NEUMOVENT GRAPHNET MODEL 3179L1V

K101401 · Tecme S.A. · CBK · Dec 7, 2010 · Anesthesiology

Device Facts

• Record ID: K101401
• Device Name: NEUMOVENT GRAPHNET MODEL 3179L1V
• Applicant: Tecme S.A.
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Neumovent GraphNet is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonatelinfant to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital and hospitaltype facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Device Story

Neumovent GraphNet is a continuous ventilator providing respiratory support to neonate, infant, and adult patients. Used in hospital settings and during hospital-type transport. Requires external electrical power and compressed gas. Device delivers mechanical ventilation to assist or control patient breathing. Healthcare providers operate the device to manage patient respiratory status. Output consists of ventilation parameters and monitoring data, enabling clinicians to adjust therapy based on patient needs. Benefits include life support and respiratory stabilization.

Clinical Evidence

No clinical data provided. Substantial equivalence determination based on bench testing and descriptive comparison to predicate devices.

Technological Characteristics

Continuous ventilator (21 CFR 868.5895, Product Code CBK). Operates via electrical power and compressed gas. Designed for hospital and transport use. Supports neonate to adult patient populations.

Indications for Use

Indicated for patients from neonate/infant to adult requiring respiratory support for a wide variety of clinical conditions.

Regulatory Classification

Identification

A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

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

TECME S.A. C/O Mr. Raymond Kelly Azary Group 56B Shadowbrook Drive Hudson, New Hampshire 03051

DEC-7 2010

Re: K101401

Trade/Device Name: Ventilator Model Neumovent GraphNet Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: November 30, 2010 Received: December 2, 2010

Dear Mr. Kelly:

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- Mr. Kelly

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,

Anthony D. Watson

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

510(k) Number (if known): K101401

DEC 7 2010

Ventilator Model Neumovent GräphNet Device Name:

Indications for Use:

The Neumovent GraphNet is intended to provide continuous ventilation to patients requiring respiratory support. The device is intended for patients from neonatelinfant to adult and for a wide variety of clinical conditions. The device is intended to be used in hospital and hospitaltype facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

L. Schutttras

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

510(k) Number: K101490/