(51 days)
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.
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.
This 510(k) submission for the NeoPIP Infant Resuscitation Unit does not contain the detailed information necessary to complete the requested table and study description regarding acceptance criteria and performance.
Here's why and what information is missing:
- Type of Submission: This is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove specific performance against pre-defined acceptance criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
- Focus on Substantial Equivalence: The document primarily focuses on stating the intended use, device description, and claiming substantial equivalence to the predicate device (K892885 Fisher & Paykel, Neopuff Infant Resuscitator).
- Lack of Performance Data: There is no section detailing specific performance metrics, test methods, results, or acceptance criteria within the provided text. The document states "Performance Standards: None applicable," which further indicates that the submission doesn't rely on meeting specific quantitative performance metrics defined by external standards for approval.
- No Clinical Study Description: There is no mention of any clinical study, either standalone or comparative, involving human readers, experts, or ground truth establishment. The document describes a "manually operated, gas powered device," suggesting its evaluation would revolve around engineering and functional testing rather than image-based diagnostic performance.
Therefore, I cannot provide the requested table and study description based on the input. The provided text is a regulatory clearance letter and a summary of the device, not a detailed performance study.
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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.
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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.
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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.
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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
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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:
§ 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).