The IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or video endoscopes for the visualization. image recording and documentation during general endoscopic and microscopic procedures.

Device Description

The modified Image1 SPIES (Storz Professional Image Enhancement System) camera control unit includes an additional camera head that can be connected to the X-link module and software updates for improvement of existing features and bug fixes. The SPIES Camera System is intended and designed for use during endoscopic and microscopic procedures.

AI/ML Overview

The document provided is a 510(k) summary for the Karl Storz Endoscopy America, Inc. Image1 SPIES System. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for proving a device meets
clinical acceptance criteria through a specific study in the way a novel AI algorithm might.

Based on the provided text, here's a breakdown of the acceptance criteria and the study that "proves" the device meets them, keeping in mind the context of a 510(k) for an endoscopic camera system:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria (e.g., minimum resolution in lp/mm, acceptable latency in ms) in a table format. Instead, it states that the device "met all its specifications." The performance validation involved a series of bench tests.

Acceptance Criterion (Implied)	Reported Device Performance
Resolution	Met specifications
Brightness	Met specifications
White Balance	Met specifications
Color Performance	Met specifications
Latency	Met specifications
Temporal Noise	Met specifications
Residual Spatial Noise	Met specifications
Step Response of Automated Exposure System	Met specifications
Software Verification Tests	Met specifications

The "bench test data for the Image1 SPIES System 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. The performance validation test report can be provided upon request."

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

Test Set Sample Size: The document does not specify a "sample size" in terms of cases or patients for the bench tests. The testing performed was on the device itself and its components.
Data Provenance: Not applicable in the context of clinical data. The tests were bench tests conducted on the device.

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

Number of Experts: Not applicable. The ground truth for bench tests is based on engineering specifications and direct physical measurements, not expert consensus on medical images.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Bench testing relies on objective measurements against predefined technical specifications.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is typically done for diagnostic aids or AI algorithms that assist human readers in interpreting medical images, assessing the impact on diagnostic accuracy, sensitivity, or specificity. The Image1 SPIES System is a camera control unit for visualization, not a diagnostic AI tool.

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

Standalone Study: Yes, in a sense, the bench testing performed is analogous to a standalone performance evaluation for the device's technical specifications. The performance of the camera control unit itself (resolution, brightness, etc.) was evaluated independently of human interpretation of clinical outcomes. However, this is not an "algorithm only" study as would be described for AI.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the bench tests was based on engineering specifications and objective physical measurements. For example, resolution would be measured against a standard test pattern, and latency would be measured with specialized equipment.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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

February 1, 2016

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

Re: K160044 Trade/Device Name: Image1 SPIES System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FET Dated: January 6, 2016 Received: January 8, 2016

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (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 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

Sincerely yours,

Herbert P. Lerner -S

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)

K160044

Device Name Image1 SPIES System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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 logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in a smaller font.

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 AvenueEl Segundo, CA 90245
Contact:	Winkie WongRegulatory Affairs Specialist424-218-8379424-218-8519
Date of Preparation:	February 1, 2016
Device Identification:	Trade Name: Image1 SPIES SystemCommon Name: Endoscopic Camera SystemClassification Name: Endoscope and accessories
Product Code:	FET
Regulation:	CFR 876.1500
Predicate Device:	Image1 SPIES (K131953)
Device Description:	The modified Image1 SPIES (Storz Professional ImageEnhancement System) camera control unit includes anadditional camera head that can be connected to the X-linkmodule and software updates for improvement of existingfeatures and bug fixes. The SPIES Camera System isintended and designed for use during endoscopic andmicroscopic procedures.
Indications For Use:	The IMAGE1 SPIES is a camera control unit (CCU) for usewith camera heads or video endoscopes for thevisualization, image recording and documentation duringgeneral endoscopic and microscopic procedures.
TechnologicalCharacteristics:	The predicate and subject devices are both camera systems thatare used for the visualization and documentation of endoscopicand microscopic procedures. There are some minor differencesin the technological characteristics. These differences are:The subject device uses a CMOS sensor instead of a CCD sensor. The subject device has a smaller telescope size attachment than the predicate device.
	The bench test data for the Image1 SPIES System demonstratesthat the design characteristics used as the basis for thecomparison have been met. The results show that the subjectdevice has met all its specifications. The performancevalidation test report can be provided upon request.
	The minor difference in specifications when compared to thepredicate device, Image1 SPIES System, does not raise newissues of safety and effectiveness and the devices aresubstantially equivalent for the visualization anddocumentation of endoscopic and microscopic procedures.
Non-ClinicalPerformance Data:	Image1 SPIES System undergone bench testing forperformance verification and validation purposes:Resolution Brightness White Balance Color Performance Latency Temporal Noise Residual Spatial Noise Step Response of Automated Exposure System Software Verification Tests
	The bench testing performed verified and validated that theImage1 SPIES System has met all its design specificationand is substantially equivalent to the predicate device,Image1 SPIES, for use in all endoscopic procedures within
	the peritoneal and thoracic cavity, including gynecologicaland urological anatomy.
Clinical	No clinical information is required for this submission
Performance Data:
Conclusion:	The Image1 SPIES System is substantially equivalent to itspredicate devices. The non-clinical testing demonstratesthat the device is as safe and effective as the legallymarketed 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.