(351 days)
Not Found
No
The description focuses on electromagnetic tracking and combining it with imaging data for navigation, without mentioning any AI or ML algorithms for image processing, data analysis, or decision support.
No
The device is used for tracking and navigation, assisting physicians with precise placement of instruments. It does not directly provide therapy or treat a disease.
No
The device aids in instrument navigation and placement during procedures by providing real-time tracking within an electromagnetic field; it does not diagnose a medical condition.
No
The device description explicitly states that the device is a "Needle Sensor" consisting of a "sensor head, cable and a connector," which are physical hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to provide tools for electromagnetic tracking of instruments with respect to image data to assist with navigation and precise placement of instruments during a procedure. This is a tool used in vivo (within the body) during a medical procedure.
- Device Description: The description reinforces this by stating the sensor is placed inside a tracked instrument and used within an electromagnetic field to detect position and orientation for navigation.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (blood, urine, tissue, etc.) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such analysis of biological specimens.
The device is clearly designed for image-guided navigation and instrument tracking during surgical or interventional procedures, which falls under the category of medical devices used in vivo.
N/A
Intended Use / Indications for Use
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.
Product codes
IYO
Device Description
The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target.
The needle sensor consists of a sensor head, cable and a connector:
Connector is a positive latching, user-removable interconnect that conducts sensor data from the Cable to the electronics unit.
Cable is the wiring harness for the sensor that conducts sensor data from the Sensor Head to the Connector.
Sensor Head contains a set of coils that make up the measuring element of the sensor assembly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Hospital
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing
The following performance test used the same ultrasound system and setup to perform the accuracy test for SonixGPS™ 0.9mm Needle Sensor, SonixGPS™ 0.55mm Needle Sensor and the predicate device.
Test Type: System Accuracy
Test Plan: Based on needle sensor accuracy performance protocol; Sonix 3D Motion Tracking (SonixGPS'") Verification Protocol and Report
Result: The SonixGPS™ 0.9mm Needle Sensor and The SonixGPS™ 0.55mm Needle Sensor demonstrated equivalent performance which met the defined criteria.
The subject devices met the same defined accuracy criteria as the predicate device. The technological differences did not affect the performance of the subject in comparison to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
JUN 1 3 2012
510(k) Summary (per 21 CFR 807.92)
l, Applicant
Ultrasonix Medical Corporation 130 - 4311 Viking Way Richmond, B.C. Canada V6V 2K9
Contact Person: Chas Yu, Quality Assurance Manager Tel: 604-279-8550 Fax: 604-279-8552 Email: chas.yu@ultrasonix.com
Date Prepared: February 28, 2011
ll. Device Name
SonixGPS™ Needie Sensor Proprietary Name:
Ultrasonic pulsed echo imaging system Classification Name:
IYO Product Codes:
Classification Regulation: 21 CFR 892.1560
Classification Panel: Radiology
(11. Predicate Device
The SonixGPS™ Needle Sensor is substantially equivalent to K092619 -Electromagnetic Tracking System.
1
Image /page/1/Picture/0 description: The image shows a logo for Ultrasonix. The logo consists of the word "ULTRASONIX" in a bold, sans-serif font, with a series of concentric circles made of dots surrounding the text. The dots are arranged in three rings, with the innermost ring having the fewest dots and the outermost ring having the most dots.
IV. Description of the Device -
The SonixGPS™ Needle Sensor is an electromagnetic sensor that is placed inside a tracked instrument and used within an electromagnetic field. The position and orientation can be detected and combined with the acquired imaging to assist with navigation of the tracked instrument. The needle sensor allows physicians the precise placement of instruments during each procedure by monitoring the real-time trajectory of the instrument as it advances through delicate anatomy to the center of a target.
The needle sensor consists of a sensor head, cable and a connector:
Connector is a positive latching, user-removable interconnect that conducts sensor data from the Cable to the electronics unit.
Cable is the wiring harness for the sensor that conducts sensor data from the Sensor Head to the Connector.
Sensor Head contains a set of coils that make up the measuring element of the sensor assembly.
V. Indications for Use of the Device
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.
Technological Characteristics VI.
The SonixGPS "" Needle Sensor has similar construction, manufacturing materials, operating principals and specifications as the predicate device.
2
Image /page/2/Picture/0 description: The image shows a logo with the word "ULTRASONIX" in bold, sans-serif font. The word is horizontally centered and flanked by a circular pattern of dots on either side. The dots are arranged in concentric circles, with the density of dots decreasing as the circles expand outward from the center.
| Table 1 – Technological Similarities and Differences |
|---|
| Product Name | SonixGPS™ Needle Sensor | Electromagnetic Tracking System |
|---|---|---|
| 510(k).Number | - | K092619 |
| Product Code(s) | IYO | IYO |
| Regulation # | 21 CFR 892.1560 | 21 CFR 892.1560 |
| Class | II | II |
| Intended Use | The SonixGPS™ Needle Sensor is | |
| intended to provide physicians | ||
| with tools for electromagnetic | ||
| tracking of instruments with | ||
| respect to image data. | The device is intended to provide | |
| physicians with tools for | ||
| electromagnetic tracking of | ||
| instruments with respect to | ||
| image data. | ||
| Diameter(s) | 0.9 mm and 0.55mm | 0.9mm |
| Length | 96.8mm and 110.0mm | 177.8mm |
| Connector | ||
| (Between Needle | ||
| Sensor and | ||
| Accessory) | Luer Lock | Clip on |
| Cable | 3.8mm OD cable | |
| medical grade PVC | ||
| metal shell connector | same | |
| Connector | ||
| (Between Needle | ||
| Sensor and control | ||
| unit) | metal shell connector | same |
| Sensor Head | polyimide tubing | same |
| Intended User | Physician | same |
| Where Used | Hospital | same |
| Duration of Use | ≤24h | same |
| Number of Uses | Reusable | same |
| Sterility | Non-Sterile | same |
The additional smaller sensor diameter, difference in sensor length and connection type compared to the predicate device does not affect performance and functionality.
・
3
Image /page/3/Picture/0 description: The image shows the word "ULTRASONIX" in a bold, sans-serif font. The word is surrounded by three concentric circles made of dots. The dots are evenly spaced and increase in size as they move outward from the center.
VII. Brief Description of Non-clinical Data
Performance Testing
The following performance test used the same ultrasound system and setup to perform the accuracy test for SonixGPS™ 0.9mm Needle Sensor, SonixGPS™ 0.55mm Needle Sensor and the predicate device.
| Test Type | Test Plan | Result |
|---|---|---|
| System | ||
| Accuracy | Based on needle sensor accuracy | |
| performance protocol; Sonix 3D Motion | ||
| Tracking (SonixGPS'") Verification | ||
| Protocol and Report | The SonixGPS™ | |
| 0.9mm Needle | ||
| Sensor and | ||
| The SonixGPS™ | ||
| 0.55mm Needle | ||
| Sensor demonstrated | ||
| equivalent | ||
| performance which | ||
| met the defined | ||
| criteria. |
The subject devices met the same defined accuracy criteria as the predicate device. The technological differences did not affect the performance of the subject in comparison to the predicate device.
Standards Testing
| Applicable Standard or Test
| Performed | Result |
|---|---|
| EN 60601-1 (2nd Edition, 1988) | |
| Electrical Safety Testing | The SonixGPS™ Needle Sensor met |
| the acceptance criteria. | |
| IEC 60601-1-2 (2.1 Edition; | |
| 2001+A1:2004) Electromagnetic | |
| compatibility testing | The SonixGPS™ Needle Sensor met |
| the acceptance criteria. | |
| ISO 10993-1:2009 Biological | |
| evaluation of medical devices | The SonixGPS™ Needle Sensor met |
| the biocompatibility requirements. |
4
Image /page/4/Figure/0 description: The image shows the word "ULTRASONIX" in a bold, sans-serif font. The word is surrounded by three concentric circles made of dots. The dots are evenly spaced and create a visual effect of radiating outward from the center.
VIII. Conclusion
Ultrasonix Medical Corporation claims the SonixGPS™ Needle Sensor to be substantially equivalent to the predicate device K092619 - Electromagnetic Tracking System, as the SonixGPS™ Needle Sensor has equivalent intended uses, manufacturing materials, operating principles, physical specifications and performance as compared to the predicate device.
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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUN 1 3 2012
Ultrasonix Medical Corporation % Mr. William J. Sammons Senior Project Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
Re: K111818
Trade/Device Name: SonixGPSTM Needle Sensor Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: June 7, 2012 Received: June 8, 2012
Dear Mr. Sammons:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r that FDA has made a determination that your device complies with other requirements of the Act that I Drinas intatutes and regulations administered by other Federal agencies. You must or any 1 vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
6
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): _
Device Name: SonixGPS™ Needle Sensor
Indications for Use:
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The device is available in two models 0.55mm and 0.9mm in diameter.
X Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111818
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