(266 days)
The Lifecare electrodes are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices and EMS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
The Lifecare electrodes are constructed with four basic components: a wire; an insulation backing, a conductive surface; and a conductive adhesive gel. The devices function by conducting an electrical signal from a neurostimulation device through the wire. The signal is then dispersed from the wire across the conductive surface. Finally the signal is transmitted from the conductive surface through the conductive adhesive gel to the surface of the patient's skin. Everyway Self Adhesive Electrode, Wire series are non-sterile, disposable laminated, flexible structures composed of material commonly used in this application: First Laver - White spun laced nonwoven tape or white thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive. Second Laver - Conductive plastic film Third Layer – Biocompatible conductive hydrogel coupling media The electrodes are designed for single-patient/single application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device the electrodes. This connection point is compatible with standard, marketed Neurostimulation devices. For the electrical connection, Everyway provides one type of connection: Wire Series - Lead wire assembly - 4.5" - 6" wire with 0.080 in. diameter female socket connected to one side of the wire. These electrodes are: TKF5050 (5x5 cm square), TKF4040 (4x4 cm square), TKF50D (5cm round), TKF75D (7.5cm round), TKF4060V (4x6cm oval), TKF50100V (5x10cm oval), TKF4080 (4x8cm rectangle) and TKF50100 (5x10cm rectangle)
The provided text is a 510(k) Summary for a medical device (Lifecare electrodes) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and claims safety and effectiveness based on this equivalence.
However, the document does not contain any information regarding acceptance criteria, specific device performance studies, sample sizes, expert involvement, adjudication methods, or ground truth establishment. The absence of this information is typical for a 510(k) summary relying on substantial equivalence rather than new performance data for a novel device.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document states: "This device is safe and effective as the predicate devices cited above as detailed within this submission," implying that the justification for safety and effectiveness is primarily through comparison to already approved devices, rather than a new standalone performance study.
To directly answer your questions based solely on the provided input:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: The document claims "This device is safe and effective as the predicate devices cited above" but does not report specific performance metrics or data.
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Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no specific test set or ground truth establishment by experts is described for this submission.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set requiring adjudication is described.
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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 device (electrodes) is not an AI-driven, image-reading, or diagnostic device that would typically involve an MRMC study or human reader improvement with AI.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a passive medical device (electrodes), not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable as no specific ground truth establishment is described for a performance study.
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The sample size for the training set:
- Not applicable as no machine learning or AI model requiring a training set is described.
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How the ground truth for the training set was established:
- Not applicable as no machine learning or AI model requiring a training set is described.
In summary: The provided 510(k) submission summary for the Lifecare electrodes relies on substantial equivalence to predicate devices (Lifecare electrodes K012463 and Gemore electrodes K062675) to demonstrate safety and effectiveness. It does not include new performance study data, acceptance criteria, or details of a study design as requested.
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510(k) Summary
AUG 0 8 2009
As Required by 21 section 807.92 ( c )
1-Submitter Name: Everyway Medical Instruments Co., Ltd 3 FL., No.5, LANE 155, Sec. 3, Peishen Rd 2-Address: Shen Keng Hsiang. 222 Taipei Hsien. Taiwan (ROC)
3-Phone:
l
(886) 2 2662 0038 (886) 2 2664 5566
4-Fax:
5-Contact Person: Mr Robert Tu (General Manager)
6-Date summary prepared: July 28, 2009
7 - Official Correspondent: Mansour Consulting LLC
8- Address: 845 Aronson Lake Court. Roswell, GA 30075 USA
9- Phone: 678-908-8180
10- Fax: 678-623-3765
11- Contact Person: Jay Mansour, President
12-Device Trade or Proprietary Name: Lifecare electrodes
13-Device Common or usual name: Lifecare Neurostimulation electrodes
14-Device Classification Name: Cutaneous electrode
15-Substantial Equivalency is claimed against the following device:
- · Lifecare electrodes from Everyway Medical
- Instruments Co., Ltd. 510k# K012463
· Gemore electrodes from Gemore Technology Co. Ltd, 510k#
16-Description of the Device:
The Lifecare electrodes are constructed with four basic components: a wire; an insulation backing, a conductive surface; and a conductive adhesive gel. The devices function by conducting an electrical signal from a neurostimulation device through the wire. The signal is then dispersed from the wire across the conductive surface. Finally the signal is transmitted from the conductive surface through the conductive adhesive gel to the surface of the patient's skin.
Everyway Self Adhesive Electrode, Wire series are non-sterile, disposable laminated, flexible structures composed of material commonly used in this application:
First Laver - White spun laced nonwoven tape or white thick Polyethylene foam or a polypropylene substrate, coated with biocompatible adhesive.
Second Laver - Conductive plastic film
Third Layer – Biocompatible conductive hydrogel coupling media
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The electrodes are designed for single-patient/single application use. Because of the adhesive nature of the biocompatible hydrogel, no securing materials are required to secure the device to the patient's skin. The electrode has one type of connection point that can be used to connect the stimulation device the electrodes. This connection point is compatible with standard, marketed Neurostimulation devices.
For the electrical connection, Everyway provides one type of connection:
Wire Series - Lead wire assembly - 4.5" - 6" wire with 0.080 in. diameter female socket connected to one side of the wire.
These electrodes are: TKF5050 (5x5 cm square), TKF4040 (4x4 cm square), TKF50D (5cm round), TKF75D (7.5cm round), TKF4060V (4x6cm oval), TKF50100V (5x10cm oval), TKF4080 (4x8cm rectangle) and TKF50100 (5x10cm rectangle)
17-Intended use of the device: (refer to FDA form attached) The Lifecare electrodes are intended for use with transcutaneous neurostimulation devices as over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices and EMS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
18-Safetv and Effectiveness of the device:
This device is safe and effective as the predicate devices cited above as detailed within this submission.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings, representing the department's mission to protect and promote the health and well-being of Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Everyway Medical Instrument Co., Ltd. % Mansour Consulting LLC Mr. Jay Mansour 845 Aronson Lake Court Roswell, Georgia 30075
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
AUG 03 2009
Re: K083302
Trade Name: Lifecare Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrodes Regulatory Class: II Product Code: GXY Dated: June 22, 2009 Received: June 24, 2009
Dear Mr. Mansour:
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 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. Jay Mansour
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/CDRH0ffices/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 (240) 276-3150 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation
Center for Devices and Radiological Health Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083302
Device Name: Lifecare Electrodes
Indications For Use:
The Lifecare electrodes are intended for use with transcutaneous neurostimulation devices as . over the counter. Some common type of neurostimulation devices include, but are not limited to, TENS devices and EMS devices. Transcutaneous neurostimulation electrodes are passive devices serving as an interface between a patient's skin and a neurostimulation device.
Prescription Use (Part 21 CFR 801 Subpart D) AND/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 Sinn-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083302
Page 1 of
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).