The KARL STORZ NAV 1 electromagnetic navigation system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures under visual control. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to radiological image data or digitized landmarks of the anatomy.

Device Description

The NAV1 Electromagnetic is an intraoperative image guided localization system that links a navigated instrument tracked by an electromagnetical sensor to a virtual computer image space on a patient's preoperative diagnostic image data set (CT or MRI). The system is intended to be used as a positioning aid for navigation in ENT stereotactic surgery, including but not limited to the endoscopic surgery. The NAV1 Electromagnetic is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure can be identified relative to the radiological imaging-based model of the anatomy (CT or MRI). Surgical procedures include but are not limited to the following: maxillary antrostomies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, extensive sino-nasal polyposis, frontal sinusotomies, intranasal procedures, intranasal tumor resections, otologic surgery, and extracranial skull base diseases.

AI/ML Overview

The provided text describes the Karl Storz NAV1 Electromagnetic Navigation System (K161555) and its performance characteristics. However, it does not include specific acceptance criteria with numerical thresholds, nor does it detail a study that explicitly proves the device meets such criteria in terms of diagnostic performance or clinical outcomes.

Instead, the document focuses on:

System Verification and Validation: Ensuring the device functions as intended and does not introduce new safety or effectiveness concerns.
Bench Testing: Evaluating accuracy, time accuracy, and user acceptance.
Biocompatibility Testing: Ensuring patient-contacting components are safe.
Electrical Safety and EMC Testing: Conforming to relevant electrical and electromagnetic compatibility standards.
Software Verification and Validation: Following FDA guidance for software in medical devices.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not present in the provided document.

Here's a summary of what can be extracted or inferred from the text:

1. Table of Acceptance Criteria and the Reported Device Performance:

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Biocompatibility (ISO 10993-1, FDA Guidance)	Passed all tests (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity). "The biological-toxicological safety of the patient is not affected by the materials used in the tested items."
Electrical Safety (IEC 60601-1)	Complies with IEC 60601-1 standards.
Electromagnetic Compatibility (IEC 60601-1-2)	Complies with IEC 60601-1-2 standards.
Software Verification & Validation	Documentation provided as recommended by FDA guidance for "moderate" level of concern software. (Implies satisfactory performance, but no specifics given).
Bench Testing (Specific Criteria Not Quantified)	Evaluation of the accuracy of electromagnetically tracked instruments (before and after Reprocessing): Performed to ensure no new issues of safety or effectiveness. (No specific accuracy metric or threshold reported). Evaluation of time accuracy of the ENT Navigation Software: Performed to ensure no new issues of safety or effectiveness. (No specific time accuracy metric or threshold reported). User acceptance testing: Performed to ensure no new issues of safety or effectiveness. (No specific user acceptance metrics reported).
Cleaning and Sterilization Efficacy	Demonstrated "sterility assurance level of 10⁻⁶" for specific steam and V-PRO® sterilization cycles. Manual cleaning effectiveness demonstrated with "sufficient recovery efficiency for residual protein and residual hemoglobin."

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified. The document refers to "system verification and validation testing," "bench testing," and "biocompatibility testing," but does not provide details on the number of units or cases tested for any of these.
Data Provenance: Not specified. Given the nature of the device (surgical navigation system), the "bench testing" would likely involve laboratory setups, while biocompatibility testing would be conducted on materials. The document does not mention any clinical data or specific geographical origin for the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. The document does not describe studies that involve expert-established ground truth for diagnostic accuracy, as it is a navigation system and not a diagnostic device in the traditional sense. The testing focuses on system performance, safety, and functionality.

4. Adjudication method for the test set:

Not applicable as there is no mention of expert-adjudicated performance studies in the provided text.

5. 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:

Not applicable. The device is a surgical navigation system, not an AI-assisted diagnostic tool for "human readers." No MRMC study is mentioned. The document states, "Animal and Clinical performance data are not required to demonstrate substantial equivalence for this type of device."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The device itself is a "standalone" system in operation (the algorithm provides the navigation aid without a separate "human-in-the-loop performance" study described here for its accuracy). The bench testing mentioned relates to the algorithm's performance (e.g., accuracy of tracked instruments, time accuracy of software). However, the document doesn't explicitly delineate "standalone" performance from integrated system performance.

7. The type of ground truth used:

For biocompatibility: Laboratory standards and chemical/biological analysis results (e.g., cytotoxicity assays, irritation indices).
For electrical safety and EMC: Compliance with international standards (IEC 60601-1, IEC 60601-1-2) implies validation against the requirements defined by these standards.
For software verification and validation: Likely internal specifications, functional requirements, and error detection/prevention.
For bench testing (accuracy): Likely comparison against known physical reference points or highly accurate measurement systems (e.g., a "true" position established by a more precise measurement device to verify the electromagnetically tracked instruments). No specific type of ground truth is explicitly stated beyond "verification and validation testing."

8. The sample size for the training set:

Not applicable. The document describes a "traditional premarket notification submission" for a navigation system, not a machine learning or AI-based diagnostic tool that would typically involve a separate "training set" in the context of image analysis. The software validation is for system functionality, not for learning from data.

9. How the ground truth for the training set was established:

Not applicable, as there is no mention of a training set or machine learning components requiring ground truth establishment in this context.

Summary

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

October 21, 2016

Karl Storz Endoscopy America, Inc. Mr. Leigh Spotten Regulatory Affairs Manager 2151 E. Grand Ave El Segundo, CA 90245

Re: K161555

Trade/Device Name: Karl Storz Nav1 Electromagnetic Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 14, 2016 Received: September 15, 2016

Dear Mr. Spotten:

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.

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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 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 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.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161555

Device Name NAV 1 electromagnetic

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 word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the second line.

7. 510(k) Summary

Traditional Premarket Notification Submission (510(k)) Summary Prepared in accordance with 21 CFR 807.92

Submitter Information 7.1

Sponsor name:	KARL STORZ Endoscopy America, Inc.
Sponsor address:	2151 E. Grand Ave. El Segundo, CA 90245 USA
Sponsor telephone:	424-218-8100
Sponsor fax:	424-218-8519
Establishment Registration:	3010202439

Contact person:	Leigh Spotten
Contact title:	Director, Regulatory Affairs
Email direct:	leigh.spotten@karlstorz.com
Telephone direct:	424-218-8738
Date summary prepared:	Oct. 21, 2016

7.2 Device Name

Trade (proprietary):	NAV1 electromagnetic
Common (usual):	Stereotaxic Instrument
Classification:	21 CFR 882.4560 (Class II)
FDA Product Code:	PGW
Review Panel:	Ear Nose & Throat

7.3 Substantially Equivalent Predicate Device

FIAGON Navigation System, K133573 KARL STORZ Navigation Panel Unit , K122096

7.4 Device Description

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7.5 Intended Use

The KARL STORZ NAV1 electromagnetic navigation system and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures under visual control. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to radiological image data or digitized landmarks of the anatomy.

7.6 Technological Characteristics

The NAV1 electromagnetic navigation system and the predicate FIAGON Navigation System both include hardware and software that enable real-time surgical navigation. mapping points between the patient's anatomy and corresponding points on radiologic images of the patient. Both systems employ instruments to continuously update the instrument position on images by electromagnetic tracking. The performance of the subject device has undergone system verification and validation testing to ensure it does not introduce new issues of safety or effectiveness.

7.7 Performance Characteristics

Nonclinical performance characteristics evaluated in support of the substantial equivalence of the NAV 1 electromagnetic navigation system include system verification and validation testing. The following performance data are provided in support of the substantial equivalence determination.

Biocompatibility testing

The biocompatibility evaluation for the patient contacting components of the system (reusable EM Navigated instruments, single-use headband and single-use patient tracker adhesive pad) was performed according to ISO 10993-1and FDA Guidance.

The following tests were conducted. based on contact type and duration:

Cytotoxicity
Sensitization
Irritation
Systemic Toxicity .

The biological-toxicological safety of the patient is not affected by the materials used in the tested items.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the KARL STORZ NAV1 electromagnetic navigation system, consisting of the NAV1 Module, the NAV1 electromagnetic Module and EM Navigated instruments. The system complies with the IEC 60601-1 standards for electrical safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device

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was considered as a "moderate" level of concern because a software malfunction could lead to a delay in diagnosis.

Bench testing

The performance of the NAV1 Electromagnetic system (40820001) has undergone verification and validation testing to ensure it does not introduce new issues of safety or effectiveness, and to demonstrate that the final design has met all of its requirements. Performance testing reports are provided in the Performance Testing (Bench) of this 510(k). The following tests were conducted:

. Evaluation of the accuracy of electromagnetically tracked instruments (before and after Reprocessing)
Evaluation of time accuracy of the ENT Navigation Software ●
User acceptance testing. ●

7.8 Cleaning and Sterilization

Reusable EM Navigated instruments (i.e. Patient Tracker, Probes, Curettes, and Suction Tubes) are delivered non-sterile; they must be cleaned and sterilized prior to the initial use and before each subsequent use. Compatible headband and patient tracker adhesive pad are single-use products and must be disposed of after patient use. Sterility efficacy demonstrated a sterility assurance level of 10 ° in a pre-vacuum steam sterilizer, STERRAD® 100NX® Standard sterilization cycle, and V-PRO® 1 Plus Lumen sterilization cycle. Manual cleaning effectiveness was demonstrated with sufficient recovery efficiency for residual protein and residual hemoglobin.

7.9 Animal and Clinical Performance Data:

Animal and Clinical performance data are not required to demonstrate substantial equivalence for this type of device.

7.10 Conclusion

Based on the information provided in this premarket notification. KARL STORZ concludes that the NAV1 electromagnetic navigation system is safe, effective, and substantially equivalent to the predicate FIAGON Navigation System in its indication for use, device design, materials, performance characteristics, and operational principles.

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).