(351 days)
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.
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.
Here's an analysis of the acceptance criteria and study information for the SonixGPS™ Needle Sensor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| System Accuracy | Equivalent performance to the predicate device (K092619) | The SonixGPS™ 0.9mm Needle Sensor and 0.55mm Needle Sensor demonstrated equivalent performance to the predicate device, which met the defined criteria. |
| Electrical Safety | Compliance with EN 60601-1 (2nd Edition, 1988) | The SonixGPS™ Needle Sensor met the acceptance criteria. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (2.1 Edition; 2001+A1:2004) | The SonixGPS™ Needle Sensor met the acceptance criteria. |
| Biocompatibility | Compliance with ISO 10993-1:2009 | The SonixGPS™ Needle Sensor met the biocompatibility requirements. |
Explanation of Implied Acceptance Criteria for System Accuracy:
The document states, "The subject devices met the same defined accuracy criteria as the predicate device," and "[The SonixGPS™] demonstrated equivalent performance which met the defined criteria." While the specific numerical accuracy criteria for the predicate are not detailed in this 510(k) summary, the core acceptance criterion for the SonixGPS™ Needle Sensor was to achieve performance equivalent to the predicate device (K092619) under its established accuracy protocol.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the numerical sample size (e.g., number of tests, number of measurements, number of devices tested) for the performance "System Accuracy" testing. It only mentions that the "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."
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "System Accuracy" test appears to be a technical or engineering performance test against a defined protocol, rather than a clinical study requiring expert interpretation or ground truth establishment in a diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable as the "System Accuracy" test described is a technical performance assessment, not a study involving human readers or interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The study described is a technical performance test comparing the new device against a predicate device's existing performance standards.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This document describes a standalone performance test of the device itself (the needle sensor), not an algorithm. The accuracy test described is for the device's ability to track position, which is an inherent function of the device, not an "algorithm only" performance separate from its intended use. While it's a "device only" test, the term "standalone" as typically used in AI/software refers to algorithmic performance without human intervention, which isn't directly applicable here as it's a physical device.
7. The Type of Ground Truth Used
For the "System Accuracy" test, the ground truth would be established by the needle sensor accuracy performance protocol and the Sonix 3D Motion Tracking (SonixGPS™) Verification Protocol and Report. This implies a defined, objective standard or known positions against which the device's tracking accuracy was measured. It's a technical ground truth rather than a clinical ground truth like pathology or expert consensus.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The SonixGPS™ Needle Sensor is an electromagnetic tracking hardware device, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no training set for this type of device.
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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.
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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.
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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 isintended to provide physicianswith tools for electromagnetictracking of instruments withrespect to image data. | The device is intended to providephysicians with tools forelectromagnetic tracking ofinstruments with respect toimage data. |
| Diameter(s) | 0.9 mm and 0.55mm | 0.9mm |
| Length | 96.8mm and 110.0mm | 177.8mm |
| Connector(Between NeedleSensor andAccessory) | Luer Lock | Clip on |
| Cable | 3.8mm OD cablemedical grade PVCmetal shell connector | same |
| Connector(Between NeedleSensor and controlunit) | 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.
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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 |
|---|---|---|
| SystemAccuracy | Based on needle sensor accuracyperformance protocol; Sonix 3D MotionTracking (SonixGPS'") VerificationProtocol and Report | The SonixGPS™0.9mm NeedleSensor andThe SonixGPS™0.55mm NeedleSensor demonstratedequivalentperformance whichmet the definedcriteria. |
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 TestPerformed | Result |
|---|---|
| EN 60601-1 (2nd Edition, 1988)Electrical Safety Testing | The SonixGPS™ Needle Sensor metthe acceptance criteria. |
| IEC 60601-1-2 (2.1 Edition;2001+A1:2004) Electromagneticcompatibility testing | The SonixGPS™ Needle Sensor metthe acceptance criteria. |
| ISO 10993-1:2009 Biologicalevaluation of medical devices | The SonixGPS™ Needle Sensor metthe biocompatibility requirements. |
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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
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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
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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
Page 1 of
§ 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.