(30 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electromechanical and magnetic stimulation principles, with the proposed change being a sensor-based accessory for quantitative measurement, not AI/ML analysis.
Yes
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and decreasing anxiety symptoms in adult patients with Major Depressive Disorder (MDD).
No
The device is indicated for treatment of depressive episodes and decreasing anxiety symptoms. While it aids in a measurement process (motor threshold determination), this measurement is for treatment planning, not for diagnosing a condition or disease.
No
The device description clearly states that the NeuroStar Advanced Therapy System is a "computerized, electromechanical medical device" and lists multiple hardware components including a mobile console, treatment chair, coil, and head support system. The proposed change also involves a hardware accessory with sensors and a display.
Based on the provided text, the NeuroStar Advanced Therapy System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- NeuroStar's Function: The NeuroStar system is a transcranial magnetic stimulation device that directly interacts with the patient's brain using magnetic fields. It does not analyze samples taken from the body.
- Intended Use: The intended use is for the treatment of depressive episodes and anxiety symptoms by stimulating the brain, not by analyzing biological samples.
- Device Description: The description details components that deliver magnetic pulses to the scalp and measure physical movements (in the case of the D-Tect™ accessory), not components for analyzing biological specimens.
Therefore, the NeuroStar Advanced Therapy System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
Product codes
OBP
Device Description
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console .
- System Software .
- . Treatment Chair
- Ferromagnetic Treatment Coil
- . Head Support System
- SenStar® Connect Treatment Link & SenStar® Treatment Link ●
- . MT Cap
- TrakStar™ Patient Data Management System ●
- D-Tect™ MT Accessory ●
The proposed change to the NeuroStar Advanced Therapy System that is the subject of this 510(k) is the addition of the NeuroStar D-Tect™ MT Accessory, which is a non-sterile, multi-use device that provides an optional method to aid in the Motor Threshold (MT) hunt process. This device is used to provide indication and amplitude of hand movement during this process. The D-Tect™ MT Accessory includes a user display interface and a human hand interface with built-in sensors for measuring thumb and finger movements. The device is a standalone accessory that does not communicate or interact with the NeuroStar Advanced Therapy System, except for receiving pulse signals in order to sync data collection. Use of the device is optional, and provides an alternative, quantitative method to determine the MT compared to the standard of care, which includes a qualitative, visual assessment. The D-Tect™ MT Accessory is only used during the Motor Threshold (MT) determination process, which is only performed the first time a patient is seen by the doctor and is performed prior to the first treatment session.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Left dorsolateral prefrontal cortex
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Inpatient and outpatient settings, including physician's offices and clinics, hospitals, and general medical/surgical 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)
Non-clinical performance testing was performed according to the standards listed above.
Additionally, usability testing was completed in accordance with IEC 60601-1-6 Edition 3.1 2013-10 and also following FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices."
There is no clinical testing required to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
August 24, 2022
Neuronetics, Inc. Amanda Pentecost, PhD Regulatory Affairs Specialist 3222 Phoenixville Pike Malvern, PA 19355
Re: K222230
Trade/Device Name: NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive Transcranial Magnetic Stimulation System Regulatory Class: Class II Product Code: OBP Dated: July 21, 2022 Received: July 25, 2022
Dear Dr. Pentecost:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Pamela Scott Assistant 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
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
NeuroStar D-Tect MT Accessory (81-00241-000)
Indications for Use (Describe)
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
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)
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Image /page/3/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a stylized font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a graphic of a star with a person in the middle.
510(k) Summary
| Date Prepared: | July 19, 2022 |
|---|---|
| Applicant: | Neuronetics, Inc. |
| 3222 Phoenixville Pike | |
| Malvern, PA 19355 | |
| Contact Person: | Amanda Pentecost, PhD |
| Regulatory Affairs Specialist | |
| Phone: 610-640-4202, ext. 1132 | |
| Email: amanda.pentecost@neurostar.com | |
| Secondary Contact: | Robin Fatzinger, RAC |
| Sr. Director, Regulatory Affairs | |
| Phone: 610-640-4202, ext. 1064 | |
| Email: robin.fatzinger@neurostar.com | |
| Device Trade Name: | NeuroStar |
| NeuroStar TMS Therapy System | |
| NeuroStar Advanced Therapy System | |
| NeuroStar Advanced Therapy System for Mental Health | |
| Device Common Name: | Transcranial Magnetic Stimulator |
| Classification: | 21 CFR 882.5805 |
| Product Code: | OBP |
| Predicate Device: | NeuroStar Advanced Therapy System (K083538, K130233, |
| K133408, K160703, K161519, K201158, K213543, and K220127) |
Image /page/3/Picture/6 description: The image shows a logo with the letters 'NS' in a stylized, sans-serif font. The letters are purple. Above the letters is a graphic of three stylized figures with outstretched arms, also in purple. The figures are arranged in a semi-circle, suggesting unity or collaboration. The overall design is simple and modern.
4
Device Description / Technological Characteristics:
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive maqnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console .
- System Software .
- . Treatment Chair
- Ferromagnetic Treatment Coil
- . Head Support System
- SenStar® Connect Treatment Link & SenStar® Treatment Link ●
- . MT Cap
- TrakStar™ Patient Data Management System ●
- D-Tect™ MT Accessory ●
The proposed change to the NeuroStar Advanced Therapy System that is the subject of this 510(k) is the addition of the NeuroStar D-Tect™ MT Accessory, which is a non-sterile, multi-use device that provides an optional method to aid in the Motor Threshold (MT) hunt process. This device is used to provide indication and amplitude of hand movement during this process. The D-Tect™ MT Accessory includes a user display interface and a human hand interface with builtin sensors for measuring thumb and finger movements. The device is a standalone accessory that does not communicate or interact with the NeuroStar Advanced Therapy System, except for receiving pulse signals in order to sync data collection. Use of the device is optional, and provides an alternative, quantitative method to determine the MT compared to the standard of care, which includes a qualitative, visual assessment. The D-Tect™ MT Accessory is only used during the Motor Threshold (MT) determination process, which is only performed the first time a patient is seen by the doctor and is performed prior to the first treatment session.
Indications for Use:
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
Image /page/4/Picture/18 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and appear to be connected. Above the letters, there are three abstract figures that resemble people with outstretched arms, arranged in a semi-circle. These figures are also purple and contribute to the overall design of the logo.
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Image /page/5/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. To the right of the word "NeuroStar" is a star-shaped design with human figures at each point.
Performance Standards:
The use of the D-Tect™ MT Accessory with the NeuroStar Advanced Therapy System has been tested and conforms to the following recognized consensus standards:
- . ISO 10993-1
- ANSI AAMI ES60601-1 ●
- IEC 60601-1-2 ●
- IEC 60601-1-6
Non-clinical Testing:
The contents of this 510(k) complies with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff." Non-clinical performance testing was performed according to the standards listed above.
Additionally, usability testing was completed in accordance with IEC 60601-1-6 Edition 3.1 2013-10 and also following FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices."
Clinical Testing:
There is no clinical testing required to support this submission.
Image /page/5/Picture/15 description: The image shows a logo with the letters 'NS' in a bold, sans-serif font. The letters are purple. Above the letters, there are three stylized figures that appear to be people holding hands, also in purple. To the right of the letters, there is a curved, swooping line that resembles a stylized star or comet tail, also in purple. The overall design is simple and modern.
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Image /page/6/Picture/0 description: The image is a logo for NeuroStar, a company that provides advanced therapy for mental health. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller, sans-serif font. To the right of the word "NeuroStar" is a stylized star shape. The star shape is made up of several curved lines that come together to form a point.
Technological Comparison:
| | NeuroStar Advanced Therapy System
(Subject Device) | NeuroStar Advanced Therapy System
(Predicate Device) | Explanation of
Differences |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Indications for Use | The NeuroStar Advanced Therapy System
is indicated for the treatment of depressive
episodes and for decreasing anxiety
symptoms for those who may exhibit
comorbid anxiety symptoms in adult
patients suffering from Major Depressive
Disorder (MDD) and who failed to achieve
satisfactory improvement from previous
antidepressant medication treatment in
the current episode. | The NeuroStar Advanced Therapy System
is indicated for the treatment of depressive
episodes and for decreasing anxiety
symptoms for those who may exhibit
comorbid anxiety symptoms in adult
patients suffering from Major Depressive
Disorder (MDD) and who failed to achieve
satisfactory improvement from previous
antidepressant medication treatment in the
current episode. | No Difference |
| Intended Use | Major Depressive Disorder (MDD) and
comorbid anxiety symptoms | Major Depressive Disorder (MDD) and
comorbid anxiety symptoms | No Difference |
| Anatomical Sites | Left dorsolateral prefrontal cortex | Left dorsolateral prefrontal cortex | No Difference |
| Target Population | Adult patients | Adult patients | No Difference |
| Clinical Setting | Inpatient and outpatient settings,
including physician's offices and clinics,
hospitals, and general medical/surgical
hospitals | Inpatient and outpatient settings, including
physician's offices and clinics, hospitals,
and general medical/surgical hospitals | No Difference |
| Materials | Standard materials commonly used in the
manufacture of electrical medical devices | Standard materials commonly used in the
manufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components use
standard materials compliant with ISO
10993-1 that are commonly used in
consumer products and medical device
applications | Patient-contacting device components use
standard materials compliant with ISO
10993-1 that are commonly used in
consumer products and medical device
applications | No Difference |
| Design | Computerized, electromechanical medical
devices that use integrated systems to
deliver TMS therapy | Computerized, electromechanical medical
devices that use integrated systems to
deliver TMS therapy | No Difference |
| Energy Source | Power console with magnetic coil for
delivery for magnetic energy | Power console with magnetic coil for
delivery for magnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliant
IEC 60601-1-2 compliant | IEC 60601-1 compliant
IEC 60601-1-2 compliant | No Difference |
| Sterility | No parts of the device, accessories or
components are required to be sterilized | No parts of the device, accessories or
components are required to be sterilized | No Difference |
| Coil Type | Ferromagnetic
Iron core
Internal cooling fan | Ferromagnetic
Iron core
Internal cooling fan | No Difference |
| Coil Positioning System | Integrated into Head Support System
Laser-aided coil placement | Integrated into Head Support System
Laser-aided coil placement | No Difference |
| Treatment Schedule | 5 days per week for 4-6 weeks
Total of 20-30 treatment sessions | 5 days per week for 4-6 weeks
Total of 20-30 treatment sessions | No Difference |
| Device Components | • Mobile Console
• Ferromagnetic Coil for delivering
treatment
• Head Support System for coil
positioning
• MT Cap for coil positioning
• D-Tect™ MT Accessory for MT
location and level determination
• Multi-use disposable for contact
sensing and magnetic field quality control
• TrakStar System for recording patient
data | • Mobile Console
• Ferromagnetic Coil for delivering
treatment
• Head Support System for coil
positioning
• MT Cap for coil positioning
• Multi-use disposable for contact
sensing and magnetic field quality control
• TrakStar System for recording patient
data | Different
The addition of
the D-Tect™ MT
Accessory is the
subject of this
special 510(k). |
| %MT Range | 25% to 140% MT | 25% to 140% MT | No difference |
| Pulses per Second (PPS)
Range | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | No difference |
| Induced Electric Field at
2 cm at 1.0 SMT | 135 V/m (Nominal) | 135 V/m (Nominal) | No difference |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid | No difference |
| Pulse Width | 185 µS (Nominal) | 185 µS (Nominal) | No difference |
| | Standard Treatment:
Level: 120% MT with allowable
adjustments
Repetition Rate: 10 PPS
Stimulation Time: 4 s
Inter-train Interval: As low as 11 s
Session Duration: As low as 18.75 min
Pulses per Session: 3000
Sessions per Week: 5 | Standard Treatment:
Level: 120% MT with allowable
adjustments
Repetition Rate: 10 PPS
Stimulation Time: 4 s
Inter-train Interval: As low as 11 s
Session Duration: As low as 18.75 min
Pulses per Session: 3000
Sessions per Week: 5 | No difference |
| Treatment Protocols | NeuroBurst Treatment:
Level: 80-120% MT with allowable
adjustments
Stimulation Time: 2 s
Inter-train Interval: 8 s
Pulses per Burst: 3
Interpulse Interval: 20 ms
Session Duration: 3.3 min
Pulses per Session: 600
Bursts per Second: 5
Amplitude: 0.22-2.08 SMT (1 PPS: 1 to 20 s | Standard Treatment:
1 PPS: 1 to 600 s
1 PPS: 1 to 20 s | No difference |
| | NeuroBurst Treatment:
1 to 10 s | NeuroBurst Treatment:
1 to 10 s | No difference |
| Inter-train Interval Range | Standard Treatment:
1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | Standard Treatment:
1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | No difference |
| | NeuroBurst Treatment:
1 to 60 s | NeuroBurst Treatment:
1 to 60 s | No difference |
| Pulses per Treatment
Session | Standard Treatment:
Nominal: 3000
Maximum: 5000 | Standard Treatment:
Nominal: 3000
Maximum: 5000 | No difference |
| | NeuroBurst Treatment:
Nominal: 600
Maximum: 2000 | NeuroBurst Treatment:
Nominal: 600
Maximum: 2000 | No difference |
| Pulses per Burst (PPB) | NeuroBurst Treatment:
1 to 5 | NeuroBurst Treatment:
1 to 5 | No difference |
| Interpulse Interval | NeuroBurst Treatment:
20 to 2000 ms | NeuroBurst Treatment:
20 to 2000 ms | No difference |
| Bursts per Second (BPS) | NeuroBurst Treatment:
0.1 to 20.0 Hz | NeuroBurst Treatment:
0.1 to 20.0 Hz | No difference |
Image /page/6/Picture/6 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned to the left of a star-like symbol. The star symbol is also purple and appears to be formed by abstract human figures with outstretched arms, creating a sense of community or connection. The overall design is simple and modern, suggesting a focus on people and collaboration.
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Image /page/7/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the tagline "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape with small circles at the end of each point.
NeuroStar.com
Image /page/7/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized, purple font. A star-like shape is incorporated into the design, with three abstract figures positioned around the star. The overall design is simple and modern, suggesting a focus on people and achievement.
8
Image /page/8/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and consists of the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. To the right of the word "NeuroStar" is a star-shaped design with small circles at the end of each point.
3222 Phoenixville Pike / Malvern, PA 19355
t 610 640 4202 / f 610 640 4206
NeuroStar.com
Image /page/8/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned to the left of a star-like symbol. The star is formed by curved lines that resemble people with outstretched arms, also in purple. The overall design is simple and modern.
9
Image /page/9/Picture/0 description: The image contains the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a bold, purple font. Below the name is the text "Advanced Therapy for Mental Health" in a smaller font. To the right of the name is a stylized star shape with small figures at the points.
t 610 640 4202 / f 610 640 4206
NeuroStar.com
Image /page/9/Picture/5 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple, and there is a star-like design above them, formed by abstract figures with outstretched arms. The overall design is simple and modern.
10
Image /page/10/Picture/0 description: The image shows the NeuroStar logo. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller font. To the right of the word "NeuroStar" is a stylized star shape with three figures on top of it.
Conclusion:
The NeuroStar Advanced Therapy System and the primary predicate device have the same indications for use and the same technological characteristics. The use of the optional D-Tect™ MT Accessory does not raise any new questions of safety or effectiveness.
Image /page/10/Picture/6 description: The image shows a logo with the letters 'NS' in a stylized font. The letters are purple and are positioned next to each other. Above the letters, there are three abstract figures that appear to be people holding hands, also in purple. To the right of the letters and figures, there are curved lines that resemble a starburst or a comet tail, adding a sense of motion or energy to the logo.