PLASIATEK ACTUATOR

K041917 · Plasiatek, LLC · BTR · Jan 7, 2005 · Anesthesiology

Device Facts

• Record ID: K041917
• Device Name: PLASIATEK ACTUATOR
• Applicant: Plasiatek, LLC
• Product Code: BTR · Anesthesiology
• Decision Date: Jan 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2

Indications for Use

The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using standard Doppler ultrasound imaging.

Device Story

PlasiaTEK Actuator is a small, battery-operated, non-invasive vibrating accessory; attaches to the proximal ventilation circuit connector of an endotracheal tube. Operated by clinicians during intubation procedures. Device induces gentle, small-scale vibrations in the endotracheal tube. A standard Doppler ultrasound system detects these vibrations to visualize tube position within the trachea. Output is visual confirmation on the ultrasound display; assists clinicians in verifying correct tracheal placement; reduces risk of esophageal intubation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Battery-operated vibrating accessory; attaches to proximal endotracheal tube connector. Non-invasive. Operates via mechanical vibration to facilitate detection by external Doppler ultrasound systems.

Indications for Use

Indicated for patients requiring endotracheal intubation to support verification of tube placement within the trachea using Doppler ultrasound imaging.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• PosiTube Esophageal Intubation Detection Device (K000045)

Submission Summary (Full Text)

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JAN - 7 2005

# 510(k) SUMMARY of SAFETY and EFFECTIVENESS

K041917

#### A. General Information

B.

| 1. | Submitter's Name: | PlasiaTEK, LLC |
|--------|----------------------|----------------------------------------------|
| 2. | Address: | 10560 Wayzata Blvd.<br>Minneapolis, MN 55305 |
| 3. | Telephone: | 952-593-9960 |
| 4. | Contact Person: | Paul Pesek |
| 5. | Date Prepared: | July 15, 2004 |
| 6. | Registration Number: | Pending |
| Device | | |
| 1. | Name: | PlasiaTEK™ Actuator |
| 2. | Trade Name: | PlasiaTEK Actuator |
| 3. | Common Name: | Actuator |
| 4. | Classification Name: | Tracheal Tube (w/wo connector) |
| 5. | Product Code: | BTR |
| 6. | Class: | II |
| 7. | Regulation Number: | 868.5730 |

#### C. Identification of Legally Marketed Devices

| 1. | Name: | PosiTube Esophageal Intubation Detection Device |
|----|-------|-------------------------------------------------|
|----|-------|-------------------------------------------------|

- 2. K Number: K000045
- 3. 3/15/2000 Date Cleared:

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#### Description of the Device D.

The PlasiaTEK™ Actuator Device is a small, non-invasive, battery operated vibrating accessory with an on/off switch that is attached to the ventilation circuit connector on the proximal end of an endotracheal tube. The PlasiaTEK Actuator is used in combination with a previously cleared-to-market endotracheal tube and standard Doppler ultrasound system to locate the endotracheal tube within the trachea. When turned on, the Actuator slightly vibrates the tube. An imaging Doppler ultrasound system can detect the endotracheal tube position because of the gentle small motion caused by the PlasiaTEK Actuator.

#### Intended Use Statement E.

The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using standard Doppler ultrasound imaging.

#### F. Intended Use and Technological Characteristics Summary

The PlasiaTEK Actuator is substantially equivalent to the PosiTube Esophageal Intubation Detection Device in terms of Intended Use.

Technologically, both devices are similar since they are non-invasive, applied to the proximal connector end of the endotracheal tube and must be activated to work.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its head, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

JAN - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul Pesek President PlasiaTEK, LLC 10560 Wayzata Boulevard Minneapolis, Minnesota 55305

Re: K041917

Trade/Device Name: PlasiaTEK™ Actuator Regulation Number: 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: December 23, 2004 Received: December 29, 2004

Dear Mr. Pesek:

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 approvisions 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 Mr), to new ob to any of any 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 - Mr. Pesek

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 Fee of ally with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and insting (21 er read in the quality systems (QS) regulation (21 CFR Part 820); and if roquicellents as 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 promainverled 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,

Clus

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

Enclosure

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## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

K041917

PlasiaTEK™ Actuator

The PlasiaTEK Actuator is a non-invasive accessory to support verification of placement of an endotracheal tube within the trachea using Doppler ultrasound imaging.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use ر (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sha G. Sumill

Anesthestology, General Hospital, fection Control, Dental Devices

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510(k) Number: K041917