(114 days)
The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
The NeoPIP Infant Resuscitator with Flow Meter 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.
The provided text is a 510(k) summary for the NeoPIP Infant Resuscitator with Flow Meter. The document focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about a study proving specific acceptance criteria for device performance as would be expected for an AI/ML powered device.
Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth are not available in the provided text. The document primarily describes the device, its intended use, classification, and asserts substantial equivalence to existing devices.
Here's an analysis based on the information provided, highlighting what is implicitly or explicitly stated and what is missing:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or a detailed performance report in the format of a table. The "Performance Standards" section explicitly states "None applicable." The premise of the 510(k) summary is to demonstrate substantial equivalence, meaning its performance should be comparable to the predicate devices, rather than meeting specific quantifiable performance metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. | Not explicitly stated in the document, but implicitly expected to be comparable to predicate devices for intended use, safety, and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a test set, sample size, or data provenance as it would for an AI/ML powered device. The 510(k) is a marketing clearance application for a medical device (a resuscitator), and the "study" demonstrating its safety and effectiveness relies on comparison to predicate devices, not on a data-driven performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a test set or the establishment of a ground truth by experts. Substantial equivalence relies on engineering and functional comparisons, not expert-adjudicated datasets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a "manual emergency ventilator" (resuscitator), not an AI/ML-powered diagnostic or assistive tool for human readers. There would be no MRMC study in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical, manually-operated medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as used in AI/ML performance evaluation is not relevant for this device. The safety and effectiveness are established through design, manufacturing controls, and comparison to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.
In summary: The provided 510(k) summary is for a traditional mechanical medical device, not an AI/ML-powered one. Therefore, the questions related to acceptance criteria for AI performance, test sets, experts, and ground truth are not addressed in this type of document. The entire document serves as a demonstration of "substantial equivalence" of the NeoPIP Infant Resuscitator with Flow Meter to legally marketed predicate devices in terms of intended use, safety, and effectiveness.
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JAN 6 2011
510(k) Summary of Safety and Effectiveness Section I
Applicant:
NeoForce Group Inc 35 Commerce Drive lvyland, Pa 18974 Registration Number: 3005599562
Contact Person:
Monica Ferrante VP Regulatory Ph 215-672-6800 x203 Fax 215-672-1123
Device trade/proprietary name:
NeoPIP Infant Resuscitator with Flow Meter
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 K072021 NeoPIP Infant Resuscitation Unit K092085 Ispira Resusciation System
Device Description
The NeoPIP Infant Resuscitator with Flow Meter 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
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adjustable. The device is intended for emergency resuscitation and is manually operated.
Intended Use
The NeoPIP Infant Resuscitator with Flow Meter 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/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features the department's seal, which includes an abstract symbol resembling three overlapping waves or lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the seal.
DEPARTMENT OF HEALTH & HUMAN SERVICES
6 Air
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Monica Ferrante Vice President of Regulatory Affairs NeoForce Group Incorporated 35 Commerce Drive lvyland, Pennsylvania 18974
Re: K102649
Trade/Device Name: NeoPIP Infant Resuscitator with Flow Meter Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: December 21, 2010 Received: December 22, 2010
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. 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- Ms. Ferrante ·
Enclosure
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/Industrv/default.htm.
Sincerely yours,
h for
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
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Section A SMDA Requirements
A.1 Indication for Use Statement
510(k) Number:
Device Name: NeoPIP Infant Resuscitator with Flow Meter
Indications for Use:
The NeoPIP Infant Resuscitator with Flow Meter is a manually operated, gas powered device with integrated flow meter intended for controlled and accurate resuscitation of neonates and infants in the clinical environment.
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
(Optional Format 1/2/96)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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).