IMAGE1 SPIES

K131953 · KARL STORZ Endoscopy-America, Inc. · FET · Dec 20, 2013 · Gastroenterology, Urology

Device Facts

• Record ID: K131953
• Device Name: IMAGE1 SPIES
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FET · Gastroenterology, Urology
• Decision Date: Dec 20, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Image1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

Device Story

Image1 SPIES is a modular camera control unit (CCU) for endoscopic/microscopic procedures; accepts raw video signals from connected camera heads (H3-Link or X-Link modules); processes signals for display, image capture, printing, and picture-in-picture representation. Used in clinical settings by physicians; integrates with KARL STORZ Communication Bus (SCB) for system control and insufflator management. Provides real-time visualization and documentation to assist clinical decision-making; benefits include enhanced image quality and workflow convenience via modular customization and external storage.

Clinical Evidence

Bench testing only. Evaluated electrical safety (IEC 60601-1, IEC 60601-1-2) and optical performance including white balance, brightness, image enhancement, video output, zoom, image quality, image capture, latency, and interface control. Software reliability also verified.

Technological Characteristics

Modular CCU system; includes Image1 Connect (TC200) display module and camera head input modules (TC300, TC301). Features: SCB communication bus, insufflator control, USB printer/storage interface. Electrical safety per IEC 60601-1/1-2. Connectivity: USB, inter-module link cables. Software-based image processing for enhancement and documentation.

Indications for Use

Indicated for visualization, image recording, and documentation during general endoscopic and microscopic procedures. No specific patient population or contraindications defined; physician discretion required based on patient condition.

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

• Image1 Video Imaging System (K070716)
• Fujinon EPX-4440HD Video Processor and Light Source (K102466)

Submission Summary (Full Text)

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K131953

DEC 2 0 2013

## 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 Ave<br>El Segundo, CA 90245<br>[phone] |
|----------------------|---------------------------------------------------------------------------------------------------|
| Contact: | Winkie Wong<br>Regulatory Affairs Specialist |
| Date of Preparation: | Nov. 25, 2013 |

## Device Identification:

| Common Name: | Endoscopic Video Imaging System/Component |
|------------------------|-----------------------------------------------------------|
| Trade Name: (optional) | Image1 SPIES |
| Device Classification: | Endoscopes and accessories<br>21 CFR 876.1500<br>Class II |

Indications: The Image1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

Contraindications: No contraindications relating directly to the medical device are currently known. The responsible physician must decide whether the foreseen application is admissible based on the general condition of the patient.

Device Description: The Image1 SPIES (Storz Professional Image Enhancement System) camera control unit is a medical device which consists of an Image1 Connect display module (TC200), and a combination of a minimum of one to a maximum of three camera head input modules that is intended and designed for use during endoscopic procedures. Image1 H3-Link (TC300) and Image1 X-Link (TC301) are available as head input modules. The device's modularity enables customers to customize their Image1 SPIES system to their specific current and future video needs. Descriptions of these three modular devices are provided below.

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## Image1 Connect (TC200):

The Image1 Connect displav module is connected to the head module(s) via an inter-module link cable. The Image1 Connect accepts video from the head module(s) and offers additional functionality such as image capture, image printing, picture-in-picture representation and generation of a digital video output for monitor viewing purposes.

## Image1 H3-Link (TC300):

The Image1 H3-Link head module processes raw video signals from the H3 family of camera heads.

## Image1 X-Link (TC301)

The Image1 X-Link head module also processes raw video signal from a certain set of imagers housed in a camera head. Visually, the card edge connector receptacle of the X-Link is wider than the receptacle of the H3-Link.

Summary of Technological Characteristics: The Image1 SPIES is a modification of the already cleared Image1 Video Imaging System (K070716). The underlying fundamental technology and intended use remains unchanged. All the changes were made to enhance image quality and to allow printing of an image via the USB printer or storing an image to a USB storage device for documentation purposes. Internal safety and performance testing are performed to ensure the safety and efficacy of the device.

The Image1 SPIES is also substantially equivalent to Fujinon EPX-4440HD Video Processor and Light Source (K102466). Both devices consist of a video processor (CCU) and a keyboard. They also share the same indications for use and fundamental technologies, providing external image storage capability and similar features such as: Brightness Control. Enhancement Control. Light Source Control. White Balance, Zoom and HD Capability. The differences between the subject and predicate devices are the subject device incorporates the KARL STORZ Communication Bus (SCB) system for ease of use and Insufflator Control for user convenience.

## Non-Clinical Performance Tests:

The bench testing performed for the subject device demonstrates the continued electrical safety of the device (IEC 60601-1 and IEC 60601-1-2), optical performance which includes white balance, brightness, image enhancement, video output format, zoom, image quality, image capture, latency and interface control as well as the reliability of the software.

## Conclusion:

. . ·

- - -

The Karl Storz Image 1 SPIES is substantially equivalent to its predicate devices. The nonclinical testing demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

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

December 20, 2013

Karl Storz Endoscopy America, Inc. Winkie Wong Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K131953

> Trade/Device Name: Imagel SPIES Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscopes and accessories Regulatory Class: Class II Product Code: FET Dated: November 27, 2013 Received: November 29, 2013

Dear Winkie 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

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#### Page 2 - Winkie Wong

(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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

## Elaine Blyskun

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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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

## Indication for Use

## 510(k) Number (if known): Not yet assigned K131953

Device Name: Image1 SPIES

#### Indication for use:

The Image1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for visualization, image recording and documentation during general endoscopic and microscopic procedures.

#### Contraindication:

No contraindications relating directly to the medical device are currently known. The responsible physician must decide whether the foreseen application is admissible based on the general condition of the patient.

Prescription Use AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use ___ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

# Elaine Blyskun for Benjamin Fisher

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