(135 days)
Not Found
No
The device description focuses solely on the physical components and intended use for signal acquisition (EEG/EP). There is no mention of any data processing, analysis, or interpretation capabilities that would typically involve AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is used for recording and monitoring physiological signals (EEG and EP), not for treating a disease or condition.
Yes
The device is described as being used for "general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP)," which are diagnostic procedures used to assess brain function.
No
The device description clearly details physical components like electrodes, lead wires, and an extension cable, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The PMT® TruScan® Surface Electrodes are described as "non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP)." This means they are placed on the surface of the skin to measure electrical activity directly from the body.
- Lack of Sample Analysis: The description does not mention the collection or analysis of any biological samples. The device is used to acquire signals from the body, not to test samples from the body.
Therefore, the PMT® TruScan® Surface Electrodes fall under the category of medical devices used for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).
The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:
- Static magnetic field strength of 1.5-T only ●
- Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less ●
- The connector hub must be placed near the center MR system's bore, and must be at ● least 20-cm from the wall of the MR system's bore at all times.
- The extension cable must be disconnected from the PMT TruScan Surface Electrode . before scanning and MUST remain disconnected throughout the entire MR scan.
- . Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Product codes
GXY
Device Description
The PMT® TruScan® Surface Electrodes are non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP).
The reusable TruScan® Surface Electrodes have a disc with a diameter of 10 mm coated with silver / silver chloride (Ag/AgCl). Each disc is permanently adhered to an insulated lead wire. An extension cable is required to connect the Truscan® Surface Electrodes to the recording equipment. The extension cable is electrically insulated and terminated by a molded touch proof connector that is compliant to the safety requirements outlined in IEC 60601-1 subclause 56.3(c).
During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes.
Numbered and color coated lead wires are provided to facilitate identification.
The electrodes are provided non-sterile and can be reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cutaneous
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
PMT Corporation 510(k) Summary
·DEC 1 9 2012
Submitter's Name, Address, and Date of Submission
Al Iversen President PMT Corporation 1500 Park Road Chanhassen, MN Phone: 952-470-0866 952-470-0865 Fax:
Establishment Registration: 2182979
| Submitted: | Friday, July 27, 2012 |
|---|---|
| Device Name: | TruScan® Surface Electrodes |
| Trade Name: | TruScan® Surface Electrodes |
| Classification Name: | 21 CFR 882.1350, Cutaneous Electrode GXY |
| Classification: | Class II |
| Common/Usual Name: | Surface Electrode, Cutaneous Electrode |
Predicate Device
Ambu, Inc (K032278) Grass Instruments (Marketed prior to 1974)
Indication for Use
The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).
The PMT® TruScan® Surface Electrodes are CT compatible and MR Conditional under the following conditions:
- Static magnetic field strength of 1.5-T only ●
- Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less ●
- The connector hub must be placed near the center MR system's bore, and must be at ● least 20-cm from the wall of the MR system's bore at all times.
1
- The extension cable must be disconnected from the PMT TruScan Surface Electrode . before scanning and MUST remain disconnected throughout the entire MR scan.
- . Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Device Description
The PMT® TruScan® Surface Electrodes are non-invasive, cutaneous devices used in the acquisition of signals for the purpose of monitoring and recording Electroencephalograph (EEG) and Evoked Potentials (EP).
The reusable TruScan® Surface Electrodes have a disc with a diameter of 10 mm coated with silver / silver chloride (Ag/AgCl). Each disc is permanently adhered to an insulated lead wire. An extension cable is required to connect the Truscan® Surface Electrodes to the recording equipment. The extension cable is electrically insulated and terminated by a molded touch proof connector that is compliant to the safety requirements outlined in IEC 60601-1 subclause 56.3(c).
During a MRI examination, the extension cable must be disconnected from the TruScan® Surface Electrodes.
Numbered and color coated lead wires are provided to facilitate identification.
The electrodes are provided non-sterile and can be reused.
| Indications | The PMT® TruScan™ Surface Electrodes are indicated for cutaneous use in the
general recording and monitoring of the Electroencephalograph (EEG) and Evoked
Potential (EP). |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MR Conditions | The PMT® TruScan™ Surface Electrodes are CT compatible and MR Conditional
under the following conditions:
Static magnetic field strength of 1.5-T only Maximum spatial gradient magnetic field of 5,000 Gauss/cm (50T/m) or less The connector hub must be placed near the center MR system's bore, and must be at least 20-cm from the wall of the MR system's bore at all times. The extension cable must be disconnected from the PMT TruScan Surface Electrode before scanning and MUST remain disconnected throughout the entire MR scan. Normal Operating Mode of operation for the MR system with a maximum whole body averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence) |
| Sensor Cup
Construction | Silver/silver chloride |
| Cup Diameter | 10 mm |
| Assembly to Cup | ABS/Carbon fiber composite |
| Lead Wire Core | Nichrome |
| Lead Wire Insulation | PVC |
Technological Characteristics and Performance
2
| Electrode length | 60" (electrode + cable) |
|---|---|
| Lead Wire | |
| Connection | 1.5 mm Brass/Polypropylene IEC 60601-1 subclause 56.3(c) compliant |
| Packaging | Non-sterile, sealed in PE pouch or equivalent |
and the comments of the comments of the comments of the comments of
and the control control control of the control of
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized human figure embracing or protecting another figure, representing the department's mission of protecting the health of all Americans.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 19, 2012
PMT Corporation c/o Mr. Al Iversen President 1500 Park Road, PO Box 610 Chanhassen. MN 55317
Re: K122376
Trade/Device Name: PMT TruScan® MR Conditional Surface Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: December 10, 2012 Received: December 13, 2012
Dear Iversen:
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.
4
Page 2 - Mr. Al Iversen
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Victor Krauthamer -A
Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known): K122376 Device Name: PMT® TruScan® Surface Electrode
Indications for Use
The PMT® TruScan® Surface Electrodes are indicated for cutaneous use in the general recording and monitoring of the Electroencephalograph (EEG) and Evoked Potential (EP).
The PMT TruScan® Sufface Electrodes are CT compatible and MR Conditional under the following conditions:
- Static magnetic field strength of 1.5-T only t
- Maximum spatial gradient magnetic field of 5,000 Gaussicm (50T/m) or less .
- The connector hub must be placed near the center MR system's bore, and must be . at least 20-cm from the wall of the MR system's bore at all times.
- The extension cable must be disconnected from the PMT TruScan Surface . Electrode before scanning and MUST remain disconnected throughout the entire MR scan.
- Normal Operating Mode of operation for the MR system with a maximum whole body . averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of CDRH, Qffice of Device Evaluation (ODE) | |
|---|---|
| · Divisior. Sign-Off) | |
| Sision of Ophthalmic, Neurological and Ear, | |
| 4636 Liki Throat Devices | · Page 1 of 1 |
| 510(is) Number. |