(265 days)
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No
The summary describes a standard TENS device and makes no mention of AI or ML.
Yes.
The device is a transcutaneous electrical nerve stimulator (TENS) intended for symptomatic pain relief, which is a therapeutic purpose.
No
Explanation: The device is described as a "transcutaneous electrical nerve stimulator used to apply an electrical current... for symptomatic pain relief," indicating a therapeutic rather than diagnostic function. It does not mention identifying, analyzing, or monitoring a disease or condition.
No
The device description explicitly states it is a "battery operated pocket-sized transcutaneous electrical nerve stimulator" with "fixed surgical steel electrodes," indicating it is a hardware device that delivers electrical current.
No, the "Buzbee" device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Buzbee's Function: The description clearly states that the Buzbee is a transcutaneous electrical nerve stimulator that applies electrical current to a patient's skin. This is a direct interaction with the patient's body, not a test performed on a sample taken from the body.
The Buzbee is a therapeutic device used for pain relief, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The "Buzbee" is a battery operated pocket-sized transcutaneous electrical nerve stimulator used to apply an electrical current through fixed surgical steel electrodes on the device to a patient's skin (without coupling gel) for symptomatic pain relief. For the symptomatic relief of chronic intractable, post-traumatic and post-surgical pain.
Product codes
GZJ
Device Description
The "Buzbee" is a battery operated pocket-sized transcutaneous electrical nerve stimulator used to apply an electrical current through fixed surgical steel electrodes on the device to a patient's skin (without coupling gel) for symptomatic pain relief.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized image of three human profiles facing right, arranged in a way that suggests forward movement or flight. The profiles are depicted with flowing lines, giving a sense of dynamism. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 1999
Mr. Manfred W. Roscher MWR Electronics Industrial Company 21 Rose Road Goodwood, Capetown South Africa 7460
Re: K982173 Trade Name: Buzbee Regulatory Class: II Product Code: GZJ Dated: November 24, 1998 December 11, 1998 Received:
Dear Mr. Roscher:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
1
Page 2 - Mr. Manfred W. Roscher
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
REVISED INDICATION FOR USE STATEMENT
510(k) Number (if known)
510(k) Number (if known):
Buzbee
Device Name:
ಪ್ರದ ಸಿ
。 上
Revised Indication for Use:
The "Buzbee" is a battery operated pocket-sized transcutaneous electrical nerve stimulator used to apply an electrical current through fixed surgical steel electrodes on the device to a patient's skin (without coupling gel) for symptomatic pain relief.
For the symptomatic relief of chronic intractable, post-traumatic and post-surgical pain.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Acoo
(Division) Sign-Off)
Division of General Restorative Devices K982173
510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)