(142 days)
Not Found
No
The description focuses on the electromechanical and software control aspects of the device for delivering magnetic stimulation, with no mention of AI or ML capabilities for diagnosis, treatment planning, or other functions.
Yes
The device is indicated for the treatment of Major Depressive Disorder and is a non-invasive tool for the stimulation of cortical neurons, aligning with the definition of a therapeutic device.
No.
The device is described as a treatment system for Major Depressive Disorder, not a diagnostic one. It produces magnetic stimulation to induce electrical currents for therapeutic purposes.
No
The device description explicitly states that the NeuroStar TMS Therapy System is an "integrated system consisting of a combination of hardware, software, accessories and consumable supplies" and details several hardware components like a Mobile Console, gantry, Treatment Coil, Head Support System, and SenStar® Treatment Link.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality or to monitor therapeutic measures.
- NeuroStar TMS Therapy System Function: The description clearly states that the NeuroStar TMS Therapy System is a device that delivers non-invasive, magnetic stimulation to the cerebral cortex to treat Major Depressive Disorder. It directly interacts with the patient's body.
- Lack of Specimen Examination: There is no mention of the device examining any specimens (blood, tissue, etc.) derived from the human body.
Therefore, the NeuroStar TMS Therapy System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Product codes
OBP
Device Description
The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec (nominal)) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS Therapy™. The Head Support System provides accurate positioning of the Treatment Coil using a laserguided alignment system. A single-use device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient. The TMS TrakStar™ practice data management system consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cerebral cortex
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
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)
Randomized Controlled Trial OPT-TMS - The OPT-TMS randomized controlled trial (RCT) (ClinicalTrials.gov Identifier NCT00149838) was conducted to evaluate the safety and efficacy of NeuroStar TMS Therapy in adult patients (N=197) with moderate to severe major depressive disorder and who failed to benefit from 1-4 adequate antidepressant medication trials as defined using the Antidepressant Treatment History Form (ATHF) (George, et al., 2010).
After determination of protocol eligibility and medication washout, patients participated in a multi-site, parallel group, double-blind, sham-controlled, randomized comparison of active NeuroStar TMS Therapy and sham treatment for a fixed trial period of 3 weeks. At the end of this period, patients who showed a criterion level of improvement were eligible to continue with their blinded, randomized assignment for up to 3 additional weeks, based on twice weekly determinations of clinical progress in a duration-adaptive phase.
Treatment was according to the standard treatment protocol described in the NeuroStar TMS Therapy System labeling. In addition to standard blinding methods, an "active" sham coil was used for blinding against TMS-related stimulation adverse effects. A post-study survey was conducted at the conclusion of the study to assess study blinding which indicated that blinding was effectively maintained.
Enrolled patients were aged 18-70, and experiencing a DSM-IV defined major depressive episode with moderate to severe depression as determined by a baseline HAMD24 ≥20 with a 5 year limit on the duration of the current depressive episode. Patients had a moderate to severe level of current treatment resistance, with at least 1 but no more than 4 ATHF level 3 (i.e., minimum labeled dose, 4 weeks duration) treatment attempts without clinical benefit, or had intolerance to 3 or more antidepressant medications. Excluded were patients who were unlikely to show response according to the TMS literature (presence of psychosis, comorbid and prominent anxiety disorder or substance abuse), and those patients for whom TMS treatment might be unsafe (e.g. those with prior head trauma, seizures, suicidal intent). Because this was an antidepressant medication-free study conducted in outpatients only, patients who could not tolerate being tapered from medications were excluded.
The primary outcome measure was the clinically significant categorical outcome of remission, defined as HAMD24 total score
§ 882.5805 Repetitive transcranial magnetic stimulation system.
(a)
Identification. A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.(b)
Classification. Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
0
NEURONETICS
510(k) Summary
NeuroStar® TMS Therapy System
| 510(k) Owner: | Neuronetics, Inc.
3222 Phoenixville Pike
Malvern, PA 19355
Phone: 610-640-4202
Fax: 610-640-4206 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Judy P. Ways, Ph.D.
Vice President,
Regulatory Affairs and Quality Assurance
Neuronetics, Inc.
3222 Phoenixville Pike
Malvern, PA 19355
Phone: 610-981-4107
Fax: 610-640-4206 |
| Date Prepared: | 27 March 2014 |
| Proprietary Name: | NeuroStar® TMS Therapy System |
| Common Name: | Transcranial Magnetic Stimulator |
| Classification Name: | Transcranial Magnetic Stimulation System [21 CFR 882.5805, Product
Code OBP] |
| Predicate Device: | NeuroStar TMS Therapy® System [K061053/K083538/K130233] |
Device Description:
The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec (nominal)) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals.
1
K133408
The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers the TMS Therapy™. The Head Support System provides accurate positioning of the Treatment Coil using a laserguided alignment system. A single-use device, the SenStar® Treatment Link, which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment, surface field cancellation to reduce stimulation of the scalp, and acts as a hygiene barrier from patient. The TMS TrakStar™ practice data management system consists of a stand-alone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.
Intended Use:
The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Technological Characteristics and Substantial Equivalence:
The subject device, NeuroStar TMS System, has the following similarities to the predicate TMS device (NeuroStar TMS Therapy System, K061053/K083538/K130233):
- . Principles of operation
- Design for delivery of Transcranial Magnetic Stimulation (TMS) .
- O Output stimulation parameters (pulse width, frequency, train duration, inter-train interval, etc.)
- Materials .
The proposed change for the NeuroStar TMS Therapy System in this submission is a modification to the current FDA-cleared Indication for Use to expand the indicated population in major depression to adult patients who have failed to benefit from one or more prior antidepressant medications in the current episode. The proposed change is supported by information submitted in this premarket notification and with the following rationale:
- Device is substantially equivalent to the FDA-cleared NeuroStar TMS Therapy System: 1. The NeuroStar TMS Therapy System that is the subject of the premarket notification is the same device cleared by the FDA under 510(k)s K061053, K083538 and K130233.
- Device new clinical data supports the revised Intended Use: New clinical data from a 2. randomized, controlled trial (OPT-TMS RCT) demonstrate the safety and efficacy of the NeuroStar TMS Therapy System in the treatment of patients with major depression as described in the revised Intended Use.
2
Changes to the device labeling are to include the revised Intended Use and new clinical data. No other changes are made to the device or labeling. Therefore, the NeuroStar TMS Therapy System with the change proposed in the premarket notification is substantially equivalent to the predicate device.
Clinical Performance:
Randomized Controlled Trial OPT-TMS
The OPT-TMS randomized controlled trial (RCT) (ClinicalTrials.gov Identifier NCT00149838) was conducted to evaluate the safety and efficacy of NeuroStar TMS Therapy in adult patients (N=197) with moderate to severe major depressive disorder and who failed to benefit from 1-4 adequate antidepressant medication trials as defined using the Antidepressant Treatment History Form (ATHF) (George, et al., 2010).
After determination of protocol eligibility and medication washout, patients participated in a multi-site, parallel group, double-blind, sham-controlled, randomized comparison of active NeuroStar TMS Therapy and sham treatment for a fixed trial period of 3 weeks. At the end of this period, patients who showed a criterion level of improvement were eligible to continue with their blinded, randomized assignment for up to 3 additional weeks, based on twice weekly determinations of clinical progress in a duration-adaptive phase.
Treatment was according to the standard treatment protocol described in the NeuroStar TMS Therapy System labeling. In addition to standard blinding methods, an "active" sham coil was used for blinding against TMS-related stimulation adverse effects. A post-study survey was conducted at the conclusion of the study to assess study blinding which indicated that blinding was effectively maintained.
Enrolled patients were aged 18-70, and experiencing a DSM-IV defined major depressive episode with moderate to severe depression as determined by a baseline HAMD24 ≥20 with a 5 year limit on the duration of the current depressive episode. Patients had a moderate to severe level of current treatment resistance, with at least 1 but no more than 4 ATHF level 3 (i.e., minimum labeled dose, 4 weeks duration) treatment attempts without clinical benefit, or had intolerance to 3 or more antidepressant medications. Excluded were patients who were unlikely to show response according to the TMS literature (presence of psychosis, comorbid and prominent anxiety disorder or substance abuse), and those patients for whom TMS treatment might be unsafe (e.g. those with prior head trauma, seizures, suicidal intent). Because this was an antidepressant medication-free study conducted in outpatients only, patients who could not tolerate being tapered from medications were excluded.
Demographic and clinical features of the enrolled population were not statistically significantly different between the active TMS and sham TMS treatment groups and were similar for patients studied in randomized controlled trial Study 101 (O'Reardon, et al., 2007). Roughly half of the population was female and the average age was 47 years. Patients had moderate to severe major depression by symptom measures. Current episode treatment resistance averaged 1.6 failed research-quality adequate treatment trials (verified by ATHF criteria), which translates
・
3
approximately to 3 to 6 clinical antidepressant medication attempts in the current episode. During their lifetime, patients had failed 3.3 research-adequate treatment trials (approximately 9 clinical attempts).
The primary outcome measure was the clinically significant categorical outcome of remission, defined as HAMD24 total score Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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10
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-6609 Silver Spring, MD 20993-0002
March 28, 2014
Orthoscan, Inc. % Mr. Adam Menzies VP Product Development 8212 E Evans Road SCOTTSDALE AZ 85260
Re: K133174
Trade/Device Name: Orthoscan FD Mini C-Arm Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, MQB Dated: February 25, 2014 Received: February 26, 2014
Dear Mr. Menzies:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce .prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 l CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
11
Page 2-Mr. Menzies
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
12
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133174
Device Name OrthoScan FD Mini C-arm
Indications for Use (Describe)
The OrthoScan FD Mini C-arm is designed to provide the physician with general fluoroscopic visualization of the patient's extremities including, but not limited to, surgical orthopedic procedures and critical emergency care procedures in hospital, emergency care, critical care, or physician office environments.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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