(203 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
Yes
The device is described as providing "continuous ventilation to patients requiring respiratory support," which is a form of treatment for a medical condition.
No
The device is described as providing continuous ventilation, which is a therapeutic function, not a diagnostic one. It supports breathing rather than identifying a medical condition.
No
The intended use clearly describes a device providing "continuous ventilation," which inherently requires hardware components to deliver air or gas to the patient. The summary does not mention it being software only.
Based on the provided information, the Neumovent GraphNet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous ventilation to patients requiring respiratory support." This is a therapeutic function, directly supporting a patient's breathing.
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The Neumovent GraphNet does not perform this function.
- Lack of IVD-related information: The provided text does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, the Neumovent GraphNet is a ventilator, which is a life-support device, not an IVD.
N/A
Intended Use / 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.
Product codes
CBK
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
neonatelinfant to adult
Intended User / Care Setting
hospital and hospital-type facilities and during hospital and hospital-type transport
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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 (800) 638-2041 or (301) 796-7100 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/