The Surgetics ENTact Endonasal Navigation System is intended for use as an aid to the surgeon for precisely locating anatomical structures either during open or percutaneous ENT/endonasal or sinus procedures.

Device Description

The Surgetics ENTact Endonasal Navigation System is specifically designed for use in ENT/endonasal and sinus procedures. It allows the surgeon to locate surgical instruments (e.g., aspirator) on three planes (axial, frontal) on a preoperative CT scan in real-time. The system uses an infrared camera for localization and guidance of the surgical instrument. Additionally, a surgical planning capability using the Consultics Station is provided which allows the surgeon to pre-operatively plan the surgery.

AI/ML Overview

The provided 510(k) summary for the "Surgetics ENTact Endonasal Navigation System" offers limited details regarding acceptance criteria and performance studies. Based on the available text, here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The Surgetics ENTact Endonasal Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and clinical experience with the system were provided."

However, specific acceptance criteria (e.g., maximum allowable error in millimeters for accuracy) and the detailed results of these tests (e.g., the exact accuracy achieved in phantom studies) are not provided in this summary. Therefore, a complete table cannot be generated from the given information.

Acceptance Criteria (Not Specified)	Reported Device Performance (Summary Only)
Electrical Safety Compliance	Tested for compliance with electrical safety standards
Electromagnetic Compatibility Compliance	Tested for compliance with electromagnetic compatibility standards
Accuracy (Specific values not provided)	Summaries of accuracy testing using phantoms were provided.
Clinical Experience (Specific outcomes not provided)	Summaries of clinical experience with the system were provided.

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

Sample Size for Test Set: Not specified. The document mentions "summaries of accuracy testing using phantoms" and "clinical experience with the system" but does not give any numbers for the phantoms used or the number of patients/cases in the clinical experience.
Data Provenance: The location of the submitter is France (Praxim "Le Grand Sablon" 4. Avenue de l'Obiou 38 700 La Tronche France). This suggests the development and potentially some of the testing occurred in France.
- Retrospective/Prospective: Not specified. The nature of "clinical experience" is not detailed enough to determine if it was retrospective or prospective.

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

Not specified. The summary does not provide any information about experts involved in establishing ground truth for any testing.

4. Adjudication method for the test set:

Not specified. No information is given about how discrepancies, if any, were resolved during testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, this type of study was not done or reported. The device is an "Image guided surgical navigation system." It aids the surgeon in precisely locating anatomical structures in real-time during procedures by tracking surgical instruments on a pre-operative CT scan. It's not an AI-assisted diagnostic tool for human readers, so an MRMC study comparing human readers with and without AI assistance is not applicable to this device's function as described.

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

Yes, implicitly in the phantom accuracy testing. The "accuracy testing using phantoms" would likely represent a standalone performance evaluation of the navigation system's ability to track and display instrument positions relative to the phantom, without direct human intervention in the tracking mechanism itself. However, specific metrics and results are not detailed.

7. The type of ground truth used:

For the "accuracy testing using phantoms," the ground truth would likely be precisely known physical dimensions and coordinates of fiducials or targets on the phantom. Phantoms are designed with known geometries to allow for direct measurement of deviation from the true position.
For "clinical experience," the ground truth is not specified. In a surgical navigation context, ground truth during clinical experience might involve comparing the system's displayed position to the actual anatomical location as perceived by the surgeon, or potentially to post-operative imaging if available, but this is speculative given the lack of detail.

8. The sample size for the training set:

Not applicable / Not specified. This device is an image-guided navigation system, not a machine learning model that typically undergoes a distinct "training phase" on a dataset in the way an AI diagnostic algorithm would. Its underlying technology (optical infrared tracking, 3D CT image processing) operates based on established physical and computational principles, not by learning from a large "training set" of labeled data.

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

Not applicable / Not specified. As noted above, this device doesn't appear to use a training set in the machine learning sense. Its functionality is based on direct measurement and processing.

Summary

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K02 2239

510(k) Summary

for

Surgetics ENTact Endonasal Navigation System

Submitter Name and Address 1.

Praxim "Le Grand Sablon" 4. Avenue de l'Obiou 38 700 La Tronche France

Contact Name: Stéphane Lavallée Telephone: 33-4 76 54 95 03

Date Prepared: July 10, 2002

2. Device Name

Surgetics ENTact Endonasal Navigation System Proprietary Name: Common/Usual Name: Image guided surgical navigation system Classification Name: Computed tomography x-ray system (accessory)

Predicate Device 3.

Marconi Medical Systems Voyager (K000310)

4. Intended Use

న. Device Description

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using the Consultics Station is provided which allows the surgeon to pre-operatively plan the surgery.

Technological Characteristics and Substantial Equivalence 6.

The Surgetics ENTact Endonasal Navigation System is substantially equivalent to other predicate image-guided systems (e.g., Marconi Voyager, K000310) that are currently marketed. It is similar to the other image-guided systems in its technological characteristics. It uses the same type of optical infrared system for instrument tracking and localization as other previously cleared image-guided systems. Like the predicate products, it includes tools and accessories that are used during the procedure and require sterilization prior to use. The various predicate image-guidance systems use a variety of methods for registration of the alignment of the patient with an image. The Surgetics uses a frameless system that doesn't require pre-operative scanning of fiducial markers. Registration is achieved prior to surgery by simply mapping multiple points or areas on the patient's face using a special ball pointer mapping probe. The mapped points are then registered with the corresponding points on a 3-D CT image of the patient's face.

7. Performance Testing

The Surgetics ENTact Endonasal Navigation System was tested for compliance with electrical safety and electromagnetic compatibility standards. In addition, summaries of accuracy testing using phantoms and clinical experience with the system were provided.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines above them, resembling a bird in flight. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 23 2002

Praxim, "Le Grand Sablon" c/o Sheila Hemeon-Heyer, J.D., RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K022239 Trade/Device Name: Surgetics ENTact Endonasal Navigation System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: July 10, 2002 Received: July 11, 2002

Dear Ms. Hemeon-Heyer:

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.

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); 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.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko22.39

510(k) Number (if known):

Device Name: Surgetics ENTact Endonasal Navigation System

Indications for Use:

(Please do not write below this line -Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Chrogdon
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Page vii

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.