(234 days)
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Not Found
No
The provided text does not mention AI, ML, or related concepts like deep learning, image processing, or specific performance metrics typically associated with AI/ML-driven devices. The description focuses solely on the intended use and patient population for ventilation devices.
Yes
The primary function of the device is to provide continuous ventilation, which is a form of respiratory support, directly treating a medical condition.
No
The devices are intended to provide continuous ventilation to patients requiring respiratory support, which is a therapeutic function, not a diagnostic one.
No
The intended use describes devices that provide continuous ventilation, which inherently requires hardware components to deliver air/gas to the patient. The lack of a device description does not negate this requirement.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use for all three models is to "provide continuous ventilation to patients requiring respiratory support." This describes a device that directly interacts with the patient's body to provide a therapeutic function (breathing support).
- IVD Definition: IVDs are defined as medical devices that are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or assays.
These devices are clearly described as ventilators, which are life-support devices that assist or replace spontaneous breathing. They are used directly on the patient and do not perform in vitro analysis of biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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
Model: Advance: neonate/infant to adult
Model: Neumovent GraphNet TS: pediatric to adult with an option for neonate/infant patients
Model: Neumovent GraphNet NEO: neonate/infant patient
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
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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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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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K111595 |