THYMATRON 2000 ELECTROCONVULSIVE SYSTEM

K945120 · Somatics, Inc. · QGH · Oct 26, 1995 · Neurology

Device Facts

Record IDK945120
Device NameTHYMATRON 2000 ELECTROCONVULSIVE SYSTEM
ApplicantSomatics, Inc.
Product CodeQGH · Neurology
Decision DateOct 26, 1995
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 882.5940
Device ClassClass 2
AttributesTherapeutic

Device Story

Thymatron 2000 Electroconvulsive System; delivers controlled electrical pulses to induce therapeutic seizures. Used in clinical settings by trained healthcare professionals. Device generates electrical stimulus; output parameters managed by clinician to treat psychiatric conditions. Benefits include rapid symptom relief for treatment-resistant patients. Device operates as an electroconvulsive therapy system.

Clinical Evidence

No clinical data provided in the provided documentation; substantial equivalence determination based on administrative review of pre-amendment status.

Technological Characteristics

Electroconvulsive therapy device; delivers electrical stimulation; Class II (special controls) per 21 CFR 882.5940; Product Code QGH.

Indications for Use

Indicated for patients age 13 years and older with catatonia or severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) who are treatment-resistant or require rapid response due to severity of psychiatric or medical condition.

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.

Submission Summary (Full Text)

{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-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 K945120 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} FDA U.S. FOOD & DRUG ADMINISTRATION July 22, 2021 Somatics, Inc. Richard Abrams President 910 Sherwood Dr., Unit 17 Lake Bluff, Illinois 60044 Re: K945120 Trade/Device Name: Thymatron 2000 Electroconvulsive System Regulation Number: 21 CFR 882.5940 Regulation Name: Electroconvulsive therapy device Regulatory Class: Class II Product Code: QGH Dear Richard Abrams: 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 October 26, 1995. 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 {2} K945120 - Richard Abrams 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, 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 Public Health Service OCT 26 1995 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Richard Abrams Somatics, Inc. 910 Sherwood Drive, Unit 17 Lake Bluff, Illinois 60044 Re: K945120 Thymatron 2000 Electroconvulsive System Regulatory Class: III (three) Product Code: GXC Dated: January 27, 1995 Received: February 1, 1995 Dear Dr. Abrams: 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 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. This letter will immediately allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. 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), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-300) at (301) 594-4639. Other general information 3 {4} on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Thomas J. Callahan Thomas J. Callahan, Ph.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health 4
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