(267 days)
No reference devices were used in this submission.
No
The description focuses on standard signal processing and measurement techniques (acceleromyography) and does not mention any AI/ML components or algorithms.
No
The device monitors the effect of neuromuscular blocking agents; it does not treat a disease or condition.
Yes
Explanation: The device monitors the neuromuscular block of a patient to assess the effectiveness of neuromuscular blocking agents or the patient's curare level, which is a diagnostic purpose.
No
The device description explicitly states that the system is composed of a monitor, a hand sensor (which includes a splint, accelerometer, electrode clamps, and cable), and a power supply unit. These are physical hardware components, not just software.
Based on the provided information, the ToFscan is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ToFscan's Function: The ToFscan directly interacts with the patient's body by applying electrical stimulation to a nerve and measuring the resulting muscle movement. It does not analyze any biological specimens taken from the patient.
- Intended Use: The intended use is to monitor neuromuscular block by measuring physical responses (muscle acceleration) to electrical stimulation, not by analyzing biological samples.
Therefore, the ToFscan falls under the category of a medical device that performs a physiological measurement, but it is not an IVD.
N/A
Intended Use / Indications for Use
The ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the acceleration of the muscle movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The ToFscan has a three-dimensional acceleration sensor (accelerometer) to detect and quantify a patient's thumb movement (contracting adductor pollicis). The sensor is directly integrated into the finger's splint, making it possible to obtain its optimal and reproducible positioning.
Product codes
KOI
Device Description
The ToFscan is a neuromuscular transmission (NMT) monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for:
-
- Objective neuromuscular transmission monitoring
-
- Subjective neuromuscular transmission monitoring
The continuous monitoring of NMT blocking involves the stimulation of the ulnar nerve and the corresponding measurement of acceleration in the adductor muscle of the thumb (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level.
The apparatus and all of the settings associated with it are designed for use on adult and paediatric patients in hospital or health institutions so that the patient's curare level can be monitored.
The ToFscan system is composed of the monitor, the hand sensor, and the US AC power supply unit. The hand sensor itself consists of the thumb splint/3D accelerometer, the electrode clamps, and the cable which connects to the monitor.
The ToFscan can perform several different modes of electrical stimulation in accordance with usual clinical practice:
- -TOF (Train Of Four)
- PTC (Post Tetanic Count) -
- -ATP (Automated TOF PTC)
- DBS (Double Burst) (3,3) (3,2) -
- ST (Single Twitch) 0.1 Hz and 1 Hz -
- -TET (Tetanus) 50 Hz
The monitor displays the various stimulation settings, the time elansed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a rotary knob.
The accessories that can be used with the device include:
- Extension Cable 1.9 m -
- Optic-serial (RS232) cable to transfer data -
- -Fixation clamp - regular size (10-40 mm / 0.4-1.6 inches)
- Fixation clamp large size (20-60 mm / 0.8-2.4 inches) -
- -Cable Support
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thumb movement (contracting adductor pollicis)
Indicated Patient Age Range
adult and paediatric patients
Intended User / Care Setting
health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) / hospital or health institutions
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing: The biocompatibility evaluation for the ToFscan device was conducted in accordance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- -Cytotoxicity
- -Sensitization
- -Irritation
The thumb sensor is the only part of the ToFscan that is in contact with the patient. The ToFscan thumb sensor is a surface-contacting device in contact with intact skin for a duration of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC): Electrical safety and EMC testing were conducted on the ToFscan device. The system complies with the IEC 60601-1, IEC 60601-1-6 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Animal and Clinical Studies: No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
TOF-Watch, manufactured by Organon Teknika, K972698
Reference Device(s)
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2775 Electrical peripheral nerve stimulator.
(a)
Identification. An electrical peripheral nerve stimulator (neuromuscular blockade monitor) is a device used to apply an electrical current to a patient to test the level of pharmacological effect of anesthetic drugs and gases.(b)
Classification. Class II (performance standards).
0
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Mav 31, 2018
IDMED Frédéric Bernert President Hotel Technoptic 2 rue Marc Donadille 13013 Marseille, France
Re: K172690
Trade/Device Name: ToFscan Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: Class II Product Code: KOI Dated: April 19, 2018 Received: April 19, 2018
Dear Frédéric Bernert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K172690 |
|---|---|
| Device Name | ToFscan |
| Indications for Use (Describe) | The ToFscan is a neuromuscular transmission monitor for monitoring the neuromuscular block of a patient in the |
| operating theatre, recovery room or intensive care unit. | |
| The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the acceleration of the muscle | |
| movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The | |
| ToFscan has a three-dimensional acceleration sensor (accelerometer) to detect and quantify a patient's thumb movement | |
| (contracting adductor pollicis). The sensor is directly integrated into the finger's splint, making it possible to obtain its | |
| optimal and reproducible positioning. |
| 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) |
|---|---|
| ------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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프
1
3
Image /page/3/Picture/0 description: The image is a logo for idmed. The word "idmed" is written in a sans-serif font, with "id" in green and "med" in blue. To the right of the word is a plus sign made up of four blue squares and one green square. Below the word "idmed" is the phrase "an eye on your patient" in a smaller sans-serif font.
5-1
5. 510 (k) Summary
This summary of 510(k) information is being submitted in accordance with the requirements of 21 CFR 807.92.
5.1. Submitter
| Submitter: | IDMED |
|---|---|
| Hotel Technoptic | |
| 2 rue Marc Donadille | |
| 13013 Marseille France | |
| +33 (0)491 118 784 |
Establishment Registration Number: Nº DUNS 260233256
| Contact person: | Frédéric BERNERT |
|---|---|
| President | |
| E-mail : f.bernert@idmed.fr | |
| Date Summary Prepared: | 2017/12/15 |
K172690 510(k) number:
5.2. Device
| Trade Name: | ToFscan |
|---|---|
| Common/Usual Name: | NeuroMuscular Transmission (NMT) monitor |
| Regulation Name: | Electrical peripheral nerve stimulator |
| Classification Regulation: | 21 CFR 868.2775 |
| Product Code: | KOI |
| Regulatory Class: | Class II |
5.3. Predicate device
| Predicate Device: | TOF-Watch, manufactured by Organon Teknika, K972698 |
|---|---|
| 510(k) — ToFscan | CONFIDENTIAL |
| 001_510(k) Summary rev E 20180522 |
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Image /page/4/Picture/0 description: The image shows the logo for Idmed. The logo has the word "idmed" in blue and green letters. Below the word is the phrase "an eye on your patient".
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
5.4. Device description
The ToFscan is a neuromuscular transmission (NMT) monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit. It is used by health professionals (anaesthesiologists, doctors, or fully qualified nurse anaesthetists) for:
-
- Objective neuromuscular transmission monitoring
-
- Subjective neuromuscular transmission monitoring
The continuous monitoring of NMT blocking involves the stimulation of the ulnar nerve and the corresponding measurement of acceleration in the adductor muscle of the thumb (with a three-dimensional acceleration sensor). Based on the force of contraction resulting from the stimulation, it is possible to draw conclusions about the effectiveness of an injected neuromuscular blocking agents or the patient's curare level.
The apparatus and all of the settings associated with it are designed for use on adult and paediatric patients in hospital or health institutions so that the patient's curare level can be monitored.
The ToFscan system is composed of the monitor, the hand sensor, and the US AC power supply unit. The hand sensor itself consists of the thumb splint/3D accelerometer, the electrode clamps, and the cable which connects to the monitor.
The ToFscan can perform several different modes of electrical stimulation in accordance with usual clinical practice:
- -TOF (Train Of Four)
- PTC (Post Tetanic Count) -
- -ATP (Automated TOF PTC)
- DBS (Double Burst) (3,3) (3,2) -
- ST (Single Twitch) 0.1 Hz and 1 Hz -
- -TET (Tetanus) 50 Hz
The monitor displays the various stimulation settings, the time elansed between stimulations, and the results for the measurements made in response to TOF, PTC, and ATP stimulations. The responses to other types of stimulation are gaged visually by the health professional. The device and stimulation settings are chosen using a rotary knob.
The accessories that can be used with the device include:
- Extension Cable 1.9 m -
- Optic-serial (RS232) cable to transfer data -
- -Fixation clamp - regular size (10-40 mm / 0.4-1.6 inches)
- Fixation clamp large size (20-60 mm / 0.8-2.4 inches) -
- -Cable Support
CONFIDENTIAL
5
Image /page/5/Picture/0 description: The image shows the logo for idmed. The logo has the letters "idmed" in green and blue. Below the letters is the phrase "an eye on your patient" in a smaller font.
5.5. Indications for use
The TOFscan is a neuromuscular transmission monitoring the neuromuscular block of a patient in the operating theatre, recovery room or intensive care unit.
The effect of neuromuscular blocking agents (NMBAs) is monitored by measuring the acceleration of the muscle movement (acceleromyography) or by visually observing muscle contractions consequent to electrical stimulation. The TOFscan has a three-dimensional acceleration sensor (accelerometer) to detect and quantify a patient's thumb movement (contracting adductor pollicis). The sensor is directly integrated into the finger's splint, making it possible to obtain its optimal and reproducible positioning.
The Indications for use statement for the ToFscan is not identical to the predicate device, however, the differences do not alter the intended diagnostic use of the device nor do they raise different questions of safety and effectiveness of the device relative to the predicate. Both devices rely on the use of acceleromyography to measure muscle response to electrical stimulation as an indication of a patient's curare level. The predicate device has an additional intended use, nerve location, which is not included in the ToFscan.
5.6. Comparison of technological characteristics with the predicate device
Measuring and/or observing the movement of the thumb in response to well-defined electrical stimulation patterns in order to monitor the neuromuscular blocking of a patient is the technological principle for both the subject and predicate devices.
At a high level, the subject and predicate devices are based on the following same technological elements as presented in the table below. The information regarding the nerve location function of the TOF-Watch have not been included as this function is not available on the ToFscan.
| Features | ToFscan (subject device) | TOF-watch (predicate device) |
|---|---|---|
| Stimulation Current | ||
| Output | Constant current, 0-60 mA, | |
| monophasic 200µsec pulse width | Constant current, 0-60 mA, | |
| monophasic 200µsec pulse width | ||
| Maximum stimulation | ||
| voltage | 300V (60 mA, 5kΩ) | 300V (60 mA, 5kΩ) |
| Stimulation | ||
| TOF | Yes | Yes |
| TOF auto | Yes | Yes |
| PTC | Yes | Yes |
| 0.1Hz and 1Hz ST | Yes | Yes |
| TET 50 Hz | Yes | Yes |
| TET 100 Hz | No | Yes |
| 3.3 and 3.2 DBS | Yes | Yes |
| ATP | Yes | No |
Calculations and measurements
510(k) — ToFscan
6
Image /page/6/Picture/0 description: The image shows the logo for Idmed. The word "idmed" is written in a sans-serif font, with "id" in green and "med" in blue. To the right of the word "med" is a blue plus sign made up of four squares. Below the word "idmed" is the tagline "an eye on your patient" in a smaller, sans-serif font.
IDMED Hotel Technoptic 2 rue Marc Donadille 13013 Marseille - France 2 +33 491 118 784 □ info@idmed.fr www.idmed.fr
| Features | ToFscan (subject device) | TOF-watch (predicate device) |
|---|---|---|
| TOF calculation | Yes | Yes |
| PTC count | Yes | Yes |
| T4/T1 | Yes | Yes |
| T4/Tref | Yes | No |
| Displays amplitude of | ||
| responses / Bars | Yes | No |
| Type of sensor | Thumb - accelerometer | Thumb - accelerometer |
| General safety | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10 |
The following technological differences exist between the subject and predicate device:
- The ToFscan does not perform 100Hz TET stimulation -
- -The ToFscan allows the user to select a repeat frequency of TOF stimulation from 15s to 15min instead of 15s only
- -The ToFscan includes the ATP mode, a combination of the TOF and PTC stimulation modes
- -The ToFscan can measure a patient's reference response to TOF stimulation and calculate T4Tet
- -The ToFscan monitor displays the amplitude of responses/bars
The differences presented here are supported by following performance data. These differences do not raise different questions of safety and effectiveness.
5.7. Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the ToFscan device was conducted in accordance with the FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- -Cytotoxicity
- -Sensitization
- -Irritation
The thumb sensor is the only part of the ToFscan that is in contact with the patient. The ToFscan thumb sensor is a surface-contacting device in contact with intact skin for a duration of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC)
CONFIDENTIAL
7
Image /page/7/Picture/0 description: The image is a logo for idmed. The logo has the word "idmed" in blue and green letters. Below the word is the phrase "an eye on your patient" in a smaller font.
Electrical safety and EMC testing were conducted on the ToFscan device. The system complies with the IEC 60601-1, IEC 60601-1-6 and IEC 60601-2-10 standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Animal and Clinical Studies
No animal or clinical testing was required to demonstrate the substantial equivalence of this device to its predicate.
5.8. Conclusions
Based on its intended use, design principles, and technological characteristics, the ToFscan device was found to be as safe, as effective, and performs comparably to the predicate device.
The technological differences identified do not raise different questions of safety and effectiveness as the non-clinical data and the hardware and software verification demonstrate that the ToFscan device should perform as intended in the specified use conditions.