(234 days)
Model: Advance
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for patients from neonate/infant to adult. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
Model: Neumovent GraphNet TS
Intended to provide continuous ventilation to patients respiratory support. The devices are intended for patients from pediatric to adult with an option for neonate/infant patients. The devices are intended to be used in hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
Model: Neumovent GraphNet NEO
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patient. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
Not Found
This document is a 510(k) premarket notification FDA clearance letter for a continuous ventilator, the Neumovent GraphNet. It indicates that the device has been found substantially equivalent to predicate devices, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.
Therefore, I cannot provide the requested information. The prompts about "acceptance criteria," "reported device performance," "sample sizes," "expert ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not addressed in this regulatory document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Tecme, Incorporated C/O Mr. Raymond Kelly Quality Engineer Azary Group 79 Brookline Road Mason. New Hampshire 03048
JAN 2 7 2012
Re: K111595
Trade/Device Name: Neumovent GraphNet Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 24, 2012 Received: January 26, 2012
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/CDRHQffices /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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Reaner
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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Calle Pública s/n Av. La Voz del Interior 5500 X5008HJY - Bº Los Boulevares Córdoba, Argentina
INDICATIONS FOR USE
510(k) Number (if known): K111595
Device name: Neumovent GraphNet
Indications for Use:
Model: Advance
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for patients from neonate/infant to adult. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
Model: Neumovent GraphNet TS
Intended to provide continuous ventilation to patients respiratory support. The devices are intended for patients from pediatric to adult with an option for neonate/infant patients. The devices are intended to be used in hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
Model: Neumovent GraphNet NEO
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patient. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.
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IT Prescription Use N ు (Part 21 CFR 801 Subpart D AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)'
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(PLEASE:DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K111595 |
§ 868.5895 Continuous ventilator.
(a)
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.(b)
Classification. Class II (performance standards).