INFINITY TRIDENT NMT POD

K042003 · Draeger Medical Systems, Inc. · KOI · Sep 1, 2004 · Anesthesiology

Device Facts

• Record ID: K042003
• Device Name: INFINITY TRIDENT NMT POD
• Applicant: Draeger Medical Systems, Inc.
• Product Code: KOI · Anesthesiology
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.2775
• Device Class: Class 2

Intended Use

The Infinity Trident NMT pod is intended for use as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve.

Device Story

Infinity Trident NMT Pod is an add-on module for Draeger Infinity patient monitoring series. Device delivers electrical stimuli via surface electrodes placed over peripheral nerve; captures resulting muscle response and skin temperature. Pod processes signals and relays data to Infinity patient monitor for display. Used in clinical settings by healthcare providers to monitor neuromuscular transmission. Output provides objective measurements of muscle response, assisting clinicians in assessing neuromuscular blockade status and guiding clinical decision-making regarding anesthesia or muscle relaxant administration.

Clinical Evidence

Clinical data analysis demonstrated that measurement values of the Infinity Trident NMT pod are equivalent to those of the predicate device.

Technological Characteristics

Peripheral nerve stimulator; measures muscle response and skin temperature via surface electrodes. Integrates with Infinity patient monitoring series. Complies with IEC 60601-1. No biocompatibility or sterilization requirements stated.

Indications for Use

Indicated for use as an objective neuromuscular transmission monitor to measure muscle response to electrical stimulation of a peripheral nerve in patients requiring neuromuscular monitoring.

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

• Organon Teknika Corp. Tof-Watch Sx (K992598)

Submission Summary (Full Text)

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K042003

# SEP - 1 2004

## 510(k) SUMMARY

as required per 807.92(c)

- 1. Submitters Name, Address:
Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone] Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: July 23, 2004

- Trade Name, Common Name and Classification Name: 2.
- A. Trade Name: Infinity Trident NMT Pod
- Common Name, Classification Name, Class and Regulation Number: B

| Common Name | Classification<br>Number | Class | Regulation Number |
|-----------------------------------------|--------------------------|-------|-------------------|
| Stimulator, Nerve, Peripheral, Electric | KOI | II | 868.2775 |

- Predicate Device Identification: 3. Organon Teknika Corp. Tof-Watch Sx K992598
- Device Description: 4.

The Infinity Trident NMT Pod is an addition to Draeger Medical Systems' Infinity patient monitoring series that provides automatic measurements of muscle response to electrical stimuli transmitted via surface electrodes placed over a peripheral nerve. The NMT sensors capture the muscle response as well as skin temperature. The pod then processes this information and relays it to the Infinity patient monitor for display.

- Intended Use: 5.
The Infinity Trident NMT pod is intended for use as an objective neuromuscular transmission monitor that measures the muscle response to electrical stimulation of a peripheral nerve.

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### COMPANY CONFIDENTIAL

Draeger Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: [phone] Fax: [phone]

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- 6. Comparison to predicate device
Similar to the TOF-Watch SX, the Infinity Trident NMT pod measures Train of Four (TOF), Post Tetanic Count (PTC), and Single Twitch Percentage.

### 7. Assessment of non-clinical performance data for equivalence:

The Infinity Trident NMT pod was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate device.

- Assessment of clinical performance data for equivalence: 8. The analysis of the data collected demonstrates that the measurement values of the test device are equivalent to that of the referenced predicate device.
- 9. Biocompatability: Not applicable
- 10. Sterilization: Not applicable

IEC 60601-1 11. Standards and Guidances:

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#### COMPANY CONFIDENTIAL

#### Draeger Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tei: [phone] Fax: [phone]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2004

Ms. Penelope H. Greco Regulatory Submissions Manager Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K042003

Trade/Device Name: Infinity Trident NMT Pod Regulation Number: 21 CFR 868.2775 Regulation Name: Electrical Peripheral Nerve Stimulator Regulatory Class: II Product Code: KOI Dated: July 23, 2004 Received: July 24, 2004

Dear: Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 ml ), it a can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Greco

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. or the recess and the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carls

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Infinity Trident NMT Pod

Indications for Use:

The Infinity Trident NMT pod can be used as an objective neuromuscular transmission monitor The milliny I rident NNT pour can or assures as the material nerve.

Prescription Use_ > (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cun Svelson

(Division Sign-Om (Division Sign-Oth)
Division of Anesthesiology, General Hospital.
Control Control Dental Devices Division Control, De

510(k) Number:

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