(151 days)
No reference devices were used in this submission.
No
The summary describes standard image processing for video endoscopy and explicitly states that the software functions are a subset of the predicate device with only an added video archive function. There is no mention of AI, ML, or related concepts.
No
The device is described as a "Camera Controller" used for signal processing of image data and image recording for high-definition video endoscopy. While it can be used in both diagnostic and therapeutic interventions, its primary function described is related to imaging and control, not directly delivering therapy.
Yes
The device is described as being able to be used for "diagnostic and therapeutic interventions," and its function involves processing image data to render a visible image for the user, which is a key component of diagnostic procedures.
No
The device description explicitly states it is a "Camera Controller" and supplies light to the endoscope, indicating it includes hardware components beyond just software. The performance studies also include testing for electromagnetic compatibility and electrical safety, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for health issues.
- Device Function: The D Camera Controller 5522101 is described as a control unit for high-definition video endoscopy. Its primary function is to process and convert electrical signals from a sensor endoscope into a visible image on a monitor. It also provides light to the endoscope and has a video archive function.
- Intended Use: The intended use is for high-definition video endoscopy for both diagnostic and therapeutic interventions. This involves visualizing internal body structures directly, not analyzing samples taken from the body.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device works with an endoscope to capture images of internal anatomy.
Therefore, the D Camera Controller 5522101 falls under the category of medical devices used for visualization and intervention within the body, not for in vitro diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.
Product codes
FET
Device Description
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The subject device is used in combination with sensor endoscopes and a monitor for visualization. In this context, the D Camera Controller is the control unit, its primary performance characteristics are signal processing of the image data and image recording. No further light source is required for the intervention. The D Camera Controller supplies the distal LED of the endoscope with light. The electrical signals provided by the sensor endoscope are processed and adequately converted to render a visible image of the endoscopic scene on a connected display device for the user.
The device features controlled by the software are:
- Sensor Endoscopes (LED light)
- Configuration of Image Processing (zoom)
- Picture Archive and Video Archive
- Temperature Monitoring
- User interface: on-screen display
The product is controlled directly via the control panel on the device front panel. Optionally, a manual remote control (not part of this submission) can be connected to the D Camera Controller via USB ports to control certain functions of the controller. The D Camera Controller must be connected to a 110 V power supply.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The product is intended for adult patients.
Intended User / Care Setting
The D Camera Controller is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.
The D Camera Controller is intended to be used in 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Testing:
- Biocompatibility: Not applicable as the device does not contact patients.
- Electromagnetic Compatibility and Electrical Safety: Tested according to IEC 60601-1-2:2014, IEC 60601-2-18:2009, EN 60601-1:2005 + A1:2012, IEC 60601-1-6:2010 + A1:2013. Showed that the subject devices function as safe and as effective as the predicate device.
- Performance Testing: Verification and validation testing performed for overall design, basic safety, essential performance, and meeting design inputs and specifications. Testing activities included Packaging, Transportation, Operating conditions, Temperature monitoring, and functionality testing. It was shown that the subject devices met all acceptance criteria and function as safe and as effective as the predicate device.
Software Verification and Validation Testing:
Performed following guidelines:
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- Off-The Shelf Software Use in Medical Devices (September 27, 2019)
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (January 14, 2005)
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2018, DRAFT)
- General Principles of Software Validation (January 11, 2002)
- IEC 62304 Edition 1.1 2015-06 (Consolidated Version).
The same software tests were concluded as for the predicate device, with additional testing due to the subject device's risk class. The software functions of the D Camera Controller are a subset of the predicate, with the only additional feature being video archive function, which does not affect safety or effectiveness. Conclusion: Changes do not raise new questions regarding safety or performance.
Clinical Performance Testing:
No clinical testing was performed with D Camera Controller.
No animal studies were performed with D Camera Controller.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 1, 2021
Richard Wolf Medical Instruments Corporation Michael Loiterman US Head of Regulatory - QA/QC 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K211332 Trade/Device Name: D Camera Controller Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FET Dated: August 27, 2021 Received: August 30, 2021
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 statutes and regulations administered by other Federal agencies.
1
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211332
Device Name D Camera Controller
Indications for Use (Describe)
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.
| 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 contains the words "RICHARD WOLF" in a stylized font, with "RICHARD" in a smaller, sans-serif font above "WOLF", which is in a larger, bolder, and more modern-looking font. To the right of the text is a logo featuring a stylized dog head with a vertical line extending down from its mouth, ending in a small burst or star shape, all enclosed in a rounded square. The overall design appears to be a logo or branding element, possibly for a company or product named Richard Wolf.
510(k) Summary 5
l Submitter
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60041
Phone:(847) 913 1113 Fax: (847) 913 0924
Contact Person, Title: Michael Loiterman Date Prepared: August 27, 2021
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen
ll Device
The "D Camera Controller" belongs to the ENDOCAM brand. Table 5-1 lists all devices for which clearance is requested.
| Table 5-1: Devices for which clearance is requested. | |
|---|---|
| Brand name | Trade name | Model Number | Product classification
name | Regulation Number
and Name | Product
Code | Device
Class | Review Panel |
|------------|---------------------|--------------|------------------------------------------------------------------------------------|------------------------------------------|-----------------|-----------------|-------------------------------|
| ENDOCAM | D Camera Controller | 5522101 | Endoscopic Video
Imaging System /
Component,
Gastroenterology-
Urology | 876.1500
Endoscope and
Accessories | FET | II | Gastroenterology /
Urology |
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Image /page/4/Picture/1 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the words is a square with rounded corners, inside of which is a white wolf with a medical instrument. The logo is simple and modern, and the colors are eye-catching.
��� Predicate Device
Name of Predicate Device: LOGIC HD LITE CAMERA CONTROLLER (5525101) 510(k) Number: K200617 Regulatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design-related recall. No reference devices were used in this submission.
Subject Device Description 5.1
5.1.1 Device Identification
Table 5-2: Subject device.
| Brand name | Type number | Trade name | Package unit |
|---|---|---|---|
| ENDOCAM | 5522101 | D Camera Controller | 1 |
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions.
Device characteristics 5.1.2
Software
The D Camera Controller does contain software. The software is classified as a moderate Level of Concern.
Materials with patient contact
The D Camera Controller is not intended to contact the patient directly or indirectly.
Single use / reusable
The devices are reusable and do require cleaning and reprocessing during their 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 D Camera Controller is delivered non-sterile.
Sterilization method
The D Camera Controller is delivered non-sterilization is not required.
5.1.3 Environment of Use
The D Camera Controller is intended to be used in professional health care facility environment.
5
05 510(k) Summary
Brief written description of the Device 5.1.4
The subject device is used in combination with sensor endoscopes and a monitor for visualization.
Image /page/5/Figure/4 description: The image shows a diagram of a D Camera Controller system. The system includes a manual remote control, a sensor endoscope, and a monitor. These components are connected to the D Camera Controller, which is labeled with the brand name "RICHARD WOLF" and the model name "ENDOCAM".
D Camera Controller
Figure 5-1: Image of the D Camera Controller and its setup possibilities.
In this context, the D Camera Controller is the control unit, its primary performance characteristics are signal processing of the image data and image recording. No further light source is required for the intervention. The D Camera Controller supplies the distal LED of the endoscope with light. The electrical signals provided by the sensor endoscope are processed and adequately converted to render a visible image of the endoscopic scene on a connected display device for the user.
The device features controlled by the software are:
- Sensor Endoscopes (LED light) ●
- Configuration of Image Processing (zoom) ●
- . Picture Archive and Video Archive
- . Temperature Monitoring
- . User interface: on-screen display
The product is controlled directly via the control panel on the device front panel. Optionally, a manual remote control (not part of this submission) can be connected to the D Camera Controller via USB ports to control certain functions of the controller. The D Camera Controller must be connected to a 110 V power supply.
6
5.1.5 Materials of Use
The D Camera Controller consists of a metal housing which does not have any body contact with the patient.
5.1.6 Key Performance Characteristics
The D Camera Controller is the control unit. The subject device processes electrical signals generated by sensor endoscopes and subsequently converts these signals to render a visible image on a connected display. Thus, its primary performance characteristics are signal processing of the image data and image recording.
5.2 Indications for Use
Statement
The D Camera Controller 5522101 has been designed for high-definition video endoscopy and can be used for both, diagnostic and therapeutic interventions. The Camera Controller is used in conjunction with other video equipment and endoscopic accessories.
User
The D Camera Controller is exclusively intended for use by specialized medical personnel and may only be used by medically qualified and adequately trained persons.
Patient population
The product is intended for adult patients.
The intended patient population is not restricted to ethnics, gender, body height, and weight.
Before use, the doctor in charge must ensure that the product can be safely used in terms of its dimensions or settings.
Explanation on differences to the predicate device
In comparison to the predicate device, the usage of the subject device is further restricted to adults. 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 logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other, with "RICHARD" in a futuristic font and "WOLF" in a bold, red font. To the right of the text is a logo of a wolf's head with a surgical instrument going through it, all enclosed in a rounded square.
Comparison of Technological Characteristics with the Predicate Device 5.3
5.3.1 Overview Table
| Technological characteristics | Subject device | Predicate device | |
|---|---|---|---|
| Key Performance characteristics | Signal processing of the image data and | ||
| image recording | Signal processing of the image data and | ||
| image recording | |||
| Weight | 2.3 kg (5.1 lbs) | 5.2 kg (11.4 lbs) | |
| Dimensions (W x H x D) [mm] | 200 mm x 67 mm x 240 mm | 300 mm x 120 mm x 416 mm | |
| Environment of use | Professional health care facility | Professional health care facility | |
| Operating conditions | +10 °C to +40 °C, 20 % to 85 % rel. | ||
| humidity, atmospheric pressure 700 hPa to | |||
| 1060 hPa | +10°C to +40°C, 30% to 75% rel. humidity, | ||
| atmospheric pressure 700 hPa to 1060 hPa | |||
| Materials of use | Metal housing | Metal housing | |
| Materials with patient contact | No | No | |
| Single use / reusable | Reusable | Reusable | |
| Delivered sterile / non-sterile | Non-sterile | Non-sterile | |
| Sterilization method | N/A | N/A | |
| Combinations | Sensor endoscopes | ||
| External light source (integrated in distal tip | |||
| of sensor endoscope) | |||
| No camera head required | |||
| Monitor via HDMI (HD + SXGA) and | |||
| 3G-SDI | |||
| USB 2.0 | Sensor endoscopes | ||
| Rigid and flexible endoscopes | |||
| External light source | |||
| Requires camera head | |||
| Monitor via 2 x HDMI HD | |||
| USB 2.0 | |||
| Power consumption [VA] / Current rating [A] | 32 / max. 0.32 | 100 / max. 1.0 | |
| Protection class according to EN/IEC 60601-1 | I | I | |
| Protection against electric shock | Type BF applied part | Type CF applied part | |
| Technological characteristics | Subject device | Predicate device | |
| Degree of protection against liquids | IP20 | IP20 | |
| Cooling method | Constant fan | Controlled fan | |
| Software functions | White balance | Preset with sensor endoscopes | Preset with sensor endoscopes |
| Automatic via button with rigid and flexible | |||
| endoscopes | |||
| Auto Shutter | Yes | Yes | |
| Output resolution [pixels] | 1280 x 1024 | ||
| 1920 x 1080 | 1280 x 1024 | ||
| 1920 x 1080 | |||
| 1920 x 1200 | |||
| Image formats | JPG | JPEG / TIFF | |
| Archive formats (video | |||
| sequence) | AVI | N/A | |
| Special imaging modes | No | Yes | |
| "Dialog" function | No, subject device supplies the LED of the | ||
| distal tip with energy | Yes, enables communication between the | ||
| camera controller and an interactive light | |||
| source | |||
| LAN (Ethernet) Network | |||
| Connector (RJ45) | No (Connection to Core nova system not | ||
| available) | Yes (Connection to Core nova system, | ||
| corresponding operator messages/alarms | |||
| available) |
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Image /page/9/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in black, while "WOLF" is in a dark red color. To the right of the text is a logo featuring a stylized wolf standing over a nail, all enclosed in a square with rounded corners.
5.3.2 Discussion
The subject device basically shares the technological characteristics of the predicate device. However, there are some improved characteristics and some differences due to technical progress when comparing the subject device with the predicate. These changes had to be verified or validated before claiming substantial equivalence. The changes are categorized as follows:
Main difference
The main difference between the subject devices and the predicate is the change in software and software functions. Several testing activities of the subject device were performed to prove safety and effectiveness. This includes
- Validation of the Software and its functions
- . Validation of electromagnetic compatibility and electrical safety
- . Validation of the functionality by performance testing bench
Minor differences
The minor differences between the subject devices and the predicate are the change in the technical characteristics such as weight, dimensions, operating conditions, power consumption, cooling method, protection against electric shock, and combination possibilities. To prove that those changed characteristics do not question safety and effectiveness of the subject devices, several performance tests were performed, such as:
- . Validation of the electromagnetic compatibility and electrical safety of the devices due to the change in the protection against electric shock, power consumption, and combination possibilities
- . Performance testing due to the change in operating conditions, power consumption, cooling method, and combination possibilities
- . Packaging validation due to different dimensions and weight
To prove that these differences do not raise any new concerns regarding safety and effectiveness, the following subsections provide an overview of the testing activities and methods performed with the D Camera Controller. For more detail, please check the applicable section.
5.4 Summary of Performance Testing
5.4.1 Non-clinical Performance Testing
5.4.1.1 Biocompatibility
The D Camera Controller does not contain components that come into direct contact with patients.
Therefore, biocompatibility testing per ISO 10993-X does not apply according to ISO 10993-1.
Electromagnetic Compatibility and Electrical Safety 5.4.1.2
The D Camera Controller includes different hardware components and a different software. Due to this change, electromagnetic compatibility and electrical safety were tested to demonstrate that the changes had no negative influence regarding electromagnetic compatibility and electrical safety. In the following, the applicable standards to which adherence has been demonstrated are listed:
10
Electromagnetic Compatibility
The devices were tested according to, and compliance was demonstrated with, the following standards:
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
Electrical Safetv
The devices were tested according to, and compliance was demonstrated with, the following standards:
EN 60601-1:2005 + A1:2012 IEC 60601-1-6:2010 + A1:2013 IEC 60601-2-18:2009
It could be shown that the subject devices function as safe and as effective as the predicate device and therefore can be deemed substantially equivalent.
5.4.1.3 Performance Testing
The efficacy and safety of Richard Wolf's D Camera Controller is documented by the verification and validation testing which confirms that the product meets all the requirements and specifications for overall design, basic safety, essential performance, and that the design inputs and specifications are met.
Due to the above-mentioned differences, testing activities of the D Camera Controller include Packaging, Transportation, Operating conditions, Temperature monitoring, and functionality testing.
The testing performed is equivalent to the testing performed on the predicate device. Therefore, no separate comparison testing was determined to be necessary.
It could be shown that the subject devices met all acceptance criteria and function as safe and as effective as the predicate device and therefore can be deemed substantially equivalent.
5.4.2 Software Verification and Validation Testing
The D Camera Controller is equipped with a new software and therefore its safety and effectiveness must be validated.
Verification and validation testing were performed on the software system and the corresponding software sub-components following the corresponding guidelines:
- . Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- Off-The Shelf Software Use in Medical Devices (September 27, 2019) .
- . Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software (January 14, 2005)
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Image /page/11/Picture/1 description: The image contains the words "RICHARD WOLF" in a stylized font. The word "RICHARD" is in a smaller, black, sans-serif font above the word "WOLF", which is in a larger, red, blocky font. To the right of the words is a logo of a dog's head with a nail being hammered into it. The logo is contained within a rounded square.
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices ● (October 2, 2018, DRAFT)
- General Principles of Software Validation (January 11, 2002) .
and IEC 62304 Edition 1.1 2015-06 (Consolidated Version).
In general, the same software tests were concluded for the subject device as for the predicate device. However, due to the subject device's risk class, additional software testing was performed to verify its safety and effectiveness. Therefore, no additional comparison testing was performed.
The software functions of the D Camera Controller are a subset of the software functions of the predicate device. The only additional feature of the D Camera Controller is the video archive function. This difference between the subject device and its predicate does not affect safety or effectiveness as shown by the software testing.
Thus, it could be shown that these changes do not raise new questions regarding safety or performance and that the D Camera Controller is substantial equivalent to the predicate device.
5.5 Clinical Performance Testing
No clinical testing was performed with D Camera Controller.
No animal studies were performed with D Camera Controller.
5.6 Conclusion
The non-clinical data support the safety of the subject device and the verification and validation demonstrate that the D Camera Controller should perform as intended in the specified use conditions. Differences in technological characteristics do not raise any new questions regarding the safety and effectiveness of the D Camera Controller compared to the predicate device.
The data demonstrate that the D Camera Controller performs comparably to the predicate device that is currently marketed for the same intended use.
The D Camera Controller has been deemed to be substantially equivalent to the legally marketed device.