The TOF-Watch S device can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring or as a nerve location device.

Device Description

The TOF-Watch S 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 electrode. The TOF - Watch S device is packaged individually in a neutral carton box. The complete package contains a TOF-Watch S, an acceleration transducer, a surface electrode cable and a multilingual manual.

AI/ML Overview

This 510(k) submission for the TOF-Watch S electric nerve stimulator does not contain a detailed study demonstrating its performance against specific acceptance criteria. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria.

The document states:
"In summary, the TOF-Watch S described in this submission is substantially equivalent to the predicate device based on the following similarities:

Have the same indicated use.
Use the same operating principle.
Incorporate the same basic design.
Incorporate the same materials ●
Packaged the same using the same materials and process."

Given this, I cannot provide the requested information. The document focuses on comparing technological characteristics to a predicate device (TOF-Watch) rather than presenting a performance study with acceptance criteria.

Therefore, for the specific questions:

A table of acceptance criteria and the reported device performance: Not provided in the document.
Sample size used for the test set and the data provenance: Not provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
Adjudication method: Not provided in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for direct patient use, not an AI algorithm.
The type of ground truth used: Not applicable, as no dedicated performance study is described.
The sample size for the training set: Not applicable, as this is a medical device, not an AI/machine learning model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

KG92596

AUG 30 1999

510(k) Summary

The submitter's name, address, telephone number, a contact person, and the date the summary was (a)(1) prepared;
Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712

Submitter's Telephone: (919) 620-2288

Submitter's Contact: Rebecca A. Rivas

Date 510(k) Summary Prepared: 7/27/99

The name of the device, including the trade or proprietary name if applicable, the common or usual name, (a)(2) and the classification name, if known;

Trade or Proprietary Name: TOF-Watch S

Common or Usual Name: TOF-Watch S

Classification Name: Electrical Nerve Stimulator

An identification of the legally marketed device to which the submitter claims substantial equivalence; (a)(3)

Device Equivalent to: TOF-Watch

A description of the device. (a)(4)

A statement of the intended use of the device. (a)(5)

{1}------------------------------------------------

(a)(6) A summary of the technological characteristics of the new device in comparison to those of the predicate device.

]

Comparison of TOF- Watch to TOF Watch S

Features	TOF-Watch	TOF-Watch S
Stimulation patterns (monitoring)
TOF	Yes	Yes
PTC	Yes	Yes
1 Hz	Yes	Yes
0.1 Hz	Yes	Yes
DBS	Yes	Yes
TET	Yes	No
TOFS (stimulation with userprogrammable interval)	No	Yes (1-60 min)
Stimulation current range	0-60mA,≤ 5 ΚΩ	60 mA, ≤ 5 ΚΩ
Stimulation pulse width	200 µS	200/300 µS
Acceleration transducer	Yes	Yes
Calibration of acceleration transducersensitivity	1 sequence - auto	2 sequences - auto
Manual sensitivity adj.	No	Yes
Automatic power switch off ( after 2hours of no operation)	Yes	Yes
Surface temperature sensor	No	No
Nerve location – LA	Yes	Yes
Current range	0-6mA,≤ 5 ΚΩ	0-6 mA, ≤ 5 ΚΩ
Pulse width	40 µS	40 µS

{2}------------------------------------------------

The conclusions drawn that demonstrate that the device is as safe, as effective, and performed as well or (b)3) better than the legally marketed device identified in (a)(3).

In summary, the TOF-Watch S described in this submission is substantially equivalent to the predicate device based on the following similarities:

Have the same indicated use .
Use the same operating principle .
Incorporate the same basic design .
Incorporate the same materials ●
Packaged the same using the same materials and process .

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an abstract caduceus symbol, which is often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 30 1999

Ms. Rebecca A. Rivas Organon Teknika Corp. 100 Akzo Avenue Durham, NC 27712

Re: K992596 TOF-Watch S Regulatory Class: II (two) Product Code: 73 KOI Dated: July 30, 1999 Received: August 3, 1999

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 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). 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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}------------------------------------------------

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 device 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 Also, please note the regulation entitled, (301) 594-4639. "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/dsma/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

{5}------------------------------------------------

Page I of

510(k) Number (If known):

Device Name:

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

JOHWutshan
Division Sign-Off

Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

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).