(352 days)
The AWQ-104 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 instrument with four channel outputs. A hand held probe allows treatment at individual sites. Output polarity, frequency, intensity, and voltage are controlled by four independent channels. Each channel drives a pair of self adhesive electrodes. A grounding pole electrically grounds the device when using the hand held probe.
The provided text describes a 510(k) submission for a transcutaneous electrical nerve stimulator (TENS) device, the AWQ-104. However, it does not contain a study proving the device meets specific acceptance criteria in the way medical imaging or AI diagnostic devices typically would.
Instead, the "Performance" section states that the device has been "designed and tested to conform to the following standards." This implies compliance with recognized safety and performance standards rather than a clinical study demonstrating efficacy against specific metrics for pain relief.
Therefore, the requested information elements related to a "study that proves the device meets the acceptance criteria" cannot be fully addressed from the provided text because such a study, with performance metrics like sensitivity, specificity, accuracy, or a multi-reader comparative effectiveness study, is not present.
Here's a breakdown of what can be extracted and what is missing based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Adherence to Safety Standards (e.g., electrical safety, biocompatibility, risk management) | "The AWQ-104 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." |
| Functional Equivalence to Predicate Device | "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 modulate pulse outputs and regulate stimulation intensity. Material composition of the electrodes is identical. Electrode 510(k) number: K946230." The FDA letter also states the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." |
| Intended Use | "The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain." (This is for a TENS device, which provides symptomatic relief, not a diagnostic or AI-powered device with performance metrics). |
Missing Information (Not applicable or not present in the document):
- 2. Sample size used for the test set and the data provenance: Not applicable. This device is not an AI diagnostic device. The "test set" would be the device itself undergoing engineering and safety tests, not a dataset of patient cases.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for pain relief via TENS is subjective and usually assessed clinically, not via expert labeling of data for a device performance study as described.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a TENS device, not an AI diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a TENS device, "ground truth" for its effectiveness would typically be patient-reported pain scales or outcomes data from clinical trials. However, the provided document focuses on substantial equivalence to a predicate device and compliance with technical standards, not new clinical efficacy data.
- 8. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) summary for a TENS device, which relies on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards. It does not describe a clinical study with performance metrics or ground truth establishment in the way the prompt's questions imply for AI-powered or diagnostic devices.
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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: 781-340-1072 ext. 20 Fax: 781-340-1637
Date Summary Prepared: April 3, 2006
Device name:
Proprietary name: Common or usual name:
Classification name:
AWQ-104 transcutaneous electrical nerve stimulator (TENS) Transcutaneous electrical nerve stimulator, Class II, 21 CFR 882.5890.
Legally marketed device for substantial equivalence comparison: TX-3 TENS, K913532
Description of the device:
The device consists of a battery powered instrument with four channel outputs. A hand held probe allows treatment at individual sites. Output polarity, frequency, intensity, and voltage are controlled by four independent channels. Each channel drives a pair of self adhesive electrodes. A grounding pole electrically grounds the device when using the hand held probe.
Intended use of the device:
The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain. 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 TX-3 TENS is identical. It does not have curative value, but relives pain symptoms.
The AWQ-104 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 influence
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on the outcome of a disease process. The potential for physical 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 modulate pulse outputs and regulate stimulation intensity. Material composition of the electrodes is identical. Electrode 510(k) number: K946230.
Performance:
The AWQ- 104 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
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
6 2006 APR
Lhasa OMS. Inc. c/o Mr. Mark W. Sheehan 230 Libbey Parkway Weymouth, Massachusetts 02189
Re: K050989
Trade/Device Name: AWQ-104 Digital TENS Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: II Product Code: GZJ Dated: January 27, 2006 Received: January 30, 2006
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page 2- Mr. Mark W. Sheehan
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 contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/industry/support/index.html.
Sincerely yours,
4 Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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G. Indications for Use
510(k) Number (if known): K050989 Device Name: AWQ-104
Indications For Use:
The AWQ-104 is intended for use in the symptomatic relief of chronic intractable pain, post traumatic acute pain, and post surgical pain.
Prescription Use x AND/OR 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division S ign-Oitl Division of General, Restorative, and Neurological Devices Page 1 of 1
510(k) Number K050989
§ 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).