The Instrument Clamp Electromagnetic Sphere and Instrument Clamp Electromagnetic Universal are accessories to the Electromagnetic Navigation Unit and are intended for navigating conventional surgical instruments.

The Stryker ENT Navigation System 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 a CT or MR based model of the anatomy.

Example procedures include, but are not limited to the following ENT procedures:

Transphenoidal access procedures:
Intranasal procedures;
Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies;
ENT related anterior skull based procedures.

Device Description

The Instrument Clamps Electromagnetic are part of the Stryker ENT Navigation System. The basic principle of this system is the generation of an electromagnetic (EM) field with an EMemitter (Field Generator). The EM devices have sensor coils that transform the detected EM field into an analogue signal is transmitted via cable to the Electromagnetic Navigation Unit. The signal is then evaluated, and the tracking data is transmitted to the platform. This technology allows tracking instruments without a line-of-sight requirement.

The Instrument Clamps Electromagnetic are to be used for localizing surgical instruments in a dedicated working volume. They are intended to be mounted on suitable surgical rigid instruments. The body of the clamp incorporates the required sensor coils, which enables tracking of conventional instruments. For accurate navigation, the instrument with the attached electromagnetic clamp needs to be calibrated prior to use.

Two electromagnetic clamps are in scope of this submission:

Instrument Clamp Electromagnetic Sphere: Clamping interface optimized for tracking instruments with a circular cross-section between 2.0 mm and 4.6 mm in diameter (inclusive)
. Instrument Clamp Electromagnetic Universal: Clamping interface optimized for tracking instruments with angular cross-section (e.g. forceps) between 3.0 mm and 6.0 mm in diameter (inclusive)

The subject devices are not intended to have patient contact. Their bodies are made of PEEK and the clamps and screws are manufactured from titanium.

They are reusable devices that need to be reprocessed prior to first use. They are limited to 10 uses.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the "Instrument Clamps Electromagnetic" by Stryker Corporation. The document focuses on establishing substantial equivalence to a predicate device (Scopis Extended Instrument Set EM, K171661) rather than presenting a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial. However, it does outline performance testing related to accuracy, reprocessing, and electrical safety.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the performance testing for accuracy was conducted according to ASTM F2554. It indicates that "The devices meet state-of-the-art acceptance criteria for point accuracy, precision and distance accuracy." However, the specific numerical acceptance criteria or the reported device performance metrics (e.g., actual point accuracy values, precision values, or distance accuracy values) are not provided in the text.

Acceptance Criteria Category	Acceptance Criteria (Specifics not provided in the document)	Reported Device Performance (Specifics not provided in the document)
Performance - Accuracy	Meets state-of-the-art acceptance criteria for point accuracy, precision, and distance accuracy as per ASTM F2554.	Achieved "state-of-the-art acceptance criteria" for point accuracy, precision, and distance accuracy. (No specific numerical results given)
Reprocessing	Validated in compliance with FDA guidance and TIRs; steam sterilization compliant with ISO 17665-1 and ANSI/AAMI ST79.	Validated in compliance. Instructions follow ISO 17664.
Electrical Safety	Certified for compliance with ANSI/AAMI ES 60601-1 as accessories to ME Equipment.	Certified for compliance.

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

The document does not specify a "test set" in the context of a clinical study with patients or data. The testing described is bench testing. Therefore, information regarding sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable to the type of testing presented.

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

Ground truth establishment by experts is typically relevant for clinical studies or image-based AI studies. Since the testing described is bench testing of physical device characteristics (accuracy, reprocessing, electrical safety), this information is not applicable.

4. Adjudication Method for the Test Set:

As no expert- Adjudicated test set is described, the adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No clinical studies, and specifically no MRMC comparative effectiveness studies involving human readers, were performed or are described in the provided text. The document explicitly states: "No clinical testing was deemed necessary for this 510(k) submission." Therefore, information on effect size of human readers with/without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance:

The device is a physical instrument clamp for surgical navigation, not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable. The accuracy testing refers to the physical tracking performance of the instrument, not an AI algorithm.

7. Type of Ground Truth Used:

For the bench testing described:

Accuracy: The ground truth would typically be established by a highly precise measurement system against which the device's tracking performance is compared. The specifics of this ground truth measurement system are not detailed beyond "state-of-the-art acceptance criteria for point accuracy, precision and distance accuracy."
Reprocessing: The ground truth for successful reprocessing would be the absence of contaminants and maintenance of device functionality after the specified reprocessing cycles, confirmed by established laboratory methods and standards.
Electrical Safety: Compliance with ANSI/AAMI ES 60601-1 is the ground truth.

8. Sample Size for the Training Set:

The device is a physical medical instrument, not an AI model requiring a "training set" of data. Therefore, this information is not applicable.

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

As there is no training set, this information is not applicable.

Summary of Key Findings from the Document:

The 510(k) submission for the Instrument Clamps Electromagnetic relies on bench testing to demonstrate substantial equivalence to a predicate device.

Accuracy testing was performed according to ASTM F2554, and the devices reportedly met "state-of-the-art acceptance criteria," but specific numerical performance values are not disclosed.
Reprocessing validation complied with FDA guidance, TIRs, ISO 17665-1, and ANSI/AAMI ST79.
Electrical safety compliance was certified to ANSI/AAMI ES 60601-1.
No clinical testing was deemed necessary.
The device is a physical instrument, not an AI/software product, so concepts like "test set sample size (for data)," "experts for ground truth," "adjudication," "MRMC studies," "standalone algorithm performance," and "training set" are not directly applicable in the context of the information provided.

Summary

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October 9, 2020

Stryker Corporation Maya Schiel Staff Regulatory Affairs Specialist Boetzinger Strasse 41 Freiburg, Baden-Wuerttemberg D-79111 Germany

Re: K202609

Trade/Device Name: Instrument Clamps Electromagnetic Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: PGW Dated: September 3, 2020 Received: September 9, 2020

Dear Maya Schiel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202609

Device Name Instrument Clamps Electromagnetic

Indications for Use (Describe)

Example procedures include, but are not limited to the following ENT procedures:

Transphenoidal access procedures:
Intranasal procedures;
Sinus procedures, such as Maxillary antrostomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies;
ENT related anterior skull based 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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510(k) Summary

Special 510(k): Instrument Clamps Electromagnetic

Submitter Information

510(k) Submitter	Stryker Leibinger GmbH & Co. KGBoetzinger Strasse 4179111 Freiburg, Germany
FDA Establishment Number	8010177
Contact Person	Maya SchielStaff Regulatory Affairs SpecialistPhone: +49 30 311 911 89Mail: maya.schiel@stryker.com
Date Submitted	September 3, 2020
Subject Device
Trade / Proprietary Name	Instrument Clamps Electromagnetic
Common Name	Ear, Nose, And Throat Stereotaxic Instrument
Classification	Class II
Classification Product Code	PGW
Classification Name	Stereotaxic Instrument
Classification Regulation	21 CFR 882.4560

Legally Marketed Predicate Device

Predicate Device Name	Scopis Extended Instrument Set EM
	Instrument Clamps
	Universal Tracker Electromagnetic
Predicate Device 510(k) Number	K171661

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The Scopis Extended Instrument Set EM was cleared under K171661 by Scopis GmbH in September 2017. This submission was an extension to the previously cleared Scopis Hybrid Navigation System (K161491).

Scopis GmbH was acquired by Stryker in November 2017. In July 2018, the legal manufacturer for the devices was changed to Stryker Leibinger GmbH & Co. KG. Since October 2019, the devices have also been also physically manufactured in Freiburg under the Stryker Leibinger Quality Management System. The 510(k) ownership was also transferred from Scopis GmbH.

As part of the post-acquisition integration the Scopis name of the system was changed from Scopis Hybrid Navigation System to Stryker ENT Navigation System.

The cleared instrument set contains instrument clamps and an electromagnetic tracker, which needs to be mounted on top of a clamp to enable tracking of conventional surgical instruments. Since the Instrument Clamps Electromagnetic are a combination of these devices, they are viewed as variants of the predicate device. The Instrument Clamps Electromagnetic themselves have the same intended purpose and indications and are therefore considered line extensions.

Device Description

Two electromagnetic clamps are in scope of this submission:

Instrument Clamp Electromagnetic Sphere: Clamping interface optimized for tracking instruments with a circular cross-section between 2.0 mm and 4.6 mm in diameter (inclusive)
. Instrument Clamp Electromagnetic Universal: Clamping interface optimized for tracking instruments with angular cross-section (e.g. forceps) between 3.0 mm and 6.0 mm in diameter (inclusive)

The subject devices are not intended to have patient contact. Their bodies are made of PEEK and the clamps and screws are manufactured from titanium.

They are reusable devices that need to be reprocessed prior to first use. They are limited to 10 uses.

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Intended Use and Indications

Example procedures include, but are not limited to the following ENT procedures:

-Transsphenoidal access procedures;
-Intranasal procedures;
Sinus procedures, such as Maxillary antrostomies. Ethmoidectomies, -Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies;
ENT related anterior skull-based procedures. -

Comparison of Technological Characteristics

This submission is about the modification of combining two products (clamp and electromagnetic tracker) into one (electromagnetic clamp).

The combination was achieved by integrating the electromagnetic sensor coil into the body of the clamp, as opposed to an EM tracker unit that must be separately attached, resulting in a smaller and lighter device. The one-piece electromagnetic clamp requires one step less of preparation and post-processing in the OR, since the devices do not need to be assembled or disassembled.

The Instrument Clamps Electromagnetic are attached to conventional surgical instruments the same way as the predicate clamps. The step of attaching a separate electromagnetic tracker (as in predicate) is not required, as it is already incorporated into the subject device.

The subject and predicate devices are identical in the following characteristics:

. 510(k) holder
FDA product codes and regulation ●
Intended Use
. Indications for Use
Application Area ●
Type of Use
Type of Patient Contact ●
Tracking Technology
Usage
Material ●
Packaging ●
Fixation ●
Calibration ●
Compatibility

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The subject and predicate devices differ in the following ways:

The key requirements of the Instruments Clamps Electromagnetic are to be smaller and lighter, but with the same functionalities as the variants of the predicate. This requires a design that allows the device to be both clamp and tracker in one device. Therefore, the same type of electromagnetic sensor coil used in the predicate is directly incorporated into the body of the subject device in a more compact form.

Performance Data

Non-Clinical Testing

A risk analysis was completed for subject devices in compliance with ISO 14971 to identify required verification and validation activities in order to evaluate the impact of the device modification and to mitigate potential risks. This submission includes appropriate supporting data to show the safety and effectiveness of the Instrument Clamps Electromagnetic.

The following bench testing was performed to evaluate performance (accuracy), reprocessing, and electrical safety.

Table 1: Performance Data

Scientific discipline	Test summary
Performance - Accuracy	To ensure accuracy, subject devices are tested in accordancewith ASTM F2554. The devices meet state-of-the-artacceptance criteria for point accuracy, precision and distanceaccuracy.
Reprocessing	Subject devices are reusable instruments and were thereforevalidated in compliance with the respective FDA guidance forreprocessing medical devices including respective TIRs.The steam sterilization was also conducted in compliancewith ISO 17665-1 and ANSI/AAMI ST79.The respective instructions follow ISO 17664.
Electrical Safety	The devices are used as parts of the Stryker ENT NavigationSystem, which is defined as ME Equipment. Therefore, deviceswere checked and certified for compliance with ANSI/AAMIES 60601-1 as accessories to a ME Equipment.

All cited standards are FDA-recognized consensus standards

Clinical Testing

No clinical testing was deemed necessary for this 510(k) submission.

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Conclusion

The intended use and fundamental scientific technologies of subject devices and their predicate are identical. The subject devices are line extensions to the variants of the predicate and are therefore part of the same ENT Navigation System, following the same operating principles and conditions. The change of combining two devices into one does not affect the indications for use, tracking technology, calibration or other basic features. The device modifications do not raise different questions of safety and effectiveness than the predicate device.

Risk management was conducted in accordance with ISO 14971 and does not show any unacceptable risk or new risks when compared to the predicate. Verification testing demonstrates that the subject devices are at least as safe and effective as the predicate.

In conclusion, the information provided demonstrates that the Instrument Clamps Electromagnetic are at least as safe and effective as their predicate (K171661) and do not introduce different questions of safety or effectiveness, and therefore supports a determination of substantial equivalence.

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).