(51 days)
Not Found
No
The description focuses on manual, gas-powered operation and pressure control, with no mention of AI/ML terms or data processing.
Yes
The device is described as a "resuscitation unit" that delivers oxygen or blended gas to neonates and infants and controls inspiratory pressure for emergency resuscitation in a clinical environment, which are all therapeutic interventions.
No
Explanation: The device is described as an "Infant Resuscitation Unit" intended for "controlled and accurate resuscitation of neonates and infants." It delivers gas and controls pressure to assist breathing. This is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a "manually operated, gas powered device" and describes physical components like a breathing circuit and pressure controls, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "controlled and accurate resuscitation of neonates and infants." This is a therapeutic and life-support function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on delivering gas, controlling pressure, and providing pressure relief. These are all related to respiratory support and resuscitation, not in vitro analysis.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests outside the body, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The NeoPIP Infant Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
Product codes
BTM
Device Description
The NeoPIP Infant Resuscitation Unit is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonates and infants
Intended User / Care Setting
Not Found
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)
K892885 Fisher & Paykel, Neopuff Infant Resuscitator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, 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
SEP 12 2007
510(k) Summary of Safety and Effectiveness Section I
Applicant:
NeoForce Group Inc 35 Commerce Drive Ivvland. Pa 18974 Registration Number: 3005599562
Contact Person:
Monica Ferrante VP Regulatory Ph 215-672-6800 Fax 215-672-1123
Device trade/proprietarv name:
NeoPIP Infant Resuscitation Unit
Device common/usual/classification name:
Emergency Resuscitation Device
Classification:
Anesthesiology 21 CFR 868.5915 Manual Emergency Ventilator, BTM, Class II
Performance Standards:
None applicable
Predicate Device:
K892885 Fisher & Paykel, Neopuff Infant Resuscitator
Device Description
The NeoPIP Infant Resuscitation Unit is intended to deliver oxygen or blended gas to a neonate while controlling peak inspiratory pressure. Positive end expiratory pressure is controlled at the patient end of the breathing circuit. The device also provides a maximum pressure relief capability which is adjustable. The device is intended for emergency resuscitation and is manually operated.
1
Intended Use
The NeoPIP Infant Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
Substantial Equivalence
The NeoPIP is believed to be substantially equivalent to currently marketed manual emergency resuscitation devices with regards to intended use, safety and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized abstract symbol that resembles three curved lines or waves stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 2 2007
Ms. Monica Ferrante Vice President Regulatory NeoForce Group, Incorporated 35 Commerce Drive Ivyland, Pennsylvania 18974-1510
Re: K072021
Trade/Device Name: NeoPIP Infant Resuscitation Unit Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: July 20, 2007 Received: July 23, 207
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 such 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
Page 2 - Ms. Ferrante
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Liu, Ph.D.
Chiu Lin, Ph.D. 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
510(k) Number: K072021
Device Name: NeoPIP Infant Resuscitation Unit
Indications for Use:
The NeoPIP Infant Resuscitation Unit is a manually operated, gas powered device intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
Prescription Use X (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)
Nil J. Patel
( Nision Sign-Off Civision of Anesthesiology, General Hospital, Infection Control, Dental Devices
072021
Page 1 of 1
510(k) Number: