(309 days)
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No
The summary describes a standard electrical muscle stimulator and contains no mention of AI, ML, or related concepts.
Yes
The device is intended to treat a medical condition (relaxation of muscle spasms) by applying an electrical current, which classifies it as therapeutic.
No
The device is described as an "electrical powered muscle stimulator" used for the relaxation of muscle spasms, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "electrical powered muscle stimulator," which implies a hardware component that delivers electrical current.
Based on the provided information, the "Surestim" 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.
- Surestim's Function: The "Surestim" is described as an electrical powered muscle stimulator that applies current through electrodes to a patient's skin. This is a direct application of energy to the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use is for the relaxation of muscle spasms, which is a therapeutic application, not a diagnostic one.
Therefore, the "Surestim" falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The "Surestim" is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient's skin for the relaxation of muscle spasms.
Product codes
IPF
Device Description
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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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§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(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 & Human Services. The logo consists of a stylized caduceus symbol, which features three diagonal lines that resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2002
Mrs. Maryna Burke Suretone International 2 President Brand Street Panorama, Cape Town, South Africa 7500
Re: K011588
Trade/Device Name: Surestim Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: January 22, 2002 Received: January 30, 2002
Dear Mrs. Burke:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications forcenous a over and in the enclosure) to legally marketed predicate devices marketed in interstate for use battled in the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1977, in textordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic For (110) has the device, subject to the general controls provisions of the Act. The r ou may, mererers, mains of the Act include requirements for annual registration, listing of general oonly is free wing practice, labeling, and prohibitions against misbranding and adulteration.
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 may or subject to dates are as a 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 r read ove as note a determination that your device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I odotal the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OF R Part 807), adoning (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 .- Mrs. Burke
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter witi anow you to oogin mating of substantial equivalence of your device to a legally prematication: "The PDF 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of IC Far 3639. Additionally, for questions on the promotion and advertising of Compliance at (301) 594 - 1 the Office of Compliance at (301) 594-4639. Also, please note the your do roo, product of the reference to premarket notification" (21CFR Part 807.97). regulation entires, "Thiss on your responsibilities under the Act may be obtained from the Other general michance turers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
b. Mark M. Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
REVISED INDICATION FOR USE STATEMENT
510(k) Number (if known):
Surestim
Device Name:
Indication for Use:
The "Surestim" is an electrical powered muscle stimulator used to apply an electrical current through electrodes to a patient's skin for the relaxation of muscle spasms.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ OR Over-The-Counter Use _
(Per 21 CFR 801.109) (Optional Format
Muk N Melku
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K011588
(Optional Format 1-2-96)