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

AI/ML Overview

This 510(k) submission (K992598) for the TOF-Watch SX does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a modern AI/ML device submission would. This document is from 1999, and the regulatory requirements and types of evidence provided for device equivalence were different then.

The submission focuses on demonstrating substantial equivalence to a predicate device (TOF-Watch) based on functional and technological characteristics, rather than on detailed performance metrics with acceptance criteria derived from clinical studies.

Therefore, much of the requested information cannot be found in the provided text. I will indicate where information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text, as the submission focuses on substantial equivalence based on feature comparison rather than detailed performance metrics with specific acceptance criteria. The document lists features of the new device (TOF-Watch SX) and compares them to the predicate device (TOF-Watch), implying that if the features are similar or enhanced, the performance is also considered equivalent.

A summary characteristic comparison is provided:

Features	TOF-Watch	TOF-Watch SX
Stimulation patterns (monitoring)
TOF	Yes	Yes
PTC	Yes	Yes
1 Hz	Yes	Yes
0.1 Hz	Yes	Yes
DBS	Yes	Yes (see P button)
TET	Yes	Yes (see P button)
TOFS (stimulation with user programmable interval)	No	Yes (1-60 min)
P button (user programmable button)	No	Yes (DBS, TET, OFF)
Stimulation current range	0-60mA, ≤ 5 KΩ	60 mA, ≤ 5 KΩ
Stimulation pulse width	200 µS	200/300 µS
Acceleration transducer	Yes	Yes
Calibration of acceleration transducer sensitivity	1 sequence - auto	2 sequences - auto
Manual sensitivity adj.	No	Yes
User programmable alarms: TOF and TOFS	No	2 (upper & lower) (limits: #/%TOF, OFF)
User programmable alarms: ON/OFF	No	Yes
Automatic power switch off (after 2 hours of no operation)	Yes	Yes
Surface temperature sensor	No	Yes (20-41.5°C)
Nerve location – LA	Yes	Yes
Current range (Nerve location)	0-6mA, ≤ 5 KΩ	0-6 mA, ≤ 5 ΚΩ
Pulse width (Nerve location)	40 µS	40 µS

The "reported device performance" is essentially the "TOF-Watch SX" column, indicating the features and specifications it possesses, which are either identical or enhanced compared to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The submission relies on technological comparison for substantial equivalence, not on specific clinical or performance test data on a "test set" in the context of modern AI/ML device evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/available. No "ground truth" establishment by experts is described for a test set in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/available. No test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device. The TOF-Watch SX functions as a standalone monitoring device, but the "standalone performance" concept here refers to AI algorithm performance which is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/available. No explicit ground truth is mentioned. The equivalence is based on the device's functional characteristics and operating principles being similar to a legally marketed predicate device.

8. The sample size for the training set

Not applicable/available. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established

Not applicable/available. There is no training set for this device.

Summary

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K992598

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: 7/28/99

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 SX

Common or Usual Name: TOF-Watch SX

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

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

Features	TOF-Watch	TOF-Watch SX
Stimulation patterns (monitoring)
TOF	Yes	Yes
PTC	Yes	Yes
1 Hz	Yes	Yes
0.1 Hz	Yes	Yes
DBS	Yes	Yes(see P button)
TET	Yes	Yes(see P button)
TOFS (stimulation with userprogrammable interval)	No	Yes (1-60 min)
P button(user programmable button)	No	Yes(DBS,TET,OFF)
Stimulation current range	0-60mA,≤ 5 KΩ	60 mA, ≤ 5 KΩ
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
User programmable alarms: TOF andTOFS	No	2(upper & lower)(limits:#/%TOF,OFF)
User programmable alarms: ON/OFF	No	Yes
Automatic power switch off ( after 2hours of no operation)	Yes	Yes
Surface temperature sensor	No	Yes (20-41.5°C)
Nerve location – LA	Yes	Yes
Current range	0-6mA,≤ 5 KΩ	0-6 mA, ≤ 5 ΚΩ
Pulse width	40 µS	40 µS

Comparison of TOF- Watch to TOF Watch SX

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Special 510(k) Premarket Notification Organon Teknika Corporation TOF-Watch SX

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

In summary, the TOF-Watch SX 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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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: K992598 TOF-Watch SX Requlatory 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 Requlation (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 requlation 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 requlations.

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Page 2 - Ms. Rebecca A. Rivas

This letter will allow you to begin marketing your device as described in vour 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 requlation (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/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

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K992598 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)

LoA. Westrom
Division Sign-Off

Cardiovascular, Respiratory, and Neurological Devi 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).