(85 days)
Not Found
No
The description focuses on hardware features, monitoring capabilities, user interface, and safety standards, with no mention of AI or ML algorithms for data analysis or treatment optimization.
Yes.
The device is specified for "treatment of 'severe depression' or 'major depressive episode with melancholia'," clearly indicating a therapeutic purpose.
No
The device is described as an ECT (Electroconvulsive Therapy) device, with its primary intended use being the treatment of "severe depression" or "major depressive episode with melancholia," which indicates a therapeutic rather than diagnostic function. While it monitors physiological signals (ECG, EEG, OMS) and provides data, this information is used to assess the efficacy and safety of the treatment being delivered, not to diagnose a condition.
No
The device description clearly details hardware components such as monitoring channels (ECG, Optical Motion Sensor), a touch screen interface, an LCD, a thermal chart recorder, stimulus control push buttons, LEDs, and various physical connections and safety features. It is described as an "ECT device" which inherently involves hardware for delivering electrical stimulation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of "severe depression" or "major depressive episode with melancholia". This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a device that delivers electrical stimulation (ECT) and monitors physiological signals (ECG, EEG, Optical Motion Sensor) during the treatment. It does not describe a device that analyzes biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens.
- Detection or measurement of analytes.
- Providing information for diagnosis, monitoring, or prognosis based on laboratory testing.
The device is clearly designed for delivering a medical treatment and monitoring the patient's response to that treatment.
N/A
Intended Use / Indications for Use
Theatment of "severe depression" or "major depressive enisode with meland onlia".
The intended use of the MECTA spECTrum ECT device is solely for the reatment of "severe depression" or "major depressive episode with melancholia". (ref 21 CFR Part 882 Part III)
Product codes (comma separated list FDA assigned to the subject device)
QGH, 84GXC
Device Description
The enhanced MECTA spECTrum Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices* will be identical to the currently legally marketed versions in every way except they will provide the clinician with slightly different parameter range options.
The spECTrum series products continue to be the state of the art ECT devices technically. The 5000 devices offer up to six channels of monitoring of ECG and One Optical Motion Sensor while the 4000 devices are only the ECT module of the 5000 devices. As such, they are upgradeable to the 5000 series units. The 5000 Q and 4000 Q offer the user flexibility with four stimulus parameters to vary energy and charge. The 5000 M and 4000 M offer the user simplicity with one single Stimulus Intensity knob which varies frequency and duration simultaneously, again varying energy and charge.
The touch screen provides the user with an interface to set pre-treatment parameters. This provides the user with more flexibility as he can access all menus by simply touching a screen. The LCD which illuminates the touch screen provides the user with alphanumerics that lead him through self-test, treatment, and monitoring of the EEG, ECG, and OMS. The LCD/touch screen includes choices of eight set-up menus in the 5000 series and one menu in the 4000 series that can help to individualize each patient's treatment in order to enhance the efficacy of each treatment. The LCD/touch screen also provides the user with more data that can be recorded on the patient's record regarding the self test and treatment to ensure greater safety. Also, up to four channels of monitoring can be seen on the LCD-touch screen.
The two channel thermal chart recorder continues to provide the user with a hard copy of the self test and treatment results. The simplicity of the chart recorder only requires the user two gain knobs as the self test and treatment results are printed automatically. The manual on/off push button offers the user the option of manually controlling this printing also. The printout continues to provide two channels of monitoring and also provides the user with elapsed time, date, time of treatment, and patient name. The four stimulus parameters on the M series and Q series are shown on the LCD/Touch Screen and the continuous updating of the percent energy on the M series helps to increase efficacy of treatment.
Several features designed to IEC 601-2-14 standards offer the user enhanced safety during the self test and treatment and as such are an advance. The hinged cover on the Stimulus Control push button prevents the user from accidentally treating. The Stimulus Status LED is illuminated to offer the user a visual confirmation that the spECTrum is enabled, that the stimulus is being delivered and finally indicates if there is a stimulus delivery fault. The three waming tones during self test and the constant tone during treatment continue to offer the user enhanced safety during the treatment process. The continuous self-test offers the user far greater accuracy in avoiding aborted or missed seizures as this bio-feedback provides him with measurements continuously which results in far greater efficacy.
The data that can now be provided to the user with the two new features of the spECTrum series now leads to even greater patient safety. The EEG data which provides analyses on seizure adequacy** and stimulus level** allows the clinician to better assess the quality and efficacy of each individual seizure. The Optical Motion Sensor (OMS) allows the user to monitor motor movement during the seizure and provide further valuable information in assessing seizure efficacy.
The event timer, and the leads off information all provide added information for the clinician which allows him to better assess and improve clinical efficacy. The event timer is printed on the chart recorder as a permanent record. The leads off feature documents that the EEG or ECG leads are off and notifies the user by providing a message on the LCD Touch Screen.
All of the above features demand the most advanced technical design to accommodate them and to meet the most stringent domestic and international standards UL 544, CSA 22.2 125, and TUV EC IEC 601-1 (601-2-14 for electroconvulsive therapy devices), all of which result in far greater safety in the 4000 and 5000 devices to comply with these standards. These approvals are pending and in process at this time. As such they are safer as the TUV standard is the most stringent safety agency internationally. The spECTrum series include extensive redundant hardware and software testing and verification that they are operating correctly. The safety of these devices is unparalleled and as such are an advance that will impact the safety and efficacy of the ECT treatment dramatically.
As the technical advances have been a result of the field's demand for greater information, efficacy, and safety, the clinical advances have primarily been ongoing in the field over the last twenty-three years of MECTA's device history. The 5000/4000 series continues to use the constant current bi-directional square waveform, while the starter kit includes improved hand-held electrodes. Again, these have been redesigned with the redundant safety features required to meet the above mentioned standards. Patents are pending on the features identified with an asterisk.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.
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)
Not Found
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
§ 882.5940 Electroconvulsive therapy device.
(a)
Identification. An electroconvulsive therapy device is a prescription device, including the pulse generator and its stimulation electrodes, used for treating severe psychiatric disturbances by inducing in the patient a major motor seizure by applying a brief intense electrical current to the patient's head.(b)
Classification. (1) Class II (special controls) when the device is intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition. The special controls for this device are:(i) The technical parameters of the device, including waveform, output mode, pulse duration, frequency, train delivery, maximum charge and energy, and the type of impedance monitoring system must be fully characterized to ensure that the device performance characteristics are consistent with existing clinical performance data.
(ii) Non-clinical testing data must confirm the electrical characteristics of the output waveform.
(iii) Components of the device that come into human contact must be demonstrated to be biocompatible.
(iv) Performance data must demonstrate electrical and mechanical safety and the functioning of all safety features built into the device including the static and dynamic impedance monitoring system.
(v) Appropriate analysis/testing must validate electromagnetic compatibility.
(vi) Appropriate software verification, validation, and hazard analysis must be performed.
(vii) Performance data must demonstrate electrical performance, adhesive integrity, and physical and chemical stability of the stimulation electrodes.
(viii) The labeling for the device must include the following:
(A) Information related to generic adverse events associated with electroconvulsive therapy device (ECT) treatment;
(B) Instructions must contain the following specific recommendations to the user of the device:
(
1 ) Conduct of pre-ECT medical and psychiatric assessment (including pertinent medical and psychiatric history, physical examination, anesthesia assessment, dental assessment, and other studies as clinically appropriate);(
2 ) Use of patient monitoring during the procedure;(
3 ) Use of general anesthesia and neuromuscular blocking agents;(
4 ) Use of mouth/dental protection during the procedure;(
5 ) Use of EEG monitoring until seizure termination;(
6 ) Instructions on electrode placement, including adequate skin preparation and use of conductive gel; and(
7 ) Cognitive status monitoring prior to beginning ECT and during the course of treatment via formal neuropsychological assessment for evaluating specific cognitive functions (e.g., orientation, attention, memory, executive function).(C) Clinical training needed by users of the device;
(D) Information on the patient population in which the device is intended to be used;
(E) Information on how the device operates and the typical course of treatment;
(F) A detailed summary of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(G) A detailed summary of the device technical parameters;
(H) Where appropriate, validated methods and instructions for reprocessing of any reusable components;
(I) The following statement, prominently placed: “Warning: ECT device use may be associated with: disorientation, confusion, and memory problems”; and
(J) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated.”
(ix) Patient labeling must be provided and include:
(A) Relevant contraindications, warnings, precautions;
(B) A summation of the clinical testing, which includes the clinical outcomes associated with the use of the device, and a summary of adverse events and complications that occurred with the device;
(C) Information on how the device operates and the typical course of treatment;
(D) The potential benefits;
(E) Alternative treatments;
(F) The following statement, prominently placed: “Warning: ECT device use may be associated with: Disorientation, confusion, and memory problems”;
(G) Absent performance data demonstrating a beneficial effect of longer term use, generally considered treatment in excess of 3 months, the following statement, prominently placed: “Warning: When used as intended this device provides short-term relief of symptoms. The long-term safety and effectiveness of ECT treatment has not been demonstrated”; and
(H) The following statements on known risks of ECT, absent performance data demonstrating that these risks do not apply:
(
1 ) ECT treatment may be associated with disorientation, confusion and memory loss, including short-term (anterograde) and long-term (autobiographical) memory loss following treatment. Based on the majority of clinical evidence, these side effects tend to go away within a few days to a few months after the last treatment with ECT. Although the incidence of permanent cognitive memory loss was not supported by the clinical literature, some patients have reported a permanent loss of memories of personal life events (i.e., autobiographical memory);(
2 ) Patients treated with ECT may experience manic symptoms (including euphoria and/or irritability, impulsivity, racing thoughts, distractibility, grandiosity, increased activity, talkativeness, and decreased need for sleep) or a worsening of the psychiatric symptoms they are being treated for; and(
3 ) The physical risks of ECT may include the following (in order of frequency of occurrence):(
i ) Pain/somatic discomfort (including headache, muscle soreness, and nausea);(
ii ) Skin burns;(
iii ) Physical trauma (including fractures, contusions, injury from falls, dental and oral injury);(
iv ) Prolonged or delayed onset seizures;(
v ) Pulmonary complications (hypoxemia, hypoventilation, aspiration, upper-airway obstruction);(
vi ) Cardiovascular complications (cardiac arrhythmias, heart attack, high or low blood pressure, and stroke); and(
vii ) Death.(2)
Classification: Class III (premarket approval) for the following intended uses: schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:(i) Patients under 13 years or
(ii) Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition.
(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before March 26, 2019, for any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976, or that has, on or before March 26, 2019, been found to be substantially equivalent to any electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section, that was in commercial distribution before May 28, 1976. Any other electroconvulsive therapy device with an intended use described in paragraph (b)(2) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
A final order reclassifying electroconvulsive therapy (ECT) indicated for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, a preamendments Class III device, into class II (special controls), was published on December 26, 2018. See here: https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-of-electroconvulsivetherapy-devices-effective-date-of
This final order also required that that ECT devices intended for the following will remain Class III devices and would not be appropriate for the premarket notification pathway (510(k)), instead requiring a premarket approval (PMA): schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:
- Patients under 13 years; or i.
- Patients 13 years and older who are not treatment-resistant or who ii. do not require a rapid response due to the severity of their psychiatric or medical condition.
While the device submitted and cleared through K965070 may serve as a valid predicate device for a new ECT device, please refer to the aforementioned final order for current regulatory requirements for this device type.
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 22, 2021
Mecta Corp. Robin H. Nicol President 7015 S.W. Mc Ewan Rd. Lake Oswego, Oregon 97035
Re: K965070
Trade/Device Name: Spectrum 5000 Q. 5000 M. 4000 Q. 4000 M. Regulation Number: 21 CFR 882.5940 Regulation Name: Electroconvulsive therapy device Regulatory Class: Class II Product Code: QGH
Dear Robin H. Nicol:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 6, 1997. Specifically, FDA is updating this SE Letter to reflect an administrative corresponding to the reclassification of electroconvulsive therapy (ECT) intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, a preamendments class III device, into class II (special controls), as detailed in the final order published on December 26, 2018 (see here:
https://www.federalregister.gov/documents/2018/12/26/2018-27809/neurological-devices-reclassification-ofelectroconvulsive-therapy-devices-effective-date-of). ECT devices intended for the following will remain Class III devices and would not be appropriate for the premarket notification pathway (510(k)), instead requiring a premarket approval (PMA): schizophrenia, bipolar manic states, schizoaffective disorder, schizophreniform disorder, and catatonia or a severe MDE associated with MDD or BPD in:
- i. Patients under 13 years; or
- ii. Patients 13 years and older who are not treatment-resistant or who do not require a rapid response due to the severity of their psychiatric or medical condition.
As a result of the final order. FDA has created a new product code (OGH) to better categorize ECT devices intended to treat catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.
2
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Pamela Scott, OHT5: Office of Neurological and Physical Medicine Devices, 301-796-5433, PamelaD.Scott@fda.hhs.gov.
Sincerely,
Vivek J. Pinto -S
Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Robin H. Nicol President MECTA Corporation 7015 SW McEwan Road Lake Oswego, Oregon 97035
MAR - 6 1997
Re: K965070 spECTrum 5000 and 4000 ECT Devices Trade Name: Requlatory Class: III Product Code: 84GXC Dated: December 10, 1996 Received: December 11, 1996
Dear Ms. Nicol:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Robin H. Nicol
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page__________________________________________________________________________________________________________________________________________________________________________ o l
0
K965970 510(k) Number (il known):
spECTrum 5000, 4000 ECT devices ice Name: {
Indications I-or Use:
Theatment of "severe depression" or "major depressive enisode with meland onlia".
(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 of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K965070
3/5/97
X
Recoription Lise
OR
Per 21 CFR 801 1091
( ) : :
Over-The-Counter Use _
(Optional Format 1-2-96)
6
MAR - 6 1997
SECTION ONE 510K Summary
- a. NAME OF DEVICE-spECTrum 5000 Q, 5000 M, 4000 Q, 4000 M.
- b. CLASSIFICATION DEVICE Electroconvulsive Therapy Device.
- c. ESTABLISHMENT REGISTRATION NUMBER 3020533
- d. ADDRESS OF MANUFACTURING FACILITIES 7015 SW McEwan Road Lake Oswego, Oregon 97035
- e. CLASS IN WHICH DEVICE HAS BEEN PLACED-Class III
- f. REASON FOR PREMARKET MODIFICATION-Device modification which is substantially equivalent to the predicate device - spECTrum 5000/4000 K960754
- g. IDENTIFICATION OF A LEGALLY MARKETED DEVICE TO WHICH CLAIM EQUIVALENCE- MECTA Models 5000 Q, 5000 M, 4000 Q, 4000M (same K#960754)
- h. NOT APPLICABLE
7
510K SUMMARY
IDENTIFICATION OF LEGALLY MARKETED DEVICE
The legally marketed devices are the MECTA Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices with parameter ranges identical to those of the MECTA SR and JR ECT devices.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The enhanced MECTA spECTrum Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices* will be identical to the currently legally marketed versions in every way except they will provide the clinician with slightly different parameter range options.
The spECTrum series products continue to be the state of the art ECT devices technically. The 5000 devices offer up to six channels of monitoring of ECG and One Optical Motion Sensor while the 4000 devices are only the ECT module of the 5000 devices. As such, they are upgradeable to the 5000 series units. The 5000 Q and 4000 Q offer the user flexibility with four stimulus parameters to vary energy and charge. The 5000 M and 4000 M offer the user simplicity with one single Stimulus Intensity knob which varies frequency and duration simultaneously, again varying energy and charge.
The touch screen provides the user with an interface to set pre-treatment parameters. This provides the user with more flexibility as he can access all menus by simply touching a screen. The LCD which illuminates the touch screen provides the user with alphanumerics that lead him through self-test, treatment, and monitoring of the EEG, ECG, and OMS. The LCD/touch screen includes choices of eight set-up menus in the 5000 series and one menu in the 4000 series that can help to individualize each patient's treatment in order to enhance the efficacy of each treatment. The LCD/touch screen also provides the user with more data that can be recorded on the patient's record regarding the self test and treatment to ensure greater safety. Also, up to four channels of monitoring can be seen on the LCD-touch screen.
The two channel thermal chart recorder continues to provide the user with a hard copy of the self test and treatment results. The simplicity of the chart recorder only requires the user two gain knobs as the self test and treatment results are printed automatically. The manual on/off push button offers the user the option of manually controlling this printing also. The printout continues to provide two channels of monitoring and also provides the user with elapsed time, date, time of treatment, and patient name. The four stimulus parameters on the M series and Q series are shown on the LCD/Touch Screen and the continuous updating of the percent energy on the M series helps to increase efficacy of treatment.
Several features designed to IEC 601-2-14 standards offer the user enhanced safety during the self test and treatment and as such are an advance. The hinged cover on the Stimulus Control push button prevents the user from accidentally treating. The Stimulus Status LED is illuminated to offer the user a visual confirmation that the spECTrum is enabled, that the stimulus is being delivered and finally indicates if there is a stimulus delivery fault. The three waming tones during self test and the constant tone during treatment continue to offer the user enhanced safety during the treatment process. The continuous self-test offers the user far greater accuracy in avoiding aborted or missed seizures as this bio-feedback provides him with measurements continuously which results in far greater efficacy.
The data that can now be provided to the user with the two new features of the spECTrum series now leads to even greater patient safety. The EEG data which provides analyses on seizure adequacy** and stimulus level** allows the clinician to better assess the quality and efficacy of each individual seizure. The Optical Motion Sensor (OMS) allows the user to monitor motor
8
movement during the seizure and provide further valuable information in assessing seizure efficacy.
The event timer, and the leads off information all provide added information for the clinician which allows him to better assess and improve clinical efficacy. The event timer is printed on the chart recorder as a permanent record. The leads off feature documents that the EEG or ECG leads are off and notifies the user by providing a message on the LCD Touch Screen.
All of the above features demand the most advanced technical design to accommodate them and to meet the most stringent domestic and international standards UL 544, CSA 22.2 125, and TUV EC IEC 601-1 (601-2-14 for electroconvulsive therapy devices), all of which result in far greater safety in the 4000 and 5000 devices to comply with these standards. These approvals are pending and in process at this time. As such they are safer as the TUV standard is the most stringent safety agency internationally. The spECTrum series include extensive redundant hardware and software testing and verification that they are operating correctly. The safety of these devices is unparalleled and as such are an advance that will impact the safety and efficacy of the ECT treatment dramatically.
As the technical advances have been a result of the field's demand for greater information, efficacy, and safety, the clinical advances have primarily been ongoing in the field over the last twenty-three years of MECTA's device history. The 5000/4000 series continues to use the constant current bi-directional square waveform, while the starter kit includes improved hand-held electrodes. Again, these have been redesigned with the redundant safety features required to meet the above mentioned standards. Patents are pending on the features identified with an asterisk.
- US PATENT PENDING
** US PATENT PENDING
THE INTENDED USE OF THIS DEVICE
The intended use of the MECTA spECTrum ECT device is solely for the reatment of "severe depression" or "major depressive episode with melancholia". (ref 21 CFR Part 882 Part III) The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.