(43 days)
Not Found
No
The description focuses on real-time localization using an infrared camera and pre-operative planning, without mentioning any AI/ML components for image analysis, decision support, or other functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is used to aid the surgeon in precisely locating anatomical structures during ENT/endonasal or sinus procedures, allowing visualization of surgical instruments on a pre-operative CT scan in real-time. It does not exert a therapeutic effect.
No
The device aids surgeons in locating anatomical structures during procedures and planning surgeries. It does not diagnose diseases or conditions.
No
The device description explicitly states the system uses an infrared camera for localization and guidance, indicating the presence of hardware components beyond just software.
Based on the provided information, the Surgetics ENTact Endonasal Navigation System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Surgetics ENTact Endonasal Navigation System is a surgical navigation system. It uses a preoperative CT scan and an infrared camera to help the surgeon locate anatomical structures and guide surgical instruments during a procedure. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's an "aid to the surgeon for precisely locating anatomical structures... during open or percutaneous ENT/endonasal or sinus procedures." This is an intraoperative tool, not a diagnostic test performed on a sample.
Therefore, the Surgetics ENTact Endonasal Navigation System falls under the category of a surgical navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
90 JAK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
ENT/endonasal or sinus procedures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, aid in open or percutaneous ENT/endonasal or sinus procedures.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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.
న. 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
1
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.
2
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.
3
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
4
Ko22.39
510(k) Number (if known):
Device Name: Surgetics ENTact Endonasal Navigation System
Indications for Use:
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.
(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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
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