(90 days)
Not Found
No
The summary describes a manually operated, gas-powered resuscitator with user-set parameters and a pressure relief capability. There is no mention of AI, ML, image processing, or any data-driven decision-making processes. The device's function is based on mechanical and gas-powered principles, not algorithmic learning or inference.
Yes
The device is described as a "Resuscitation System" intended for "pulmonary resuscitation and emergency respiratory support" and to "provide CPAP to spontaneously breathing patients," which are therapeutic interventions.
No
The device is a resuscitator and CPAP system, designed for providing respiratory support and resuscitation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "manually operated, gas powered resuscitator" and mentions setting "Peak Inspiratory Pressure and flow," indicating it is a physical hardware device that delivers gas.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The NeoForce ISPIRA Resuscitation System is a device that provides respiratory support and resuscitation directly to a patient. It is a manually operated, gas-powered system that delivers air or blended gas to the lungs.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device interacts directly with the patient's respiratory system.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics. It is a therapeutic and life-support device.
N/A
Intended Use / Indications for Use
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask, Laryngeal Mask or Endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask, Laryngeal Mask or Endotracheal tube.
Product codes
BTL
Device Description
The ISPIRA Resuscitation System is intended to deliver a consistent tidal volume rescue breath of oxygen or blended gas to a pediatric or adult patient. Peak Inspiratory Pressure and flow are set by the user. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated. In addition to resuscitation the device also provides CPAP capability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pulmonary
Indicated Patient Age Range
pediatric and adult patients with a body weight of more than 22 lbs (10 kg.)
Intended User / Care Setting
hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5925 Powered emergency ventilator.
(a)
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.(b)
Classification. Class II (performance standards).
0
Section I 510(k) Summary of Safety and Effectiveness
Applicant:
NeoForce Group Inc 35 Commerce Drive lvyland, Pa 18974 Registration Number: 3005599562
Contact Person:
Monica Ferrante VP Regulatory Ph 215-672-6800 Fax 215-672-1123
Device trade/proprietary name:
ISPIRA Resuscitation System
Device common/usual/classification name:
Emergency Resuscitation Device
Classification:
Anesthesiology 21 CFR 868.5925 Ventilator, Emergency Power, BTL, Class II
Performance Standards:
None applicable
Predicate Device:
K892885 Fisher & Paykel, Neopuff Resuscitator K080692 Airon Corp, MACS CPAP K053140 Ambu, Mark IV
OCT - 7 2009
:1
1
Device Description
The ISPIRA Resuscitation System is intended to deliver a consistent tidal volume rescue breath of oxygen or blended gas to a pediatric or adult patient. Peak Inspiratory Pressure and flow are set by the user. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated. In addition to resuscitation the device also provides CPAP capability.
Intended Use
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask, Laryngeal Mask or Endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask, Laryngeal Mask or Endotracheal tube.
Substantial Equivalence
The ISPIRA is believed to be substantially equivalent to currently marketed manual emergency resuscitation and CPAP devices with regards to intended use, safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized graphic of three curved lines, which are likely meant to represent the human form. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring. MD 20993-0002
Ms. Monica Ferrante Vice President Regulatory NeoForce Group, Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974
OCT - 7 2009
Re: K092085
Trade/Device Name: ISPIRA Resuscitation System Regulation Number: 21CFR 868.5925 Regulation Name: Powdered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: July 9, 2009 Received: July 9, 2009
Dear Ms. Ferrante:
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.
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.
3
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,
Nh for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
4
Indication for Use Statement
510(k) Number:
Device Name: ISPIRA Resuscitation System
Indications for Use:
The NeoForce ISPIRA Resuscitation System is a manually operated, gas powered resuscitator intended for controlled and accurate pulmonary resuscitation and emergency respiratory support of pediatric and adult patients with a body weight of more than 22 lbs (10 kg.) in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
The device is also intended to provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via face mask, laryngeal mask or endotracheal tube.
This is a prescription device.
(Please do not write below this line continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use × (Per 21 CFR 801.109) OR
Over-the-Counter Use
l Hth
(Optional Format 1/2/96)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092085