(530 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or specific algorithms. The device description is also not available.
Yes
The device is used for pain therapy and to induce regional anesthesia for surgical procedures, which are therapeutic interventions.
No
The device is used to inject local anesthesia or analgesic, which is a therapeutic intervention, not a diagnostic one. Its use of ultrasound is for targeting during the therapeutic procedure, not for diagnosing a condition.
No
The device is described as a "Nerve Block Needle Kit," which inherently includes hardware components (the needle). The description focuses on the physical use of the needle with an ultrasound device, not on a standalone software application.
Based on the provided information, the SonixGPS Nerve Block Needle Kit 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.
- Device Function: The SonixGPS Nerve Block Needle Kit is a medical device used in vivo (within the body) to deliver medication (local anesthesia or analgesic) to a specific anatomical site (peripheral nerves) under ultrasound guidance. It is a tool for a medical procedure, not a test performed on a sample outside the body.
The intended use clearly describes a procedure performed directly on a patient, not a laboratory test on a biological sample.
N/A
Intended Use / Indications for Use
The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.
Product codes
BSP
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound imaging
Anatomical Site
peripheral nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, in regional anesthesia and pain therapy
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 2, 2013
Ultrasonix Medical Corporation C/O Mr. Raymond Kelly Licensale Incorporated 57 Lazy Brook Road Monroe, CT 06468
Re: K121812
Trade/Device Name: SonixGPS Nerve Block Needle Kit Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: November 21, 2013 Received: November 26, 2013
Dear Mr. Kelly:
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,
1
Page 2 - Mr. Kelly
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); 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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,
ErinFDXAith
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): K121812
SonixGPS Nerve Block Needle Kit Device Name:
Indications for Use:
The SonixGPS Nerve Block Needle Kit is intended for use in regional anesthesia and pain therapy by a trained physician, to target peripheral nerves by visualization at the needle tip using an ultrasound imaging device. The needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures.
V 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)
Nayan Patel
2013.12.02 11:37:59 -05'00'