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 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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the KARL STORZ Image1 SPIES, an endoscopic video imaging system. It details the device, its intended use, and substantial equivalence to predicate devices, but does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria through a clinical trial or a statistically designed non-clinical study that would typically generate the requested performance metrics.

The document focuses on demonstrating substantial equivalence to previously cleared devices (Image1 Video Imaging System K070716 and Fujinon EPX-4440HD Video Processor and Light Source K102466) through non-clinical bench testing.

Here's an analysis based on the provided text, addressing each point as much as possible:

Table of acceptance criteria and the reported device performance:

The document mentions the types of non-clinical tests performed but does not provide specific numerical acceptance criteria or the reported performance values. It states:

Test Category	Acceptance Criteria (Not explicitly stated with values)	Reported Device Performance (Not explicitly stated with values)
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-1-2 standards.	"demonstrates the continued electrical safety of the device"
Optical Performance	"includes white balance, brightness, image enhancement, video output format, zoom, image quality, image capture, latency and interface control"	Implied to meet or exceed predicate devices' performance.
Software Reliability	(Not explicitly stated)	"reliability of the software" is tested.
Overall Performance	As safe, as effective, and performs as well as or better than legally marketed predicate devices.	"demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed devices."

Note: The document only lists the categories of tests and a general conclusion of meeting requirements, rather than providing specific quantifiable acceptance criteria (e.g., "latency must be <X ms") and the measured results.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The studies mentioned are described as "non-clinical bench testing," which implies physical device testing rather than testing on a dataset of images or clinical cases.
- Data Provenance: Not applicable in the context of clinical/image data. The testing involves the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests are non-clinical bench tests focusing on technical specifications and safety, not on human interpretation or diagnosis.
Adjudication method for the test set:
- Not applicable as no human interpretation or ground truth establishment by multiple experts is described for this type of non-clinical bench testing.
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. The document explicitly states "non-clinical performance tests." There is no mention of an MRMC study, human readers, or AI assistance. The device is a camera control unit, not an AI-driven diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly applicable in the context of an "algorithm only" performance because the device is hardware (a camera control unit) with integrated software for image processing and control. The performance tests are for the device's functional capabilities, such as image quality and safety, rather than a standalone algorithm's diagnostic accuracy. The non-clinical tests assess the device's technical performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. For non-clinical bench testing, "ground truth" would relate to engineering specifications and objective measurements (e.g., a calibrated light source for brightness, a specific pattern for image resolution, electrical safety standards compliance). No clinical ground truth (like pathology) is used as it's not a diagnostic device with outputs requiring such validation.
The sample size for the training set:
- Not applicable. The device is not described as using machine learning or AI that would require a "training set."
How the ground truth for the training set was established:
- Not applicable, as there is no training set described.

In summary:

The provided document describes the KARL STORZ Image1 SPIES as a camera control unit that underwent non-clinical bench testing to demonstrate electrical safety, optical performance (white balance, brightness, image enhancement, video output, zoom, image quality, image capture, latency, interface control), and software reliability. The conclusion is that these tests demonstrate the device is as safe and effective as, and performs as well as or better than, its predicate devices. However, the document lacks specific, quantifiable acceptance criteria and detailed numerical results for any of these tests, and it does not involve clinical studies with human readers or AI components that would typically require the detailed information requested in points 2-9.

Summary

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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.2151 E. Grand AveEl Segundo, CA 90245(424) 218-8379
Contact:	Winkie WongRegulatory 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 accessories21 CFR 876.1500Class 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 (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/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 (800) 638-2041 or (301) 796-7100 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:

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

Page 007-1

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.