(86 days)
No
The device description focuses on mechanical and gas-powered components for manual ventilation and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is intended for pulmonary resuscitation, delivering oxygen/air/oxygen mixtures and providing manual ventilation to neonatal infants, which are direct therapeutic interventions.
No
The device is described as a resuscitator providing ventilation and oxygen/air mixtures, and it lists controls for pressure and flow, which are therapeutic functions. There is no mention of it acquiring, analyzing, or interpreting biological data for diagnosis.
No
The device description clearly outlines multiple hardware components including flowmeters, an oxygen blender, manometer, pressure controls, an alarm, and a T-piece resuscitator. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide equipment for pulmonary resuscitation, which involves establishing an airway, providing oxygen/air mixtures, and manual ventilation. This is a direct intervention on the patient's respiratory system.
- Device Description: The device is a gas-powered emergency resuscitation system that delivers gases and controls pressure. It interacts directly with the patient's airway.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. This device does not perform any such analysis of biological samples.
The Puffin Lite Infant Resuscitator is a therapeutic device used for direct patient care, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.
Product codes (comma separated list FDA assigned to the subject device)
BTL
Device Description
The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb). The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
Indicated Patient Age Range
Neonatal infants weighing less than 10 kg (22 lb)
Intended User / Care Setting
Trained medical professionals / Hospital, delivery suites, nursery, ICU
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)
Bench testing was conducted to establish conformance to performance specifications.
Tests included:
- Valve Function after Vomitus: The proper function of the circuit shall be verified within 20 seconds of becoming disabled by vomitus. Function is verified by verifying flow valve accuracy. Result: Passed.
- Inspiratory Resistance: Pressure generated at the patient connection port during expiration should not exceed -5 cmH2O with inspiratory airflow set to 6 L/min. Result: Passed.
- Expiratory Resistance: Pressure generated at the patient connection port during expiration should not exceed 5 cmH2O with expiratory airflow set to 6 L/min. Result: Passed.
- Dead Space: The deadspace volume of the T-Piece circuit should be less than 7 mL. Result: Passed.
- FIO2 accuracy: The proper function of the FIO2 adjustment knob shall be verified by comparing the FIO2 setting value with the output oxygen concentration. Values shall be within 5%. Result: Passed.
- Primary and Secondary Flow Valve - Peak Flow: The proper function of the primary and secondary flow valves shall be verified by comparing the flow setting with the actual measured output flow. Result: Passed.
- Airway Manometer Accuracy: The proper function of the airway manometer shall be verified by comparing the pressure readings with the actual measured output pressure. Result: Passed.
- VOC Testing: The device should not add volatile organic compounds (VOCs) to the output gas delivered to the patient. Result: Passed.
- Particulate Analysis: The output of particulate matter sizes 2.5 microns or less are no more than 12 micrograms/cubic meter of air at one atmospheric pressure. Result: Passed.
The Puffin Lite Infant Resuscitator met all the performance requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
International Biomedical, K140707
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
January 18, 2018
International Biomedical Amy Pieper Director of Regulatory Affairs 8206 Cross Park Drive Austin, Texas 78754
Re: K182956
Trade/Device Name: Puffin Lite Infant Resuscitation System Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL Dated: December 19, 2018 Received: December 19, 2018
Dear Amy Pieper:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
James J. Lee -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182956
Device Name Puffin Lite Infant Resuscitation System
Indications for Use (Describe)
The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.
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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3
510(k) SUMMARY
| Submitter Information: | Regulatory Affairs Contact: | |
|---|---|---|
| International Biomedical | Amy Pieper | |
| 8206 Cross Park Drive | Director of Regulatory Affairs | |
| Austin, TX 78754 | (512) 873-0033 - phone | |
| U.S.A. | (512) 873-9090 - fax | |
| Date Summary Prepared: January 8, 2019 | ||
| Device Identification: | ||
| Trade Name: Puffin Lite Infant Resuscitation System | ||
| Common Name: Ventilator, Emergency Gas Powered (Resuscitator) | ||
| Regulatory Class: II | ||
| Regulation: 868.5925 | ||
| Product Code: BTL | ||
| Panel: Anesthesiology | ||
| Predicate Device: | ||
| LifeBorne Infant Resuscitator. International Biomedical, K140707 |
Device Description:
The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The Puffin Lite Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, and manual ventilation as established by resuscitation guidelines to neonatal infants weighing less than 10 kg (22 lb).
4
The resuscitation system includes two medical gas flowmeters, an integrated oxygen blender, airway pressure manometer, peak inspiratory pressure (PIP) control, positive end expiratory pressure (PEEP) control, a gas supply pressure alarm and T-piece resuscitator.
Modifications from the predicate device were:
- The integrated venturi suction was removed from the LifeBorne Infant Resuscitation System to create the Puffin Lite Infant Resuscitation System.
- . The overall form-factor was reduced (based on the removal of the suction function and the redundant air and oxygen gas inputs)
- Changes made to the device did not impact delivery of flow, pressure or waveform delivered to the patient
Indications for Use:
The Puffin Lite Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.
Functional Description and Technological Characteristics:
The Puffin Lite Infant Resuscitation System incorporates the following components for neonatal resuscitation, all of which are unchanged from the predicate device:
- . Medical blender to mix air and oxygen to a precise FIO2 (K883038 or K925982, also part of K140707 submission)
- Flowmeters for the delivery of oxygen or air/oxygen mixtures (included in K140707 submission)
- Peak Inspiratory Pressure (PIP) control to set the maximum pressure delivered during an inspiratory phase of a manual breath (included in K140707 submission)
- Peak End Expiratory Pressure (PEEP) control located on a provided T-piece circuit to set the maximum pressure during the expiratory phase of a manual breath (K093913, also part of K140707 submission)
- . An airway pressure manometer to monitor both PIP and PEEP airway pressure (included in K140707 submission)
Substantial Equivalence:
5
The Puffin Lite Infant Resuscitation System described in this submission is substantially equivalent to the predicate device, in regard to intended use. The intended use of the Puffin Lite Infant Resuscitation System is unchanged from the predicate device.
Changes made to the Puffin Lite versus the Puffin did not impact delivery of flow, pressure or waveform delivered to the patient. The Puffin Lite differs from the Puffin in that the venturi suction and the redundant air and oxygen inputs were eliminated. These changes allow for a smaller footprint that is easier to integrate. The airway portion of the Puffin Lite is identical to the predicate Puffin Infant Resuscitator. Calibration of the Puffin Lite airway is identical to the predicate Puffin device as all output parameters such as flow, peak inspiratory pressure (PIP) and fractional of inspired oxygen concertation (FIO2) are the same. Because these output parameters have not changed, when the interface circuit is attached, flow, PIP and FIO2 delivered to the patient does not change. Additionally, all pressure, flow and volume waveforms for the Puffin Lite are identical to its predicate device given the same compliance and resistance of the lung impacted.
| | Proposed
Puffin Lite Infant Resuscitator | LifeBorne Infant Resuscitator
K140707 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Puffin Lite Infant Resuscitator is
intended to provide the basic
equipment required for pulmonary
resuscitation of neonatal infants.
Pulmonary resuscitation includes
practices necessary to establish a clear
airway and provide oxygen or
air/oxygen mixtures and/or manual
ventilation to the neonatal infant. | The LifeBorne Infant Resuscitator is
intended to provide the basic
equipment required for pulmonary
resuscitation of neonatal infants.
Pulmonary resuscitation includes
practices necessary to establish a clear
airway and provide oxygen or air/oxygen
mixtures and/or manual ventilation to
the neonatal infant. |
| Environment for Use | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU |
| Patient Population | Neonatal Infant