KSEA CMOS Camera System (C-cam)

K143640 · KARL STORZ Endoscopy-America, Inc. · GCJ · Sep 17, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K143640
• Device Name: KSEA CMOS Camera System (C-cam)
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: Sep 17, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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.

Device Story

KSEA CMOS Camera System (C-CAM) consists of camera head, cable, and monitor; designed for general endoscopic observation. Camera head attaches to standard KARL STORZ endoscopes/fiberscopes; requires connection to C-MAC monitor or C-HUB. Used in operating rooms or doctor's offices by clinicians. Device captures endoscopic visual data; transmits to monitor for real-time visualization. Provides lower-cost alternative to existing high-cost camera systems. Output assists clinicians in viewing internal anatomy during procedures; facilitates clinical decision-making through direct visualization. Benefits patient by enabling standard endoscopic diagnostic/surgical observation.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including resolution, field flatness, and white balance verification, alongside compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18 standards.

Technological Characteristics

CMOS sensor-based endoscopic camera system; 350 TVL [H] resolution. Compatible with KARL STORZ endoscopes/fiberscopes. Requires C-MAC monitor or C-HUB. Standards: IEC 60601-1 (General safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (Endoscopic equipment).

Indications for Use

Indicated for general endoscopic procedures in operating rooms or doctor's offices. Suitable for use with standard KARL STORZ endoscopes and fiberscopes for observation purposes. No specific age or gender restrictions noted.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Tricam (K950862)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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, Inc<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong<br>Regulatory Affairs Specialist<br>424-218-8379 [voice]<br>424-218-8519 [fax] |
| Date of Preparation: | September 10, 2015 |
| Device Identification: | Trade Name: KSEA CMOS Camera System (C-CAM)<br>Common Name: Endoscopic Camera System<br>Classification 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 a<br>camera head, a cable and a monitor. The camera head<br>must be connected to the C-MAC monitor, 8403ZX. The<br>KSEA CMOS Camera System is compatible for use with all<br>standard KARL STORZ Endoscopes and Fiberscopes for<br>endoscopic observation in general endoscopic procedures. |
| Indications For Use: | The KSEA CMOS Camera System is a camera system<br>designed for use in the operating room for general<br>endoscopic procedures. The camera head is suitable for<br>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. |
| Technological<br>Characteristics: | 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-Clinical<br>Performance 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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