(196 days)
The E-Stim II is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.
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.
This 510(k) summary describes a premarket notification for the E-Stim II, a portable transcutaneous electrical nerve stimulator (TENS) intended for pain relief.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly define acceptance criteria as typically seen for AI/ML device performance (e.g., sensitivity, specificity, AUC thresholds). Instead, the substantial equivalence determination for the E-Stim II is based on its conformity to established safety and performance standards and its similarity to a legally marketed predicate device (Well-TENS).
The "study" used here is a comparison of the E-Stim II to a predicate device and adherence to relevant standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Electrical Performance Conformity to 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. |
| Intended Use Equivalence to Predicate 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. "The intended use of the Well-Tens is identical." |
| Technological Characteristics (No New Safety Concerns) | Both devices (E-Stim II and Well-TENS) 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. |
2. Sample Size for Test Set and Data Provenance
This submission is for a medical device (TENS unit), not an AI/ML product that typically involves a "test set" of data. The "testing" refers to non-clinical bench testing for electrical safety, electromagnetic compatibility, and biocompatibility against recognized standards. Therefore, concepts like "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the context of this 510(k) submission for a TENS device. The performance is assessed against engineering and medical device standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this 510(k) submission. "Ground truth" in the context of electrical device testing relies on adherence to the specifications of the standards (e.g., a waveform must be a square wave; a certain current must be delivered within a defined range). No human experts are used to establish "ground truth" for the device's electrical output or material properties in the same way they would for diagnostic image interpretation.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic imaging or similar scenarios where expert consensus is needed to define a reference standard. This is not relevant for the technical performance testing of a TENS device against established engineering standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These types of studies are typically performed for diagnostic devices (especially AI-powered ones) to assess the impact of a device on reader performance. This submission is for a therapeutic TENS device, and its evaluation relies on its technical specifications, safety, and equivalence to a predicate device, not on how it changes human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware-based TENS unit, not an algorithm or AI product. Its performance is inherently "standalone" in the sense that it delivers electrical stimulation as designed, but this is not an "algorithm-only" performance as understood in AI/ML contexts.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance, in the absence of an AI/ML component, is derived from:
- Compliance with Recognized Standards: The device meets the technical specifications and safety requirements outlined in the listed ISO, EN, IEC, and AAMI standards (e.g., electrical output parameters, biocompatibility, risk management). These standards define the expected and acceptable performance characteristics.
- Equivalence to Predicate Device: The electrical characteristics and intended use are considered "substantially equivalent" to a legally marketed predicate device (Well-TENS), implying that its performance is comparable and acceptable.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
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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.
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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
§ 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).