(74 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
The WL-2206A is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
The provided text is a 510(k) summary for a medical device called the "IF series True sine interferential stimulator / Model: WL-2206A." It describes the device, its intended use, and its substantial equivalence to a predicate device (WL-2206, K024100).
However, the document does not contain details about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a medical device performance study (e.g., diagnostic accuracy, clinical effectiveness).
Instead, the submission for this device (an interferential stimulator used for pain relief) focuses on demonstrating substantial equivalence to a previously cleared device. This means the primary "study" is a comparison to the predicate device and compliance with relevant standards, rather than a de novo clinical trial with defined performance metrics, patient cohorts, and ground truth establishment.
Therefore, many of the requested details about acceptance criteria and a study proving performance are not available in the provided text.
Here's an breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence (Inferred):
| Acceptance Criteria Category | Description (Inferred from 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (WL-2206). | "The WL-2206A ... has the same intended use..." |
| Technological Characteristics | Similar to predicate device (WL-2206). | "...and technological characteristics as the cleared device of WL-2206 (K024100)." |
| Safety | Maintain same safety as predicate device. | "verification and validation tests... demonstrate that the difference... could maintain the same safety..." |
| Effectiveness | Maintain same effectiveness as predicate device. | "...could maintain the same... effectiveness as that of cleared device." |
| Voluntary Standards Compliance | Compliance with ANSI/AAMI, EN 60601-1, EN 60601-1-2. | "Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement." |
| Software Verification | Software verification carried out according to FDA guidance. | "In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance." |
| Engineering Differences Impact | Differences do not affect intended use or alter fundamental scientific technology. | "...those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device." |
Actual performance metrics (e.g., pain reduction scores, specific electrical output specifications) are not detailed as acceptance criteria in this summary for the purpose of a clinical performance study. The acceptance criteria here are about equivalence and compliance.
2. Sample Size for the Test Set and Data Provenance
Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a test set of patient data. The evaluation is based on technical specifications comparison and compliance with standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. As there is no clinical performance study involving a patient test set, there is no mention of experts establishing a ground truth for diagnostic or outcome data.
4. Adjudication Method
Not applicable/Not provided. No adjudication method is described as there is no clinical performance study involving multiple reviewers or a ground truth process.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document does not describe an MRMC comparative effectiveness study. The device is for pain relief, and the submission focuses on substantial equivalence based on technical characteristics and intended use.
6. Standalone Performance Study
No. While the device itself will operate standalone for a patient, the submission does not detail a standalone performance study in the context of diagnostic accuracy or clinical outcomes that would typically be performed without human intervention for evaluation. The "tests performed" are non-clinical and focus on compliance and technical equivalence.
7. The Type of Ground Truth Used
Not applicable/Not provided in the context of clinical outcomes. The "ground truth" for this submission revolves around the predicate device's established safety and effectiveness and the new device's compliance with technical standards. It's not about a clinical ground truth like pathology or expert consensus on patient data.
8. The Sample Size for the Training Set
Not applicable/Not provided. This type of device (electrical stimulator) does not typically involve a "training set" in the machine learning sense for its primary function. Its design and validation rely on engineering principles, compliance with standards, and comparison to existing technology.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no training set mentioned, this information is not relevant.
In summary: The provided 510(k) summary focuses entirely on demonstrating substantial equivalence for the IF series True sine interferential stimulator (Model: WL-2206A) to its predicate device (WL-2206). It relies on comparisons of intended use, technological characteristics, and compliance with non-clinical voluntary standards and software verification guidance. It does not detail a clinical performance study with defined acceptance criteria, patient cohorts, ground truth establishment, or human reader performance metrics, as would be common for new diagnostic or AI-powered devices.
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510(K) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: Ko50847
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- Submitter's Identifications: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
Contact: Mr. Mike Price
- Submitter's Identifications: Theratech, Inc. 1109 Myatt Blvd, Madison, TN 37115
Date of Summary Preparation: March 2005.
2. Name of the Device:
IF series True sine interferential stimulator / Model: WL-2206A.
3. Information of the 510(k) Cleared Device (Predicate Device):
WL-2206 (K024100) .
4. Device Description:
The WL-2206A is the device which generates the small real-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved.
5. Intended Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
In addition, the standard format for the statement of indications and contraindication for use are provided hereafter.
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6. Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence are as follows:
Compliance to applicable voluntary standards includes ANSI/AAMI, NS4-1985, as well as EN 60601-1, and EN 60601-1-2 requirement.
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.
7. Conclusions
The true sine interferential stimulator, model WL-2206A, has the same intended use and technological characteristics as the cleared device of WL-2206 (K024100). Moreover, verification and validation tests contained in this submission Moronstrate that the difference in the submitted demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.
In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a circular seal for the U.S. Department of Health & Human Services. The seal features the department's name around the perimeter in a circular fashion. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States.
Public Health Service
JUN 1 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Price Official Correspondent Theratech Incorporated 1109 Myatt Boulevard Madison, Tennessee 37115
Re: K050847
Trade/Device Name: IF series True sine interferential stimulator / Model: WL-2206A Regulatory Class: Unclassified Product Code: IPF Dated: May 6, 2005 Received: May 20, 2005
Dear Mr. Price:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 I ou may, merclere, mains of the Act include requirements for annual registration, listing of general controls profitions 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. Mike Price
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of any of a lot a first and starticle spiralence of your device to a This letter will allow you to begin marketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equipe of the pe premarket notification. The FDA Inding of backansa organity of the 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
rst lead If you desire specific advice for your de necessor of views note the regulation entitled, the regulation entitled, the contact the Office of Compulance at (210) 278 ation" (21CFR Part 807.97). You may obtain "Misbranding by relerence to peniance notification (the Act from the Division of Small)
other general information on your responsibilities under the Act from the 6800 638.00 other general information on your responsion installed on the enumber (800) 638-2041 or 1980) of the Manufacturers, International and Consulter 11bostoner of carb/industry/support/index.html.
Sincerely yours,
Sincercly yours,
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
1050844 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: JF series True sine interferential stimulator / Model: WL-2206A.
Indications For Use:
The device is an interferential stimulator with TENS indications used for The device is an interferential stimatic intractable pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✓ OR
Over-The-Counter Use __
Division of General, Restorative
and Neurological Devices (Optional Format 1-2-96)
§ 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).