(191 days)
Not Found
No
The summary describes a simple electrode for TENS and NMES, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML information.
Yes
The device is intended for use with TENS and NMES for muscle reeducation, which are therapeutic applications.
No.
The device description states its intended use is for TENS and NMES, including for muscle reeducation by applying external stimulation. This indicates a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "self-adhering electrode," which is a physical hardware component. The summary does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The Guardian 150 electrode is an external electrode used with TENS and NMES devices. It applies electrical stimulation to muscles. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for muscle reeducation through external stimulation, not for diagnostic testing of bodily fluids or tissues.
Therefore, the Guardian 150 electrode falls under the category of a therapeutic or stimulation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
Guardian 150 electrode is indicated for use with TENS and NMES, including for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
Product codes
GXY
Device Description
Guardian 150 electrode is a single-patient, single use, self-adhering electrode for use with TENS and NMES, and available in cloth (models 150. 151. 152 and 3637), pre-wired (model 3637), snap (models 150, 151 and 152) and pin style (model 3637) configurations. It is latexfree.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
ATTACHMENT 13
510(k) Summarv As Required by 21 section 807.92 ( c )
KC083756
1-Submitter Name: SelectiveMed™ Components, Inc 2-Address: 564 Harcourt Road Mount Vernon, OH 43050 3-Phone: 740 397 7838 740 397 6112 4-Fax: 5-Contact Person: Mr Rick Fisher (President) 6-Date summary prepared: June 11th, 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
JUN 2 6 2009
12-Device Trade or Proprietary Name: Guardian 150 electrode. Model Numbers 150, 151, 152 and 3637
13-Device Common or usual name: Electrode for TENS, TENS/NMES including for muscles necessary for pharyngeal contraction
14-Device Classification Name: Electrode, cutaneous
15-Substantial Equivalency is claimed against
The electrode of the Chattanooga VitalStim, cleared under K023347 (Chattanooga group)
Guardian disposable TENS and TENS/NMES electrodes cleared under K945676 (SelectiveMed TM Components, Inc)
Columbia 600 Electrode cleared under K080386 (Columbia Scientific Development, LLC)
16-Description of the Device:
Guardian 150 electrode is a single-patient, single use, self-adhering electrode for use with TENS and NMES, and available in cloth (models 150. 151. 152 and 3637), pre-wired (model 3637), snap (models 150, 151 and 152) and pin style (model 3637) configurations. It is latexfree.
17-Intended use of the device: (refer to FDA form attached)
Guardian 150 electrode is intended for use with TENS and NMES, including for Muscle reeducation by application of external stimulation to the muscles necessary for pharyngeal contraction.
18-Safety and Effectiveness of the device:
Guardian 150 electrode is safe and effective as the predicate devices cited above.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle-like symbol with three overlapping strokes, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
JUN 26 2009
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SelectiveMed Components, Inc. % Mansour Consulting Inc. Mr. Jay Mansour President 845 Aronson Lake Court Roswell, Georgia 30075
Re: K083756
Trade/Device Name: Guardian 150 electrode- Models 150, 151, 152 and 3637 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: June 11, 2009 Received: June 17, 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
2
Page 2 - Mr. Jay Mansour
forth in the quality systems (OS) 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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ATTACHMENT 14
Indications for Use
510(k) Number (if known):
Device Name: Guardian 150 electrode- Models 150, 151, 152 and 3637
Indications For Use:
Guardian 150 electrode is indicated for use with TENS and NMES, including for Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction.
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)
Haywood S. Gill
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number _