(448 days)
No
The description focuses on basic signal processing (stimulating current, conceiving EMG signals, interpreting signals for auditory/visual notifications, displaying voltage and latency) and does not mention any AI or ML techniques for interpretation or decision-making. The "interpreting" of signals appears to be based on predefined thresholds or rules rather than learned patterns.
No
The device is described as a nerve locator and monitor intended to help surgeons preserve cranial motor nerves during surgery by providing real-time stimulation and monitoring of nerve activity. It does not exert a therapeutic effect on the patient.
Yes
The device aids surgeons in locating, identifying, and preserving cranial motor nerves by stimulating them and monitoring EMG signals to interpret nerve function and provide real-time feedback (auditory and visual notifications), which is a form of intraoperative diagnostic assessment.
No
The device description explicitly states it has "Electronic" and "Mechanic" infrastructures in addition to "Software," and describes hardware components like stimulation probes and electrodes.
Based on the provided information, the Bioscope Neuromonitor Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- The Bioscope Neuromonitor Device operates in vivo (within the body). It directly interacts with the patient's nerves and muscles during surgery by applying electrical stimulation and detecting electrical signals (EMG).
- Its purpose is to assist surgeons in real-time during a surgical procedure to locate and preserve nerves, not to analyze biological samples for diagnostic purposes.
The device's function aligns with that of a surgical accessory or a neuromonitoring system used during surgery, which falls under a different regulatory classification than IVD devices.
N/A
Intended Use / Indications for Use
The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.
Product codes
ETN
Device Description
Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure;
- Electronic
- Mechanic
- Software
These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given.
The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings.
Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cranial, thyroid, parathyroid, mastoid. Specific nerves mentioned are cranial motor nerves, cranial peripheral motor nerves, recurrent laryngeal nerve, and vagus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons and OR staff, in an operating room.
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 conducted to support the safety and effectiveness of the Bioscope Device. The device is subject to the following standards and requirements are met, and test results demonstrate compliance:
- IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021]: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance.
- ANSI AAMI IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
- ANSI AAMI IEC 62304:2006/A1:2016: Medical device software - Software life cycle processes [Including Amendment 1 (2016)].
- ANSI AANI IEC 61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION: Safety requirements for electrical equipment for measurement control and laboratory use - Part 1: General requirements.
- IEC 60601-2-10 Edition 2.1 2016-04: Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.
- IEC 60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems.
In addition, the following performance tests were performed:
- Software verification and validity test;
- Usability test;
- Electrical safety and electromagnetic compatibility (EMC) test;
- Low Voltage Directive Test (LVD);
- System Performance test - (All basic functions of the device were tested: Device opening, closing, parameter change, accuracy of the current coming out of the device, accuracy of the signal detected by the device, compatibility of the device with consumables.)
Key results: The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as the legally marketed predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1820 Surgical nerve stimulator/locator.
(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2024
Biosys Biyomedikal Muhendislik San. Ve Tic. A.S. Cemal Erdogan General Manager Universiteler Mah. Ihsan Dogramaci Bul. Cd. Sk. No:23/C Ankara. 06800 Turkey
Re: K233001
Trade/Device Name: Bioscope Neuromonitor Device Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: November 15, 2024 Received: November 15, 2024
Dear Cemal Erdogan:
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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software
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).
Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Joyce C. Lin-S
for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233001
Device Name Bioscope Neuromonitor Device
Indications for Use (Describe)
The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.
| 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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4
Image /page/4/Picture/0 description: The image shows the word "biosys" with the "o" replaced by a stethoscope. The first three letters, "bio", are in blue, while the "sys" is in red. The stethoscope is also red and is positioned to look like it is part of the word.
| 510(k) Summary | |
|---|---|
| 510(k) Submitter | Biosys Biyomedikal Mühendislik San. ve Tic. A.S. |
| 510(k)Submitter Address | Üniversiteler Mah. İhsan Doğramaci Bul. Cd. Sk. No:23/C ÇANKAYA ANKARA |
| 510(k) Submitter Telephone No | Phone: +90 850 800 62 97 |
| Fax: +90 850 800 62 97 | |
| Primary Correspondent Contact Information | Cemal ERDOGAN +90 532 698 |
| 32 48 | |
| cemal.erdogan@biosys.com.tr | |
| Summary Preparation Date | 12/10/2024 |
| Trade Or Proprietary Name | Bioscope Neuromonitor Device |
|---|---|
| Common Name | Nerve Monitor |
| Regulation Number | 21 CFR 874.1820 |
| Regulation Name | Surgical Nerve Stimulator/Locator |
| Regulatory Class | Class II |
| Review Panel | Ear Nose & Throat |
| Product Code | ETN |
| Subject Device
Name | Subject
Device 510k
No | Predicate
Device 510k
No | Reference
Device | Predicate Device
Manufacturer | Reference Device
Manufacturer |
|------------------------------------|------------------------------|--------------------------------|---------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Bioscope
Neuromonitor
Device | K233001 | K083242 | K083124 | THE MAGSTIM
COMPANY LTD.
SPRING GARDENS,
WHITLAND
CARMARTHENSHIRE
, WALES, UK SA34
OHR | MEDTRONIC XOMED
INC.
6743 SOUTHOINT
DR. NORTH
JACKSONVILLE, FL
32216 |
5
Image /page/5/Picture/0 description: The image shows the word "biosys" in blue font. The "s" is stylized to look like a stethoscope, with the bell of the stethoscope in red and the tubing in red as well. The stethoscope is positioned so that the bell is below the "s" and the tubing curves around to the left.
Device Description
Bioscope Neuromonitor Device is a nerve locator and monitor. The device has 3 infrastructure;
- Electronic
- Mechanic
- Software
These infrastructures are integrated with each other and work with the principle of stimulating current at 0.01-10 mA levels, conceiving EMG signals from related muscles groups. Collected signals are interpreted by the device and auditory and visual notifications will be given.
The device basically consists of stimulation and EMG subsystems. Both stimulation and EMG lines can send and collect signals from 2 channels. Depending on the operation, an EMG Endotracheal Tube or needle electrode is inserted into the muscles innervated by the relevant nerves for EMG reading. The electrode parts of the EMG tube are placed in contact with the muscles attached to the vocal cords. Needle electrodes are also inserted into the relevant muscle. Appropriate current is sent with the stimulation probe. The electrical changes in the muscles in the region and are transmitted to the device as a signal. The device gives audible and visual warnings.
Channels works on the principle of potentially stimulating the critical region through monopolar or bipolar probe connection and completing the circuit, allowing the device to make a nerve-tissue separation audibly and visually. It allows the detection of nerves such as the recurrent laryngeal nerve, which are connected to the vocal cords. The doctor brings the probe into contact with the area of potential nerve risk. The current sent to the patient through the probe causes a change in the electrical activity of the nerves and the muscles to which the nerves are connected, and this change can be detected by the device. Based on the collected data, the device gives clear audible alerts for nerve-tissue separation. The EMG signal collected from the patient is displayed as a both voltage value and latency times on the output. These values can be recorded and the interface can be used to select specific details, such as the right and left sides of the vagus, and recurrent laryngeal nerves.
Intended Use
The Bioscope Neuromonitor Device is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. Intra-operative monitoring and stimulation of cranial peripheral motor nerves.
Indications for Bioscope Neuromonitor Device Procedures include: thyroidectomy and parathyroidectomy, mastoidectomy.
6
Image /page/6/Picture/0 description: The image shows the word "biosys" in blue font. The "s" in "biosys" is stylized to look like a red stethoscope. The stethoscope is curved and has a red circle at the end.
Technological Characteristics
| Criteria | Subject Device | Predicate Device | Reference Device | Comparison |
|---|---|---|---|---|
| Device Name | Bioscope | |||
| Neuromonitor | ||||
| Device | ||||
| (Subject Device) | Neurosign Avalanche | |||
| Thyroid Motor Nerve | ||||
| Monitor | ||||
| (Predicate Device) | Nerve Integrity | |||
| monitor 3.0 | ||||
| (Reference Device) | ||||
| Owner | Biosys Biyomedikal | |||
| Mühendislik San. ve | ||||
| Tic. A.S. | THE MAGSTIM | |||
| COMPANY LTD. | Medtronic Xomed | |||
| 510(k) No | not yet assigned | K083242 | K083124 | - |
| Product code / | ||||
| Class | Product Code ETN | |||
| Class II | Product Code ETN | |||
| Class II | Product Code ETN, | |||
| G W F , Class II | Same | |||
| Description | The Bioscope | |||
| neuromonitor | ||||
| device provides the | ||||
| surgeon with | ||||
| information through | ||||
| a waveform graph | ||||
| of EMG activity and | ||||
| sound amplification | ||||
| of this signal so that | ||||
| the surgeon can | ||||
| hear it during | ||||
| surgery. | Motor Nerve Monitor, | |||
| based upon standard | ||||
| computer components, | ||||
| running Windows XP | ||||
| embedded operating | ||||
| system; information is | ||||
| provided to the surgeon | ||||
| via a waveform graph of | ||||
| EMG activity, and audio | ||||
| amplification of this | ||||
| signal so that the surgeon | ||||
| hears this as he/she is | ||||
| operating. | NIM 3.0 is a | |||
| multichannel | ||||
| intraoperative | ||||
| neurophysiological | ||||
| monitor capable of | ||||
| connecting various | ||||
| styles of patient | ||||
| monitoring electrodes | ||||
| and supplying | ||||
| electrical stimulus for | ||||
| evoked responses. | same | |||
| Specific | ||||
| indication | ||||
| for use | Thyroidectomy, | |||
| parathyroidectomy | ||||
| , mastoidectomy | Thyroidectomy, | |||
| parathyroidectomy, | ||||
| mastoidectomy, | ||||
| cochlear implant | Intracranial, | |||
| Extracranial, | ||||
| Intratemporal, | ||||
| Extratemporal, Neck | ||||
| Dissections, | ||||
| Thoracic Surgeries, | ||||
| Upper | ||||
| and | ||||
| and | ||||
| Lower Extremities | same | |||
| Hardware | ||||
| (main unit) | Embedded PCB | |||
| Card | Standard PC components | unknown | Different 1 | |
| Headbox | ||||
| bandwidth | 2 channel | |||
| 100 Hz — 2 KHz | 2 channel | |||
| 8Hz - 8 kHz +3dB | 4/8 Channel 15 | |||
| Hz - 1,85 | ||||
| kHZ±3dB | Different 2 | |||
| Software | Embedded | |||
| Software ( C ) | Windows XP Embedded | unknown | Different 3 | |
| Screen | 10.1" colour touch | |||
| screen (1024×600 | ||||
| pixel) | 15" colour touchscreen | Touch screen, | ||
| (1024×768 pixel) | Different 4 | |||
| Method of | ||||
| control | Touchscreen - all | |||
| controls via | ||||
| software except | ||||
| power ON/OFF | Touchscreen - | |||
| all | ||||
| controls via software | ||||
| except power ON/OFF | Touchscreen | same | ||
| Manner of | ||||
| stimulator | Electrical | |||
| stimulation via a | ||||
| probe | Electrical stimulation via | |||
| a probe | Electrical | |||
| stimulation | ||||
| via a probe | same | |||
| Stimulation | ||||
| range | 0.01-10 mA | 0.05mA - 10mA | 0.01-30 mA | Different 5 |
| Stimulation | ||||
| type | Constant Current | |||
| (100 μs - 300 μs) | Square wave, negative | |||
| edge, 200μs pulse width, | ||||
| constant current | Monophasic, square | |||
| pulse, constant | ||||
| current duration 50- | ||||
| 250 μs | Different 6 | |||
| Stimulation | ||||
| frequency | 1 Hz - 5 Hz | 3 or 30Hz | 1 Hz, 4 Hz, 7 Hz, 10 Hz | Different 7 |
| Training | ||||
| required for | ||||
| use | Yes; both for | |||
| surgeon and OR | ||||
| staff | Yes; both for surgeon and | |||
| OR staff | Yes; both for surgeon | |||
| and OR staff | same | |||
| Location of | ||||
| use | Operating room | Operating room | Operating room | same |
| Audio | Amplified raw EMG | |||
| to provide audio | ||||
| (10W output) | Amplified raw EMG to | |||
| provide audio (10W | ||||
| output) | Amplified raw EMG to | |||
| provide audio | same | |||
| Display and | ||||
| storage | Waveform signals | |||
| displayed on screen; | ||||
| stimulated | ||||
| responses may be | ||||
| optionally | ||||
| automatically | ||||
| recorded to disc | Waveform signals | |||
| displayed on screen; | ||||
| stimulated responses | ||||
| may be optionally | ||||
| automatically recorded | ||||
| to disc | Waveform signals | |||
| displayed on screen, | ||||
| storage on USB | ||||
| storage Device | same | |||
| capacity | Flash storage | Waveform data and | ||
| patient information can | ||||
| be printed using the | ||||
| internal thermal printer | ||||
| or via an external Letter | ||||
| sized inkjet printer for | ||||
| the generation of reports | ||||
| using stored data and | ||||
| annotated comments | Waveform data can be | |||
| printed external | ||||
| printer | Different 8 | |||
| Power | 100- 240 V | |||
| 50/60 Hz | 110/230V 50/60Hz | 100-240 V 50/60 | ||
| Hz | same | |||
| Electrical | ||||
| safety | EN60601-1; | |||
| Type BF, Class | ||||
| I | EN60601-1; Type | |||
| BF, Class I | EN60601-1; | |||
| Type BF, Class I | same | |||
| Compliance | ||||
| Standards | CE Mark, EN | |||
| ISO 13485, | ||||
| ISO 9001 | CE Mark, EN ISO | |||
| 13485, ISO 9001 | CE Mark, EN ISO | |||
| 13485, ISO 9001 | same |
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Image /page/7/Picture/0 description: The image shows the word "biosys" in blue font, with a red stethoscope replacing the letter "s". The stethoscope is curved and positioned to resemble the shape of the letter. The overall design is simple and clean, with a focus on the text and the medical symbol.
8
Image /page/8/Picture/9 description: The image shows the word "biosys" in blue font. The "u" in the word is replaced by a red stethoscope. The stethoscope is positioned so that the earpieces are above the "s" and the chest piece is below the "s".
The technological characteristics between the subject and predicate device are the same, with some exceptions given below:
Difference 1: Embedded PCB Card vs. Standard PC components
Justification: The difference in the internal components of the subject device (Embedded PCB Card) compared to the predicate device (Standard PC components) does not impact the safety or performance of the device. The subject device has been tested and passed the Low Voltage Directive (LVD) and Electromagnetic Compatibility (EMC) standards, ensuring that it complies with essential electrical safety and electromagnetic interference requirements. The use of an Embedded PCB Card may provide certain advantages, such as increased reliability and durability, which can contribute to the overall safety and performance of the device.
Different 2: Headbox bandwidth (2 channel 100 Hz-2KHz) vs. (2 channel 8Hz-8 kHZ) vs. (4,8 Channel 15 Hz – 1,85 kHZ)
Justification: Although the channel numbers of the devices (Bioscope and Neurosign Avalanche) are the same, their bandwidths are different, but this difference is not a significant difference that will affect the operation of the device and does not create any security vulnerability or risk factor between the equivalent device and the Bioscope Neuromonitor Device. Nerve Integrity Monitor and Bioscope have different channel counts. Reference device (Nerve Integrity Monitor) has 4 or 8 channels. While this Nerve Integrity Monitor device allows working in a wider diameter and area, the Bioscope device is narrower than this predicate device. This difference does not create any security vulnerability or risk factor between the equivalent device and the Bioscope Neuromonitor Device.
9
Image /page/9/Picture/0 description: The image shows the word "biosys" with a stethoscope incorporated into the design. The letters "bio" are in blue, while the "s" is also in blue but slightly smaller. The stethoscope is red and replaces the "u" in "biosys", with the earpieces of the stethoscope forming the top part of the "u" and the tube extending down and around to form the bottom part of the "u". The bell of the stethoscope is positioned below the word.
Difference 3: Embedded Software (C) vs. Windows XP Embedded
Justification: The difference in software architecture between the subject device (Embedded Software in C) and the predicate device (Windows XP Embedded) does not pose a significant risk to safety or performance. The subject device's software has been validated according to the EN 62304 standard, demonstrating that it meets the necessary software development and validation requirements. This ensures the reliability and safety of the software in controlling the device's functions, making it equivalent to the predicate device's software in terms of safety and performance.
Difference 4: 10.1″ Color Touch Screen vs. 15″ Color Touchscreen
Justification: The difference in screen size between the subject device (10.1" color touchscreen) and the predicate device (15" color touchscreen) is unlikely to affect safety or performance. The subject device's 10.1" color touchscreen is legible and provides sufficient interface for users to operate the device effectively. The primary purpose of the touchscreen is to display information and allow user interaction, and the smaller size does not compromise the device's core functionality, safety, or performance.
Different 5: Stimulation Range (0.01-10 mA) and (0.01 mA - 30 mA)
Justification: The subject device (0.01-10 mA) and predicate device (0.01 mA – 10 mA) stimulation ranges are the same. The reference device stimulation range (0.01 mA – 30 mA) is different from the subject device and predicate device. The reference device has a wider stimulation range. The current ranges of devices produced as nerve monitors may vary. The current range of the subject device is sufficient for the operations in which the device will be used.
Different 6: Stimulation type Constant Current 100 µs – 300 µs and Constant Current 200 µs pulse width - Constant Current 50 - 250 µs
Justification: There are differences between the stimulation types of devices. While the Bioscope Neuromonitor Device is in the Constant Current (100 µs – 300 µs) range, Neurosign Avalanche is in the constant current (200 µs pulse width) range and Nerve Integrity Montor is in the constant current (50-250 µs pulse width) range. This difference does not create a significant difference between devices and does not pose a risk. Devices operate with constant current, and the operating value of the equivalent devices is within the operating range of the Bioscope Neuromonitor device.
Difference 7: Stimulation Frequency (1 Hz - 5 Hz) vs. (3 Hz or 30 Hz) vs. (1 Hz, 4 Hz, 7 Hz, 10 Hz)
Justification: The difference in stimulation frequency between the subject device (1 Hz - 5 Hz) and the predicate device Neurosign Avalanche is (3 Hz or 30 Hz) and reference device Nerve Integrity Montor is (1 Hz, 4 Hz, 7 Hz, 10 Hz)) does not pose a significant safety or performance concern. The frequency range of the subject device is between the ranges of predicate device and reference device. The frequency range of the subject device is between the ranges of predicate device and reference device's broader frequency range (1 Hz - 5 Hz) offers flexibility and compatibility with a wider range of clinical scenarios without compromising safety.
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Image /page/10/Picture/0 description: The image shows the word "biosys" with a stethoscope incorporated into the design. The letters "bio" and "s" are in blue, while the stethoscope is in red. The stethoscope is positioned so that the bell of the stethoscope is below the "o" and the earpieces replace the "y".
Difference 8: Flash Storage Print Capacity vs. Thermal Printer and External Printer
Justification: The difference in data printing methods between the subject device (flash storage print capacity) and the predicate device (thermal printer and external printer) does not impact safety or performance. The subject device is capable of printing waveform data and patient information using flash storage, ensuring that data can be accurately documented and reported. This approach offers an alternative and equally effective method for generating reports and preserving data integrity without loss, equivalent to the predicate device's printing capabilities.
The Bioscope Neuromonitor device has similar technical features to predicate device and reference device. Performance testing has been conducted to support the safety and effectiveness of the Bioscope Device. This 510(k) submission demonstrates that the similarities and common features between the Bioscope and predicate device and reference device do not raise any questions about its safety and effectiveness. The Bioscope Neuromonitor, as designed and manufactured, is as safe and effective as the predicate device and reference device therefore, has been determined to be substantially equivalent to the referenced predicate device. In summary, the identified differences between the subject device and the predicate device do not pose significant risks to safety or performance. Additionally, it meets essential safety and regulatory standards.
Non-Clinical Performance Testing
The Bioscope Neuromonitor Device is subject to the following standards and requirements are met. Test results demonstrate that the Bioscope Neuromonitor Device complies with the applicable standards.
| Recognition
number | Standard Designation
Number and Date | Title of Standard |
|-----------------------|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-49 | IEC 60601-1 Edition
3.2 2020-08
CONSOLIDATED
VERSION | Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance - Note: This standard is recognized
with relevant US national differences applied, see references #1 and
#2 in the Relevant FDA Guidance and/or Supportive Publication
section below. |
| 19-36 | ANSI AAMI IEC 60601-
1-2:2014 [Including
AMD 1:2021] | Medical electrical equipment - Part 1-2: General requirements for
basic safety and essential performance |
| 5-132 | ANSI AAMI IEC 60601-
1-6 Edition 3.2 2020-
07 CONSOLIDATED
VERSION | Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral standard: Usability |
| 13-79 | ANSI AAMI IEC
62304:2006/A1:2016 | Medical device software - Software life cycle processes [Including
Amendment 1 (2016)] |
11
| 15
| دالمع ال |
|---|
| 19-34 | ANSI AANI IEC 61010-1
Edition 3.1 2017-01
CONSOLIDATED
VERSION | Safety requirements for electrical equipment for measurement control
and laboratory use- Part 1: General requirements |
|-------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 17-16 | IEC 60601-2-10 Edition
2.1 2016-04 | Medical electrical equipment - Part 2-10: Particular requirements for
the basic safety and essential performance of nerve and muscle
stimulators |
| 5-131 | IEC 60601-1-8 Edition
2.2 2020-07
CONSOLIDATED
VERSION | Medical electrical equipment - Part 1-8: General requirements for basic
safety and essential performance - Collateral Standard: General
requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems |
In addition, the following performance tests were performed to test and prove the performance of the device:
- Software verification and validity test;
- Usability test;
- Electrical safety and electromagnetic compatibility (EMC) test;
- · Low Voltage Directive Test (LVD);
• System Performance test - (All basic functions of the device were tested: Device opening, closing, parameter change, accuracy of the current coming out of the device, accuracy of the signal detected by the device, compatibility of the device with consumables.)
Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the devices are as safe, as effective, and perform as well as the legally marketed predicate device.