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.

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.

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.

AI/ML Overview

This document, a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA), describes the "LOGIC 4K CAMERA CONTROLLER LOGIC 4K CAMERA HEAD" (K180583) and its substantial equivalence to a predicate device. It primarily focuses on technical specifications, safety, and performance testing rather than a study designed to meet specific clinical acceptance criteria in the way one might evaluate an AI/CAD product.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a camera system and not an AI or diagnostic tool with typical performance metrics like sensitivity/specificity, the "acceptance criteria" are related to technical standards and functional performance.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Electrical Safety	IEC 60601-1: 2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 (or IEC 60601-1: 2012 reprint) / ANSI/AAMI ES60601-1: 2005 / A2:2010 (3rd edition)	Complies with specified IEC and ANSI/AAMI standards.
Electromagnetic Compatibility (EMC)	EN60601-1-2:2015-09 (4th edition) / EN 60601-1-2:2007 §6 / EN 60601-1-2/AC:2010 (3rd edition) for Emission (Limit Class A)	Complies with specified EN (4th and 3rd edition) standards, achieving Limit Class A for Emissions.
	EN 60601-1-2:2015-09 (4th edition) / EN 60601-1-2:2007 §6 / EN 60601-1-2/AC:2010 (3rd edition) for Immunity (Limit Class A)	Complies with specified EN (4th and 3rd edition) standards, achieving Limit Class A for Immunity.
Endoscopic Equipment Specific Safety	IEC 60601-2-18:2009 (Third Edition) for use in conjunction with IEC 60601-1:2005 (Third Edition)	Complies with specified IEC standard for endoscopic equipment.
Usability (Human Factors)	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)	Complies with specified IEC standards for usability.
Functional Performance (Bench Testing)	Meeting all requirements and specifications for overall design and electrical safety as per internal verification/validation testing; Substantial equivalence to predicate device (K130423) in bench comparison testing.	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. The efficacy and safety are documented by verification/validation testing, confirming it meets requirements, specifications, and design inputs.
Software Verification & Validation (V&V)	Adherence to FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," with software classified as "minor" level of concern.	Software V&V testing was conducted and documentation provided as recommended by FDA guidance. The software was considered a "minor" level of concern.
Biocompatibility	Not applicable, as the device does not contact the patient directly or indirectly, per ISO 10993-1.	Not applicable; biocompatibility testing was not required nor performed.
Sterilization/Reprocessing Procedures	Device must be reusable and have documented cleaning, disinfection, and sterilization methods for initial and subsequent use. (Acceptance is implied by providing these details in the Instruction for Use and the device being "Autoclavable Camera Head").	The devices are reusable and require processing. Methods are detailed in the Instruction for Use. The Camera Head is autoclavable.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: This document does not describe a "test set" in the context of clinical data or imaging studies. The performance evaluation was primarily through bench testing and compliance with recognized electrical safety and EMC standards. Therefore, the "sample size" would refer to the number of devices tested in engineering labs rather than patient data. Specific numbers of units tested are not provided in this summary.
Data Provenance: Not applicable in the context of patient data. The provenance of the engineering test data would be from internal testing labs of Richard Wolf Medical Instruments Corporation (USA) and Richard Wolf GmbH (Germany), as well as potentially external accredited testing facilities for standard compliance. The data is prospective in the sense that the testing was performed on the device itself to verify its performance against predefined standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document does not describe a clinical study involving experts to establish ground truth for a diagnostic outcome. The evaluation is focused on the device's technical functionality and safety compliance.

4. Adjudication method for the test set

This information is not applicable as the document does not describe a clinical study requiring adjudication of expert interpretations.

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, an MRMC comparative effectiveness study was not done. This device is a 4K camera system, an imaging component, not an AI or CAD system. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a camera system, not an algorithm.

7. The type of ground truth used

This is not applicable in the context of clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for this device's evaluation was engineering specifications, international safety standards (electrical, EMC, usability), and functional requirements for an endoscopic video imaging system.

8. The sample size for the training set

This information is not applicable. There is no mention of a "training set" as this device is a hardware camera system, not an AI or machine learning model.

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set for a machine learning model, there is no ground truth relevant to a training set to be established.

Summary

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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.

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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); 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

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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)
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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

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 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.

This product 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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5.2 Indications for Use

5.2.1 LOGIC 4K CAMERA CONTROLLER

Indications for use:

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.

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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
· 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.

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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.

Regulation Number and Section

§ 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.