(341 days)
The BT-1000 external Trigeminal Nerve Stimulation System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes. The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead.
The provided document, a 510(k) Summary for the BT-1000 device, describes the device's technical specifications and performance testing but does not include a study proving the device meets acceptance criteria related to its clinical efficacy in treating ADHD.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Monarch eTNS System) based on technical specifications and non-clinical performance. The "acceptance criteria" presented are primarily related to safety, electrical performance, and physical integrity of the device components, rather than clinical effectiveness for ADHD treatment.
Therefore, I can provide information based on the safety and performance acceptance criteria and related tests, but not for a clinical efficacy study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Safety Focused)
The document primarily shows a comparison table for substantial equivalence, where the "acceptance criteria" are implied by matching the predicate device's specifications and by meeting recognized safety and electrical standards. The "reported device performance" is a statement that the device complied with these specifications or passed the tests.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Stated) | Reported Device Performance / Compliance |
|---|---|---|
| Indications for Use (Clinical) | Same as predicate device (Monarch eTNS System): Treatment of pediatric ADHD as monotherapy in patients aged 7-12 not on ADHD medications, prescription only, at home under caregiver supervision during sleep. | Claimed "Same" as predicate. (No clinical study demonstrating this claim for the BT-1000 itself, relies on substantial equivalence to predicate) |
| Physical State | Electrical stimulation unit with leads and cutaneous electrodes. | Compliant (Stated "Same" as predicate) |
| Technical Method | Applies an electrical current through electrodes on patient's skin. | Compliant (Stated "Same" as predicate) |
| Target Area | Trigeminal nerve. | Compliant (Stated "Same" as predicate) |
| Power Source | Rechargeable battery. | Compliant (Stated "Same" as predicate) |
| Software Documentation Level | "Basic Documentation Level" (equivalent to previous "MODERATE level of concern") | Compliant (Stated "Same" as predicate) |
| Max Output Current | 10mA. | Compliant (Stated "Same" as predicate) |
| Patient Override Control | On/Off button. | Compliant (Stated "Same" as predicate) |
| Max Leakage Current | None (battery operated). | Compliant (Stated "Same" as predicate) |
| Indicator Display: Unit Functioning | Yes (indicator). | Compliant (Stated "Same" as predicate) |
| Low Battery Indicator | Yes (indicator). | Compliant (Stated "Same" as predicate) |
| Timer Setting | Yes (timer). | Compliant (Stated "Same" as predicate) |
| Expected Service Life (Device) | 5 years. | Compliant (Stated "Same" as predicate) |
| Electrical Protection | Type BF. | Compliant (Stated "Same" as predicate) |
| Battery Type | Lithium ion Battery. | Compliant (Stated "Same" as predicate) |
| Expected Service Life (Battery) | 300 cycles of complete charge-discharge. | Compliant (Stated "Same" as predicate; predicate stated "300 charges per battery (10 months each)") |
| Device Housing Materials | Plastic ABS. | Compliant (Stated "Same" as predicate) |
| Net Charge per Pulse | 2.5 uC (Max 10 mA). | Compliant (Stated "Same" as predicate) |
| Peak and Peak-to-Peak Current | $\pm$ 10 mA. | Compliant (Stated "Same" as predicate) |
| Phase Duration | 250 us. | Compliant (Stated "Same" as predicate) |
| Maximum Average Power Density | 7.5 mW/cm^2. | Compliant (Stated "Same" as predicate) |
| Maximum Current Density | 1.4 mA/cm^2. | Compliant (Stated "Same" as predicate) |
| Stimulating Surface Area of Electrode | 7.1 cm^2. | Compliant (Stated "Same" as predicate) |
| Stimulation Modulation Specifications | 30 Sec ON, 1 Sec Ramp Down / 30 sec OFF, 1 Sec Ramp Up, Steady 7-9 hours. | Compliant (Stated "Same" as predicate) |
| Biocompatibility (Electrode) | Non-cytotoxic (Grade 1 or better), Non-irritant, Non-sensitizer. | In Vitro Cytotoxicity Test: Cytotoxic grade 1 (compliant: acceptable) Irritation Test: Non-irritant Skin Sensitization Test: Non-sensitizer |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10 standards. | Device complies with standards (bench tests conducted). |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2. | Device complies with standards (bench tests conducted). |
| Performance (Bench Tests) | Ability to produce intended stimulation parameters, confirm operating/charging time, operate for set duration, accuracy of electrical output, adhesive/visual/dimension/impedance/packing integrity of electrode, electrical performance of electrodes meet specifications. | Stimulation output waveform confirmed, Battery performance confirmed, Stimulation duration confirmed, Stimulation signal output accuracy confirmed, Electrode testing met specifications, Electrode signal output electrical performance met specifications. |
| Software Validation | Compliance with IEC 62304 and FDA Guidance "Content of Premarket Submissions for Device Software Functions", ISO 14971:2019. | Software was designed, developed, verified, and validated according to mentioned standards and guidance. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set for evaluating the device's efficacy in ADHD treatment. All tests mentioned are non-clinical (bench testing, biocompatibility, electrical safety). Therefore, there is no information on a "sample size for the test set" in a clinical context or data provenance in terms of country of origin of patient data.
- For biocompatibility, the tests were performed on standard laboratory models/materials as per ISO standards.
- For electrical safety, EMC, and performance bench testing, the "test set" would be the device itself and its components, or simulated environments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as there was no clinical test set requiring expert adjudication for ground truth. For non-clinical tests, "ground truth" is defined by the parameters of the test standards (e.g., ISO, IEC).
4. Adjudication Method for the Test Set
This information is not applicable due to the absence of a clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical studies were considered necessary and performed." The device relies on substantial equivalence to a predicate, which would have undergone clinical testing, but this document does not contain such a study for the BT-1000.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable in the context of clinical efficacy for ADHD. The BT-1000 is an electrical stimulation device, not an "algorithm only" device in the sense of AI-powered diagnostic/interventional software. Its safety and technical performance were assessed without human-in-the-loop performance studies, but these were for non-clinical aspects.
7. The Type of Ground Truth Used
For the non-clinical tests (biocompatibility, electrical safety, performance bench tests), the "ground truth" is established by:
- International Standards: e.g., ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC.
- Device Design Specifications: The device is tested against its own design specifications (e.g., for stimulation output, battery performance, duration, electrode properties).
- Predicate Device Specifications: Many "acceptance criteria" are based on matching the technical specifications of the legally marketed predicate device (Monarch eTNS System) to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not a machine learning or AI algorithm that would typically have a "training set" for model development. The software validation mentioned pertains to standard software development lifecycle processes and verification/validation, not AI model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI model, this question does not apply.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the acronym "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
August 28, 2024
Bistos Co., Ltd. Goeun Choi Regulatory Affairs Staff 7th Fl., A Bldg., Woolim Lions Valley 5-Cha, 302 Galmachi-Ro, Jungwon-Gu, Seongnam Gyeonggi, 13201 Korea. South
Re: K232991
Trade/Device Name: Bt-1000 Regulation Number: 21 CFR 882.5898 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Attention Deficit Hyperactivity Disorder Regulatory Class: Class II Product Code: OGL Dated: July 5, 2024 Received: July 29, 2024
Dear Goeun Choi:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Doe W. Kumsa -S
Pamela D. 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
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Enclosure
Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K232991
Device Name BT-1000
Indications for Use (Describe)
The BT-1000 external Trigeminal Nerve Stimulation System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
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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510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared [21 CFR 807.92(a)(a)] 1.
July 5, 2024
Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2.
- Name of Manufacturer: BISTOS Co., Ltd.
- Address: 7th Fl. A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seongnam-si, Gyeonggi-do, Korea (Zip. 13201)
- Contact Name: Goeun Choi / RA Staff
- Telephone No.: +82-(0)31-750-0340
- Fax No .: +82-(0)31-750-0344
- Email Address: gechoi@bistos.co.kr
Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] 3.
- Trade name: BT-1000
- Common name: Transcutaneous electrical nerve stimulator for Attention Deficit Hyperactive Disorder
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Transcutaneous Nerve Stimulator For Adhd | 882.5898 | QGL |
As stated in 21 CFR parts 882.5898 of devices has been classified as Class II.
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate device within this submission are shown as follows:
Predicate device
- De Novo Number: DEN180041
- Applicant: NeuroSigma, Inc.
- Classification Name: Transcutaneous nerve stimulator for adhd ●
- Trade Name: Monarch eTNS System
5. Description of the Device [21 CFR 807.92(a)(4)]
Electrical stimulator that alleviate the symptoms of Attention Deficit Hyperactivity Disorder (ADHD), a psychological mental disorder, by non-invasively stimulating cranial nerves with fine electrical stimulation using extracorporeal electrodes.
The treatment protocol using the BT-1000 is administered each night while the patient is sleeping, for 7-9 hours. The device is designed to provide non-invasive electrical stimulation of the trigeminal nerve via an electrode placed on the forehead. The trigeminal nerve is the largest cranial nerve and has three major sensory divisions of the face, all of which are bilateral.
The trigeminal nerve provides a direct connection to multiple brain structures implicated in ADHD and other neurologic and neuropsychiatric disorders.
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-si, Gyeonggi-do, Republic of Korea
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Indications for Use [21 CFR 807.92(a)(5)] 6.
The BT-1000 external Trigeminal Nerve Stimulation System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder (ADHD) as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications.
The device is to be used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.
7th Fl., A Bldg, Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-si, Gyeonggi-do, Republic of Korea
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7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
The identified predicate device within this submission are shown in the following table:
| Proposed Device | Predicate Device | SE decision | |
|---|---|---|---|
| 510(k)/Denovo Number | K232991 | DEN180041 | - |
| Manufacturer | Bistos Co., Ltd | NeuroSigma, Inc. | - |
| Trade/Device Name | BT-1000 | Monarch eTNS System | |
| Intended Use | Transcutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder. | Monarch eTNS System isTranscutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder. | Same |
| Definition | A transcutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder (ADHD)is a prescription device thatstimulates transcutaneously orpercutaneously through electrodesplaced on the forehead. | A transcutaneous electrical nervestimulator for Attention DeficitHyperactivity Disorder (ADHD)is a prescription device thatstimulates transcutaneously orpercutaneously through electrodesplaced on the forehead. | Same |
| Review Panel | Neurology | Neurology | Same |
| Physical State | Electrical stimulation unit withleads and cutaneous electrodes. | Electrical stimulation unit withleads and cutaneous electrodes. | Same |
| TechnicalMethod | Applies an electrical currentthrough electrodes on patient'sskin. | Applies an electrical currentthrough electrodes on patient'sskin. | Same |
| Target Area | Trigeminal nerve | Trigeminal nerve | Same |
| Indications forUse | The BT-1000 external TrigeminalNerve Stimulation System isindicated for treatment ofpediatric Attention DeficitHyperactivity Disorder (ADHD)as a monotherapy in patients ages7 through 12 years old who arenot currently taking prescriptionADHD medications.The device is to be used forpatient treatment by prescriptiononly and is intended to be used inthe home under the supervision ofa caregiver during periods ofsleep. | The Monarch external TrigeminalNerve Stimulation (eTNS)System is indicated for treatmentof pediatric Attention DeficitHyperactivity Disorder (ADHD)as amonotherapy in patients ages 7through 12 years old who are notcurrently taking prescriptionADHD medications.The device is to be used forpatient treatment by prescriptiononly and is intended to be used inthe home under the supervision ofa caregiver during periods ofsleep. | Same |
| Picture | Image: Head with electrodes | Image: Hands placing electrodes on head | Similar |
| Power Source | Rechargeable battery | Rechargeable battery | Same |
| S/W provided | Basic Documentation Level | MODERATE level of concern | Same |
| Max outputcurrent | 10mA | 10mA | Same |
| Patient OverrideControl Method | On/Off button | On/Off button | Same |
| Max LeakageCurrent | None (battery operated) | None (battery operated) | Same |
| Indicatordisplay: Unitfunctioning | Yes | Yes | Same |
| Low batteryindicator | Yes | Yes | Same |
| Timer Setting | Yes | Yes | Same |
| ExpectedServiceLife(Device) | 5 years | 5 years | Same |
| ElectricalProtection | Type BF | Type BF | Same |
| Battery Type | Lithium ion Battery | Lithium ion Battery | Same |
| ExpectedServiceLife(Battery) | 300 cycles of complete charge-discharge | 300 charges per battery(10 months each) | Same |
| Device housingmaterials | Plastic ABS | Plastic ABS | Same |
| Net Charge perpulse | 2.5 uC (Max 10 mA) | 2.5 uC | Same |
| Peak and peak-to-peak currentPeak voltage | $\pm$ 10 mA | $\pm$ 10 mA | Same |
| Phase duration | 250 us | 250 us | Same |
| Maximumaverage powerdensity | 7.5 mW/cm^2 | 7.5 mW/cm^2 | Same |
| Maximumcurrent density | 1.4 mA/cm^2 | 1.4 mA/cm^2 | Same |
| StimulatingSurface Area ofthe Electrode | 7.1 cm^2 | 7.1 cm^2 | Same |
| And include thestimulationmodulationspecifications(Ramp up,Ramp down, on,andoff and times forramp up, rampdown, on, andoff | 30 Sec ON, 1 Sec RampDown / 30 sec OFF,1 Sec Ramp UpSteady 7-9 hours | 30 Sec ON: 1 Sec RampDown: 30 SecOFF: 1 Sec Ramp UpSteady 7-9 hours | Same |
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seoungnam-si, Gyeonggi-do, Republic of Korea
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7th Fl., A Bldg., Woolin Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seoungnam-si, Gyeonggi-do, Republic of Korea
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Comparison between Subject and Predicate Device
1) Similarities
The subject device has the same indications for use as the predicate device. It also has the same performance parameters, such as physical state, technical method, stimulating surface area of the electrode, and the same technical specifications, such as maximum output current, net charge per pulse, and maximum current density, indicator, expected service life(battery), battery type, electrical protection, and etc. Regarding the technical specification about electric power and current, please refer to performance testing result.
The requirements for the Basic Documentation Level presented in the FDA Guidance "Content of Premarket Submissions for Device Software Functions" are equivalent to the MODERATE level of
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seoungnam-si, Gyeonggi-do, Republic of Korea
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concern in the previous obsolete Guidance. Therefore, the Software Documentation Level of the subject device is considered to be the same as that claimed in the Predicate Device.
2) Discussion
Based on the similarities between the subject device and the predicate device, the subject device is substantially equivalent to the predicate device. And, safety and biocompatibility testing confirmed that the subject device was producing the intended performance advocated by the subject device. Therefore, BT-1000 is considered to be substantially equivalent to the predicate device and can be safely marketed.
8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]
1) Biocompatibility Test
The electrode has limited duration (<24 hours) with intact skin. Therefore, per the FDA guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1 : Evaluation and testing within a risk management process", and ISO 10993-1 : Biological Evaluation of Medical Devices - Part 1 : Evaluation and Testing, Cytotoxicity, Sensitization, and Irritation testing were performed for the electrode. The following table summarizes the tests performed and the results :
| Test Title | Test Standard | Test Result | Date of Issue | Test Report |
|---|---|---|---|---|
| In VitroCytotoxicityTest | ISO 10993-5:2009 | Cytotoxicgrade 1 | 24 May 2024 | AD-G2248 |
| Irritation Test | ISO 10993-23:2021 | Non-irritant | 27 October 2023 | AD-G1721 |
| SkinsensitizationTest | ISO 10993-10:2021 | Non-sensitizer | 27 October 2023 | AD-G1722 |
-
- Electrical Safety and Electromagnetic Compatibility Testing Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards;
| No. | Standard Identifier | Standard Title |
|---|---|---|
| 1 | IEC 60601-1:2005+A1:2012+A2:2020 | Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance |
| 2 | IEC 60601-1-2:2014+A1:2020 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance |
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seoungnam-si, Gyeonggi-do, Republic of Korea 7 / 9
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| 4 | IEC 60601-1-11:2015+A1:2020 | Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance |
|---|---|---|
| 5 | IEC 60601-2-10 :2012/AMD2:2023 | Medical electrical equipment - Part 2-10: Particularrequirements for the basic safety and essential performanceof nerve and muscle stimulators |
3) Performance Testing - bench
The following tests were performed to assess effectiveness of performance of the device.
| No. | Test Item | Description | Report. No. |
|---|---|---|---|
| 1 | Stimulation outputWaveform Testing | To confirm the simulation output using anoscilloscope to demonstrate that the device canproduce its intended stimulation parameters | RDD-2311-0001 |
| 2 | Battery performancetesting | To confirm the operating time and charging timeof the battery | RDD-2402-0008 |
| 3 | Stimulation durationtesting | To confirm that it operates for the set duration | RDD-2403-0002 |
| 4 | Stimulation signaloutput testing | To confirm the accuracy and measurementaccuracy of stimulation electrical output. | RDD-2403-0005 |
| 5 | Electrode testing | To confirm that adhesive integrity, visual,dimension, impedance and packing integrity of theelectrode met specifications for the duration of itsshelf life. | TR-BSTS-240308 |
| 6 | Stimulation signaloutput of electrodetesting | To confirm that the electrical performance ofelectrodes met specifications for the duration of itsshelf life. | RDD-2403-0003 |
4) Software Validation
The BT-1000 contains Basic documentation level. The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: "Content of Premarket Submissions for Device Software Functions, on June 14, 2023" and "ISO 14971:2019 Medical Devices -Application of Risk Management to Medical Devices".
7th Fl., A Bldg., Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seoungnam-si, Gyeonggi-do, Republic of Korea
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| No. | Test Items | Standards and FDA Guidance Documents |
|---|---|---|
| 1 | General requirementfor safety –Programmableelectrical medicalsystems (PEMS) | - IEC 62304:2006/AMD1:2015- FDA Guidance (Content of Premarket Submissions forDevice Software Functions) |
Clinical Test Summary [21 CFR 807.92(b)(2)] 9.
No clinical studies were considered necessary and performed.
10. Conclusion [21 CFR 807.92(b)(3)]
The subject device and the predicate device are substantially equivalent in terms of general information, performance parameters, and technical specifications. Although there are some differences, the safety and performance test reports support the safety and effectiveness of the subject device. In this regard, we conclude that the subject device is substantially equivalent to the predicate device.
7th Fl., A Bldg, Woolim Lions Valley 5-cha, 302, Galmachi-ro, Jungwon-gu, Seoungnam-si, Gyeonggi-do, Republic of Korea
§ 882.5898 Transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder.
(a)
Identification. A transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) is a prescription device that stimulates transcutaneously or percutaneously through electrodes placed on the forehead.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(3) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be performed:
(i) Electrical performance testing must validate electrical output and duration of stimulation;
(ii) Battery performance testing must be performed; and
(iii) Adhesive integrity testing of the electrodes must be conducted.
(4) The technical parameters of the device including waveform, maximum output current and voltage, pulse duration, frequency, net charge per pulse, maximum current density, maximum average current, and maximum average power density must be fully characterized.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Shelf life testing of the electrodes must be performed to demonstrate continued package integrity and component functionality over the labeled shelf life.
(7) Labeling must include the following:
(i) A contraindication for patients with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator;
(ii) A warning that the device is only for use on clean, intact skin;
(iii) Information on how the device operates and the typical sensations experienced during treatment;
(iv) A detailed summary of the device technical parameters;
(v) A shelf life for the electrodes;
(vi) Instructions for use, including placement of the device on the patient; and
(vii) Cleaning instructions.