TOF-WATCH

{0}------------------------------------------------ K972698 # 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<br>Use | 1.Objective neuromuscular<br>transmission monitoring<br>2.Subjective neuromuscular<br>transmission monitoring<br>3.Nerve location for loco-regional<br>anesthesia | Objective neuromuscular<br>transmission monitoring | 1. Subjective neuromuscular<br>transmission monitoring.<br>2. Nerve location for loco-regional<br>anesthesia | | Output | For 1 and 2:<br>Constant current,0-60 mA,<br>monophasic 200 µsec pulse width,<br>max voltage 300 V (60 mA into<br>5000 ohm)<br>For 3:<br>Constant current, 0-6mA,<br>monophasic, 40 µsec pulse width,<br>max voltage 6V (6mA into 1000<br>ohm) | Constant current, 0-<br>60 mA monophasic,<br>200 or 300 µsec<br>pulse width, max<br>voltage 300 V(60<br>mA into 5000 ohm) | For 1:<br>Constant current, 0-70 mA,<br>monophasic, 200 µsec pulse width<br>max voltage 140 V (70 mA<br>into 2000 ohm)<br>For 2:<br>Constant current, 0-6mA,<br>monophasic, 200 µsec pulse<br>width, max voltage 12 V<br>(6mA into 2000 ohm) | | Stimula-<br>tion | TOF (Train of Four)<br>PTC (Post Tetanic Count)<br>1 Hz Twitch<br>0.1 Hz Twitch<br>Tetanic stimulation (50 or 100 Hz)<br>DBS 3.3 and 3.2 (Double Burst)<br>Auto ( calibration of acceleration<br>transducer at set current) | TOF (Train of<br>Four)<br>PTC (Post Tetanic Count)<br>1 Hz Twitch<br>0.1 Hz Twitch<br>SLOW TOF<br>DBS 3.3 and 3.2 (Double<br>Burst)<br>AutoI(Calibration<br>of acceleration<br>transducer at<br>supramaximal<br>current<br>AutoII(Calibration of<br>acceleration transducer at<br>submaximal current) | TOF (Train of Four)<br>PTC (Post Tetanic Count)<br>1 Hz Twitch<br>2 Hz Twitch<br>Tetanic stimulation (50 or100 Hz)<br>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. - 1. Functionality analysis of output current at different simulated skin resistances. - 2. Internal checking of software r ¿ - 3. 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}------------------------------------------------ K972698 # 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<br>Use | 1.Objective neuromuscular<br>transmission monitoring<br>2.Subjective neuromuscular<br>transmission monitoring<br>3.Nerve location for loco-regional<br>anesthesia | Objective neuromuscular<br>transmission monitoring | 1. Subjective neuromuscular<br>transmission monitoring.<br>2. Nerve location for loco-regional<br>anesthesia | | Output | For 1 and 2:<br>Constant current,0-60 mA,<br>monophasic 200 $\mu$ sec pulse width,<br>max voltage 300 V (60 mA into<br>5000 ohm)<br>For 3:<br>Constant current, 0-6mA,<br>monophasic,40 $\mu$ sec pulse width,<br>max voltage 6V (6mA into 1000<br>ohm) | Constant current, 0-<br>60 mA monophasic,<br>200 or 300 usec<br>pulse width, max<br>voltage 300 V(60<br>mA into 5000 ohm) | For 1:<br>Constant current, 0-70 mA,<br>monophasic, 200 $\mu$ sec pulse width<br>max voltage 140 V (70 mA<br>into 2000 ohm)<br>For 2:<br>Constant current, 0-6mA,<br>monophasic, 200 $\mu$ sec pulse<br>width, max voltage 12 V<br>(6mA into 2000 ohm) | | Stimula-<br>tion | TOF (Train of Four)<br>PTC (Post Tetanic Count)<br>1 Hz Twitch<br>0.1 Hz Twitch<br>Tetanic stimulation (50 or100 Hz)<br>DBS 3.3 and 3.2 (Double Burst)<br>Auto ( calibration of acceleration<br>transducer at set current) | TOF (Train of<br>Four)PTC (Post Tetanic Count)<br>1 Hz Twitch<br>0.1 Hz Twitch<br>SLOW TOF<br>DBS 3.3 and 3.2 (Double<br>Burst)<br>AutoI(Calibration<br>of acceleration<br>transducer at<br>supramaximal<br>current<br>AutoII(Calibration of<br>acceleration transducer at<br>submaximal current) | TOF (Train of Four)<br>PTC (Post Tetanic Count)<br>1 Hz Twitch<br>2 Hz Twitch<br>Tetanic stimulation (50 or100 Hz)<br>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. - 1. Functionality analysis of output current at different simulated skin resistances. - 2. Internal checking of software r ¿ - 3. 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 | <strong>Labels</strong> | <strong>Values</strong> | |---------------------------|-------------------------| | 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)