TOF-WATCH SX

K992598 · Organon Teknika Corp. · KOI · Aug 30, 1999 · Anesthesiology

Device Facts

• Record ID: K992598
• Device Name: TOF-WATCH SX
• Applicant: Organon Teknika Corp.
• Product Code: KOI · Anesthesiology
• Decision Date: Aug 30, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

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 Story

TOF-Watch SX is a neuromuscular transmission monitor for anesthetized patients. It functions as an objective monitor using accelerometry to measure muscle contraction following motorneuron stimulation, a peripheral nerve stimulator for subjective monitoring, and a nerve location device. Operated by clinicians in clinical settings. Inputs include electrical stimulation pulses delivered to the patient; outputs include measured muscle contraction data and nerve location feedback. Device features include user-programmable stimulation patterns (TOF, PTC, 1Hz, 0.1Hz, DBS, TET, TOFS), programmable alarms, and a surface temperature sensor. It assists clinicians in assessing the degree of neuromuscular block, facilitating clinical decision-making regarding anesthesia management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarities to the predicate device.

Technological Characteristics

Electrical nerve stimulator; utilizes accelerometry for objective monitoring. Stimulation current: 60mA (monitoring), 0-6mA (nerve location). Pulse width: 200/300µS (monitoring), 40µS (nerve location). Includes surface temperature sensor (20-41.5°C). Features user-programmable stimulation patterns (TOF, PTC, 1Hz, 0.1Hz, DBS, TET, TOFS) and programmable alarms. Powered device; includes acceleration transducer and surface electrode cable.

Indications for Use

Indicated for anesthetized patients requiring neuromuscular transmission monitoring, including objective measurement of muscle contraction via accelerometry, subjective peripheral nerve stimulation, or nerve location.

Regulatory Classification

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.

Predicate Devices

• TOF-Watch (K992598)

Submission Summary (Full Text)

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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: [phone]

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)

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.

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

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.

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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 user<br>programmable interval) | No | Yes (1-60 min) |
| P button(user programmable button) | No | Yes<br>(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<br>sensitivity | 1 sequence - auto | 2 sequences - auto |
| Manual sensitivity adj. | No | Yes |
| User programmable alarms: TOF and<br>TOFS | No | 2(upper & lower)<br>(limits:<br>#/%TOF,OFF) |
| User programmable alarms: ON/OFF | No | Yes |
| Automatic power switch off ( after 2<br>hours 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

(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)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

LoA. Westrom
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Cardiovascular, Respiratory, and Neurological Devi 510(k) Number