The intended use of the MECTA spECTrum device is solely for the treatment of Severe depression "SE" and Clinical setting is in hospitla ECT suites, Operating Rooms, or on patient wards.

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.

Device Description

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.

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 SRJR 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 ventication 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

AI/ML Overview

The provided text describes the reclassification of Electroconvulsive Therapy (ECT) devices and mentions a 510(k) submission (K960754) for the MECTA Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M. However, this document does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical trial with specific performance metrics.

Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MECTA Models SR JR and Thymatron DGx) and highlights design features intended to enhance safety and efficacy based on existing clinical understanding and regulatory standards.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain a study with detailed acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert adjudication.

However, I can extract the information available from the document regarding the device and its intended use, and the basis for its clearance, noting where information is explicitly absent.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily related to meeting safety and performance aspects of legally marketed predicate devices and relevant regulatory standards, rather than specific performance metrics from a dedicated clinical study as might be seen for novel technologies.

Acceptance Criteria (Implied from 510(k) Context)	Reported Device Performance (as described in 510(k) Summary)
Intended Use: Treatment of "severe depression" or "major depressive episode with melancholia" (now updated to "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 spECTrum 5000/4000 series is intended for the same clinical application as the predicate MECTA SR/JR/D/C devices, used in hospital ECT suites, Operating Rooms, or patient wards. The device maintains the constant current bi-directional square waveform. The indications for use were updated administratively by the FDA in 2018 based on reclassification of ECT devices.
Substantial Equivalence: To legally marketed predicate devices (MECTA SR/JR, Thymatron DGx).	The spECTrum 5000/4000 devices are described as the "fourth generation of MECTA ECT devices" that offer "even more safety and efficacy clinically" compared to the predicate MECTA SR/JR devices. Specific shared features are indicated.
Safety Standards: Compliance with relevant domestic and international safety standards (UL 544, CSA 22.2 125, IEC 601-1, IEC 601-2-14).	The spECTrum 5000/4000 devices are designed to comply with UL, CSA, and TUV CE (IEC 601-1) standards, with approvals pending/in process at the time of submission. The predicate devices (SR/JR) were UL, CSA listed, and partially approved to IEC 601-1. The new devices include "extensive redundant hardware and software testing and verification."
Enhanced Safety Features: (e.g., prevention of accidental treatment, stimulus status indication, warning tones, continuous self-test).	Hinged cover on Stimulus Control push button: Prevents accidental treatment. Stimulus Status LED: Visual confirmation of enabled status, stimulus delivery, and fault indication. Three warning tones during self-test, constant tone during treatment: Enhanced safety. Continuous self-test: Greater accuracy in avoiding aborted/missed seizures, providing continuous acceptable ranges. IEC 601-2-14 standards: Advanced safety.
Enhanced Efficacy Monitoring Features: (e.g., EEG data analysis, Optical Motion Sensor (OMS), event timer, leads off information).	EEG data: Provides analyses on seizure adequacy and stimulus level to assess quality and efficacy (similar to Thymatron DGx's seizure indices). Optical Motion Sensor (OMS): Monitors motor movement during seizure for assessing seizure efficacy (similar to Thymatron DGx's motor monitor/EMG). Event timer: Provides a permanent record on the chart recorder. Leads off feature: Documents EEG/ECG lead disconnections via LCD message. Continuous updating of percent energy on M series: Helps to increase efficacy.
User Interface and Control: Flexibility in stimulus parameters, user-friendly interface.	Touch screen: Interface for setting pre-treatment parameters, accessing menus, and displaying alphanumeric information for self-test, treatment, and monitoring (EEG, ECG, OMS). Eight set-up menus (5000 series) / one menu (4000 series): Individualizes patient treatment. Chart recorder: Hard copy of self-test and treatment results, with automatic printing and manual control option, showing two channels of monitoring, elapsed time, date, time, and patient name. 5000 Q / 4000 Q: Four stimulus parameters to vary energy and charge. 5000 M / 4000 M: Single Stimulus Intensity knob varying all four parameters simultaneously.
Modular Design/Upgradeability:	4000 devices: ECT module of the 5000 devices, upgradable to the 5000 series, identical in modularity to SR/JR (i.e., JR upgrade to SR, 4000 upgrade to 5000).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a clinical evaluation or "test set" in the context of a prospective study for the MECTA Spectrum 5000/4000 devices. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through technical and performance comparisons. Therefore, there is no information on sample size, data provenance, or study design for a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No test set requiring expert ground truth establishment is described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No such study is described. ECT devices are therapeutic devices, and the document describes design specifications and comparison to predicate devices, not an AI-assisted diagnostic or interpretative tool that would typically involve MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This request is not applicable. The MECTA Spectrum 5000/4000 is an ECT device, not an algorithm, and is used with a human in the loop (a clinician).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For 510(k) substantial equivalence, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices (MECTA SR/JR, Thymatron DGx) and the general understanding of ECT efficacy and safety in the medical community at the time based on clinical outcomes for the intended indications. The device's features are designed to enhance these known parameters (e.g., by providing more detailed monitoring of seizure activity via EEG and OMS, which are recognized proxies for treatment effectiveness). No specific "ground truth" studies for the Spectrum 5000/4000 itself are mentioned.

8. The sample size for the training set

No training set is mentioned in the context of this 510(k) submission. Design verification and validation would have been performed on the device itself, but not a "training set" of data for an algorithm.

9. How the ground truth for the training set was established

Not applicable as no training set is mentioned.

Summary

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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-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 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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Image /page/1/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

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 vears 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.

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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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SED 18 1

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

Re : K960754 Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M Trade Name: Regulatory Class: III Product Code: 84GXC Dated: June 7, 1996 June 20, 1996 Received:

Dear Ms. Nicol:

We have reviewed your Section 510(k) notification of intent to market we have reviewed your beceien blowe determined the device is the device referenced above and wo have and one stated in the substantially equivalor (about the marketed in interstate commerce prior to enclosure) to devices marketed in the Medical Device Amendments, or
May 28, 1976, the enactment date of the Medical with the May 26, 1976, the chaosmono dissified in accordance with the to devices that have been Food Drug, and Cosmetic Act (Act).
provisions of the Federal Food, Drug, and Cosmeral gon You provisions of the reactar rood, blog, budgest to the general controls may, therefore, market the derice, controls provisions of the Act. provisions of the Act. The generation, listing of devices, good include requirements for annual regiordialia.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device Is Crassiried (boo above) , it may be subject to such Controls) or Class III (Fremaries ispectulations affecting your device additional concrols. Entrologiang major and Regulations, Title 21, Parts 800 ound in the cour equivalent determination assumes compliance to 895. Co 695. A substancially Squaractice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP) (GMP) Tegulation (2) Cruc Rase (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Tation, In addition, FDA may publish further amouncements
regulatory action. In addition, FDA may publish further and subject regulatory accron. In the Federal Register. Please note: this concerning your actification submission does not affect any obligation you might have under sections 531 through 542 of the Act. obligation you might have ander Product Radiation Control provisions, for devices, 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 inis receir will allow for tification. The FDA finding of substantial in your 510 (i) promained e to a legally marketed predicate device equivalence of your device of a not 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 regulation (zi erk rare over contact the Office of Compliance at (301) araghebers additionally, for questions on the promotion and 594-4640. "Addrerendry" 2017-12-11.
advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (301) 354 4037. Tirol) premarket notification" (21 CFR 807.97). Mrsbranding by responsibilities under the Act may ocher general information of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.

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

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510(k) Number (if known): _ K960754

Device Name: spEcTrum 5000 0, 5000 M, 4000 Q, 4000 M

Indications For Use:

The intended use of the MECTA spECTrum device is solely for The intended use of the morn opior or "major depressive episode with the treatment of Severe depression "SE" and Clinical setting is in hospitla 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)

Initia Sign Off

9/12/96

sion Sign-Off Sion of Cardiovascular, Respiratory, od Neurological Devices 510(k) Number

$\checkmark$

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

. .

(Optional Format 1-2-96)

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SEP 1 8 1996

Image /page/6/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be a combination of letters and numbers. The sequence reads 'K960754'. The characters are written in a bold, somewhat stylized font, with varying stroke thicknesses. The overall impression is that of a handwritten code or identifier.

7015 SW McEwan Road Lake Oswego, Oregon 97035 5031624-8778 FAX 5031624-8729

MECTA Corporation

PREMARKET NOTIFICATION SUBMISSION

510K SUMMARY

23 FEB 96 10 30
RECEIVED
FDA/CERA/008/DMC

MECTA CORPORATION
7015 SW MCEWAN ROAD
LAKE OSWEGO, OR 97035
Telephone-(503) 624-8778
Fax-(503) 624-8729
CONTACT PERSON:
Robin H. Nicol, President
SIGNATURE
2/21/96

Presidental,

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.

ﻢ

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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 INTENDED USE OF THIS DEVICE

Regulation Number and Section

§ 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.