TOF-WATCH S

K992596 · Organon Teknika Corp. · KOI · Aug 30, 1999 · Anesthesiology

Device Facts

• Record ID: K992596
• Device Name: TOF-WATCH S
• 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 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 Story

TOF-Watch S 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 using a needle electrode. The device delivers electrical stimulation patterns (TOF, PTC, 1 Hz, 0.1 Hz, DBS, TOFS) to a patient's nerve; an acceleration transducer measures the resulting muscle response. Clinicians use the device in surgical or clinical settings to assess the degree of neuromuscular block. Output is displayed to the clinician to guide anesthetic management and clinical decision-making regarding muscle relaxant administration. The device includes an acceleration transducer, surface electrode cable, and manual.

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: 200/300 µS (monitoring), 40 µS (nerve location). Features include automatic power switch-off and manual/auto sensitivity adjustment. Device is a standalone unit.

Indications for Use

Indicated for anesthetized patients requiring neuromuscular transmission monitoring, peripheral nerve stimulation, or nerve location during clinical procedures.

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 (K992596)

Submission Summary (Full Text)

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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: [phone]

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)

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.

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

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.

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## (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 user<br>programmable 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 transducer<br>sensitivity | 1 sequence - auto | 2 sequences - auto |
| Manual sensitivity adj. | No | Yes |
| Automatic power switch off ( after 2<br>hours 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 |

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# 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 .

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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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: 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.

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, [phone]. "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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Page I of

510(k) Number (If known):

Device Name:

Indications For Use:

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.

(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)

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