(151 days)
Not Found
Not Found
No
The document describes a neuromuscular transmission monitor using accelerometry and electrical stimulation, with no mention of AI or ML technologies.
No
The device is described as a monitor and stimulator, not as a device that delivers therapy or treatment. Its primary function is to measure neuromuscular block and locate nerves.
Yes
The device is described as a "neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients," which implies it is used to assess a patient's physiological state to aid in diagnosis or treatment.
No
The device description explicitly mentions hardware components like a neuromuscular transmission monitor, accelerometry for measuring muscle contraction, a peripheral nerve stimulator, and a nerve location device utilizing a needle electrode. It also mentions safety testing according to hardware standards (EN60601 series, IEC 601-2-10).
Based on the provided information, the TOF-Watch device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use/Indications for Use: The device is used to monitor neuromuscular block in anesthetized patients by measuring muscle contraction or stimulating nerves. This is a direct measurement of physiological responses within the patient's body.
- Device Description: The description reinforces its function as a neuromuscular transmission monitor and nerve stimulator, again focusing on in-vivo measurements and stimulation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests outside of the body. IVDs are specifically designed for testing samples in vitro (in glass or outside the living organism).
Therefore, the TOF-Watch device is a medical device used for in-vivo monitoring and stimulation, not an IVD.
N/A
Intended Use / Indications for Use
The TOF-Hatch device can be used as an objective monitor using accelermetry for masclear The TOP-Match device as an objective monton as a periodal nerve contraction following a stimulation of the respective monitoring or as a newe location stimulator (with and the electrone device utilizing a needle electrode.
Product codes (comma separated list FDA assigned to the subject device)
73 KOI
Device Description
TOF Watch® device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometry for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle elctrode (needle electrode not supplied by Organon Teknika).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 performance characteristics of the new device are substantially equivalent to those of the predicate devices and typical of these systems in general. The results of testing for functionality, internal checking of software, and safety testing performed in accordance with EN60601 series, IEC 601-2-10 and standards set forth in Medical Device Directive (93/42/ECC) demonstrate that the device is safe and effective and meets the requirements of safety for these types of devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary TOF-Watch®
DEC 1 6 1997
The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;
Submitter's Name: Organon Teknika Corporation
Submitter's Address: 100 Akzo Avenue, Durham, North Carolina, 27712 USA
Submitter's Telephone: (919) 620-2288
Submitter's Contact:Rebecca A. Rivas Cabecca A. Rivas
Date 510(k) Summary Prepared: July 16, 1997
- The name of the device, including the trade or proprietary name if applicable, the (a)(2) common or usual name, and the classification name, if known;
Trade or Proprietary Name: TOF-Watch®
Common or Usual Name: TOF-Watch®
Classification Name: Peripheral Nerve Stimulator
- An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;
Device Equivalent to: Organon Teknika - TOF-Guard Neuro Technology - Digistim 3 Plus
A description of the device. (a)(4)
Device Description: TOF Watch® device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometry for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle elctrode (needle electrode not supplied by Organon Teknika).
A statement of the intended use of the device. (೩)(၃)
Device Intended Use: TOF Watch® is a device which can be used for monitoring neuromuscular transmission by means of acceleromyography, for peripheral nerve stimulation, and also as a nerve locator for loco-regional anesthesia.
1
A summary of the technological characteristics of the new device in comparison (a)(6) to those of the predicate device.
| TOF-Watch® | TOF-GuardINMT | DigiSTIM 3 PLUS | |
|---|---|---|---|
| Feature | |||
| Intended | |||
| Use | 1.Objective neuromuscular | ||
| transmission monitoring | |||
| 2.Subjective neuromuscular | |||
| transmission monitoring | |||
| 3.Nerve location for loco-regional | |||
| anesthesia | Objective neuromuscular | ||
| transmission monitoring | 1. Subjective neuromuscular | ||
| transmission monitoring. |
- Nerve location for loco-regional
anesthesia |
| Output | For 1 and 2:
Constant current,0-60 mA,
monophasic 200 µsec pulse width,
max voltage 300 V (60 mA into
5000 ohm)
For 3:
Constant current, 0-6mA,
monophasic, 40 µsec pulse width,
max voltage 6V (6mA into 1000
ohm) | Constant current, 0-
60 mA monophasic,
200 or 300 µsec
pulse width, max
voltage 300 V(60
mA into 5000 ohm) | For 1:
Constant current, 0-70 mA,
monophasic, 200 µsec pulse width
max voltage 140 V (70 mA
into 2000 ohm)
For 2:
Constant current, 0-6mA,
monophasic, 200 µsec pulse
width, max voltage 12 V
(6mA into 2000 ohm) |
| Stimula-
tion | TOF (Train of Four)
PTC (Post Tetanic Count)
1 Hz Twitch
0.1 Hz Twitch
Tetanic stimulation (50 or 100 Hz)
DBS 3.3 and 3.2 (Double Burst)
Auto ( calibration of acceleration
transducer at set current) | TOF (Train of
Four)
PTC (Post Tetanic Count)
1 Hz Twitch
0.1 Hz Twitch
SLOW TOF
DBS 3.3 and 3.2 (Double
Burst)
AutoI(Calibration
of acceleration
transducer at
supramaximal
current
AutoII(Calibration of
acceleration transducer at
submaximal current) | TOF (Train of Four)
PTC (Post Tetanic Count)
1 Hz Twitch
2 Hz Twitch
Tetanic stimulation (50 or100 Hz)
DBS 3.3 (Double Burst) |
A brief discussion of the nonclinical tests submitted, referenced, or relied on in (b)1) (0)1) == bremarket notification for a determination of substantial equivalency.
the premation between butting on only the performance characteristics of the new device including. resulig was personned to oscabilities analysis, Type Test Report, EMC Report and FCC Report.
-
- Functionality analysis of output current at different simulated skin resistances.
-
- Internal checking of software
r ¿
-
- Safety testing performed according to EN60601 series,IEC 601-2-10 and standards set forth in Medical Device Directive (93/42/EEC).
2
(b)(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalency.
Not Applicable.
(b)3) The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The performance characteristics of the new device are substantially equivalent to those of the predicate devices and typical of these systems in general. The results of testing for functionality, internal checking of software, and safety testing performed in accordance with EN60601 series, IEC 601-2-10 and standards set forth in Medical Device Directive (93/42/ECC) demonstrate that the device is safe and effective and meets the requirements of safety for these types of devices ..
3
Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps.
Rockville MD 20857
DEC 1 6 1997
Ms. Rebecca A. Rivas Organon Teknika Corporation 100 Akzo Avenue Durham, North Caralina 27712
Re : K972698 TOF-Watch Regulatory Class: II (two) Product Code: 73 KOI December 2, 1997 Dated: December 3, 1997 Received:
Dear Ms. Rivas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Rebecca A. Rivas
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your dev`ice to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Summary TOF-Watch®
DEC 1 6 1997
The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;
Submitter's Name: Organon Teknika Corporation
Submitter's Address: 100 Akzo Avenue, Durham, North Carolina, 27712 USA
Submitter's Telephone: (919) 620-2288
Submitter's Contact:Rebecca A. Rivas Cabecca A. Rivas
Date 510(k) Summary Prepared: July 16, 1997
- The name of the device, including the trade or proprietary name if applicable, the (a)(2) common or usual name, and the classification name, if known;
Trade or Proprietary Name: TOF-Watch®
Common or Usual Name: TOF-Watch®
Classification Name: Peripheral Nerve Stimulator
- An identification of the legally marketed device to which the submitter claims (a)(3) substantial equivalence;
Device Equivalent to: Organon Teknika - TOF-Guard Neuro Technology - Digistim 3 Plus
A description of the device. (a)(4)
Device Description: TOF Watch® device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometry for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle elctrode (needle electrode not supplied by Organon Teknika).
A statement of the intended use of the device. (೩)(၃)
Device Intended Use: TOF Watch® is a device which can be used for monitoring neuromuscular transmission by means of acceleromyography, for peripheral nerve stimulation, and also as a nerve locator for loco-regional anesthesia.
6
A summary of the technological characteristics of the new device in comparison (a)(6) to those of the predicate device.
| TOF-Watch® | TOF-GuardINMT | DigiSTIM 3 PLUS | |
|---|---|---|---|
| Feature | |||
| Intended | |||
| Use | 1.Objective neuromuscular | ||
| transmission monitoring | |||
| 2.Subjective neuromuscular | |||
| transmission monitoring | |||
| 3.Nerve location for loco-regional | |||
| anesthesia | Objective neuromuscular | ||
| transmission monitoring | 1. Subjective neuromuscular | ||
| transmission monitoring. |
- Nerve location for loco-regional
anesthesia |
| Output | For 1 and 2:
Constant current,0-60 mA,
monophasic 200 $\mu$ sec pulse width,
max voltage 300 V (60 mA into
5000 ohm)
For 3:
Constant current, 0-6mA,
monophasic,40 $\mu$ sec pulse width,
max voltage 6V (6mA into 1000
ohm) | Constant current, 0-
60 mA monophasic,
200 or 300 usec
pulse width, max
voltage 300 V(60
mA into 5000 ohm) | For 1:
Constant current, 0-70 mA,
monophasic, 200 $\mu$ sec pulse width
max voltage 140 V (70 mA
into 2000 ohm)
For 2:
Constant current, 0-6mA,
monophasic, 200 $\mu$ sec pulse
width, max voltage 12 V
(6mA into 2000 ohm) |
| Stimula-
tion | TOF (Train of Four)
PTC (Post Tetanic Count)
1 Hz Twitch
0.1 Hz Twitch
Tetanic stimulation (50 or100 Hz)
DBS 3.3 and 3.2 (Double Burst)
Auto ( calibration of acceleration
transducer at set current) | TOF (Train of
Four)PTC (Post Tetanic Count)
1 Hz Twitch
0.1 Hz Twitch
SLOW TOF
DBS 3.3 and 3.2 (Double
Burst)
AutoI(Calibration
of acceleration
transducer at
supramaximal
current
AutoII(Calibration of
acceleration transducer at
submaximal current) | TOF (Train of Four)
PTC (Post Tetanic Count)
1 Hz Twitch
2 Hz Twitch
Tetanic stimulation (50 or100 Hz)
DBS 3.3 (Double Burst) |
A brief discussion of the nonclinical tests submitted, referenced, or relied on in (b)1) (0)1) == bremarket notification for a determination of substantial equivalency.
the premation between butting on only the performance characteristics of the new device including. resulig was personned to oscabilities analysis, Type Test Report, EMC Report and FCC Report.
-
- Functionality analysis of output current at different simulated skin resistances.
-
- Internal checking of software
r ¿
-
- Safety testing performed according to EN60601 series,IEC 601-2-10 and standards set forth in Medical Device Directive (93/42/EEC).
7
(b)(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalency.
Not Applicable.
(b)3) The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a)(3).
The performance characteristics of the new device are substantially equivalent to those of the predicate devices and typical of these systems in general. The results of testing for functionality, internal checking of software, and safety testing performed in accordance with EN60601 series, IEC 601-2-10 and standards set forth in Medical Device Directive (93/42/ECC) demonstrate that the device is safe and effective and meets the requirements of safety for these types of devices ..
8
Image /page/8/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all caps.
Rockville MD 20857
DEC 1 6 1997
Ms. Rebecca A. Rivas Organon Teknika Corporation 100 Akzo Avenue Durham, North Caralina 27712
Re : K972698 TOF-Watch Regulatory Class: II (two) Product Code: 73 KOI December 2, 1997 Dated: December 3, 1997 Received:
Dear Ms. Rivas:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
9
Page 2 - Ms. Rebecca A. Rivas
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your dev`ice to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Page
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K912698 |
| Device Name: | TOF-Watch |
Indications For Use:
The TOF-Hatch device can be used as an objective monitor using accelermetry for masclear The TOP-Match device as an objective monton as a periodal nerve contraction following a stimulation of the respective monitoring or as a newe location
stimulator (with and the electrone device utilizing a needle electrode.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972698
Prescription Use
(Per 21 CFR 801.109)
OR.
Over-The-Counter Use
(Optional Format 1-2-96)