SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M

K960754 · Mecta Corp. · QGH · Sep 18, 1996 · Neurology

Device Facts

• Record ID: K960754
• Device Name: SPECTRUM 5000 Q, 5000 M, 4000 Q, 4000 M
• Applicant: Mecta Corp.
• Product Code: QGH · Neurology
• Decision Date: Sep 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5940
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the MECTA spECTrum device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref CFR Part 882 Part III). The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.

Device Story

Electroconvulsive therapy (ECT) device; delivers constant current bi-directional square waveform electrical stimulus to induce therapeutic seizures. Inputs include ECG, EEG, and Optical Motion Sensor (OMS) signals; device processes these to monitor seizure adequacy and motor movement. Outputs include visual monitoring data on LCD touch screen, thermal chart recordings of self-test/treatment results, and stimulus delivery status via LEDs/tones. Used in hospital ECT suites, ORs, or wards by clinicians. Features include touch-screen interface for parameter setup, redundant hardware/software self-testing, and hinged stimulus control for safety. Provides clinicians with real-time seizure quality data and motor monitoring to assess efficacy and improve patient safety during treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technical design, adherence to safety standards, and comparison to predicate device functionality.

Technological Characteristics

Constant current bi-directional square waveform generator. Materials: redesigned hand-held electrodes. Standards: UL 544, CSA 22.2 125, IEC 601-1, IEC 601-2-14. Connectivity: thermal chart recorder, LCD touch screen. Monitoring: up to 6 channels (ECG, EEG, OMS). Safety: redundant hardware/software, stimulus status LEDs, warning tones, hinged stimulus cover.

Indications for Use

Indicated for patients with severe depression or major depressive episode with melancholia.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MECTA Models SR JR (K852069)

Reference Devices

• Thymatron DGx (K852069)

Submission Summary (Full Text)

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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-electroconvulsive-therapy-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:

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.

While the device submitted and cleared through K960754 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.

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 22, 2021

Mecta Corp.
Robin Nicol
President
7015 S.W. Mc Ewan Rd.
Lake Oswego, Oregon 97035

Re: K960754
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 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 September 18, 1996. Specifically, FDA is updating this SE Letter to reflect an administrative correction 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-of-electroconvulsive-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 (QGH) 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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K960754 - Robin Nicol
Page 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, [e-mail].

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

SEP 18 1996

Ms. Robin H. Nicol
Mecta Corporation
7015 S. W. McEwan Road
Lake Oswego, Oregon 97035

Re: K960754
Trade Name: Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M
Regulatory Class: III
Product Code: 84GXC
Dated: June 7, 1996
Received: June 20, 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, Drug, 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, labeling, and prohibitions against 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 regulations 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 Drug 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.

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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 regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,


Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

2

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Page ___ of ___

510(k) Number (if known): K960754

Device Name: spECTrum 5000 Q, 5000 M, 4000 Q, 4000 M

Indications For Use:

The intended use of the MECTA spECTrum device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref CFR Part 882 Part III). The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH: Office of Device Evaluation (ODE)

[Signature: "Laurie J. Harris" with date "9/12/96" below it]

Division Sign-Off

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K960754

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)

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SEP 18 1996
K960754
7015 SW McEwan Road
Lake Oswego, Oregon 97035
503/624-8778 FAX [phone]

# MECTA Corporation

## PREMARKET NOTIFICATION SUBMISSION

### 510K SUMMARY

MECTA CORPORATION
7015 SW MCEWAN ROAD
LAKE OSWEGO, OR 97035
Telephone-[phone]
Fax-[phone]
CONTACT PERSON:
Robin H. Nicol, President
SIGNATURE
*Handwritten signature: Robin H. Nicol, President*
2/21/96

## SECTION ONE

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-New device which is substantially equivalent to the predicate device - K852069
g. IDENTIFICATION OF A LEGALLY MARKETED DEVICE TO WHICH CLAIM EQUIVALENCE- MECTA Models SR JR (same K# 852069)
h. NOT APPLICABLE

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# 510K SUMMARY

IDENTIFICATION OF LEGALLY MARKETED DEVICE

The legally marketed devices MECTA SR and JR ECT devices are the current generation of MECTA devices that are substantially equivalent to the MECTA spECTrum 5000 and 4000 ECT devices.

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

The MECTA spECTrum 5000 and 4000 ECT devices * are the fourth generation of MECTA ECT devices and continue to be the state of the art ECT devices technically, while continuing to offer even more safety and efficacy clinically. The 5000 devices offer up to six channels of monitoring of ECG and EEG and one Optical Motion Sensor while the 4000 devices are only the ECT module of the 5000 devices. As such, they are upgradable to the 5000 series units and are identical to the SR JR series in their modularity (i.e. JR upgrade to SR, 4000 upgrade to 5000). 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 all four stimulus parameters 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 talk him through 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 to set 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 also shown on the LCD/Touch Screen and the continuous updating of the percent energy on the M series also helps to increase efficacy of treatment.

Two features that offer the user enhanced safety during the self test and treatment are IEC 601-2-14 standards 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 warning 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 acceptable ranges continuously which results in far greater efficacy.

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12
the user far greater accuracy in avoiding aborted or missed seizures as this bio-feedback provides him with acceptable ranges continuously which results in far greater efficacy.

The data that can now be provided to the user with two new MECTA features affecting the safety and effectiveness of the treatment, now leads to even greater patient safety. The EEG data which provides analyses on seizure adequacy **and stimulus level** will allow the clinician to better assess the quality and efficacy of each individual seizure. The predicate device that has been marketing seizure indices for a number of years is the Thymatron DGx marketed by Somatics Inc. (K#852069). The Optical Motion Sensor (OMS) will allow the user to monitor motor movement during the seizure and provide further valuable information in assessing seizure efficacy. The predicate device that has been marketing a motor monitor (EMG) for a number of years is the Thymatron DGx marketed by Somatics Inc. (K#852069).

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 demanded the most advanced technical design to accommodate them as did the commitment to design to the most stringent domestic and international standards UL 544, CSA 22.2 125, and IEC 601-1 (601-2-14 for electroconvulsive therapy devices), all of which resulted in far greater safety in the 4000 and 5000 devices to comply with these standards. The predicate devices SR/JR were UL, CSA listed and approved and partially approved to the IEC 601-1 standards. The spECTrum 5000/4000 devices are designed to the above UL, CSA, and TUV CE (IEC 601-1) 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. These new devices 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. Therefore, the MECTA 5000/4000 series will be used in a clinical setting with modified ECT that is identical to the setting that was used for the SR/JR, D, and C devices. Therefore, the clinical application of treating with the MECTA will remain the same. The 5000/4000 series continues to use the constant current bi-directional square waveform and the starter kit items accompanying these devices remains the same with the exception of the hand-held electrodes. Again, these have been redesigned with all of the redundant safety that was designed into the new devices. The patents that are pending on the above features are identified with an asterik.

* 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 treatment 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.
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