(414 days)
Not Found
No
The device description focuses on the physical characteristics and intended use of a simple electrode, with no mention of AI, ML, or any data processing beyond basic signal recording.
No.
The device is described as an electrode for recording electroencephalograms (EEG) and evoked potentials (EP), or for use as a ground and reference in these recordings. Its function is to interface with the body to collect electrical signals, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any condition.
Yes
Explanation: The device is intended for recording the electroencephalogram (EEG) or evoked potential (EP), which are diagnostic procedures used to assess brain activity and nervous system function.
No
The device description explicitly states it is a physical electrode made from Nitinol and is a single-use, disposable hardware component.
Based on the provided information, the PressOn™ electrode is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for recording the electroencephalogram (EEG) and evoked potential (EP), which are measurements of electrical activity in the brain. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device is an electrode designed for subdermal placement to pick up electrical signals from the scalp.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens, including blood, urine, and tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. The PressOn electrode does not analyze specimens in vitro (outside the body).
The PressOn electrode is a medical device used for in vivo (within the body) physiological measurement.
N/A
Intended Use / Indications for Use
The PressOn™ electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.
Product codes (comma separated list FDA assigned to the subject device)
GXZ
Device Description
The PressOn electrode is a single-use, disposable EEG electrode. The electrode is very small, with a footprint of approximately 0.6 cm and a very thin (~0.004 inch) height profile. It is made from a super-elastic Nitinol and is flexible. The electrode has 3 legs (a tri-pod configuration) that each terminate in micro-teeth that penetrate the top layers of the scalp dermis during subdermal electrode placement.
The PressOn electrode is used in conjunction with an accessory PressOn lead that is provided non-sterile and is reusable. The lead is approximately 48" in length and is used to connect one of the PressOn electrodes to a commercially available EEG monitor. The EEG monitor/ equipment is not part of the PressOn device offering.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp dermis
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The PressOn electrode underwent biocompatibility, bench and performance testing and demonstrated acceptable results in all testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
DEC - 8 2011
510(k) Summary of Safety and Effectiveness II.
PressOn™ electrode
General Information
| Criteria | Information |
|---|---|
| Trade Name | PressOn™ electrode |
| Catalog/Model Number | PR01 |
| Common Name | Needle (electroencephalograph) electrode |
| Classification | 21 CFR 882.1350 - Needle electrode |
| Class II; product code: GXZ | |
| 510(k) Submitter | Persyst Development Corporation |
| 3177 Clearwater Drive | |
| Prescott, AZ 86305 | |
| Contact Person | Scott B. Wilson |
| Chief Executive Officer | |
| Persyst Development Corporation | |
| scottw@persyst.com | |
| 858.755.4568 (phone) 858.755.4565 (fax) |
Summary of Substantial Equivalence
The PressOn electrode does not raise any new safety or effectiveness issues and is substantially equivalent to legally marketed needle electrodes that are in commercial distribution, and have been determined to be substantially equivalent to devices in commercial distribution, prior to May 28, 1976.
Date: October 5, 2010
1
Substantially Equivalent Devices
| Manufacturer | Substantially equivalent device | 510(k) |
|---|---|---|
| Rhythmlink International, LLC | ||
| Cayce, South Carolina USA | Rhythmlink subdermal | |
| needle electrodes | K022914 |
Device Description
The PressOn electrode is a single-use, disposable EEG electrode. The electrode is very small, with a footprint of approximately 0.6 cm and a very thin (~0.004 inch) height profile. It is made from a super-elastic Nitinol and is flexible. The electrode has 3 legs (a tri-pod configuration) that each terminate in micro-teeth that penetrate the top layers of the scalp dermis during subdermal electrode placement.
The PressOn electrode is used in conjunction with an accessory PressOn lead that is provided non-sterile and is reusable. The lead is approximately 48" in length and is used to connect one of the PressOn electrodes to a commercially available EEG monitor. The EEG monitor/ equipment is not part of the PressOn device offering.
Indications for Use
The PressOn™ electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.
Testing
The PressOn electrode underwent biocompatibility, bench and performance testing and demonstrated acceptable results in all testing.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Persyst Development Corporation c/o Mr. Scott B. Wilson Chief Executive Officer 3177 Clearwater Drive Prescott, Arizona 86305
Re: K103103
Trade/Device Name: PressOn Electrode Regulation Number: 21 CFR 882.1350 Regulation Name: Needle Electrode Regulatory Class: Class II Product Code: GXZ Dated: November 18, 2011 Received: November 21, 2011
Dear Mr. Wilson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
DEC - 8 2011
3
Page 2 - Mr. Scott B. Wilson
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 madical 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.
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/CDRHOffices/ucm1118001.html 01 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.
/MedicalDevices/ResourceSion/Fou/Industry/default.ill
Sincerely yours,
Kesia Alexander
for
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
4
1. Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: PressOn™ electrode
Indications for Use:
The PressOn™ electrode is intended for use in the recording of the electroencephalogram (EEG), the evoked potential (EP), or as ground and reference in an EEG or EP recording.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
| page 1 of 1 | (Division Sign-Off) |
|---|---|
| Division of Ophthalmic, Neurological and Ear, | |
| Nose and Throat Devices |
| 510(k) Number | K103103 |
|---|---|
| --------------- | --------- |
| PressOn Electrode 510(k) | page 3 of 44 |
|---|---|
| Persyst Development Corporation | Confidential |