MANUJET III

K112783 · VBM Medizintechnik GmbH · BTL · Dec 22, 2011 · Anesthesiology

Device Facts

• Record ID: K112783
• Device Name: MANUJET III
• Applicant: VBM Medizintechnik GmbH
• Product Code: BTL · Anesthesiology
• Decision Date: Dec 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Designed to provide transtracheal ventilation in specific emergency situations of upper airway obstruction, used in conjunction with a transtracheal catheter, or a cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

Device Story

Manujet III is a manual jet ventilator for emergency airway management. Device connects to an oxygen source and a transtracheal catheter or cricothyrotomy needle inserted through the cricothyroid membrane. Operator manually triggers intermittent oxygen jets to inflate lungs. Used in emergency clinical settings by trained medical professionals. Provides life-saving ventilation when standard airway access is obstructed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual jet ventilator; pneumatic operation; connects to external oxygen supply; designed for use with transtracheal catheters or cricothyrotomy needles.

Indications for Use

Indicated for patients experiencing upper airway obstruction requiring emergency transtracheal ventilation via cricothyrotomy needle or catheter.

Regulatory Classification

Identification

A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DEC 2 2 2011

Mrs. Anke Blocher Quality Assurance VBM Medizintechnik GmbH 1 Einsteinstrasse Sulz am Neckar GERMANY 72172

Re: K112783

Trade/Device Name: Manujet III Manual Jet Ventilator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: September 23, 2011 Received: September 26, 2011

Dear Mrs. Blocher:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device 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 - Mrs. Blocher

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh foc

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement

510(k) Number (if known):

Device Name: Manujet III Manual Jet Ventilator

Indications for Use:

Designed to provide transtracheal ventilation in specific emergency situations of upper airway obstruction, used in conjunction with a transtracheal catheter, or a cricothyrotomy needle, which is inserted through the cricothyroid membrane. Ventilation is accomplished by manual, intermittent jetting of oxygen through the catheter for subsequent lung inflation.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schullchen

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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510(k) Number: K112783