The C-cam camera head is designed for general endoscopic procedures in an operating room or a doctor's office. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and must be used with a C-MAC monitor or C-HUB for observation purposes in general endoscopic procedures.

The KSEA CMOS Camera System is a camera system designed for use in the operating room for general endoscopic procedures. The camera head is suitable for attachment to all standard KARL STORZ Endoscopes and Fiberscopes and must be used with a C-MAC™ monitor or C-HUB for observation purposes in general endoscopic procedures.

Device Description

The KSEA CMOS Camera System (C-CAM) consists of a camera head, a cable and a monitor. The camera head must be connected to the C-MAC monitor, 8403ZX. The KSEA CMOS Camera System is compatible for use with all standard KARL STORZ Endoscopes and Fiberscopes for endoscopic observation in general endoscopic procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the KARL STORZ Endoscopy America Incorporated KSEA CMOS Camera System (C-cam). This document focuses on demonstrating substantial equivalence to a predicate device (Tricam) rather than proving the device meets acceptance criteria through a specific study with detailed performance metrics.

However, based on the information provided, I can infer the "acceptance criteria" through the comparison to the predicate device and the "study" appears to be internal bench testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Compatibility with KARL STORZ Endoscopes and Fiberscopes	Compatible for use with all standard KARL STORZ Endoscopes and Fiberscopes
Used with C-MAC monitor or C-HUB	Must be connected to the C-MAC monitor, 8403ZX, or C-HUB
Suitable for general endoscopic procedures in an operating room or doctor's office	Designed for general endoscopic procedures in an operating room or a doctor's office
Resolution (compared to predicate)	Slightly lower than the predicate (350 TVL [H])
Meeting design specifications	Met all its design specifications
Safety and Effectiveness (compared to predicate)	Does not raise new issues of safety and effectiveness; substantially equivalent to the predicate
Compliance with standards	Tested according to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18
Performance verification for Resolution, Field Flatness, White Balance	Bench testing performed verified and validated these aspects

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical or performance data from a specific number of samples. The evaluation primarily relies on bench testing and comparison to a predicate device. Therefore, a sample size for a test set and data provenance (country of origin, retrospective/prospective) are not explicitly mentioned for evaluation of the device's performance against defined acceptance criteria, but rather for validation against design specifications and regulatory standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The document does not describe a study involving expert readers or ground truth establishment in a clinical setting. The evaluation is based on engineering and regulatory standards and a comparison with a predicate device.

4. Adjudication Method for the Test Set

Not applicable. As there is no "test set" with expert assessment described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states: "No clinical information is required for this submission." This indicates that no MRMC comparative effectiveness study was conducted or presented.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a way. The performance evaluation described is for the device operating on its own through bench testing. The results "show that the subject device has met all its specifications" and its performance for resolution, field flatness, and white balance was verified and validated through this testing. This can be considered a standalone assessment of the device's technical performance.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established through its design specifications and compliance with international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18). The device's performance (e.g., resolution, field flatness, white balance) is measured and compared against these predefined technical specifications and functional requirements.

8. The Sample Size for the Training Set

Not applicable. This is a medical device approval, not an AI/machine learning algorithm, so there is no "training set" in the context of data-driven model development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set, there's no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them that resemble a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the central image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

KARL STORZ Endoscopy America Incorporated Winkie Wong Regulatory Affairs Specialist 2151 East Grand Avenue El Segundo, California 90245

September 17, 2015

Re: K143640

Trade/Device Name: KSEA CMOS Camera System (C-cam) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: August 14, 2015 Received: August 18, 2015

Dear Ms. Wong:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

For

Sincerelv vours.

Joshua

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143640

Device Name

KSEA CMOS Camera System (C-cam)

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.

Applicant:	Karl Storz Endoscopy-America, Inc2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Winkie WongRegulatory Affairs Specialist424-218-8379 [voice]424-218-8519 [fax]
Date of Preparation:	September 10, 2015
Device Identification:	Trade Name: KSEA CMOS Camera System (C-CAM)Common Name: Endoscopic Camera SystemClassification Name: Endoscopic Camera System
Product Code:	GCJ
Regulation:	CFR 876.1500
Predicate Device(s):	Tricam (K950862)
Device Description:	The KSEA CMOS Camera System (C-CAM) consists of acamera head, a cable and a monitor. The camera headmust be connected to the C-MAC monitor, 8403ZX. TheKSEA CMOS Camera System is compatible for use with allstandard KARL STORZ Endoscopes and Fiberscopes forendoscopic observation in general endoscopic procedures.
Indications For Use:	The KSEA CMOS Camera System is a camera systemdesigned for use in the operating room for generalendoscopic procedures. The camera head is suitable forattachment to all standard KARL STORZ Endoscopes and
	Fiberscopes and must be used with a C-MAC™ monitor or C-HUB for observation purposes in general endoscopic procedures.
TechnologicalCharacteristics:	The predicate and subject devices are both camera system that are used for observation purposes in general endoscopic surgery. However, in order to provide a lower cost alternative of the subject device to the end user compare to the current high cost camera in the market, they have minor differences in the technological characteristics. These differences are:
	The subject device uses a CMOS sensor instead of a CCD sensor. The resolution of the device is slightly lower than the predicate (350 TVL [H]).
	The bench test data for the KSEA CMOS Camera System (C-CAM) demonstrates that the design characteristics used as the basis for the comparison have been met. The results show that the subject device has met all its specifications.
	Combining the minor difference in specifications with the benefit of providing a lower cost device compared to the predicate device, Tricam, C-CAM does not raise new issues of safety and effectiveness and the devices are substantially equivalent for general endoscopic application.
Non-ClinicalPerformance Data:	C-CAM is tested according to the following standard: IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18
	Additional bench testing for performance verification and validation purposes: Resolution
	Field Flatness White Balance
	The bench testing performed verified and validated that the C-CAM has met all its design specification and is substantially equivalent to the predicate device, Tricam, for general endoscopic procedures.
Clinical Performance Data:	No clinical information is required for this submission
Conclusion:	The Karl Storz's CMOS Camera System (C-CAM) is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe and effective as the legally marketed devices.

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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.