Control pain associated with injections, venipuncture, IV starts, cosmetic injections and the temporary relief of minor injuries (muscle or tendon aches, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion and muscle tension

Device Description

Not Found

AI/ML Overview

The document provided is an FDA 510(k) clearance letter for the device "Buzzy®". This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, study details, or performance metrics of the device.

The letter confirms that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It lists the "Indications for Use" for the Buzzy® device, but it does not present any data from studies proving that the device meets those indications with specific performance metrics.

To address your specific questions:

A table of acceptance criteria and the reported device performance: This information is not present in the provided FDA letter.
Sample size used for the test set and the data provenance: Not available in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
Adjudication method for the test set: Not available in this document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available in this document. This device is a therapeutic vibrator, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available in this document. As it is not an algorithm-based device, this is not relevant.
The type of ground truth used: Not available in this document.
The sample size for the training set: Not available in this document.
How the ground truth for the training set was established: Not available in this document.

In summary, the provided FDA 510(k) clearance letter is a regulatory document affirming substantial equivalence, not a clinical study report that would detail the performance metrics or the underlying studies used for validation.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 13, 2014

MMJ Labs, LLC Valerie Staffey Director of Manufacturing 322 Sutherland Place Atlanta, GA 30307

Re: K130631 Trade/Device Name: Buzzy Regulation Number: 21 CFR 890.5975 Regulation Name: Therapeutic Vibrator Regulatory Class: Class I Product Code: PHW, IME Dated: July 14, 2014 Received: July 15, 2014

Dear Valerie Staffey:

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.

We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 CFR Part 890.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type, that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 890.9 will be exempt from the premarket notification requirements of the Act.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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 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. 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,

Felipe Aquel -S

Carlos L. Peña, Ph.D., M.S. for 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) K130631

Device Name Buzzy ®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.08.13 15:56:07 -04'00'

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Regulation Number and Section

§ 890.5975 Therapeutic vibrator.

(a)
Identification. A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor aches and pains.(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.