(281 days)
Not Found
None
No
The provided text describes a device with standard electrical stimulation therapy modes (Interferential Current and Neuro-Muscular Stimulation) and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML device submissions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "symptomatic relief and management of chronic pain," "post-surgical and post-traumatic pain," "relaxation of muscle spasm," and "preventing venous thrombosis," all of which indicate therapeutic purposes.
No
The 'Intended Use / Indications for Use' section describes therapeutic actions like pain relief, muscle relaxation, increasing circulation, and preventing disuse atrophy, but it does not mention any diagnostic purposes (e.g., identifying or characterizing a disease or condition).
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The "Intended Use" describes a therapy that typically involves hardware (electrical stimulation), but without a device description, it's impossible to confirm if the submission is for the software controlling such hardware or the hardware itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes therapeutic applications involving electrical stimulation for pain relief and muscle function. This is a direct interaction with the patient's body for treatment purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The device described does not involve analyzing such samples.
The device described falls under the category of a therapeutic medical device that delivers electrical stimulation.
N/A
Intended Use / Indications for Use
- . Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
- Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circu-. lation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Product codes
IPF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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
§ 890.5850 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
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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines representing the wings and a wavy line representing the body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2000
Mr. John Hayden Control Solutions, Inc. 508 West Fifth Avenue Naperville, Illinois 60563
Re: K993420
Trade Name: CS3101 Interferential Stimulator Regulatory Class: II Product Code: IPF Dated: May 16, 2000 Received: May 17, 2000
Dear Mr. Hayden:
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 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 control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against 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 Regulations, Title 21, Parts 800 to 895. A 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 action. In addition, FDA may publish further announcements 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 regulations.
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.
1
Page 2 - Mr. John Havden
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,
Dma R. Lochner.
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
Indications For Use
510(k) Number;
Device Name:
CS3101 Interferential Stimulator
Indications For Use:
- . Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
- Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circu-. lation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danne R. Lochner
Dision Sign-Off) Orvision of General Restoration Devices 510(k) Number_K99342
Prescription Use 区 (Per 21 CFR 801.109)
OR
Over-The-Counter Use 0