(549 days)
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support. A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir. The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel. The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.
The provided text describes the regulatory clearance for the NeoNatalie Resuscitator and includes a comparison to a predicate device, as well as general information about testing performed. However, it does not contain the detailed clinical study information typically provided when discussing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device.
The NeoNatalie Resuscitator is a mechanical medical device (manual resuscitator), not an AI/ML device, and therefore the specific questions regarding test sets, training sets, ground truth, expert adjudication, and MRMC studies are not directly applicable in the way they would be for an AI/ML diagnostic or predictive tool.
Based on the provided text, here's an attempt to answer the questions, highlighting where the information is not directly available or applicable:
1. A table of acceptance criteria and the reported device performance
The document frames the "acceptance criteria" and "device performance" in terms of compliance with international standards and functional requirements for a manual resuscitator, rather than traditional clinical performance metrics like sensitivity or specificity for an AI algorithm.
| Acceptance Criteria (Defined by Standards/Functional Requirements) | Reported Device Performance (NeoNatalie Resuscitator) | Predicate Device Performance (Ambu® Mark IV Baby Resuscitator) |
|---|---|---|
| Expiratory Resistance | < 2.5 cmH2O at 5 LPM | 0.6 cmH2O at 5 LPM |
| Inspiratory Resistance | < 0.5 cmH2O at 5 LPM | 0.5 cmH2O at 5 LPM |
| Dead Space | 4 ml | < 6 ml |
| Biocompatibility | Meets FDA guidance and ISO-10993 requirements | Not explicitly stated for predicate in this context |
| Compliance with ISO 10651-4:2002 (Operator-powered resuscitators) | Demonstrates compliance with only minor deviations | Not explicitly stated for predicate in this context |
| Compliance with ISO 5356-1:2004 (Conical connectors) | Demonstrates compliance with only minor deviations | Not explicitly stated for predicate in this context |
| Reprocessing (High-level disinfection & performance after repeated reprocessing) | Meets reprocessing instructions and performance criteria | Not explicitly stated for predicate in this context |
Note: The document states "Design verification and design validation testing demonstrates that the NeoNatalie Resuscitator meets its functional requirements and performance specifications." The table above reflects specific quantitative metrics provided and general statements about compliance with standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. For a mechanical device, "test set" typically refers to physical units or simulated environments rather than patient data. The testing mentioned appears to be laboratory-based design verification and validation.
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)
This information is not applicable and therefore not provided. The testing relates to engineering and material performance, not expert-derived ground truth for an interpretive task.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. Adjudication methods are relevant for subjective interpretations, often in clinical studies or AI ground truth establishment.
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
This information is not applicable and therefore not provided. MRMC studies are used to evaluate the performance of diagnostic systems, often AI-assisted, and are not relevant for a manual mechanical resuscitator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and therefore not provided. This device is a manual resuscitator and does not involve an algorithm. Its operation inherently involves a "human-in-the-loop" as it is "operator-powered."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is compliance with established engineering standards (e.g., ISO 10651-4:2002 for lung ventilators, ISO 5356-1:2004 for conical connectors) and functional specifications (e.g., specific resistance values, dead space, biocompatibility). It is determined by objective physical measurements and established test protocols, not clinical outcomes data, pathology, or expert consensus in an interpretive sense.
8. The sample size for the training set
This information is not applicable and therefore not provided. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided. There is no "training set" for this device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
Laerdal Medical AS Mari Kaada Regulatory Affairs Manager Tanke Svilandsgate 30 P.O. Box 377 4002 Stavanger Norway
Re: K132172
Trade/Device Name: NeoNatalie resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual emergency ventilator Regulatory Class: Class II Product Code: BTM Dated: January 6, 2015 Received: January 7, 2015
Dear Ms. Kaada:
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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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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K132172
Device Name NeoNatalie Resuscitator
Indications for Use (Describe)
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Submitter's Name and Address
Mari Kaada Corporate Regulatory Affairs Manager Laerdal Medical AS Tanke Svilandsgate 30 P.O. Box 377 4002 Stavanger Norway T: (011) 47-51-51-16-30 Fax: (011) 47-51-51-17-17 Mari.Kaada@laerdal.no
Date the 510(k) Summary was Prepared
14 January 2015
Device Name
| Proprietary Name: | NeoNatalie Resuscitator |
|---|---|
| Common Name: | Manual Resuscitator (Reusable) |
| Classification Name: | Ventilator, Emergency, Manual (Resuscitator)(21 CFR 868.5915, Product Code BTM, Class II) |
Predicate Devices
The legally marketed devices to which Laerdal Medical AS claims equivalence for the NeoNatalie Resuscitator are:
- Ambu® Mark IV Baby Resuscitator (Ambu A/S), K053142
Device Description
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
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A manual resuscitator is a resuscitation device in which ventilation of the lungs is produced by the operator compressing the compressible unit of the device, the ventilation bag. The ventilation bag is self-inflating: the compressed bag will refill with ambient air via the bag inlet valve. The resuscitator provides positive pressure ventilation of the lungs (when used with a face mask). The resuscitator can be used to provide supplemental oxygen when used with the oxygen kit, the NeoNatalie Resuscitator Oxygen Kit. When a resuscitator fitted with an oxygen reservoir is used to provide supplemental oxygen, the ventilation bag will refill with oxygen from the oxygen reservoir.
The NeoNatalie Resuscitator is made of polysulfone, silicone rubber and stainless steel.
The NeoNatalie Resuscitator is reusable resuscitator which may be sterilized by autoclaving.
The NeoNatalie Resuscitator is intended for use by persons trained in the use of resuscitators.
Indication for Use
The NeoNatalie Resuscitator is a self-inflating, manual resuscitator intended for newborns and infants up to 5 kg body mass who require respiratory support.
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Substantial Equivalence
The NeoNatalie Resuscitator and Oxygen Kit has the same intended use as the Ambu® Mark IV Baby Resuscitator (Ambu A/S), K053142. It has the same fundamental design, method of use (ventilation via mask, bag, and optional oxygen reservoir) and similar materials to the predicate device. The following table compares the NeoNatalie Resuscitator with the predicate device with respect to indication and technological characteristics.
| NeoNatalie Resuscitator(this 510(k)) | Ambu® Mark IV BabyResuscitator(K053142) | |
|---|---|---|
| Indication | The NeoNatalie Resuscitator is aself-inflating, manual resuscitatorintended for newborns and infantsup to 5 kg body mass who requirerespiratory support. | Ambu® Mark IV BabyResuscitator is intended formanual pulmonary resuscitationand emergency respiratorysupport of neonate, infants andchildren with a body weight up to44 lbs (20 kg), approximately 4-5years of age. |
| Parts | • Two circular masks• Self-inflating ventilation bag• Patient valve• Oxygen kit (Oxygen ReservoirBag, Valve and Tubing) | • Patient valve with pressurerelief valve• Ventilation bag• Inlet valves• Oxygen tube |
| Materials | • Polysulfone• Silicone rubber• Stainless steel (spring) | • Silicone rubber• Polysulfone• Reinforced polypropylene• Ethylene propylene dienemonomer rubber• Polyoxymethylene• Polyethylene• Polyethersulfone• Thermoplastic polyurethane• Stainless steel• Aluminum |
| Expiratory Resistance | < 2.5 cmH2O at 5 LPM | 0.6 cmH2O at 5 LPM |
| Inspiratory Resistance | < 0.5 cmH2O at 5 LPM | 0.5 cmH2O at 5 LPM |
| Dead Space | 4 ml | < 6 ml |
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Data Used in Determination of Substantial Equivalence
Design verification and design validation testing demonstrates that the NeoNatalie Resuscitator meets its functional requirements and performance specifications. In particular,
- · Biocompatibility testing in accordance with FDA guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (Blue Book Memo G95-1, May 1, 1995). Testing of the patient contacting part and three indirect patient contact parts of the NeoNatalie Resuscitator demonstrate an applicable biocompatibility profile for the device,
- Testing in accordance with ISO 10651-4:2002 Lung ventilators Part 4: Particular requirements for operator-powered resuscitators demonstrates compliance with the standard with only minor deviations,
- · Testing in accordance with ISO 5356-1:2004 Anesthetic and respiratory equipment - Conical connectors – Part 1: Cones and sockets demonstrates compliance with the standard with only minor deviations .
- · Testing has demonstrated that the device can be high level disinfected by the reprocessing instructions given in the device labeling.
- · Testing has demonstrated that the device meet performance criteria after repeated reprocessing
Conclusion
Based on the results of the testing and other information submitted in the 510(k) application, the NeoNatalie Resuscitator does not raise any different questions regarding the safety or effectiveness compared to the predicate device. Further, the device was tested based on accepted scientific methods and the performance data demonstrate substantial equivalence: therefore, the NeoNatalie Resuscitator is considered to be as safe and effective.
§ 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).