(115 days)
Not Found
No
The summary describes standard video processing and recording capabilities, with no mention of AI or ML algorithms for image analysis, diagnosis, or other functions.
No
The device is described as being used for "high-definition video endoscopy" and specifically for signal processing and image recording, which are diagnostic functions, not therapeutic ones. While it mentions use in diagnostic and therapeutic interventions, the device itself performs imaging, not therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "can be used for both diagnostic and therapeutic interventions."
No
The device description clearly details physical hardware components: a Camera Controller (housing made of powder-coated stainless steel) and a Camera Head (housing made of stainless steel). It also mentions electrical safety and EMC testing, which are relevant to hardware. While software is mentioned for control and processing, the device is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "high-definition video endoscopy" for "diagnostic and therapeutic interventions." This involves visualizing internal body structures, which is an in vivo (within a living organism) procedure, not in vitro (outside the body, typically involving samples).
- Device Description: The description details a camera system used to capture images from endoscopes. This aligns with in vivo imaging, not the analysis of biological samples.
- Lack of Mention of Samples: There is no mention of analyzing blood, urine, tissue, or any other biological samples, which are characteristic of IVD devices.
- Direct/Indirect Patient Contact: The description explicitly states the devices are "not intended to contact the patient directly or indirectly." While some IVDs might not directly contact the patient, the overall context of this device points away from IVD use.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This camera system is for visualizing the inside of the body directly.
N/A
Intended Use / Indications for Use
The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions.
Product codes (comma separated list FDA assigned to the subject device)
FET
Device Description
Richard Wolf's ENDOCAM® Logic 4K Camera System 5525 consists of the Logic 4K Camera Controller and Logic 4K Camera Head. The Logic 4K Camera System has been designed for highdefinition video endoscopy and is used in conjunction with other video equipment and endoscopic accessories.
The Logic 4K Camera Controller is the control center of the system, its primary performance characteristics are signal processing of the image data and image recording. The Logic 4K Camera Controller is equipped with various outputs (e.g. HDMI 4K and HDMI HD) and can process a 2K / HD or 4K resolution. The Logic 4K Camera Controller device parameters are controlled and set via the touchscreen, access to all control elements / parameters is possible in OSD via the PC keyboard the handheld remote control or via core.nova.
The Logic 4K Camera Controller housing is made of of powder-coated stainless steel measuring 300mm x 120mm x 416mm; the front foil consists of Polyester AUTOPEX.
The Logic 4K Camera Head is used in conjunction with the Logic 4K Camera Controller, its primary performance characteristic is to receive and transfer an optical image from a variety of endoscopes (rigid, semi-rigid, and flexible endoscopes).
The Logic 4K Camera Head housing is made of stainless steel measuring approximately 40mm x 47mm x 102mm. The camera head cable is securely attached and is 3.0m in length.
The LOGIC 4K Camera Controller and LOGIC 4K Camera Head are not intended to contact the patient directly or indirectly. Therefore, material biocompatibility according to ISO 10993-1 Biological Evaluation of Medical Devices is not required.
The LOGIC 4K Camera Controller and Logic 4K Camera Head are delivered non-sterile. The devices are reusable and do require processing during their use-life. Users are required to process the device for initial use and after each use. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction in Use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.
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)
Bench testing of performance specifications were completed and demonstrate that the device met all requirements. Bench comparison testing between the predicate device (K130423) and the LOGIC 4K CAMERA System demonstrated that the devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name of the agency, "U.S. Food & Drug Administration," is in blue text.
June 28, 2018
Richard Wolf Medical Instruments Corporation Michael Loiterman US Head of Regulatory - QA/QC 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K180583
Trade/Device Name: LOGIC 4K CAMERA CONTROLLER LOGIC 4K CAMERA HEAD Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FET Dated: May 18, 2018 Received: May 21, 2018
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Timothy Martin -S 2018.06.28 15:38:28 -04'00'
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180583
Device Name LOGIC 4K CAMERA CONTROLLER LOGIC 4K CAMERA HEAD
Indications for Use (Describe)
LOGIC 4K CAMERA CONTROLLER
The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
LOGIC 4K CAMERA HEAD
Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions.
This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. 510(k) Summary | ||
|---|---|---|
| I. Submitter: | Date of Preparation: February 28, 2018 | |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | Phone number (include area code): (847 ) 913 1113 | |
| Street address: 353 Corporate Woods Parkway | FAX number (include area code): (847 ) 913 0924 | |
| City: Vernon Hills | State/Province: Illinois | |
| Country: USA | ZIP / Postal Code: 60061 | |
| Contact name: Mr. Michael G. Loiterman | ||
| Contact title: US Head of Regulatory - QA/QC | ||
| Parent Company: | ||
| Company / Institution name: Richard Wolf GmbH | FDA establishment registration number: 96 111 02 | |
| Street address: Pforzheimer Str. 32 | ||
| City: Knittlingen | State/Province: Baden-Württemberg | |
| Country: Germany | ZIP / Postal Code: 75438 | |
| II. Device (subject device): | ||
| Name of Device: LOGIC 4K CAMERA CONTROLLER LOGIC 4K CAMERA HEAD | Brand Name: ENDOCAM® Model numbers: 5525301 85525942 | |
| Common / Usual name: Endoscopic Video Imaging System | Classification name: Endoscope and Accessories,(21 CFR 876.1500) | |
| Regulatory Class: II | ||
| Product Code: FET | ||
| III. Predicate device: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| K130423 | THE RICHARD WOLF ENDOCAM® LOGIC HD CAMERA SYSTEM 5525 | Richard Wolf Medical Instruments Corporation |
| This predicate has not been subject to a design-related recall. |
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5.1 Description
Richard Wolf's ENDOCAM® Logic 4K Camera System 5525 consists of the Logic 4K Camera Controller and Logic 4K Camera Head. The Logic 4K Camera System has been designed for highdefinition video endoscopy and is used in conjunction with other video equipment and endoscopic accessories.
The Logic 4K Camera Controller is the control center of the system, its primary performance characteristics are signal processing of the image data and image recording. The Logic 4K Camera Controller is equipped with various outputs (e.g. HDMI 4K and HDMI HD) and can process a 2K / HD or 4K resolution. The Logic 4K Camera Controller device parameters are controlled and set via the touchscreen, access to all control elements / parameters is possible in OSD via the PC keyboard the handheld remote control or via core.nova.
The Logic 4K Camera Controller housing is made of of powder-coated stainless steel measuring 300mm x 120mm x 416mm; the front foil consists of Polyester AUTOPEX.
The Logic 4K Camera Head is used in conjunction with the Logic 4K Camera Controller, its primary performance characteristic is to receive and transfer an optical image from a variety of endoscopes (rigid, semi-rigid, and flexible endoscopes).
The Logic 4K Camera Head housing is made of stainless steel measuring approximately 40mm x 47mm x 102mm. The camera head cable is securely attached and is 3.0m in length.
The LOGIC 4K Camera Controller and LOGIC 4K Camera Head are not intended to contact the patient directly or indirectly. Therefore, material biocompatibility according to ISO 10993-1 Biological Evaluation of Medical Devices is not required.
The LOGIC 4K Camera Controller and Logic 4K Camera Head are delivered non-sterile. The devices are reusable and do require processing during their use-life. Users are required to process the device for initial use and after each use. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use.
This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
5
5.2 Indications for Use
5.2.1 LOGIC 4K CAMERA CONTROLLER
Indications for use:
The ENDOCAM® Logic 4K Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic 4K Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
5.2.2 LOGIC 4K CAMERA HEAD
Indications for use:
Logic 4K Camera Head 85525942 is used for applications in conjunction with the Logic 4K Camera Controller 5525301 for diagnostic and therapeutic interventions.
This product is exclusively intended for use by specialized medical personnel and may only be used by adequately qualified and trained medical doctors.
5.3 Comparison of technological characteristics with the predicate device
The following information summarizes the characteristics of the LOGIC 4K CAMERA products, and The Richard Wolf ENDOCAM® LOGIC HD Camera System 5525 (K130423).
There are similarities and minor differences in the technological characteristics. These similarities are:
5.3.1 Similarities
LOGIC 4K CAMERA 5.3.1.1
- . Have equivalent Indications for use.
- Have the same basic design and same / equivalent materials.
- Are used in conjunction with other video equipment and endoscopic accessories. .
- Reusable.
- Autoclavable Camera Head.
- Conforms to Safety Standards IEC 60601-1 and IEC 60601-1-2.
6
5.3.2 Differences
LOGIC 4K CAMERA CONTROLLER: 5.3.2.1
- Power consumption and current rating ●
- Weight
- Maximum resolution (4K) .
- LAN(Ethernet) network connector usage ●
- Archive format and image compression ●
- . HDMI-4K Output (instead of analog video)
- Removed Interfaces: Video BNC, CAN, S-Video ●
- Special Imaging Modes (SIM) .
- Compatibility with 4K Camera Heads ●
- Compatiblity to core.nova ●
- Image compression ●
LOGIC 4K CAMERA HEAD: 5.3.2.2
- . Imaging Sensor Type
- Weight and dimensions of head with cable
- Reprocessing / Sterilization procedures .
- . Operating, storage and transport/shipping conditions
- Components and Materials
5.3.3 Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing 5.3.3.1
The Logic 4K Camera Controller 5525301 does not contain components that come into direct or indirect contact with patients. Biocompatibility testing per ISO 10993-x does not apply per ISO 10993-1. The Logic 4K Camera Head 85525942 does not contain components that come into direct or indirect contact with patients. Biocompatibility testing per ISO 10993-x does not apply per ISO 10993-1.
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5.3.3.2 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Logic 4K Camera Controller and Logic 4K Camera Head. The ENDOCAM® Logic 4K Camera System 5525 complies with:
- IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint): Medical electrical equipment Part 1; with differences according to ANSI/AAMI ES60601-1: 2005 / A2:2010: General requirements for basic safety and essential performance (3rd edition).
- EN60601-1-2:2015-09 (4th edition) and EN 60601-1-2:2007 §6 / EN 60601-1-2/AC:2010 (3rd edition): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests (IEC 60601-1-2:2014); German version EN 60601-1-2:2015
- o Emission:
- . EN 60601-1-2:2015-09 (4th edition) Limit Class: A
- . EN 60601-1-2:2007 §6 / EN 60601-1-2/AC:2010 (3rd edition) Limit Class: A
- o Immunity
- . EN 60601-1-2:2015-09 (4th edition)
- EN 60601-1-2:2007 §6 / EN 60601-1-2/AC:2010 (3rd edition) Limit Class: A
- . EN 60601-1-2:2015-09 (4th edition)
- o Emission:
- · IEC 60601-2-18:2009 (Third Edition) for use in conjunction with IEC 60601-1:2005 (Third Edition):
Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of endoscopic equipment
- IEC 60601-1-6:2010 (Third Edition) + A1:2013 for use in conjunction with IEC 62366:2007 (First Edition) + A1:2014 and IEC 60601-1:2005 (Third Edition) + Corr.1 (2006) + Corr.2 (2007) + A1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1): Medical electrical equipment Part 1-6: General requirements for safety - Collateral Standard: Usabilitv
Bench testing of performance specifications were completed and demonstrate that the device met all requirements. Bench comparison testing between the predicate device (K130423) and the LOGIC 4K CAMERA System demonstrated that the devices are substantially equivalent.
Software Verification and Validation Testing 5.3.3.3
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, since failures or latent design flaws are unlikely to cause any injury to the patient or operator.
5.3.3.4 Technical data verification
The efficacy and safety of the LOGIC 4K products is documented by the verification / validation testing, which confirms that the products meets all the requirements/ specifications for overall design and electrical safety and that the design inputs and specifications are met.
8
5.3.4 Animal Study
Not applicable, no animal testing was performed.
5.3.5 Clinical Studies
Not applicable, clinical studies were not performed.
5.3.6 Conclusion
Richard Wolf's ENDOCAM® Logic 4K Camera System 5525 consisting of the Logic 4K Camera Controller and Logic 4K Camera Head have equivalent Indications for Use as the predicate device Richard Wolf ENDOCAM® Logic HD Camera System 5525 cleared with 510(k) K130423. Safety, EMC, and Performance Testing has shown that the Logic 4K Camera Controller and Logic 4K Camera Head perform as intended and meet their technological specifications. The minor difference in specifications when compared to the predicate device Richard Wolf ENDOCAM® Logic HD Camera System 5525 (K130423) does not raise new issues of safety and effectiveness and is substantially equivalent to legally marketed devices.