LIFEBORNE INFANT RESUSCITATOR

K140707 · International Biomedical · BTL · May 28, 2014 · Anesthesiology

Device Facts

• Record ID: K140707
• Device Name: LIFEBORNE INFANT RESUSCITATOR
• Applicant: International Biomedical
• Product Code: BTL · Anesthesiology
• Decision Date: May 28, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Gas-powered emergency resuscitation system for neonatal/infant patients (<10 kg). Used in hospital settings (delivery suites, nursery, ICU) by trained medical professionals. Inputs: wall gas or cylinder source. Components: Venturi vacuum device for airway suctioning; vacuum gauge; medical blender for FIO2 control (21-100%); flowmeters; T-piece circuit with PEEP control; PIP control; airway pressure manometer. Operation: clinician manually controls ventilation via face mask or ET tube. Output: controlled gas delivery and airway pressure monitoring. Benefits: provides precise FIO2, manual ventilation, and emergency airway clearance to support neonatal resuscitation.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via testing: valve function after vomitus, inspiratory/expiratory resistance, dead space (<7 mL), FIO2 accuracy (within 5%), flow valve accuracy, airway manometer accuracy, VOC testing, and particulate analysis.

Technological Characteristics

Gas-powered manual resuscitator. Components: Venturi vacuum, vacuum gauge, medical blender, flowmeters, PIP/PEEP controls, airway pressure manometer. Patient connection: face mask or ET tube. Gas source: wall or cylinder. FIO2 range: 21-100%. Manometer range: -10 to 80 cm H2O. Max flow: 15 LPM. Mechanical/pneumatic operation; no software or electronic algorithms.

Indications for Use

Indicated for pulmonary resuscitation of neonatal infants and infants weighing less than 10 kg. Used to establish clear airway and provide oxygen/air mixtures and manual ventilation.

Regulatory Classification

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.

Predicate Devices

• GE - Giraffe and Panda T-Piece Resuscitation System (k070210)
• Fisher & Paykel - NeoPuff (k892885)

Submission Summary (Full Text)

{0}------------------------------------------------

K140707

## Traditional 510(k) Submission MAY 28 2014 LifeBorne Infant Resuscitator - March 18, 2014

## 510(k) SUMMARY

Submitter Information:

International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A.

Regulatory Affairs Contact:

Amy Pieper Director of Regulatory Affairs [phone] - phone [phone] - fax

Date Summary Prepared: March 18, 2014

Device Identification:

Trade Name: LifeBorne Infant Resuscitator Common Name: Ventilator, Emergency Gas Powered (Resuscitator) Regulatory Class: II Regulation: 868.5925 Product Code: BTL Panel: Anesthesiology

Predicate Device:

GE - Giraffe and Panda T-Piece Resuscitation System - k070210 Fisher & Paykel - NeoPuff - k892885

Device Description:

The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne 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, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).

#### Intended Use:

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.

{1}------------------------------------------------

## Traditional 510(k) Submission LifeBorne Infant Resuscitator - March 18, 2014

### Functional Description and Technological Characteristics:

The LifeBorne Infant Resuscitation System incorporates the following components for neonatal resuscitation:

- Venturi vacuum device for suctioning airways (no 510k) .
- Vacuum gauge for monitoring suction pressures (no 510k) .
- . Medical blender to mix air and oxygen to a precise FIO2 (k883038 or k925982)
- . Flowmeters for the delivery of oxygen or air/oxygen mixtures (no 510k)
- . Peak Inspiratory Pressure (PIP) control to set the maximum pressure delivered during an inspiratory phase of a manual breath (no 510k)
- . 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)
- . An airway pressure manometer to monitor both PIP and PEEP airway pressure (no 510k)

### Substantial Equivalence:

The LifeBorne Infant Resuscitator described in this submission is, in our opinion, substantially equivalent to the predicate device, in regards to intended use and safety and effectiveness. The intended use of the LifeBorne Infant Resuscitator is identical to the intended use of the predicate k070210.

| | Proposed<br>LifeBorne Infant<br>Resuscitator | Predicate<br>k070210 GE Giraffe and Panda | Predicate<br>k892885 F&P NeoPuff |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LifeBorne Infant<br>Resuscitator is intended<br>to provide the basic<br>equipment required for<br>pulmonary resuscitation<br>of neonatal infants.<br>Pulmonary resuscitation<br>includes practices<br>necessary to establish a<br>clear airway and provide<br>oxygen or air/oxygen<br>mixtures and/or manual<br>ventilation to the<br>neonatal infant. | The T-piece resuscitation<br>system provides the basic<br>equipment required for<br>pulmonary resuscitation of<br>infants. Pulmonary<br>resuscitation includes<br>practices necessary to<br>establish a clear airway and<br>provide oxygen or<br>air/oxygen mixtures and or<br>manual ventilation to the<br>infant. | Manually operated, gas<br>powered resuscitator<br>which provides<br>controlled and accurate<br>resuscitation of newborn<br>babies. |
| Environment for Use | Hospital, delivery suites,<br>nursery, ICU | Hospital, delivery suites,<br>nursery, ICU | Hospital, delivery suites,<br>nursery, ICU |
| Patient Population | Infant < 10 kg | Infant < 10 kg | Infant < 10 kg |
| Patient Connection | Face mask; ET tube | Face mask; ET tube | Face mask; ET tube |
| Air/Oxygen Mixture | 21-100% | 21-100% | Not specified |
| Gas Flow Source | Wall gas or cylinder | Wall gas or cylinder | Wall gas or cylinder |
| Manometer Range | -10 to 80 cm H2O | -10 to 80 cm H2O | -20 to 80 cm H2O |

FDA Submission - Resuscitator

{2}------------------------------------------------

# Traditional 510(k) Submission LifeBorne Infant Resuscitator - March 18, 2014

| Peak Inspiratory<br>Pressure (PIP) | Max 45 +/- 5 cm H2O | Max 45 +/- 5 cm H2O | 2 – 80 cm H2O |
|-----------------------------------------------|------------------------------------|------------------------------------|---------------------------------------|
| Positive End<br>Expiratory Pressure<br>(PEEP) | 0-6 cm H2O | 0-6 cm H2O | 1-25 cm H2O,<br>depending on flowrate |
| Vacuum Pressure<br>Range | 0 - 150 mmHg, negative<br>pressure | 0 - 150 mmHg, negative<br>pressure | N/A – suction not<br>available |
| Maximum gas flow<br>rate | 15 LPM | 15 LPM | 15 LPM |
| Maximum pressure<br>relief | 55 cm H2O | 55 cm H2O | 40 cm H2O |
| Features: Venturi<br>Vacuum Device | Present, same as<br>predicate | Present | N/A |
| Features: Vacuum<br>gauge | Present, same as<br>predicate | Present | N/A |
| Features: Integrated<br>Medical Blender | Present, same as<br>predicate | Present | Non integrated, but<br>available |
| Features: Flowmeters<br>for delivery of gas | Present, same as<br>predicate | Present | Not integrated, but<br>available |
| Features: PIP control | Present, same as<br>predicate | Present | Present |
| Features: PEEP<br>control | Present, same as<br>predicate | Present | Present |
| Features: Airway<br>pressure manometer | Present, same as<br>predicate | Present | Present |

Performance Testing:

Pulmonary resuscitation of infants includes well established clinical practices; clinical testing is not necessary to support safety and effectiveness. Conformance of the LifeBorne Infant Resuscitation System to performance specifications has been established through bench testing.

| TEST | TEST REQUIREMENTS | SUMMARY OF<br>RESULTS |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Valve Function<br>after Vomitus | The proper function of the circuit shall be verified within<br>20 seconds of becoming disabled by vomitus. Function is<br>verified by verifying flow valve accuracy. | Passed. |
| Inspiratory<br>Resistance | Pressure generated at the patient connection port during<br>expiration should not exceed -5 cmH2O with inspiratory<br>airflow set to 6 L/min. | Passed. |
| Expiratory<br>Resistance | Pressure generated at the patient connection port during<br>expiration should not exceed 5 cmH2O with expiratory<br>airflow set to 6 L/min. | Passed. |
| Dead Space | The deadspace volume of the T-Piece circuit should be less<br>than 7 mL. | Passed. |

{3}------------------------------------------------

# Traditional 510(k) Submission LifeBorne Infant Resuscitator - March 18, 2014

| 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%. | Passed. |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Primary and<br>Secondary Flow<br>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. | Passed. |
| Airway Manometer<br>Accuracy | The proper function of the airway manometer shall be verified by comparing the pressure readings with the actual measured output pressure. | Passed. |
| VOC Testing | The device should not add volatile organic compounds (VOCs) to the output gas delivered to the patient. | Passed |
| Particulate<br>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. | Passed |

The LifeBorne Infant Resuscitator met all the performance requirements as outlined above and thus can be found to be substantially equivalent to the predicate devices.

### Conclusion:

In regards to intended use and technology the LifeBorne Infant Resuscitator is substantially equivalent to the listed predicates. Any differences between the LifeBorne Infant Resuscitator and the predicates do not raise any new questions of safety and effectiveness.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2014

International Biomedical, Ltd. Amy Pieper Director of Regulatory Affairs 8206 Cross Park Drive Austin, TX 78754

Re: K140707

Trade/Device Name: LifeBorne Infant Resuscitator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered emergency ventilator Regulatory Class: Class II Product Code: BTL Dated: March 18, 2014 Received: March 24, 2014

Dear Ms. 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. 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.

{5}------------------------------------------------

### Page 2 - Amy Pieper

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 [phone] or [phone] 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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Tejashri Parohit-Sheth, M.D.
Tejashri Purohitt Sheth HD
Chalal Deputy Director
DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

| Device Name | |
|-------------|--|
|-------------|--|

LifeBorne Infant Resuscitator

Indications for Use (Describe)

The LifeBome 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Comments the FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR F Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

> Anva C. Harry -S 1.8.00 2014.05.23 10:09:29 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)