BABI PLUS NEONATAL RESUSCITATION BAG

K112852 · A Plus Medical · BTM · Jan 13, 2012 · Anesthesiology

Device Facts

• Record ID: K112852
• Device Name: BABI PLUS NEONATAL RESUSCITATION BAG
• Applicant: A Plus Medical
• Product Code: BTM · Anesthesiology
• Decision Date: Jan 13, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.

Device Story

Babi Plus Neonatal Resuscitation Bag is a single-patient-use manual resuscitator; designed to provide temporary ventilation for neonates/infants (≤ 3.3 kg). Device operated by clinicians in hospital, transport, or emergency settings. Manual compression of bag delivers air/oxygen to patient via face mask or 15 mm connector. Includes pressure gauge connector for monitoring; integrated pressure limitation (25 cm H2O) with 40 cm H2O override. Provides supplemental oxygen delivery; assists in managing ventilatory insufficiency or failure. Benefits include portable, immediate respiratory support for low-birth-weight infants.

Clinical Evidence

Bench testing only. Performance attributes compared to predicate include oxygen delivery efficiency at various rates/volumes, inspiratory/expiratory resistance, dead space, and pressure limitation accuracy. All parameters met ISO 10651-4:2002 standards.

Technological Characteristics

Manual resuscitator; 15 mm I.D. patient connector; 4.0 mm O.D. tapered pressure gauge connector. Pressure limitation: 25 cm H2O ± 3.0 cm H2O with 40 cm H2O ± 5.0 cm H2O override. Dead space: 6.35 mls. Conforms to ISO 10651-4:2002. Single-patient use.

Indications for Use

Indicated for temporary ventilation of neonates, newborns, or infants with body mass ≤ 3.3 kg in hospital, transport, emergency, and post-hospital settings. Contraindicated for patients > 3.3 kg.

Regulatory Classification

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.

Predicate Devices

• Dispo - Manual Resuscitation Bag (K082092)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for A Plus Medical. The logo consists of the letter "a" in a circle, followed by the words "A Plus Medical" in a bold font. Below the words "A Plus Medical" is the phrase "Solutions for Respiratory Care" in a smaller font. The logo is black and white.

#### K 112852 રું... 510(k) Summary

#### December 12, 2011 Date:

## Owner:

A Plus Medical

5431 Avenida Encinas, STE G Carlsbad, CA 92008-4411 + 760-930-4025 Tel: + 760-930-0040 Fax:

Owner/Operator Number: 10023166

# Official Contact:

Thomas C. Loescher + 760-930-4025 Tel: + 760-930-0040 Fax:

Trade Names: Bobs. Plus" Neonatal Resuscitation Bag Babs. Plus" N Bag

Common/Usual Name:

Manual Resuscitation Bag

# Classification Name:

Device Name: Ventilator, Emergency, Manual (Resuscitator

Product Code: BTM

Regulation: CFR 868.5915

II

Device Class:

Device: Babs. Plus Neonatal Resuscitation Bag

# Predicate Devices:

| Number: | K082092 |
|----------------|----------------------------------|
| Product Name: | Dispo - Manual Resuscitation Bag |
| Manufacturer: | GaleMed Corporation |
| Product Codes: | 2328 |

### Device Description:

Single patient use medical device, which temporarily augment ventilation insufficiency or ventilatory failure.

# Indications for Use:

Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg in hospital, transport, emergency and post hospital care environments.

> 5411 Avenida Encinas, STE G Carlsbad, CA 92008-4411 2 . [phone] Fax: [phone] ~ 13~~

# JAN 1 3 2012

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Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo consists of the letter "a" inside of a circle on the left, followed by the words "A Plus Medical" in bold font. Below "A Plus Medical" are the words "Solutions for Respiratory Care" in a smaller font.

# Contraindications:

Body mass greater than 3.3 Kg.

# Patient Population:

Patient populations of neonate, newborn or infant with a body mass of less than or equal to 3.3 Kg.

#### Environment of Use:

Hospital, transport, emergency and post hospital care environments

# Comparative of Technological Characteristics:

Babs. Plus" and predicate products conform to requirements set forth in ISO 10651-4:2002 entitled "Lung ventilators -Part 4: Particular requirements for opered resuscitators". A summary of critical performance attributes include:

| Item | Babi.Plus™ | Predicate |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient Connector: | 15 mm I.D. | 15 mm I.D. / 22 mm O.D. |
| Face Mask: | Option offered, 15 mm O.D. | Option offered, 15 mm O.D. |
| Pressure Gauge Connector: | 4.0 mm O.D. tapered | None |
| Supplemental oxygen delivery: | VT-20 mls, Rate – 60 BPM:<br>@ 2 LPM – 91%, @ 10 LPM – 99+%<br>VT-20 mls, Rate – 120 BPM:<br>@ 2 LPM – 91%, @ 10 LPM – 99+ %<br>VT-50 mls, Rate – 30 BPM:<br>@ 2 LPM – 75%, @ 10 LPM – 99+%<br>VT-50 mls, Rate – 60 BPM:<br>@ 2 LPM – 66%, @ 10 LPM – 99+% | VT-20 mls, Rate – 60 BPM:<br>@ 2 LPM – 82%, @ 5 LM – 97%<br>@ 10 LPM – 98+% @ 15 LM – 99+%<br>VT-150 mls, Rate – 25 BPM:<br>@ 2 LPM – 50% @ 5 LM – 96%<br>@ 10 LPM – 98+% @ 15 LM – 99+% |
| Expiratory resistance: | < 1.7 cm H2O @ 5 LPM | < 2.8 cm H2O @ 5 LPM |
| Inspiratory resistance: | < 1.3 cm H2O @ 5 LPM | < 2.8 cm H2O @ 5 LPM |
| Patient Valve malfunction: | < 6.0 cm H2O @ 30 LPM | < 6.0 cm H2O @ 30 LPM |
| Dead space: | 6.35 mls | 6.8 mls |
| Minimum / Maximum<br>Volume: | 20 mls / 50 mls | 20 mls / 150 mls |
| Body mass range: | ≤3.3 Kg | ≤ 10.0 Kg |
| Pressure limitation: | 25 cm H2O ± 3.0 cm H2O with 40 cm<br>H2O ± 5.0 cm H2O over-ride | 40 cm H2O ± 5.0 cm H2O with over-<br>ride, unlimited pressure |

#### Conclusion:

Back Plus" Neonatal Manual Resuscitation bags are substantially equivalent in indication for use, environment of use, patient population design, material and function of the identified predicate.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion.

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

Mr. Thomas C. Loescher President A Plus Medical 5431 Avenida Encinas, Suite G Carlsbad, California 92008

JAN 1 3 2012

Re: K112852

Trade/Device Name: Babi Plus™ Neonatal Resuscitation Bag Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: December 12, 2011 Received: December 13, 2011

Dear Mr. Loescher:

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 - Mr. Loescher

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

hn 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

# Enclosure

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# Indications for Use Statement

(To be assigned) 510(k) Number:

Bobl.Plus" Neonatal Resuscitation Bag

Device Name: Indications for Use:

Single patient use manual resuscitation device to temporary ventilate neonate, newborn or infant with a body mass of less than or equal to 3.3

Kg in hospital, transport, emergency and post hospital care environments.

Over-the-counter use Prescription Use X or (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Schultheis

(Division Sign-Uff) Oivision of Anesthesiology, General Hospital Infection Control, Dental Devices

11/2852 510(k) Number: