(151 days)
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.
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. 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.
This document is a 510(k) Summary for the Richard Wolf D Camera Controller (K211332), filed with the FDA. It declares substantial equivalence to a predicate device, the LOGIC HD LITE CAMERA CONTROLLER (K200617). The core argument for equivalence primarily rests on non-clinical performance testing and software verification.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: This device, the "D Camera Controller," is a hardware component (a camera controller) for endoscopy, not an AI or imaging diagnostic device in the traditional sense. Therefore, many of the typical acceptance criteria and study types associated with AI/ML diagnostic tools (like those involving image classification, human reader performance, ground truth establishment by expert consensus, etc.) are not applicable or described in this document. The focus here is on the functional safety and effectiveness of the device as a video endoscopy component.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML diagnostic device, the acceptance criteria are largely related to functional performance, electrical safety, electromagnetic compatibility, and software validation. The document describes that the device met these criteria rather than providing a quantitative table of thresholds vs. observed performance in a diagnostic context.
| Acceptance Criteria Category | Description of Performance / Met Status |
|---|---|
| Functional Performance (Image Data Processing & Recording) | "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." The device processes electrical signals from sensor endoscopes to render a visible image and records images/videos. |
| Electromagnetic Compatibility (EMC) | "Tested according to, and compliance was demonstrated with... IEC 60601-1-2:2014 and IEC 60601-2-18:2009." Performance shown to be "safe and as effective as the predicate device." |
| Electrical Safety | "Tested according to, and compliance was demonstrated with... EN 60601-1:2005 + A1:2012, IEC 60601-1-6:2010 + A1:2013, IEC 60601-2-18:2009." Performance shown to be "safe and as effective as the predicate device." |
| Software Verification & Validation | "Verification and validation testing were performed on the software system and the corresponding software sub-components following the corresponding guidelines... and IEC 62304 Edition 1.1 2015-06." "The software functions of the D Camera Controller are a subset of the software functions of the predicate device. The only additional feature... is the video archive function. This difference... does not affect safety or effectiveness as shown by the software testing." |
| Packaging & Transportation | Tested/validated due to changes in dimensions and weight compared to the predicate. |
| Operating Conditions | Tested/validated due to changes in operating conditions, power consumption, and cooling method compared to the predicate. |
| Temperature Monitoring | Tested/validated. |
| Biocompatibility | Not applicable as the device does not have patient contact. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "test set" sample size in terms of clinical cases or patient data. The testing described is primarily bench testing (performance, electrical safety, EMC) and software testing, not a clinical study involving a dataset of medical images or patient outcomes.
- Data Provenance: Not applicable in the context of clinical image data. The testing is described as internal verification and validation of the device's engineering performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The "ground truth" for this device is its adherence to engineering specifications, electrical safety standards, electromagnetic compatibility, and software functionality, as verified through standard testing procedures. It is not an AI diagnostic device where expert interpretation of clinical data constitutes "ground truth."
4. Adjudication Method for the Test Set
- Not applicable. As the performance testing is against technical specifications and standards, there is no need for expert adjudication of medical findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No. An MRMC study is relevant for AI image analysis tools where human reader performance (with and without AI assistance) is being evaluated. This device is a camera controller, not such an AI tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Study was done
- Not applicable. This device is a hardware component with integrated software for image acquisition and processing. Its "standalone" performance is its ability to meet specified technical and functional requirements, which are detailed implicitly through the various compliance tests mentioned (EMC, electrical safety, software V&V, functional tests). It's not a standalone diagnostic algorithm that produces a finding independent of human interaction.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is:
- Engineering Specifications: The device must meet its design requirements for signal processing, image recording, user interface functions, etc.
- Regulatory Standards: Compliance with electrical safety (e.g., EN/IEC 60601-1), electromagnetic compatibility (e.g., IEC 60601-1-2), and software development/validation standards (e.g., IEC 62304).
- Predicate Device Equivalence: The ultimate "ground truth" sought by the 510(k) pathway is demonstrating that the device is "substantially equivalent" to a legally marketed predicate device in terms of safety and effectiveness. This is achieved by showing that any differences do not raise new questions of safety or effectiveness.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI models that require a "training set" of data in the common sense. Its software performs fixed algorithms for image processing and control, not adaptively learning from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8).
In Summary:
The provided document describes the regulatory submission for a medical device (a camera controller for endoscopy) that is primarily a hardware component with integrated software. The "acceptance criteria" and "study" proving it meets them are focused on engineering and regulatory compliance (e.g., electrical safety, EMC, software validation) rather than the clinical performance metrics often associated with AI/ML diagnostic tools (like sensitivity, specificity, or human reader study endpoints). The substantial equivalence claim is built on non-clinical performance testing and software verification, demonstrating that any technological differences from the predicate device do not raise new questions of safety or effectiveness. No clinical or image-based diagnostic performance studies are mentioned or required for this type of device.
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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.
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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/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
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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 classificationname | Regulation Numberand Name | ProductCode | DeviceClass | Review Panel |
|---|---|---|---|---|---|---|---|
| ENDOCAM | D Camera Controller | 5522101 | Endoscopic VideoImaging System /Component,Gastroenterology-Urology | 876.1500Endoscope andAccessories | 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.
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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.
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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 andimage recording | Signal processing of the image data andimage 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 to1060 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 endoscopesExternal light source (integrated in distal tipof sensor endoscope)No camera head requiredMonitor via HDMI (HD + SXGA) and3G-SDIUSB 2.0 | Sensor endoscopesRigid and flexible endoscopesExternal light sourceRequires camera headMonitor via 2 x HDMI HDUSB 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 endoscopesAutomatic via button with rigid and flexibleendoscopes |
| Auto Shutter | Yes | Yes | |
| Output resolution [pixels] | 1280 x 10241920 x 1080 | 1280 x 10241920 x 10801920 x 1200 | |
| Image formats | JPG | JPEG / TIFF | |
| Archive formats (videosequence) | AVI | N/A | |
| Special imaging modes | No | Yes | |
| "Dialog" function | No, subject device supplies the LED of thedistal tip with energy | Yes, enables communication between thecamera controller and an interactive lightsource | |
| LAN (Ethernet) NetworkConnector (RJ45) | No (Connection to Core nova system notavailable) | Yes (Connection to Core nova system,corresponding operator messages/alarmsavailable) |
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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:
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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.
§ 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.