(276 days)
The intended use of ACULIFE/Model IDOC-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states. ACULIFE/model IDOC-01 is intended for the stimulation at hands of patient.
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation.
The provided documentation describes the 510(k) summary for the ACULIFE/Model IDOC-01 electro-acupuncture device. It does not contain information about a study proving the device meets specific performance acceptance criteria for diagnostic or clinical efficacy beyond electrical safety, EMC, biocompatibility, and output characteristics.
Here’s an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | EN 60601-1 & EN 60601-1-1 | Device complies with standards |
| Electromagnetic Compatibility (EMC) | EN 60601-1-2 | Device complies with standard |
| Biocompatibility | ISO 10993 | Device complies with standard |
| Output Characteristics | Product specification | Testing performed to meet product specifications |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The performance data listed (electrical safety, EMC, biocompatibility, output characteristics) are typically evaluated through engineering tests on a sample of manufactured devices, rather than a "test set" in the context of clinical or AI performance evaluation. The provenance of any data used for these engineering tests (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of performance data presented. The document describes compliance with technical standards and product specifications, which do not typically involve expert-established ground truth in the same way clinical or AI studies do.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported. This type of study is relevant for diagnostic devices where human readers interpret data, often with or without AI assistance. The ACULIFE/Model IDOC-01 is an electro-acupuncture device for stimulation, not a diagnostic device requiring human interpretation of medical images or other complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is not an algorithm or AI system for standalone performance evaluation. It is a physical electro-acupuncture device.
7. The Type of Ground Truth Used
The ground truth used for the performance data mentioned (electrical safety, EMC, biocompatibility, output characteristics) is based on established international standards and the manufacturer's engineering specifications. For example, electrical safety is grounded in the pass/fail criteria defined by EN 60601-1. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The Sample Size for the Training Set
This information is not applicable as the device is not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI model.
Summary of what the document does describe:
The document primarily focuses on establishing substantial equivalence to a predicate device (Inno-Health Aculife Electro-Acupuncture/ model SMW-01, K051197) for regulatory clearance. This equivalence is based on the device's intended use and technological characteristics, and its compliance with relevant international standards for safety and performance (EN 60601-1, EN 60601-1-1, EN 60601-1-2, ISO 10993) and its own product specifications for output. There is no mention of clinical studies, performance studies involving human subjects beyond safety and biocompatibility, or AI-related performance evaluations.
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510(k) SUMMARY
. . •
Inno-Health Technology, Co., Ltd. submitters Information: 8F-2. No.61. Kung Yi Road Sec. 2, Taichung, Taiwan 408, Republic of China
APR - 2 2010
Terry C. Chiang Contact Person: Tel: +886- 4 2327 0788
Date Summary Prepared: June 20, 2009
Device Information:
| Classification name: | Electro-Acupuncture. |
|---|---|
| Common / Usual name: | ACULIFE/Model IDOC-01. |
| Classification: | Class II. |
| Regulatory Class: | Unclassified. |
| Product Code: | BWK. |
Substantial equivalence: Inno-Health Aculife Electro-Acupuncture/ model SMW-01 (510K number: K051197)
Description of the Device:
The device consists of a battery powered portable instrument, with a basic power pack which is connected by conducting lead wire to two electrodes (one probe electrode and one big adhesive electrode) which make contact for hands stimulation.
Indications For Use:
The intended use of ACULIFE/Model IDOC-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
ACULIFE/model IDOC-01 is intended for the stimulation at hands of patient.
Technological Characteristics:
ACULIFE uses a 4.5V/DC battery or 5V adaptor as the supply power of the stimulation unit. It can be adjusted for the output amplitude, keep the memory of chosen amplitude, and set the operation time. The electrode combination and lead wire provide the electro-acupuncture stimulation for hand by or on the order of a qualified practitioner of acupuncture as determined by the states.
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Performance Data:
- EN 60601-1 & EN 60601-1-1 for Electric Safety. -
- EN 60601-1-2 for EMC. -
- ISO 10993 for biocompatibility. -
- Output Characteristics testing for product specification. -
Statement of indication for use : See the following page.
Conclusion : Based on the documents provided in the 510(K) submission, the Inno-Health electrod-acupuncture, model ACULIFE/ IDOC-01 is substantial equivalent the chosen FDA cleared model : Inno-Health Aculife Electro-Acupuncture/ model SMW-01 (510K number: K051197).
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract depiction of an eagle with three stylized wing segments, symbolizing service, science, and security. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Inno-Health Technology, Co., Ltd. c/o Mr. Terry C. Chiang Official Correspondent 8F-2, No. 61, Kung Yi Road, Sec. 2 Taichung, Taiwan 408
Re: K091933
Trade/Device Name: ACULIFE Model IDOC-01 Regulatory Class: Unclassified Product Code: BWK Dated: March 5, 2010 Received: March 8, 2010
Dear Mr. Chiang:
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 indictions 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
APR - 2 2010
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, FDD mark 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 Isting (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 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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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.html 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
A 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):
Device Name: Electro-Acupuncture; ACULIFE/Model IDOC-01.
Indications For Use:
The intended use of ACULIFE/Model IDOC-01 is an ELECTRO-ACUPUNCTURE DEVICE for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.
ACULIFE/model IDOC-01 is intended for the stimulation at hands of patient.
Prescription Use __ V (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)-
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K091933.
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