(29 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
The WL-2206D are the device which generates the small true-sine pulses of electrical current. The qenerated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
The provided text is a 510(k) summary for the IF series True sine interferential stimulator, Model: WL-2206D. It primarily focuses on demonstrating substantial equivalence to a predicate device (WL-2206B) and does not contain detailed information about a specific study comparing performance against acceptance criteria in the way envisioned by the request. The submission emphasizes non-clinical tests and compliance with standards rather than human-data performance studies.
Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment are not available in the provided document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in the format of a table as typically seen for AI/diagnostic devices. Instead, the "acceptance criteria" are implied by adherence to voluntary standards and the claim of substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ANSI/AAMI, NS4-1985 | Performed |
| Compliance with EN 60601-1 | Performed |
| Compliance with EN 60601-1-2 | Performed |
| Software verification according to FDA software guidance | Carried out |
| Maintain same safety and effectiveness as predicate device (WL-2206B) despite engineering differences | Demonstrated by verification and validation tests |
| Not affect intended use compared to predicate device | Demonstrated by verification and validation tests |
| Not alter fundamental scientific technology of the device compared to predicate device | Demonstrated by verification and validation tests |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable and not provided. The submission focuses on non-clinical engineering and software verification/validation, not a clinical "test set" in the context of device performance on human data.
- Data provenance: Not applicable. The tests are engineering and software validations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable and not provided.
- Qualifications of experts: Not applicable and not provided.
4. Adjudication method for the test set:
- Adjudication method: Not applicable and not provided.
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:
- MRMC study: No, an MRMC study was not done. This device is an interferential stimulator, not an AI-powered diagnostic or interpretive tool that would involve human "readers" or AI assistance in that sense.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance: Not applicable. The device itself is a stimulator; there isn't a standalone "algorithm" for performance evaluation in isolation from the device's function. The "software verification" mentioned confirms the software functions as designed within the device.
7. The type of ground truth used:
- Type of ground truth: The "ground truth" for this submission is adherence to engineering standards, functional specifications, and documented software requirements. There isn't a "ground truth" derived from patient outcomes, pathology, or expert consensus in the context of a clinical performance study.
8. The sample size for the training set:
- Sample size for training set: Not applicable and not provided. This device does not involve machine learning or AI models developed using training sets of data.
9. How the ground truth for the training set was established:
- Ground truth for training set: Not applicable as there is no training set mentioned or implied.
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510(K) Summary
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K092763 |
|---|---|
| -------------------------------- | --------- |
1. Submitter's Identifications:
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| Company Name: | Well Life Healthcare Limited |
|---|---|
| Contact person: | Jenny Hsieh |
| Address: | 1FL., No.16, Lane 454, Jungjeng Rd., Yunghe City, Taipei County,Taiwan, R.O.C. |
| TEL No.: | 886-2-2928-2112 |
| Fax No.: | 886-2-2928-1880 |
| E-mail address: | jenny@welllifehealthcare.com.tw |
2. Name of the Device:
IF series True sine interferential stimulator / Model: WL-2206D.
Information of the 510(k) Cleared Device (Predicate Device): ന്
WL-2206B(K090023).
4. Device Description:
The WL-2206D are the device which generates the small true-sine pulses of electrical current. The qenerated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
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 for the statement of indications and contraindication for use are provided hereafter.
6. Substantial Equivalence Comparison
The WL-2206D has output characteristics and controls that are identical to those of the predicate device. The new devices are different in that WL-2106D is controlled using push button to control the output intensity to replace the output turning knob control of WL-2206B. In addition to that, WL-2206D is functionally identical to WL-2206B.
Patrick Axtell
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7. 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.
8. Conclusions
イ
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The true sine interferential stimulator, model WL-2206D, has the same intended use and technological characteristics as the cleared device of WL-2206B (K090023). Moreover, verification and validation tests contained in this submission demonstrate 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are likely meant to represent the department's mission of promoting health and well-being. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Well-Life Healthcare Limited c/o Ms. Jenny Hsieh Official Correspondent 1FL, No. 16, Lane 454, Jungjeng Road Younghe City, Taipei County Taiwan
OCT - 8 2009
Re: K092763
Trade/Device Name: IF True Sine Interferential Stimulator, WL-2206D Regulation Number: Unclassified Regulation Name: Interferential Current Therapy Regulatory Class: Unclassified Product Code: LIH Dated: September 4, 2009 Received: September 9, 2009
Dear Ms. Hsieh:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Jenny Hsieh
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. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander Jr
Malvina B. Eydelman, M.D. Director Division of Ophthalmic. Neurological and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications For Use
510(k) Number (if known):
K092763
Device Name: IF series True sine interferential stimulator / Model: WL-2206D.
Indications For Use:
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Prescription Use 1 (Part 21 CFR 801 Subpart D) OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patnek Axtell
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(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092763
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§ 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).