(252 days)
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Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven performance metrics typically associated with AI/ML devices. The device description and intended use point to a mechanical orthosis.
No
Explanation: While the device aims to aid recovery and provide relief for certain wrist conditions, its primary function is to support, limit motion, and provide feedback, rather than to treat, cure, prevent, or mitigate disease. The indications for use describe aiding recovery from injuries and providing temporary relief of symptoms, which aligns more with a supportive or rehabilitative device than a therapeutic one designed to directly treat a disease or condition. The term "therapeutic device" typically implies active treatment or intervention for a medical condition.
No
Explanation: The device is an orthosis that provides support, limits motion, and immobilizes the wrist for recovery and functional improvement, as well as providing temporary relief of symptoms and feedback. It is not described as analyzing or interpreting biological signals or data to identify diseases or conditions.
No
The device is described as an "orthosis worn on the wrist," which is a physical brace or support. The description and intended use clearly indicate a hardware component (the orthosis) is the primary medical device, even if it might incorporate some software functionality (like providing feedback).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is an orthosis worn on the wrist. Its function is to provide physical support, limit motion, and aid in recovery from injuries. It does not involve the analysis of any biological specimens.
The provided information clearly describes a physical support device, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
With rigid insert:
- to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries
- to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist
Without rigid insert:
- to provide wrist support
- to provide temporary relief of associated symptoms of some repetitive motion wrist conditions
- to provide feedback to the user when the wrist reaches maximal flexion or extension
Product codes
IQI, ILH
Device Description
An orthosis worn on the wrist
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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
§ 890.3475 Limb orthosis.
(a)
Identification. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Auqust 13, 2015
Neurospectrum, LLC c/o Jean Bigoney Nu Device Consulting LLC 210 Farmers Top Dr Murphy, NC 28906
Re: K143458
Trade/Device Name: Neurosplint Regulation Number: 21 CFR 890.3475 Regulation Name: Limb Orthosis Regulatory Class: Class I Product Code: IQI, ILH Dated: July 1, 2015 Received: July 8, 2015
Dear Jean Bigoney:
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 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
1
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 Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K143458
Device Name Neurosplint
Indications for Use (Describe)
An orthosis worn on the wrist
With rigid insert:
to limit wrist motion while worn, allowing the body to recover from the damage of repetitive motion or other injuries
to immobilize and / or support for functional improvement following, repetitive motion-type of injuries such as carpal tunnel syndrome (CTS), wrist strains or sprains, and similar injuries of the wrist
Without rigid insert:
- . to provide wrist support
- . to provide temporary relief of associated symptoms of some repetitive motion wrist conditions
- to provide feedback to the user when the wrist reaches maximal flexion or extension
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ------------------------------------------------- | -- | -- |
___ Prescription Use (Part 21 CFR 801 Subpart D)
JX Over-The-Counter Use (21 CFR 801 Subpart C)
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