(106 days)
ENDOCAM Logic 5525 Camera Controller:
LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER:
The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
LOGIC HD LITE CAMERA CONTROLLER:
The Logic HD lite Camera Controller 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 ENDOCAM Logic 5525 Camera Controller describes all Richard Wolf ENDOCAM Logic Camera Controllers, by name LOGIC 4K CAMERA CONTROLLER, LOGIC HD CAMERA CONTROLLER and LOGIC HD Lite CAMERA CONTROLLER.
The main purpose of the ENDOCAM Logic 5525 Camera Controller is identifying the applied part(s) and configuring the data stream, managing the interaction and providing an access point for the user.
The ENDOCAM Logic 5525 Camera Controller contains software which is classified as a minor Level of Concern. The main features of the software are configuration of the image processing, archiving and providing different views and a user interface to the user.
The ENDOCAM Logic 5525 Camera Controller is not intended to contact the patient directly or indirectly.
The ENDOCAM Logic 5525 Camera Controller is delivered non-sterile. 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.
The provided text describes a 510(k) premarket notification for the ENDOCAM Logic 5525 Camera Controller. This submission focuses on demonstrating substantial equivalence to a predicate device, specifically the LOGIC 4K CAMERA CONTROLLER (K180583), rather than presenting a novel device that requires extensive clinical studies or a new set of acceptance criteria with detailed performance metrics.
Therefore, many of the requested points regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment are not applicable or explicitly stated in the provided document. The document primarily focuses on verifying that an updated software version and the subject devices maintain the same performance and safety characteristics as the predicate device.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating that the updated device continues to meet the safety and performance standards established for the predicate device. The general "acceptance criteria" are implied to be compliance with relevant standards and demonstration of equivalent performance to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Software Functionality & Safety: | |
| * Meets requirements for "Minor Level of Concern" software. | The software documentation was prepared for a Minor Level of Concern. All changes (including new features) were verified and validated, showing they "do not raise new questions regarding safety or performance." |
| * Complies with relevant software guidance documents. | The documentation followed guidance from: "Content of Premarket Submissions for Software Contained in Medical Devices," "Off-The Shelf Software Use in Medical Devices," "Cybersecurity for Networked Medical Devices," "Content of Premarket Submissions for Management of Cybersecurity," "General Principles of Software Validation," and "Deciding when to submit a 510(k) for a Software Change." |
| Electromagnetic Compatibility (EMC) & Electrical Safety: | |
| * Complies with IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, | Electromagnetic compatibility testing proved compliance with these standards. The changes "do not raise new questions regarding safety or performance." |
| and IEC 60601-2-18 standards. | |
| General Performance & Operational Functionality: | |
| * Meets all requirements and specifications for overall design, | Verification and validation testing confirm that the product "meets all the requirements and specifications for overall design, basic safety and essential performance, and that the design inputs and specifications are met." Functional testing was performed to "prove the performance of the devices." Testing demonstrated proper operation and functionality after specified storage and transport conditions. |
| basic safety, and essential performance. | |
| * Functionality after storage and transport conditions. | |
| Intended Use Equivalence: | The ENDOCAM Logic 5525 Camera Controller "has the same intended use as the predicate device." |
| Technical Characteristics Equivalence (Hardware/Design): | The device "has equivalent technical characteristics and design as the predicate device. The operating principle, mechanical design, dimensions and device material are equivalent or the same." The only major difference noted is a software upgrade from Version 2.0.1 to 2.0.8. |
| Overall Safety and Effectiveness Equivalence to Predicate: | The nonclinical tests demonstrate that the devices are "as safe, as effective, and perform as well as or better than the legally marketed device." Hence, the device is deemed "substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The studies cited are "verification and validation testing" and "functional testing" which are typically internal engineering tests performed on the device itself, rather than testing with a "test set" of clinical data.
- Data Provenance: Not applicable in the context of clinical data. The testing described is non-clinical (engineering and software verification/validation).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts & Qualifications: Not applicable. This type of information would be relevant for studies involving the interpretation of results (e.g., image analysis by radiologists). The described testing focuses on the camera's technical performance and safety compliance.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no evidence of a "test set" that requires adjudication by human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study was done.
- The device is an endoscopic camera controller, not an AI diagnostic aid. Therefore, this type of study is not relevant to its regulatory submission as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a camera controller, an imaging component, not a standalone algorithm. Its function is to process and manage video streams for human operators.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the clinical sense. For the non-clinical testing, the "ground truth" would be established engineering specifications, performance standards (e.g., signal-to-noise ratio, resolution, color accuracy), and regulatory compliance requirements.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. The device relies on embedded software/firmware for camera control and image processing, not on machine learning or deep learning models that require a "training set" of data in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no "training set" in the context of this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 23, 2020
Richard Wolf Medical Instruments Corporation Michael Loiterman US Head of Regulatory- OA/OC 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K200617
Trade/Device Name: ENDOCAM Logic 5525 Camera Controller: LOGIC 4K CAMERA CONTROLLER / LOGIC HD CAMERA CONTROLLER / LOGIC HD LITE CAMERA CONTROLLER Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: May 29, 2020 Received: June 2, 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
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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,
for
Shani P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant 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) K200617
Device Name
ENDOCAM Logic 5525 Camera Controller: LOGIC 4K CAMERA CONTROLLER / LOGIC HD CAMERA CONTROLLER / LOGIC HD LITE CAMERA CONTROLLER
Indications for Use (Describe) ENDOCAM Logic 5525 Camera Controller:
LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER:
The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
LOGIC HD LITE CAMERA CONTROLLER:
The Logic HD lite Camera Controller 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 shows the text "K200617 Page 1 of 5" at the top. Below the text is the Richard Wolf logo. The logo has the word "RICHARD" in black, with the word "WOLF" in red below it. To the right of the text is a graphic of a dog.
5 510(k) Summary
l Submitter
Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL 60046
Phone:(847) 913 1113 Fax: (847) 913 0924
Contact Person, Title: Michael Loiterman Date Prepared: March 6, 2020
Legal Manufacturer
Richard Wolf GmbH Pforzheimer Straße 32 75438 Knittlingen
ll Device
The ENDOCAM Logic 5525 Camera Controller: LOGIC 4K CAMERA CONTROLLER / LOGIC HD CAMERA CONTROLLER / LOGIC HD LITE CAMERA CONTROLLER go under the common name "endoscopic video imaging system". The following table lists all devices for which clearance is requested:
| Trade name | ModelNumber(s) | Productclassificationname | RegulationNumber andName | ProductCode | DeviceClass | ReviewPanel | |
|---|---|---|---|---|---|---|---|
| ENDOCAM Logic 5525Camera Controller | LOGIC HD LITECAMERACONTROLLER | 5525201 | EndoscopicVideo ImagingSystem/Component,Gastroenterology-Urology | 876.1500EndoscopeandAccessories | FET | II | Gastro-enterology /Urology |
| LOGIC HDCAMERACONTROLLER | 55251015525102552510355251045525105552510655251075525108 | ||||||
| LOGIC 4KCAMERACONTROLLER | 5525201 |
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Image /page/4/Picture/2 description: The image is a logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the words is a white square with rounded corners, inside of which is a black drawing of a dog with a nail being hammered into its head.
��� Predicate Device
Name of Predicate Device: LOGIC 4K CAMERA CONTROLLER (5525301) 510(k) Number: K180583 Regulatory Class: II Product Code: FET Manufacturer: Richard Wolf GmbH
The predicate has not been subject to a design-related recall.
5.1 Device Description
5.1.1 Subject Device Identification
| ENDOCAM Logic 5525Camera Controller | Type number | Description |
|---|---|---|
| 5525301 | LOGIC 4KCAMERA CONTROLLER | |
| 5525101 | LOGIC HDCAMERA CONTROLLER | |
| 5525102 | ||
| 5525103 | ||
| 5525104 | ||
| 5525105 | ||
| 5525106 | ||
| 5525107 | ||
| 5525108 | ||
| 5525201 | LOGIC HD LITECAMERA CONTROLLER |
ENDOCAM Logic 5525 Camera Controller describes all Richard Wolf ENDOCAM Logic Camera Controllers, by name LOGIC 4K CAMERA CONTROLLER, LOGIC HD CAMERA CONTROLLER and LOGIC HD Lite CAMERA CONTROLLER.
The main purpose of the ENDOCAM Logic 5525 Camera Controller is identifying the applied part(s) and configuring the data stream, managing the interaction and providing an access point for the user.
5.1.2 Subject device characteristics
The ENDOCAM Logic 5525 Camera Controller contains software which is classified as a minor Level of Concern. The main features of the software are configuration of the image processing, archiving and providing different views and a user interface to the user.
The ENDOCAM Logic 5525 Camera Controller is not intended to contact the patient directly or indirectly.
The ENDOCAM Logic 5525 Camera Controller is delivered non-sterile. 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.
The ENDOCAM Logic 5525 Camera Controller is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
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05 510(k) Summary
Image /page/5/Picture/2 description: The image shows the logo for Richard Wolf. The words "RICHARD WOLF" are stacked on top of each other, with "RICHARD" in black and "WOLF" in red. To the right of the words is a black and white graphic of a dog with a nail in its mouth.
5.2 Indications for Use
ENDOCAM Logic 5525 Camera Controller:
LOGIC HD CAMERA CONTROLLER / LOGIC 4K CAMERA CONTROLLER
The Logic HD Camera Controller and the Logic 4K Camera Controller have been designed for highdefinition video endoscopy and can be used for both diagnostic and therapeutic interventions. The Camera Controllers are used in conjunction with other video equipment and endoscopic accessories.
LOGIC HD LITE CAMERA CONTROLLER
The Logic HD lite Camera Controller 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.
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05 510(k) Summary
5.3 Comparison of Technological Characteristics with the Predicate Device
The ENDOCAM Logic 5525 Camera Controller has the same intended use as the predicate device. It also has equivalent technical characteristics and design as the predicate device. The operating principle, mechanical design, dimensions and device material are equivalent or the same.
There is only one major difference to the predicate device: The software version was upgraded from Version 2.0.1 (predicate device) to Version 2.0.8.
5.4 Performance Testing
The same testing that was used for the predicate device to prove performance and functionality was applied to the subject devices.
5.4.1 Software verification and validation
The documentation was prepared for a Minor Level of Concern.
The following Guidance documents were used to prepare the required documentation:
- . 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, 2014)
- . General Principles of Software Validation (January 11, 2002)
- . Deciding when to submit a 510(k) for a Software Change to an Existing Device (Oct. 25, 2017)
All changes that were made, including new features, were verified and validated, if needed with the respective application part. It could be shown that these changes do not raise new questions regarding safety or performance and that the ENDOCAM Logic 5525 Camera Controller is substantial equivalent to the LOGIC 4K Camera Controller (predicate device, K180583).
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05 510(k) Summary
Image /page/7/Picture/2 description: The image shows the logo for Richard Wolf. The words "RICHARD" and "WOLF" are stacked on top of each other. "RICHARD" is in black, and "WOLF" is in red. To the right of the text is a logo of a dog with a nail gun pointed at its head, all inside of a square with rounded corners.
Electromagnetic Compatibility and Electrical Safety 5.4.2
Electromagnetic compatibility testing proved compliance with the following standards for ENDOCAM Logic 5525 Camera Controller
- . 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 the changes do not raise new questions regarding safety or performance and that the ENDOCAM Logic 5525 Camera Controller is substantial equivalent to the LOGIC 4K CAMERA CONTROLLER (predicate device K180583).
5.4.3 Performance and Operational testing
The efficacy and safety of Richard Wolf's ENDOCAM Logic 5525 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 and essential performance, and that the design inputs and specifications are met.
Functional testing was performed on the ENDOCAM Logic 5525 Camera Controller to prove the performance of the devices.
To demonstrate that the ENDOCAM Logic 5525 Camera Controller is working properly during operation and that functionality is still given after specified storage and transport conditions, testing was performed.
5.4.4 Animal testing
No animal testing was performed on the ENDOCAM Logic 5525 Camera Controller (LOGIC HD LITE, LOGIC HD and LOGIC 4K CAMERA CONTROLLER).
5.4.5 Clinical studies
No clinical studies were performed on the ENDOCAM Logic 5525 Camera Controller (LOGIC HD LITE, LOGIC HD and LOGIC 4K CAMERA CONTROLLER).
5.5 Conclusions
ENDOCAM Logic 5525 Camera Controller (LOGIC HD LITE, LOGIC HD and LOGIC 4K CAMERA CONTROLLER) and their accessories have the same indications for use as the predicate device. The nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as or better than the legally marketed device.
Therefore, the ENDOCAM Logic 5525 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.