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.

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).

AI/ML Overview

The provided text describes the TOF-Watch® device, a peripheral nerve stimulator and neuromuscular transmission monitor. The information about acceptance criteria and the study that proves the device meets them is primarily focused on nonclinical testing for substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., accuracy percentages, output ranges with defined limits) for performance and then directly report the device's measured performance against each. Instead, it refers to general analyses and adherence to standards.

However, we can infer some "acceptance criteria" related to functionality and safety, and the "reported performance" is that the device meets these.

Acceptance Criteria (Implied)	Reported Device Performance
Functionality: Output current at different simulated skin resistances meets specifications.	"Functionality analysis of output current at different simulated skin resistances." "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... demonstrate that the device is safe and effective and meets the requirements of safety for these types of devices."
Software Integrity: Internal software functions correctly.	"Internal checking of software." "The results of testing for... internal checking of software... demonstrate that the device is safe and effective and meets the requirements of safety for these types of devices."
Safety: Compliance with relevant medical device safety standards.	"Safety testing performed according to EN60601 series, IEC 601-2-10 and standards set forth in Medical Device Directive (93/42/EEC)." "The results of testing for... 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." Further details on specific performance metrics (e.g., current output ranges, pulse widths, maximum voltages) are provided in the comparison table to predicate devices, implying these are met by the TOF-Watch® as well for substantial equivalence.
Substantial Equivalence: Performance is equivalent to predicate devices.	"The performance characteristics of the new device are substantially equivalent to those of the predicate devices and typical of these systems in general... demonstrate that the device is safe and effective and meets the requirements of safety for these types of devices." This is the overarching "performance" conclusion driven by the nonclinical tests when compared to the TOF-Guard INMT and DigiSTIM 3 PLUS, particularly regarding features like intended use, output specifications (current, pulse width, voltage), and stimulation modes (TOF, PTC, Twitch, Tetanic, DBS). The comparative table (Section 1 and 6) implicitly functions as a set of comparative performance criteria for substantial equivalence, which the TOF-Watch® is stated to meet.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that clinical tests were "Not Applicable" for this 510(k) submission. Therefore, there is no information provided about a "test set" in the context of clinical data. The testing was nonclinical (bench testing and software review).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

As clinical tests were not performed and no human-reviewed test set was created, this information is not applicable. The ground truth for the nonclinical tests would be defined by engineering specifications and international safety standards.

4. Adjudication Method for the Test Set

Since no clinical test set requiring human review or expert consensus was used, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Not Applicable" for clinical tests. The evaluation was based on nonclinical testing and substantial equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself, the TOF-Watch®, is a standalone device in its operational use for monitoring neuromuscular transmission. The evaluation described in the 510(k) summary is based on standalone nonclinical performance (functionality analysis, software checking, safety testing). There is no mention of an algorithm in the sense of AI or a software-only evaluation, but rather a holistic assessment of the physical device and its embedded software.

7. The Type of Ground Truth Used

For the nonclinical tests, the ground truth was based on:

Engineering Specifications: For functionality analysis of output current at different simulated skin resistances.
Software Requirements/Specifications: For internal checking of software.
International Safety Standards: EN60601 series, IEC 601-2-10, and Medical Device Directive (93/42/EEC) for safety testing.

8. The Sample Size for the Training Set

Since there is no mention of AI or machine learning algorithms that would require a training set in the modern sense (e.g., for image classification or prediction), this concept is not applicable to this 1997 medical device submission. The "software" mentioned in the document refers to embedded control software rather than a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

As there was no training set for an AI/ML algorithm, this information is not applicable.

Summary

{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
IntendedUse	1.Objective neuromusculartransmission monitoring2.Subjective neuromusculartransmission monitoring3.Nerve location for loco-regionalanesthesia	Objective neuromusculartransmission monitoring	1. Subjective neuromusculartransmission monitoring.2. Nerve location for loco-regionalanesthesia
Output	For 1 and 2:Constant current,0-60 mA,monophasic 200 µsec pulse width,max voltage 300 V (60 mA into5000 ohm)For 3:Constant current, 0-6mA,monophasic, 40 µsec pulse width,max voltage 6V (6mA into 1000ohm)	Constant current, 0-60 mA monophasic,200 or 300 µsecpulse width, maxvoltage 300 V(60mA into 5000 ohm)	For 1:Constant current, 0-70 mA,monophasic, 200 µsec pulse widthmax voltage 140 V (70 mAinto 2000 ohm)For 2:Constant current, 0-6mA,monophasic, 200 µsec pulsewidth, max voltage 12 V(6mA into 2000 ohm)
Stimula-tion	TOF (Train of Four)PTC (Post Tetanic Count)1 Hz Twitch0.1 Hz TwitchTetanic stimulation (50 or 100 Hz)DBS 3.3 and 3.2 (Double Burst)Auto ( calibration of accelerationtransducer at set current)	TOF (Train ofFour)PTC (Post Tetanic Count)1 Hz Twitch0.1 Hz TwitchSLOW TOFDBS 3.3 and 3.2 (DoubleBurst)AutoI(Calibrationof accelerationtransducer atsupramaximalcurrentAutoII(Calibration ofacceleration transducer atsubmaximal current)	TOF (Train of Four)PTC (Post Tetanic Count)1 Hz Twitch2 Hz TwitchTetanic 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.

1. Functionality analysis of output current at different simulated skin resistances.
1. Internal checking of software

r ¿

1. 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)

A statement of the intended use of the device. (೩)(၃)

{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
IntendedUse	1.Objective neuromusculartransmission monitoring2.Subjective neuromusculartransmission monitoring3.Nerve location for loco-regionalanesthesia	Objective neuromusculartransmission monitoring	1. Subjective neuromusculartransmission monitoring.2. Nerve location for loco-regionalanesthesia
Output	For 1 and 2:Constant current,0-60 mA,monophasic 200 $\mu$ sec pulse width,max voltage 300 V (60 mA into5000 ohm)For 3:Constant current, 0-6mA,monophasic,40 $\mu$ sec pulse width,max voltage 6V (6mA into 1000ohm)	Constant current, 0-60 mA monophasic,200 or 300 usecpulse width, maxvoltage 300 V(60mA into 5000 ohm)	For 1:Constant current, 0-70 mA,monophasic, 200 $\mu$ sec pulse widthmax voltage 140 V (70 mAinto 2000 ohm)For 2:Constant current, 0-6mA,monophasic, 200 $\mu$ sec pulsewidth, max voltage 12 V(6mA into 2000 ohm)
Stimula-tion	TOF (Train of Four)PTC (Post Tetanic Count)1 Hz Twitch0.1 Hz TwitchTetanic stimulation (50 or100 Hz)DBS 3.3 and 3.2 (Double Burst)Auto ( calibration of accelerationtransducer at set current)	TOF (Train ofFour)PTC (Post Tetanic Count)1 Hz Twitch0.1 Hz TwitchSLOW TOFDBS 3.3 and 3.2 (DoubleBurst)AutoI(Calibrationof accelerationtransducer atsupramaximalcurrentAutoII(Calibration ofacceleration transducer atsubmaximal current)	TOF (Train of Four)PTC (Post Tetanic Count)1 Hz Twitch2 Hz TwitchTetanic 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.

1. Functionality analysis of output current at different simulated skin resistances.
1. Internal checking of software

r ¿

1. 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).

{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:

{9}------------------------------------------------

Page 2 - Ms. Rebecca A. Rivas

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)

Regulation Number and Section

§ 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).