3D TIPCAM®1: The Rigid Videoendoscope is intended to be used together with the camera control unit is for use during diagnostic and/or surgical procedures when endoscopic video assistance is required. For use in all endoscopy and endoscopic surgery within the peritoneal and thoracic cavity, including gynecological anatomy.

IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

Device Description

The SPIES 3D System is intended for use during diagnostic and/or surgical procedures when endoscopic video assistance is required within the peritoneal and thoracic cavity, including gynecological and urological anatomy.

The SPIES 3D System is a medical device system which consists of the camera control unit (CCU) – a combination of the previously 510k cleared device (K131953) – Image1 Connect module (TC200) and the D3-Link module, and 3D Tipcam®1.

AI/ML Overview

The provided text is a 510(k) summary for the Karl Storz Endoscopy-America, Inc. SPIES 3D System. Based on the information provided, here's a detailed breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding reported performance values for each criterion. Instead, it lists the types of performance characteristics that were tested and states that the device "met all its specifications" and "met all its design specification." Since specific numerical criteria and corresponding results are not given, the table below will summarize the areas of performance validated and the general conclusion.

Performance Characteristic	Acceptance Criterion (Implicit)	Reported Device Performance
Functional Performance	- Resolution adequate for endoscopic visualization	Met all specifications; substantially equivalent to predicate device.
	- Brightness adequate for endoscopic visualization	Met all specifications; substantially equivalent to predicate device.
	- White Balance accurate for tissue differentiation	Met all specifications; substantially equivalent to predicate device.
	- 3D-2D Mode functionality as designed	Met all specifications; substantially equivalent to predicate device.
	- Color Performance accurate for tissue differentiation	Met all specifications; substantially equivalent to predicate device.
	- Latency within acceptable limits for real-time surgical use	Met all specifications; substantially equivalent to predicate device.
	- Minimum Illumination adequate for endoscopic visualization	Met all specifications; substantially equivalent to predicate device.
	- Auto Exposure Step Response as designed	Met all specifications; substantially equivalent to predicate device.
	- Zero Degree Parallax maintained	Met all specifications; substantially equivalent to predicate device.
Electrical Safety/EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18	Compliant with relevant IEC standards.
Biocompatibility	Compliance with ISO 10993 standards for cytotoxicity, systemic toxicity, sensitization, and irritation for patient-contacting materials	Compliant with relevant ISO 10993 standards.
Software Validation	Software validated to a moderate level of concern per FDA guidance.	Software validation completed per FDA guidance.
Reprocessing Validation	Reprocessing validated per FDA guidance.	Reprocessing validation completed per FDA guidance.
Electrosurgical Unit Susceptibility	Device functions adequately in the presence of Electrosurgical Unit (ESU) interference.	Met all specifications; substantially equivalent to predicate device.

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

The document explicitly states: "No clinical information is required for this submission." The performance data presented are from bench tests and non-clinical performance tests.

Sample Size for Test Set: Not applicable for a clinical test set, as no clinical studies were performed. For bench tests, the sample size is not specified but would typically involve one or a small number of devices tested under various conditions.
Data Provenance: The data provenance is from internal non-clinical performance and bench testing conducted by the manufacturer (Karl Storz Endoscopy-America, Inc.). It is retrospective in the sense that the tests were performed on finished devices, but the data itself is from laboratory settings, not patient data. Country of origin of data is not specified but implicitly North America (where the applicant is located) and/or Germany (where Karl Storz is headquartered).

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

Not applicable. No clinical test set was used, and thus no expert ground truth panels were involved. The "ground truth" for the non-clinical tests would be the established engineering and performance specifications, and the judgment was made by engineers and quality assurance personnel performing the tests.

4. Adjudication Method for the Test Set

Not applicable. Since no clinical test set requiring human interpretation or judgment was used, there was no adjudication method involving multiple experts.

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." Therefore, no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence. The "standalone" performance here refers to the device's technical specifications and functionality independent of human interpretation of its output in a clinical scenario. The document describes various "bench test data" and "non-clinical performance data" that demonstrate the device's capabilities. These include tests for resolution, brightness, white balance, color performance, latency, minimum illumination, auto-exposure response, and zero-degree parallax. These tests evaluate the inherent technical performance of the device itself.

7. The Type of Ground Truth Used

The ground truth for the non-clinical performance tests was the engineering design specifications and recognized international standards (e.g., IEC 60601 series for safety, ISO 10993 series for biocompatibility). The device was tested to verify that it met these predetermined functional and safety requirements.

8. The Sample Size for the Training Set

Not applicable. This device is an imaging system (hardware and associated software), not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves its design, manufacturing, and internal testing to ensure it meets its intended specifications.

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

Not applicable. As mentioned, this is not an AI/machine learning algorithm requiring a separate training set. The "ground truth" for the device's development (design and manufacturing of the hardware and embedded software) would effectively be established through engineering principles, established medical device development processes, and adherence to relevant industry standards and regulatory requirements.

Summary

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

November 20, 2015

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

Re: K150525

Trade/Device Name: SPIES 3D System Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic Laparoscope And Accessories Regulatory Class: Class II Product Code: HET, GCJ, FGB Dated: October 16, 2015 Received: October 19, 2015

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.

Sincerely yours.

Herbert P. Lerner -S

Benjamin R. Fisher, Ph.D. for 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) K150525

Device Name SPIES 3D System

Indications for Use (Describe)

IMAGE1 SPIES is a camera control unit (CCU) for use with camera heads or videoendoscopes for the visualization and documentation of endoscopic and microscopic procedures.

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 text "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 25, 2015
Device Identification:	Trade Name: SPIES 3D SystemCommon Name: Endoscopic Camera SystemClassification Name: Gynecologic Laparoscope AndAccessories
Product Code:	HET, GCJ, FGB
Regulation:	21 CFR 884.1720
Predicate Device(s):	ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPESYSTEM (K123365)
Device Description:	The SPIES 3D System is intended for use during diagnosticand/or surgical procedures when endoscopic videoassistance is required within the peritoneal and thoraciccavity, including gynecological and urological anatomy.The SPIES 3D System is a medical device system whichconsists of the camera control unit (CCU) – a combination ofthe previously 510k cleared device (K131953) – Image1Connect module (TC200) and the D3-Link module, and 3DTipcam®1.

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Indications For Use:	3D TIPCAM®1: The Rigid Videoendoscope is intended to beused together with the camera control unit is for use duringdiagnostic and/or surgical procedures when endoscopicvideo assistance is required. For use in all endoscopy andendoscopic surgery within the peritoneal and thoraciccavity, including gynecological and urological anatomy.IMAGE1 SPIES is a camera control unit (CCU) for use withcamera heads or videoendoscopes for the visualization anddocumentation of endoscopic and microscopic procedures.
TechnologicalCharacteristics:	The predicate and subject devices are both camera systemsthat are used for observation purposes in generalendoscopic surgery within the thoracic and peritonealcavity, including gynecological and urological anatomy.There are some minor differences in the technologicalcharacteristics. These differences are:
	• The subject device uses a CMOS sensor instead of aCCD sensor.• The subject device has a more limited specificationon field of view (82° vs. 90°) due to the deflectable tipin the predicate device.• The subject device includes different patientcontacting materials
	The bench test data for the SPIES 3D System demonstratesthat the design characteristics used as the basis for thecomparison have been met. The results show that thesubject device has met all its specifications. Theperformance validation test report is provided in section021_Performance Testing of this submission.
	The minor difference in specifications when compared to thepredicate device, ENDOEYE FLEX 3D DEFLECTABLEVideoscope System, is that the SPIES 3D System does notraise new issues of safety and effectiveness and the devicesare substantially equivalent for general endoscopicapplication within the thoracic and peritoneal cavity.
Non-Clinical	Software validation was completed for a moderate level of concern per the FDA guidance document: "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
Performance Data:	Reprocessing validation as completed per the FDA guidance document: "Reprocessing Medical Devices in Heath Care Settings: Validation Methods and Labeling" dated March 2, 2015.
	SPIES 3D System is tested according to the following standard:
	• IEC 60601-1
	• IEC 60601-1-2
	• IEC 60601-2-18
	• ISO 10993-5, 2009 (Cytotoxicity)
	• ISO 10993-11, 2010 (Systemic Toxicity)
	• ISO 10993-10, 2010 (Sensitization and Irritation)
	Additional bench testing for performance verification and validation purposes:
	• Resolution
	• Brightness
	• White Balance
	• 3D-2D Mode
	• Color Performance
	• Latency
	• Electrosurgical Unit Susceptibility
	• Minimum Illumination
	• Auto Exposure Setp Response

	• Zero Degree Parallax
	The bench testing performed verified and validated that the SPIES 3D System has met all its design specification and is substantially equivalent to the predicate device, ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE SYSTEM, for use in all endoscopic procedures within the peritoneal and thoracic cavity, including gynecological and urological
	anatomy.
Clinical	No clinical information is required for this submission
Performance Data:
Conclusion:	The SPIES 3D 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

§ 884.1720 Gynecologic laparoscope and accessories.

(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.