Neurosplint

K143458 · Neurospectrum, LLC · IQI · Aug 13, 2015 · Physical Medicine

Device Facts

• Record ID: K143458
• Device Name: Neurosplint
• Applicant: Neurospectrum, LLC
• Product Code: IQI · Physical Medicine
• Decision Date: Aug 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3475
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

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

Device Story

Neurosplint is a wrist orthosis designed for over-the-counter use. It functions in two configurations: with a rigid insert to immobilize or limit wrist motion for recovery from repetitive motion injuries, CTS, or sprains; or without the rigid insert to provide general wrist support, symptom relief, and proprioceptive feedback when the wrist reaches maximal flexion or extension. The device is worn by the patient to facilitate functional improvement and recovery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Limb orthosis consisting of a wrist support structure with an optional rigid insert. Mechanical design provides physical immobilization or motion feedback. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients requiring wrist immobilization, support, or motion feedback due to repetitive motion injuries, carpal tunnel syndrome (CTS), wrist strains, or sprains. Suitable for over-the-counter use.

Regulatory Classification

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.

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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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