(221 days)
Not Found
No
The description focuses solely on the physical components and electrical properties of an EEG electrode array. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is described as an EEG electrode for recording electrophysiologic signals, not for providing therapy.
No
The device is an electrode used to record electrophysiologic signals (like EEG), not to interpret or diagnose. It is a component of a diagnostic system, but not a diagnostic device itself.
No
The device description clearly details a physical electrode array with hardware components (electrodes, foam, adhesive, gel, cable connector) and is intended for direct application to the patient's skin. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enable recording of electrophysiologic signals (such as EEG)" by being applied directly to the patient's skin. This is a diagnostic device that measures electrical activity from the body, not a device that examines specimens derived from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
- Device Description: The description details an electrode array designed to pick up electrical signals from the skin. This aligns with the function of a device used for physiological measurement, not for analyzing biological samples.
- No mention of analyzing biological specimens: The entire description focuses on the physical characteristics of the electrode and its function in recording electrical signals from the patient's skin. There is no mention of collecting, processing, or analyzing any biological samples.
IVD devices are specifically designed to perform tests on specimens taken from the body to diagnose or monitor conditions. This device is designed to measure electrical activity of the body.
N/A
Intended Use / Indications for Use
The Physiometrix PSArray² EEG Electrode is applied directly to the patient's skin to enable recording of electrophysiologic signals (such as EEG).
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Physiometrix Model 4310, PSArray² EEG Electrode, is a single-use, disposable, pre-gelled electrode array. The PSArray² is comprised of six (6) electrodes located at F7, Fp1, FpZ', FpZ, Fp2 and F8. The electrode is packaged with 1 electrode per pouch, 25 pouches per box and 4 boxes per case. The electrodes are mounted in a polyethylene foam coated with a pressure sensitive adhesive. The electrode pad is an area of silver/silver chloride ink that is connected to cable connector by a silver ink trace. An electrolyte gel is held in place over the electrode pad by a open-cell polyurethane sponge located in wells created by the foam basepad. The electrolyte gel was selected for its low impedance properties. No pre-application prepping is required to achieve adequate impedance levels for operation of the PSA4000. The PSArray² EEG Electrode is connected to the PSA4000 System via a patient cable that attaches to the substrate connector. The PSArray² is designed for use with the PSA4000 System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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)
Electrical testing was conducted in accordance with the American National Standard for Disposable ECG Electrodes, AAMI/ANSI EC-12 (1991). The PSArray² device exceeded requirements indicated in the standard. Biocompatibility testing was conducted in accordance with the International Standard ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing and FDA Guidance, "Protocol for Dermal Toxicity Tosting for Medical Devices In Contact with Skin." The skin contact materials were determined to be safe for contact with skin.
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
§ 882.1320 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
Pase page v
510(K) SUMMARY
| Date: | February 25, 2002 |
|---|---|
| OCT 08 2002 | |
| Company: | Physiometrix, Inc. |
| Five Billerica Park | |
| 101 Billerica Avenue | |
| N. Billerica, MA 01862 | |
| Contact: | Dawn E. Frazer |
| Vice President | |
| Regulatory Affairs & Quality Assurance | |
| (978) 670-2422 x243 | |
| dfrazer@physiometrix.com | |
| Subject Device: | Model 4310 PSArray² EEG Electrode |
| Classification: | Class II, CFR 21 Part 882.1320, Cutaneous Electrodes |
| Intended Use: | The Physiometrix PSArray² EEG Electrode is applied directly to the patient's skin to enable recording of electrophysiologic signals (such as EEG). |
| Description: | The Physiometrix Model 4310, PSArray² EEG Electrode, is a single-use, disposable, pre-gelled electrode array. The PSArray² is comprised of six (6) electrodes located at F7, Fp1, FpZ', FpZ, Fp2 and F8. The electrode is packaged with 1 electrode per pouch, 25 pouches per box and 4 boxes per case. The electrodes are mounted in a polyethylene foam coated with a pressure sensitive adhesive. The electrode pad is an area of silver/silver chloride ink that is connected to cable connector by a silver ink trace. An electrolyte gel is held in place over the electrode pad by a open-cell polyurethane sponge located in wells created by the foam basepad. The electrolyte gel was selected for its low impedance properties. No pre-application prepping is required to achieve adequate impedance levels for operation of the PSA4000. The PSArray² EEG Electrode is connected to the PSA4000 System via a patient cable that attaches to the substrate connector. The PSArray² is designed for use with the PSA4000 System. |
| Predicate Device: | K001055, Model 4300, PSArray EEG Electrode |
| Similarities: | The PSArray² is similar to the predicate device in the following ways: |
| a. The intended use is same. | |
| b. The technology is same. | |
| c. The materials are the same. | |
| Differences: | The PSArra'y is different from the predicate device in the following way: |
| a. The PSArray² has 6 electrodes while the predicate device has 7 electrodes. | |
| Test Results: | Electrical testing was conducted in accordance with the American National Standard for Disposable ECG Electrodes, AAMI/ANSI EC-12 (1991). The PSArray² device exceeded requirements indicated in the standard. |
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K020670 page 2 of 2
page vi
Biocompatibility testing was conducted in accordance with the International Standard ISO-10993, Biological Evaluation of Medical Devices Part I: Evaluation and Testing and FDA Guidance, "Protocol for Dermal Toxicity Tosting for Medical
Devices In Contact with Skin." The skin contact materials were determined to be safe for contact with skin.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
PHYSIOMETRIX INC. Dawn E. Frazer Vice President, Regulatory Affairs & Quality Assurance Five Billerica Park 101 Billerica Avenue North Billerica,Massachusetts & 862
APR - 9 2012
Re: K020670
Trade/Device Name: PSArray2 EEG Electrode Model 4310 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): October 7, 2002 Received (Date on orig SE ltr): October 7, 2002
Dear Ms. Frazer:
This letter corrects our substantially equivalent letter of October 8, 2002.
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.
3
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.
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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Kesia Alexander
Sincerely yours,
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
for
4
Model 4310, PSArray2 EEG Electrode Special 510(k): Device Modification
.
the
INDICATIONS FOR USE STATEMENT
| Applicant: | Physiometrix, Inc. |
|---|---|
| 510(k) Number (if known) | Not assigned |
| Device Name | Model 4310 PSArray $2$ EEG Electrode |
| Indications For Use | The Physiometrix PSArray $2$ EEG Electrode is applied directly to |
| patient's skin to enable recording of electrophysiologic (such as | |
| EEG) signals. |
.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _
Hyt Rurd
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_KOZO670