(210 days)
No
The document describes a neuronavigation system with intraoperative ultrasound capabilities and tool tracking. There is no mention of AI or ML in the intended use, device description, or performance studies. The submission focuses on adding new accessories (localizers and adapters) and explicitly states "There are no changes to the Intended use, function or technological aspects including software of the SonoWand Invite."
No
The device is described as a neuronavigation system and ultrasound scanner used to aid intraoperative imaging and guided surgery, showing the position of surgical tools relative to medical images, rather than directly treating a disease or condition.
No
The device is described as a neuronavigation system with intraoperative imaging capabilities, which aids in procedures by showing tool positions relative to images and acquiring ultrasound images. Its primary function is to assist surgical procedures rather than to diagnose conditions.
No
The device description explicitly states that the SonoWand Invite System is a neuronavigation system with intraoperative imaging capabilities and that an ultrasound scanner is physically integrated with a neuronavigation system in a single rack of equipment. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It's also a standard neuronavigation system and a stand-alone ultrasound scanner. This describes a system used during a surgical procedure to guide the surgeon, not a test performed in vitro (outside the body) on biological specimens to diagnose a condition.
- Device Description: The description reinforces its function as a neuronavigation system with integrated ultrasound, used to show the position of tools relative to medical images. This is a surgical guidance tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical navigation and imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Sonowand Invite System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner.
The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images
The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.
Product codes
HAW, IYN
Device Description
The 510(k) cleared SonoWand Invite System is a neuronavigation system with intraoperative imaging capabilities. An ultrasound scanner is physically integrated with a neuronavigation system in a single rack of equipment.
SonoWand Invite can be used as a conventional neuronavigation system based on preoperative MR or CT-images, or as a stand-alone ultrasound scanner for real-time 2D imaging or as a combined system where 3D ultrasound data can be transferred to the navigation system for direct navigation.
SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. It also makes it possible for the surgeon to acquire ultrasound images during operation, which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen. The secondary control is by a footswitch.
The new accessories, General purpose localizers with adapters, shall be used to attach surgical tools manufactured by other vendors. SonoWand Invite will then display position and orientation of the tools in the medical images on the screen in the same way as the previous 510(k) cleared Navigator tool.
The localizers with adapters are designed to fit surgical tools normally used in the operating room.
There are no changes to the Intended use, function or technological aspects including software of the SonoWand Invite. The additional accessories are being added to increase usability of the SonoWand Invite system.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR, CT, Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, intraoperative, neurosurgery, operating room
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
The new localizers and adapters have been tested to and comply with all applicable cleaning and sterilization standards.
The devices subject to this submission do not contain software module in the cleared SonoWand Invite System that supports the function of the subject devices has been tested to and complies with requirements.
The Localizers have been tested to and comply with requirements of the SonoWand Invite System Test. The Adapters were tested for fit, calibration and accuracy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of the tests performed show the General purpose localizers and adapters are as safe and effective as the accessories of the predicate device.
The conclusion drawn from the testing is that the localizers and adapters can be used for supporting the surgeon by showing the position of surgical tools.
Connecting a localizer to the device does not affect the intended use of the connected device. Results of the tests performed show the new accessories (localizers and adapters) to SonoWand Invite are as safe and effective as the predicate devices.
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
§ 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).
0
510(k) Summarv
KII 2469
t
510(k) Number:
| Device Trade Name: | General purpose localizers and adapters - new accessories for SonoWand Invite System |
|---|---|
| Device Common Name: | Diagnostic ultrasound neuronavigation intraoperative imaging system |
| Device Regulation Name: | Sterotaxic instrument (21 CFR 882.4560, Class II, Code: HAW,IYN) |
| Submitter: | SONOWAND AS |
| Nedre lla 39 | |
| 7018 Trondheim | |
| NORWAY | |
| Phone number: 0047 73805900 | |
| Contact Information: | Constance G. Bundy |
| C. G. Bundy Associates, Inc. | |
| 435 Rice Creek Terrace NE | |
| Fridley, MN 55432 | |
| 763-574-1976 | |
| Fax: 763-571-2437 | |
| cgbundy@live.com | |
| Submission Date: | August 24, 2011 |
Equivalent Device Identification:
The purpose of this submission is to add additional accessories to the SonoWand Invite System. The additional accessories are general purpose localizers with adapters. These accessories are equivalent in function and intended use to the Navigator tool which was cleared in the original 510(k), K083597.
Device Description:
The 510(k) cleared SonoWand Invite System is a neuronavigation system with intraoperative imaging capabilities. An ultrasound scanner is physically integrated with a neuronavigation system in a single rack of equipment.
SonoWand Invite can be used as a conventional neuronavigation system based on preoperative MR or CT-images, or as a stand-alone ultrasound scanner for real-time 2D imaging or as a combined system where 3D ultrasound data can be transferred to the navigation system for direct navigation.
SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. It also makes it possible for the surgeon to acquire ultrasound images during operation, which can be compared with other images (such as MR or CT) and can be used for supporting the surgeon by showing the position of tools and pointers. The control is primarily by a graphical touch screen. The secondary control is by a footswitch.
The new accessories, General purpose localizers with adapters, shall be used to attach surgical tools manufactured by other vendors. SonoWand Invite will then display position and orientation of the tools in the medical images on the screen in the same way as the previous 510(k) cleared Navigator tool.
The localizers with adapters are designed to fit surgical tools normally used in the operating room.
There are no changes to the Intended use, function or technological aspects including software of the SonoWand Invite. The additional accessories are being added to increase usability of the SonoWand Invite system.
1
Intended Use:
The Sonowand Invite system is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner.
The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images
The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.
Comparison Chart:
| Element of
| Comparison | Subject | Predicate Device | Comment | ||
|---|---|---|---|---|---|
| SonoWand Invite new | |||||
| accessories | K083597 | ||||
| SonoWand Invite | |||||
| accessories | |||||
| Common | |||||
| name | General | ||||
| purpose | |||||
| localizers, | |||||
| small and | |||||
| large | User tool | ||||
| adapters (*) | |||||
| Bracket & | |||||
| Clamp adapter | Navigator, | ||||
| intraoperative | Probe | ||||
| localizers | |||||
| for variable | |||||
| size | |||||
| ultrasound | |||||
| probes | |||||
| Pictures | Image: General purpose localizers | Image: User tool adapters | Image: Navigator | Image: Probe localizers | Accessories are |
| biocompatible and | |||||
| sterilizable. | |||||
| Image: General purpose localizers | Image: User tool adapters | Image: Navigator | Image: Probe localizers | ||
| Intended | |||||
| use of | |||||
| accessories | The intended | ||||
| use of a | |||||
| localizer is to | |||||
| enable | |||||
| navigation by | |||||
| showing the | |||||
| position of | |||||
| surgical | |||||
| instruments or | |||||
| pointers relative | |||||
| to MR, CT or | |||||
| Ultrasound | |||||
| images | The adapter is | ||||
| intended to | |||||
| connect the | |||||
| general purpose | |||||
| localizer with a | |||||
| variety of | |||||
| surgical | |||||
| instruments | The intended use | ||||
| of a localizer is to | |||||
| enable navigation | |||||
| by showing the | |||||
| position of the | |||||
| Navigator (pointer) | |||||
| relative to MR, CT | |||||
| or Ultrasound | |||||
| images | The intended | ||||
| use of a probe | |||||
| localizer is to | |||||
| enable | |||||
| accurate | |||||
| imaging during | |||||
| surgery by | |||||
| tracking the | |||||
| probes | |||||
| location | |||||
| relative to the | |||||
| patient. | No changes to | ||||
| intended use or the | |||||
| functionality of | |||||
| SonoWand Invite(**). | |||||
| The adapted surgical | |||||
| instruments are given | |||||
| the same functionality | |||||
| as the Navigator | |||||
| (pointer). | |||||
| Connecting a localizer | |||||
| to the device does not | |||||
| affect the intended use | |||||
| of the connected | |||||
| device. | |||||
| Materials | 316 L Stainless | ||||
| steel, | |||||
| 6082 Aluminium | |||||
| DLC Coating | 316 L Stainless | ||||
| steel, | |||||
| Plastic Radel | |||||
| PPSU (PEEK) | 316 L Stainless | ||||
| steel, | |||||
| 6082 Aluminium | |||||
| DLC Coating | 316 L | ||||
| Stainless | |||||
| steel, | |||||
| 6082 | |||||
| Aluminium | |||||
| DLC Coating | New material; Plastic | ||||
| Radel PPSU (PEEK) | |||||
| are widely used for | |||||
| surgical instruments. | |||||
| The material is in | |||||
| compliance with both | |||||
| United States | |||||
| Pharmacopeias (USP) | |||||
| and ISO 10993-1 | |||||
| guideline requirements | |||||
| for Biocompatibility | |||||
| Testing of Materials. |
2
(*) Images show adapters attached to localizers
(**) SonoWand Invite has basically two functionalities. It supports the surgeon by showing the position of tools or pointers relative to MR, CT or Ultrasound images. It also makes it possible for the surgeon to acquire ultrasound images during operation, which can be compared with other images (such as MR or CT) and can be used for surgeon by showing the position of tools and pointers.
Intended use:
There are no changes to the Intended use of the SonoWand Invite.
The additional accessories (localizers and adapters) will facilitate the commonly used surgical instruments with the same functionality as the Navigator (pointer).
Connecting a localizer to the device does not affect the intended use of the connected device.
Technological and performance characteristics:
Technological characteristics of the localizers and adapters, including device design and performance, are substantially equivalent to the accessories of the predicate device SonoWand Invite. K083597.
Summary of Testing:
The new localizers and adapters have been tested to and comply with all applicable cleaning and sterilization standards.
The devices subject to this submission do not contain software module in the cleared SonoWand Invite System that supports the function of the subject devices has been tested to and complies with requirements.
The Localizers have been tested to and comply with requirements of the SonoWand Invite System Test. The Adapters were tested for fit, calibration and accuracy.
Results of the tests performed show the General purpose localizers and adapters are as safe and effective as the accessories of the predicate device.
Conclusion:
The conclusion drawn from the testing is that the localizers and adapters can be used for supporting the surgeon by showing the position of surgical tools.
Connecting a localizer to the device does not affect the intended use of the connected device. Results of the tests performed show the new accessories (localizers and adapters) to SonoWand Invite
are as safe and effective as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sonowand AS % C.G. Bundy Associates, Inc. Ms. Constance G. Bundy 435 Rice Creek Terrace NE Fridley, Minnesota 55432
Re: K112469
Trade/Device Name: General purpose localizers and adapters - new accessories for SonoWand Invite System
Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW, IYN Dated: March 14, 2012 Received: March 20, 2012
Dear Ms. Bundy:
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. 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
MAR 2 3 2012
4
Page 2 - Ms. Constance G. Bundy
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erinl Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
wand
Indications for Use
K112469 510(k) Number (if known):
Device Name: General purpose localizers and adapters - new accessories for SonoWand Invite System
Indications For Use:
The Sonowand Invite System is intended for use as a tool to aid intraoperative ultrasound imaging and image guided surgery during neurosurgery. It is also intended for use as a standard neuronavigation system and as a stand-alone ultrasound scanner.
The intended use of a localizer is to enable navigation by showing the position of surgical instruments or pointers relative to MR, CT or Ultrasound images
The General purpose localizers with adapters are intended to be used to attach surgical tools manufactured by other vendors. SonoWand Invite System will display position and orientation of the tools in the medical images on the screen.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R.P. Ogle for mx
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K112469