(308 days)
The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms.
The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.
The device consists of a battery powered portable instrument with a remote grounding pole and a hand held locator/stimulator probe. Six output channels are grounding polo and time. The grounding pole is held in order to make contact with the skin. Moving the probe tip across the skin identifies places where the risk of skin burns is low. Auditory signals as well as a meter reading indicate when this has occurred. Holding the probe in place and pushing the stimulation button generates low level electrical pulses as long as the button is pressed.
The provided text is a 510(k) summary for the ES-160 Transcutaneous Electrical Nerve Stimulator (TENS) unit. It focuses on demonstrating substantial equivalence to a predicate device, the Pointer F-3 (K904388), rather than presenting a study specifically designed to establish acceptance criteria and prove the device meets them through performance testing with human subjects or a large test set.
Therefore, many of the requested elements for describing an acceptance criteria study are not present in the provided document.
Here's an analysis based on the available information:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Safety: Device operates without raising new safety concerns compared to predicate. | "Details of electrical output are different but new safety concerns are not raised by the differences." |
| Technological Characteristics: Similar modes (location, stimulation), battery type, output waveform (for stimulation), controls for skin burn risk and intensity regulation. | "Both devices use four 1.5 volt batteries. Both devices have a location mode and a stimulation mode. The location output of both devices is DC current. During stimulation the electrical output for both devices is square waveform pulses." |
| Intended Use: Identical intended use for pain relief, prescription use only, with similar contraindications/warnings. | "The ES-160 is intended for use in pain relief... This is a prescription device... The intended use of the Pointer F-3 is identical." |
| Compliance with Standards: Meets relevant electrical and electromagnetic compatibility (EMC) standards. | Lists 11 EN and IEC standards. |
Explanation: The document's primary goal is to show the ES-160 is "substantially equivalent" to an already marketed device (Pointer F-3). This means the device doesn't necessarily need to meet new, quantitative performance acceptance criteria in a clinical trial setting. Instead, the "acceptance criteria" are effectively that the device's technological characteristics and intended use are similar enough to the predicate that it raises no new questions of safety or effectiveness.
-
Sample Size for Test Set and Data Provenance:
- Not Applicable/Not Provided. The submission does not detail a study with a test set of patients or a dataset to prove performance against specific clinical acceptance criteria. The "performance data" listed refers to compliance with electrical and safety standards, not clinical efficacy data.
-
Number of Experts for Ground Truth and Qualifications:
- Not Applicable/Not Provided. No ground truth establishment is described for a clinical performance study. The "ground truth" here is essentially the regulatory acceptance of the predicate device.
-
Adjudication Method for Test Set:
- Not Applicable/Not Provided.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is a TENS unit, not an imaging or diagnostic device where an MRMC study would typically be performed.
-
Standalone (Algorithm Only) Performance Study:
- No. This device is a physical medical device providing electrical stimulation, not an algorithm.
-
Type of Ground Truth Used:
- Not Applicable/Not Provided in the context of a clinical performance study. The "ground truth" for the submission is the regulatory acceptance and safety/efficacy profile of the legally marketed predicate device (Pointer F-3), and compliance with recognized safety and electrical standards.
-
Sample Size for Training Set:
- Not Applicable/Not Provided. The document describes a physical medical device, not a machine learning algorithm that would require a training set.
-
How the Ground Truth for the Training Set Was Established:
- Not Applicable/Not Provided.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to a predicate device and compliance with applicable safety standards, rather than proving performance against quantitative acceptance criteria through a specific clinical study with a detailed test set and ground truth establishment.
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K 05/020
FEB 2 4 2006
F-1
F. 510(k) Summary
Submitters information: OMS Medical Supplies, Inc. 230 Libbey Parkway Weymouth, MA 02189
Contact Person: Mark W. Sheehan Telephone: 781-340-1072 ext. 20 Fax: 781-340-1637
Date Summary Prepared: April 15, 2005
Device name:
| Proprietary name: | ES-160 |
|---|---|
| Common or usual name: | Portable transcutaneous electrical nervestimulator (TENS) |
| Classification name: | Transcutaneous electrical nervestimulator, Class II, 21 CFR 882.5890. |
Legally marketed device for substantial equivalence comparison: Pointer F-3, K904388
Description of the device:
The device consists of a battery powered portable instrument with a remote grounding pole and a hand held locator/stimulator probe. Six output channels are grounding polo and time. The grounding pole is held in order to make contact with the skin. Moving the probe tip across the skin identifies places where the risk of skin burns is low. Auditory signals as well as a meter reading indicate when this has occurred. Holding the probe in place and pushing the stimulation button generates low level electrical pulses as long as the button is pressed.
Intended use of the device:
The ES-160 is intended for use in pain relief. It can be used by a physician on his patients. This is a prescription device and should be used under continued medical supervision. The intended use of the Pointer F-3 is identical. It does not have curative value, but relieves pain symptoms.
The ES-160 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 an 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
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influence on the outcome of a disease process. The potential for physical and/or innuchoe on the outsome on on 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 four 1.5 volt batteries. Both devices have a location mode and a stimulation mode. The location output of both devices is DC current. 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 assess skin burn risk and regulate stimulation intensity. Electrode 510(k) number: K946230.
Performance Data: Below is the list of the applied standards: EN 50081-1/1991 EN 50081-3/1993 EN 55011/1998 A1/ 1999 EN 55014-1/ 1993 A2/ 1999 EN 55022/ 1998 EN 60601-1-2/ 1993 EN 61326/ 1997 A1/ 1998 EN 60555-2/ 1987 EN 60555-3/ A1 1992 EN 6100-3-2/A13 1997 EN 61000-3-3/ 1995 IEC 60601-1 IEC 60601-2-10
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2006
Mr. Mark W. Sheehan OMS Medical Supplies, Inc. 230 Libbey Parkway Weymouth, Massachusetts 02189
Re: K051020
Trade Name: ES-160 TENS Unit Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: February 6, 2006 Received: February 8, 2006
Dear Mr. Sheehan:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your bocurent of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suited in the encreate) 75 ttg enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, the exacted with the provisions of the Federal Food, Drug, de rices that have been reciasined require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererore, maines of the Act include requirements for annual registration, listing of genoral controls provisiveing 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 If your device is elaboried (soval controls. Existing major regulations affecting your device can may or saleyee to back added of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the over cements 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 that 1151 has Intact a and regulations administered by other Federal agencies. You must of any I cacal statutes und regaintents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by sections (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 his letter will anow you to ocgin marketing of substantial equivalence of your device to a legal!y premarket nothication. The PDA midning of backanda vip.
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), please If you desire specific advice for your do 7.0 % on a more the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain " Misbranding by reference to premance hourfeasons
other general information on your responsibilities under the Act from the 1990s 628.000 other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Consulter Prosposition of the more of the new onlyindex.html.
Sincerely yours,
Hecho Lenero
for
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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ltem 2. Indications for Use
510(k) Number (if known): K051020, Device Name: ES-160
Indications for Use:
The ES-160 is designed to be used in the treatment of chronic, acute and post-operative pain.
Prescription Use × AND/OR 21 CFR 810 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use (Part
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
tion (ODE)
Page 1 of 1
(Division Sign-Off Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
§ 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).