FR WL 600 MM
Sensor-Ureterorenoscopes are used within the scope of therapeutic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid.
The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract.
ADAPTER FOR CONTROLLER 5525
The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated.
Product codes
FGB
Device Description
The Sensor-Ureterorenoscope features a semi-rigid instrument sheath and a flexible and actively deflectable tip. It is equipped with two separate working channels for applications with laser fibers and/or flexible auxiliary instruments. The two working channels have different diameters, allowing the insertion of the laser fiber via working channel (2) and a stone-extraction basket or flexible auxiliary instruments via working channel (1). Irrigation is effected via working channel (1) and is connected via the luer connector marked in blue on the housing. A third channel integrated in the instrument sheath allows the return flow via distal holes on the instrument head. The drain is effected via the lower luer connector marked in gray. The flexible deflectable tip can be controlled in both directions (upward and downward) +/-300° via the control wheel on the handle. Thanks to the high torsional stiffness of the semi-rigid instrument sheath the sheath movements are transmitted directly in radial and axial directions. The working channel (2) permits the insertion of laser fibers up to a diameter of 272 µm. For visualization the Sensor-Ureterorenoscope is connected to an endoscopy camera controller. The Sensor-Ureterorenoscope is sterile and for single-use.
The ADAPTER FOR CONTROLLER 5525 is an accessory to the RIWO D-URS, which serves as an interface to connect the RIWO D-URS to an ENDOCAM Logic 5525 Camera Controller (not part of this submission).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavities via natural passages, upper urinary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specialized medical personnel, medically qualified and adequately instructed persons, professional health care facility environment.
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
Non-Clinical Performance Testing:
Sterilization: The ethylene oxide sterilization process for the RIWO D-URS was validated according to EN ISO 11135:2014 Annex B (half-cycle method). The sterile packaging was subjected to several tests including Environmental conditioning (ASTM D4169-16 and ASTM D4332-14), Accelerated aging (ASTM F1980-16), Transportation Simulation (ASTM D4169-16), Visual Inspection of packaging and seal integrity (ASTM F1886-16), Packaging Challenging Testing [Bubble Test] (ASTM F2096-11), Seal Integrity Test [Liquid Dye] (ASTM F1929-15), and Seal Strength Test (ASTM F88-15). All test methods were applied to non-aged as well as accelerated aged products. The results proved that the RIWO D-URS is as safe as the predicate device.
Biocompatibility: A biological risk assessment was performed considering ISO 10993-1:2018 and FDA guidance on the Use of International Standard ISO 10993. Biological testing and chemical characterization proved that the RIWO D-URS is as safe as the predicate device.
Electromagnetic Compatibility and Electrical Safety: Testing proved compliance with IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012; IEC 60601-1-6:2010 + A1:2013; IEC 60601-1-2:2014; and IEC 60601-2-18:2009. It was shown that the devices are as safe and effective.
Performance and Operational testing: Verification and validation testing confirms that the product meets all requirements and specifications for overall design, basic safety and essential performance. This includes Packaging, Transportation, Environmental conditions, photobiological safety and functionality testing. A usability study was performed, and optical performance was evaluated for the RIWO D-URS and parameters without defined acceptance criteria were compared to those of the predicate device. It was shown that the RIWO D-URS including the ADAPTER FOR CONTROLLER 5525 functions as safe as effective as the predicate device.
No clinical or animal studies were performed.
Key Metrics
Not Found
Predicate Device(s)
Flexible Sensor Ureterorenoscope COBRA VISION EF (COBRA) (73561076) K183188
Reference Device(s)
No reference devices were used in this submission.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 15, 2021
Richard Wolf Medical Instruments Corporation Michael Loiterman US Head of Regulatory - OA/OC 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K201897
Trade/Device Name: Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter for Controller 5525 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: December 17, 2020 Received: December 18, 2020
Dear Michael 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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 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 medical devices and radiation-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, M.S. Acting 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
Indications for Use
510(k) Number (if known) K201897
Device Name SENSOR-URETERORENOSCOPE 9 FR WL 600 MM ADAPTER FOR CONTROLLER 5525
Indications for Use (Describe) SENSOR-URETERORENOSCOPE 9 FR WL 600 MM
Sensor-Ureterorenoscopes are used within the scope of therapeutic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid.
The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract.
User
These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
ADAPTER FOR CONTROLLER 5525
The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated.
User
This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons.
| 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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Image /page/3/Picture/1 description: The image shows a logo with the text "K201897 Page 1 of 8" at the top. Below that is the text "RICHARD WOLF" in a stylized font, with the word "WOLF" in red. To the right of the text is a logo of a dog with a medical instrument inserted into it.
5 510(k) Summary
l Submitter
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60061
Phone:(847) 913 1113 Fax: (847) 913 0924
Contact Person, Title: Michael Loiterman, US Head of Regulatory - QA/QC Date Prepared: December 16, 2020
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen
ll Device
| Device name | Common name | Commercial name | Model Number(s) | Classification name | Regulation Number and Name | Product Code | Device Class |
|---|---|---|---|---|---|---|---|
| SENSOR- | |||||||
| URETERORENOSCOPE | |||||||
| 9 FR WL 600 MM | Ureteroscope | RIWO D-URS | 473572075 | ||||
| 473572076 | Ureteroscope | ||||||
| and | |||||||
| Accessories, | |||||||
| Flexible/rigid | 876.1500 | ||||||
| Endoscope | |||||||
| and | |||||||
| accessories | FGB | II | |||||
| ADAPTER FOR | |||||||
| CONTROLLER 5525 | --- | --- | 5525410 |
��� Predicate Device
Name of Predicate Device: Flexible Sensor Ureterorenoscope COBRA VISION EF (COBRA) (73561076) 510(k) Number: K183188 Regulatory Class: II Product Code: FGB / FGA / ODC Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4
Subject Device Description 5.1
5.1.1 Device Identification
| Type number | Description | Package
unit |
|-------------|----------------------------------------|-----------------|
| 473572075 | SENSOR-URETERORENOSCOPE 9 FR WL 600 MM | 1 |
| 473572076 | SENSOR-URETERORENOSCOPE 9 FR WL 600 MM | 3 |
| 5525410 | ADAPTER FOR CONTROLLER 5525 | 1 |
Device characteristics 5.1.2
Software
The RIWO D-URS and ADAPTER FOR CONTROLLER 5525 do not contain software.
Materials with patient contact
The RIWO D-URS includes components with direct and indirect patient contact.
The ADAPTER FOR CONTROLLER 5525 has no components with direct or indirect patient contact.
Single use / reusable
The RIWO D-URS is a single use device.
The ADAPTER FOR CONTROLLER 5525 is reusable and does requires cleaning and reprocessing during its use-life, i.e. users are required to clean and disinfect the device before every application and before returning for repairs. Methods of cleaning and reprocessing are detailed in the Instruction for Use.
Delivered sterile / non-sterile
The RIWO D-URS is delivered sterile. The ADAPTER FOR CONTROLLER 5525 is delivered non-sterile.
Sterilization Method
The RIWO D-URS is sterilized with ethylene oxide. The ADAPTER FOR CONTROLLER 5525 is not intended to be sterilized.
5.1.3 Environment of Use
The RIWO D-URS and ADAPTER FOR CONTROLLER 5525 are intended to be used in professional health care facility environment.
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Image /page/5/Picture/1 description: The image shows the text 'K201897' at the top, followed by 'Page 3 of 8'. Below this is the name 'RICHARD WOLF' in a stylized font, with the word 'WOLF' in a bold, red, sans-serif font. To the right of the name is a logo featuring a dog-like figure standing next to a vertical line with a hook at the top.
5.1.4 Brief Written Description of the Device
The Sensor-Ureterorenoscope features a semi-rigid instrument sheath and a flexible and actively deflectable tip. It is equipped with two separate working channels for applications with laser fibers and/or flexible auxiliary instruments. The two working channels have different diameters, allowing the insertion of the laser fiber via working channel (2) and a stone-extraction basket or flexible auxiliary instruments via working channel (1)
Irrigation is effected via working channel (1) and is connected via the luer connector marked in blue on the housing.
A third channel integrated in the instrument sheath allows the return flow via distal holes on the instrument head. The drain is effected via the lower luer connector marked in gray.
The flexible deflectable tip can be controlled in both directions (upward and downward) +/-300° via the control wheel on the handle. Thanks to the high torsional stiffness of the semi-rigid instrument sheath the sheath movements are transmitted directly in radial and axial directions. The working channel (2) permits the insertion of laser fibers up to a diameter of 272 µm.
For visualization the Sensor-Ureterorenoscope is connected to an endoscopy camera controller. The Sensor-Ureterorenoscope is sterile and for single-use.
Image /page/5/Figure/8 description: This image shows a medical device with several labeled parts. The labels indicate the "Objective Lens", "Working channel (1)", "Working channel (2)", and "Light exit". The device appears to be an endoscope or similar instrument used for medical imaging and procedures.
Figure 1: Image of the SENSOR-URETERORENOSCOPE 9 FR WL 600 MM with detailed display of the tip
The ADAPTER FOR CONTROLLER 5525 is an accessory to the RIWO D-URS, which serves as an interface to connect the RIWO D-URS to an ENDOCAM Logic 5525 Camera Controller (not part of this submission).
5.1.5 Materials of Use
The RIWO D-URS consists of stainless steel, glass, polymer, glue and instrument oil. The materials can come into direct and indirect body contact with the patient for a maximal contact duration of 3 hours.
The ADAPTER FOR CONTROLLER 5525 consists of stainless steel, polymer, composite, copper and gold. The materials do not have any body contact with the patient.
5.1.6 Key Performance Characteristics
The RIWO D-URS provides a deflection angle of 300° upwards and downwards, two working channels, a working length of 600 mm and a 160000 pixel CMOS sensor for imaging.
The ADAPTER FOR CONTROLLER 5525 provides electromechanical connectivity with a camera controller.
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Image /page/6/Picture/1 description: The image shows the text "K201897 Page 4 of 8" in the upper left corner. Below that is the text "RICHARD WOLF" in a stylized font. To the right of the text is a logo of a dog with a nail being hammered into its head.
Indications for Use 5.2
5.2.1 Statement
SENSOR-URETERORENOSCOPE 9 FR WL 600 MM
Sensor-Ureterorenoscopes are used within the scope of therapeutic and diagnostic interventions. The products are active, sterile and for single-use. They are used for visualizing body cavities via natural passages and for the insertion of auxiliary instruments through the working channel as well as the supply of irrigation fluid.
The Sensor-Ureterorenoscope is used in Urology for examination, diagnostics and/or therapy of the upper urinary tract.
User
These products are exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately instructed persons.
ADAPTER FOR CONTROLLER 5525
The products are used for operating a sensor endoscope in conjunction with an ENDOCAM Logic 5525 Camera Controller, for the mechanical connection to the sensor endoscope as well as for controlling the signals generated.
User
This product is designed exclusively for use by specialized medical personnel and may only be applied by medically qualified and adequately trained persons.
5.2.2 Explanation on differences to predicate device
In comparison to the predicate device, the subject device does have only the urological indication of use and restricts usage of the device to natural passages.
However, the full indication of use for the subject device is covered by the predicate device and reducing the scope does not lead to new questions regarding safety and effectiveness.
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Image /page/7/Picture/1 description: The image shows the text "K201897 Page 5 of 8" in the upper left corner. Below this text is the name "RICHARD WOLF" in a stylized font, with "RICHARD" in black and "WOLF" in red. To the right of the name is a logo featuring a dog-like figure with a tool or instrument near its head.
Comparison of Technological Characteristics with the Predicate Device 5.3
5.3.1 Overview
| Technolgical
characteristic | Submitted device
RIWO D-URS | Predicate device |
|------------------------------------|--------------------------------|---------------------|
| Software | NA | NA |
| Materials with
patient contact | Direct and indirect | Direct and indirect |
| Single use /
reusable | Single use | Reusable |
| Delivered sterile /
non-sterile | Delivered sterile | Non-sterile |
| Sterilization
method | Ethylene oxide | Hydrogen peroxide |
5.3.2 Discussion
There are some differences between the subject device and the predicate device that had to be verified or validated before claiming substantial equivalence.
Main difference:
-
l. The RIWO D-URS is a single use and sterile delivered device whereas the predicate device can be reprocessed which lead to changes in material, sterilization process, storage, etc.
Minor differences: -
i. The RIWO D-URS requires the ADAPTER FOR CONTROLLER 5525 to establish the connection with an ENDOCAM Logic 5525 Camera Controller whereas the predicate device can be connected directly.
-
ii. The RIWO D-URS has a different handle design which requires different operation of the instrument.
-
The RIWO D-URS is designed with small deviations in technical characteristics such as iii. sheath diameter, working channel diameter, working length, deflection range, LED positioning and pixel size
- l. For the main difference, several testing activities of the subject device were necessary to prove safety and effectiveness. This includes
- Storage and packaging validation of the sterile packaging
- Validation of the sterilization process ●
- Biocompatibility testing due to the new materials
- Performance testing due to new materials
- l. For the main difference, several testing activities of the subject device were necessary to prove safety and effectiveness. This includes
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Image /page/8/Picture/1 description: The image shows the text "K201897 Page 6 of 8 RICHARD WOLF" in black font. Below the text is the word "WOLF" in large red font. To the right of the word "WOLF" is a logo of a dog with a nail in its mouth.
- i. The first minor difference was evaluated by bench testing and electromagnetic compatibility testing to prove the compatibility of the devices. Every functional performance test was done using the ADAPTER FOR CONTROLLER 5525 as otherwise no image would have been visible.
- ii. The second difference was evaluated by a usability study which proved that the subject device can be operated as safe and effective as the predicate device.
- iii. The third difference was evaluated by bench testing, proving that the deviations have no negative impact on the safety and effectiveness of the device and that it can perform within its specifications.
The following subsections provide an overview of the testing activities and methods, for more detail please check the applicable section.
5.4 Clinical Performance Testing
No clinical testing was performed with RIWO D-URS or ADAPTER FOR CONTROLLER 5525
No animal studies were performed with RIWO D-URS or ADAPTER FOR CONTROLLER 5525
Non-Clinical Performance Testing 5.5
5.5.1 Sterilization
The ethylene oxide sterilization process for the RIWO D-URS was validated according to EN ISO 11135:2014 Annex B (half-cycle method). The sterile packaging was subjected to several tests to ensure the sterility including
- . Environmental conditioning ASTM D4169-16 and ASTM D4332-14
- Accelerated aging ASTM F1980-16 .
- Transportation Simulation ASTM D4169-16 .
- . Visual Inspection of packaging and seal integrity ASTM F1886-16
- . Packaging Challenging Testing [Bubble Test] ASTM F2096-11
- . Seal Integrity Test [Liquid Dye] ASTM F1929-15
- . Seal Strength Test ASTM F88-15
All test methods were applied to non-aged as well as accelerated aged products.
The ADAPTER FOR CONTROLLER 5525 is delivered non-sterile, therefore no validation was required.
The results proved that the RIWO D-URS is as safe as the predicate device and that the RIWO D-URS including ADAPTER FOR CONTROLLER 5525 can be deemed substantially equivalent to the predicate device.
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Image /page/9/Picture/1 description: The image shows a logo with the text "K201897" at the top, followed by "Page 7 of 8". Below this is the name "RICHARD WOLF" in a stylized font, with "WOLF" in large red letters. To the right of the name is a logo featuring a dog-like figure with a medical instrument, possibly a scope, inserted into it.
Biocompatibility 5.5.2
The RIWO D-URS includes components with direct and indirect patient contact. Therefore, a biological risk assessment was performed considering the following:
- . ISO 10993-1:2018: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- . 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
The ADAPTER FOR CONTROLLER 5525 has no components with direct or indirect patient contact, therefore biocompatibility testing according to ISO 10993-1 was not necessary.
Biological testing and chemical characterization proved that the RIWO D-URS is as safe as the predicate device and that the RIWO D-URS including ADAPTER FOR CONTROLLER 5525 can be deemed substantially equivalent to the predicate device.
5.5.3 Electromagnetic Compatibility and Electrical Safety
Electromagnetic compatibility testing proved compliance with the following standards for RIWO D-URS including ADAPTER FOR CONTROLLER 5525
- IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012; Medical electrical equipment Part 1: . General requirements for basic safety and essential performance
- . IEC 60601-1-6:2010 + A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- . 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 tests
- . IEC 60601-2-18:2009 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
It could be shown that regarding electromagnetic compatibility and electrical safety the devices are as safe and effective and therefore substantially equivalent to the predicate device.
5.5.4 Performance and Operational testing
The efficacy and safety of Richard Wolf's RIWO D-URS including ADAPTER FOR CONTROLLER 5525 is documented by the verification and validation testing, which confirms that the product meets all the reguirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met.
This includes Packaging, Transportation, Environmental conditions, photobiological safety and functionality testing, performed for the RIWO D-URS as well as the ADAPTER FOR CONTROLLER 5525. In addition, a usability study was performed, and optical performance was evaluated for the RIWO D-URS and parameters without defined acceptance criteria were compared to those of the predicate device to prove equivalence.
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Image /page/10/Picture/1 description: The image shows the text "K201897 Page 8 of 8 RICHARD WOLF" in a bold, sans-serif font. The word "WOLF" is in a larger font size and is red. To the right of the text is a logo featuring a dog-like figure with a medical instrument.
It could be shown that the RIWO D-URS including the ADAPTER FOR CONTROLLER 5525 functions as safe as effective as the predicate device and therefore can be deemed substantially equivalent.
5.6 Conclusions
The non-clinical data support the safety of the device and the verification and validation demonstrate that the RIWO D-URS and ADAPTER FOR CONTROLLER 5525 should perform as intended in the specified use conditions. The data demonstrate that the RIWO D_URS and ADAPTER FOR CONTROLLER 5525 perform comparably to the predicate device that is currently marketed for an equivalent intended use.
Therefore, the RIWO D-URS with ADAPTER FOR CONTROLLER 5525 has been deemed to be substantially equivalent to the legally marketed device.