(196 days)
No
The device description details manual controls for setting stimulation parameters and does not mention any automated or adaptive features typically associated with AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended for the symptomatic relief of pain, which is a therapeutic purpose.
No
Explanation: The device is described as providing "symptomatic relief" and "delivering stimulation," which are therapeutic functions, not diagnostic ones. It helps to manage pain, not to identify its cause or presence.
No
The device description explicitly states it is a "battery powered portable instrument with dual channel outputs connected to lead wires and electrodes," indicating it is a hardware device, not software-only.
Based on the provided information, the E-Stim II is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the symptomatic relief of pain, which is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device description details a portable instrument that delivers electrical stimulation to the body. This is consistent with a therapeutic device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, using reagents, or providing diagnostic information based on laboratory tests.
The E-Stim II is a therapeutic device used for pain management through electrical stimulation.
N/A
Intended Use / Indications for Use
The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain. It is designed for use by a therapist. This is a prescription device and should be used under continued medical supervision.
Product codes
GZJ
Device Description
The device consists of a battery powered portable instrument with dual channel outputs connected to lead wires and electrodes. Setting the output switch and the intensity controls will deliver the desired stimulation. Adjusting the frequency control will change the stimulation as well. Treatment continues as long as the intensity control dial switch is on.
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
Designed for use by a therapist. Used under continued medical supervision.
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)
Well- TENS, K002874
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
F. 510(k) Summary
Submitters information: Lhasa OMS, Inc. 230 Libbey Parkway Weymouth, MA 02189
Contact Person: Mark W. Sheehan
Telephone: 781-340-1071 ext. 20 Fax: 781-340-1637
Date Summary Prepared: June 10, 2005
Device name:
| Proprietary name: | E-Stim II |
|---|---|
| Common or usual name: | Portable transcutaneous electrical |
| nerve stimulator (TENS) | |
| Classification name: | Transcutaneous electrical nerve |
| stimulator, Class II, 21 CFR 882.5890. |
Legally marketed device for substantial equivalence comparison: Well- TENS, K002874
Description of the device:
The device consists of a battery powered portable instrument with dual channel outputs connected to lead wires and electrodes. Setting the output switch and the intensity controls will deliver the desired stimulation. Adjusting the frequency control will change the stimulation as well. Treatment continues as long as the intensity control dial switch is on.
Intended use of the device:
The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain. It is designed for use by a therapist. This is a prescription device and should be used under continued medical supervision. The intended use of the Well-Tens is identical. It does not have curative value, but relieves pain symptoms.
The E-Stim II cannot be used transcerebrally, in the carotid sinus area or during pregnancy. Patients suspected of having heart disease should consider adequate precautionary measures prior to administration. Severe spasm of the laryngeal and pharyngeal muscles may occur when the electrode is placed across the neck or mouth. This may be enough to close off the airway. Stimulation will inhibit the output of some demand cardiac pacemakers and therefore, is not recommended for patients with this type of pacemaker.
Electrical nerve stimulation is a symptomatic treatment, and as such may suppress the progress of pain which would otherwise serve as a protective influence on the outcome of a disease process. The potential for physical
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and/or psychological dependence upon nerve stimulation as a means of relieving pain has not been determined.
It has been noted that some patients find the sensation of electrical stimulation extremely unpleasant and should probably be excluded from further use of the stimulator.
Technological Characteristics:
Both devices use one 9 volt battery. During stimulation, the electrical output for both devices is square waveform pulses. Details of electrical output are different but new safety concerns are not raised by the differences. Controls on each device regulate stimulation intensity and frequency. Material composition of the electrodes and the lead wires is identical.
Standards: The E-Stim II has been designed and tested to conform to the following standards: ISO 14971:2000 EN ISO 10993.1:1997/EN ISO 10993.5:1999/ EN ISO 10993.10.2002 EN 60601-1:1990+A1:1993+A2:1995+A13:1996/ IEC 60601-1:1988+A1:1991+A2:1995 EN 60601-1-2:2001/IEC 60601-1-2:2001 EN 980:2003
Applicable testing criteria from the AAMI standards for Transcutaneous Electrical Nerve Stimulators NS4: 1985 for Well-TENS.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in a circular arrangement.
SEP - 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mark W. Sheehan Lhasa OMS, Inc. 230 Libbey Parkway Weymouth, Massachusetts 02189
Re: K050435
Trade/Device Name: E-Stim II Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 3, 2005 Received: June 8, 2005
Dear Mr. Sheehan:
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.
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.
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); 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.
3
Page 2 - Mr. Mark W. Sheehan
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter whi anow you to begin manieting your antial equivalence of your device to a legally premarket notification. The PDA miding of cassification 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), please If you desire specific advice ion Jour accil 2011 276-0120. Also, please note the regulation entitled, Contact the Office of Compullier in (21 CFR Part 807.97). You may obtain Misoraning Uy reference to premailsonsibilities under the Act from the Division of Small other general miorination on Jour responser Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ocusantery/www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nil R. P. Dyler
Mark N. Melkerson Co.
Melkerson Mark N. Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use G. Indications for Use
510(k) Number (if known): K050435
Device Name: E-Stim II
Indications For Use: The E-Stim II is intended for use in the syptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative, Page 1 of __ 1 __ 1 __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ and Neurological Devices
510(k) Number_KOSD435