BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20

K110383 · A Plus Medical · BZD · Aug 1, 2011 · Anesthesiology

Device Facts

• Record ID: K110383
• Device Name: BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20
• Applicant: A Plus Medical
• Product Code: BZD · Anesthesiology
• Decision Date: Aug 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.

Device Story

Babi.Plus Pressure Limitation Manifold is a single-patient-use accessory for positive pressure breathing systems. It connects to the gas supply line to protect patients ≤ 10 Kg from excessive pressure caused by downstream occlusions. The device features a rigid plastic connector with a vertical-axis pressure relief valve and horizontal-axis ports for fresh gas inlet and oxygen sensor. It operates mechanically; when pressure exceeds the fixed threshold (10, 12.5, or 15 cm H2O), the valve relieves pressure and automatically resets once the occlusion is cleared. Used in hospital critical care units and during transport, it is operated by clinicians. The device provides a safety mechanism to prevent barotrauma, with output monitored by clinicians via the breathing circuit's pressure status. It benefits patients by ensuring consistent, safe pressure delivery during respiratory support.

Clinical Evidence

No clinical or animal testing was performed. Evidence is based on bench testing, including accelerated shelf-life testing (simulating 1 year), pressure relief accuracy testing at 1-15 LPM, and 28-day service life testing simulating 12 obstructions per hour.

Technological Characteristics

Rigid plastic manifold; fixed pressure relief valve configurations (10.0, 12.5, 15.0 cm H2O); 22 mm ID outlet port (ISO 5356-1 compliant); includes oxygen sensor port and fresh gas inlet; single-patient use; non-adjustable; mechanical operation.

Indications for Use

Indicated for neonates, infants, and children ≤ 10 Kg requiring pressure limitation during continuous gas flow therapy (up to 12 LPM) in hospital settings. Contraindicated for patients > 10 Kg or gas flows > 12 LPM.

Regulatory Classification

Identification

A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

Predicate Devices

• Infant Nasal Cannula System (K093716)
• BC110 Pressure Manifold (K040366)

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 features the letter "a" in a stylized font, with a small circle above it. To the right of the "a" is the text "A Plus Medical" in a bold font. Below "A Plus Medical" is the text "Solutions for Respiratory Care" in a smaller font.

| 5.0. | 510(k) Summary of Safety and Effectiveness Information |
|------|--------------------------------------------------------|
|------|--------------------------------------------------------|

# 038.2

Date:

May 25, 2011

AUG - 1 2011

# 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 Tel: + 760-930-4025 + 760-930-0040 Fax:

Trade Names:

The Bobs.Plus" Pressure Limitation Manifold

#### Common/Usual Name:

Pressure Relief Valve Manifold

#### Classification Name:

Ventilator, non-continuous (respirator) Device Name: Product Code: BZD Regulation: 868.5905 Device Class: II

## Device:

Babli.Plus" Pressure Limitation Manifold

#### Predicate Devices:

| K Number: | K093716 |
|----------------|-----------------------------|
| Product Name: | Infant Nasal Cannula System |
| Manufacturer: | A Plus Medical |
| Product Codes: | 20216 & 20217 |
| K Number: | K040366 |
| Product Name: | BC110 Pressure Manifold |
| Manufacturer: | Fisher & Paykel Healthcare |
| Product Codes: | BC110 & BC110-17 |

#### Device Description:

The Book Plus" single patient use Pressure Limitation Manifold is an accessory to the Book Plus" Infant Nasal Cannula System cleared for sale in K093716. The device is designed to protect patients up to 10 Kg from excessive pressure should a downstream occlusion occur in a positive pressure breathing system. The device is offered in 10 cm H2O and 15 cm HsO pressure relief valve configurations. The device is supplied with oxygen senor port, fresh gas inlet and a 1 meter length of gas supply tubing. The device connector molded in a rigid plastic to which a pressure relief valve is mounted on the vertical axis, the fresh gas inlet and oxygen senror port are located adgacent to each other on the hporzontial axis. The device relieves pressure cause by an occlusion before the expiratory port and automatically resets upon correction of the occlusion. The outlet port of the device is a 22 mm inside diameter connection in compliance with ISO 5356-1, Version 3.

#### Indications for Use:

Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit.

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Image /page/1/Picture/0 description: The image shows the logo for A Plus Medical. The logo features a stylized letter "A" with a small circle above it, followed by the words "A Plus Medical" in a bold, sans-serif font. Below the company name is the tagline "Solutions for Respiratory Care" in a smaller font size.

#### Contraindications:

Body mass >10 Kg Gas flows > 12 liters per minute.

#### Patient Population:

Neonate (premature infant), infant and children with a body mass of less than or equal to (≤) 10 Kg.

#### Environment of Use:

Hospitals and Patient Transport

# Comparative Table of Technological Characteristics:

| Item | Pressure Limitation Manifold | Predicate K093716 | Predicate K040366 |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Gas Supply Inlet: | 5.0 mm Gas Inlet | 10 mm Tubing Connector | 5.0 mm Gas Inlet |
| Gas Flow Range: | Less than 12 LPM | Less than 12 LPM | Less than 15 LPM |
| Oxygen Senor Port: | Present | None | Present |
| Pressure Monitoring Port: | None | Proximal Port | Present |
| Pressure Limitation: | Fixed 10.0 cm H2O<br>Fixed 12.5 cm H2O<br>Fixed 15.0 cm H2O | None | Variable with flow:<br>17.5 cm H2O @ 8 LPM |
| Intend Use: | Elimination of excessive<br>pressure should an obstruction<br>occur between gas supply and<br>exhalation port during<br>continuous gas flow therapy. | Gas delivery via nasal prong<br>interface during intermittent or<br>continuous gas flow therapy. | Pressure relief in case of<br>downstream obstruction in<br>circuit. |
| Location in Circuit - "dry<br>side" of humidifier inlet | "Dry side" of humidifier<br>(humidifier inlet) | "Wet side" of humidifier<br>(near patient) | "Dry side" of humidifier<br>(humidifier inlet) |

#### Non-Clinical Tests Performed

The following bench testing has been performed on the Book Plus Pressure Limitation Manifold to document performance and claims of this application:

- Accelerated shelf-life testing, simulating a one (1) year shelf life. 1.
- Accuracy of pressure relief for each offered configuration at gas flow rates of one (1) to fifteen (15) liters per minute, dry 2. air.
- Service life testing of twenty eight (28) days at a gas flow rate of 15 LPM simulating a downstream obstruction twelve 3. (12) times per hour.

#### Clinical and/or Animal Tests Performed:

No clinical testing was performed on any human; no testing was performed on any animal.

## Safety, Effectiveness and Performance

Book Plus" Pressure Limitation Manifold ranges are based on clinical practice guidelines and allows the clinician to determine the appropriate pressure limitation valve. Additionally, the each Pressure Limitation Manifold is tested at the time of manufacture at the minimum, mean and maximum gas flow rates to assure accuracy. The construction of the valve does not allow adjustment by the clinician. Each device is provided with a precise Instruction for Use and id clearly labeled as a "single patient use, not intended for reprocessing or use on multiple patients. Additionally the pressure relief value is clearly marked on the device using specific colors and indicia for each Pressure Limitation Manifold. The Pressure Limitation manifold has been tested under simulated clinical conditions after accelerated life and shipping tests.

#### Conclusion:

- The Backs Plus" Pressure Limitation Manifold is substantially equivalent in technology used to relieve excessive 1. pressure to as Predicate K040366.
- The Book Plus Pressure Limitation Manifold performance (ability to relieve pressure, ability to supply fresh gas, 2. ability to connect an oxygen sensor and ability to connect to a humidifier is substantially equivalent to Predicate K040366.
- The Bobe Plus" Pressure Limitation Manifold is identical of the Predicates named in Section 15 of this 3. application and are is substantially equivalent in intended use, patient population and environment stated in Predicates K040366 and K093716.

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#### 5411 Avenida Encinas, STE G

¹ Anerican Association for Respiration of Continuous Positive Arnay Pressure of Neonaes via Nasel Pronzes via Nasel Prongs, Nasepharynged. Tute, or Nasl Mask-2004 Revision & Update in RESPIRATORY CARE • SEPTEMBER 2004 VOL 49 NO 9, pages 1100 - 1108

Carlsbad, CA 92008-4411 2 . [phone] Fax: [phone]

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

AUG - 1 2011

Re: K110383

> Trade/Device Name: Babi*Plus™ Pressure Limitation Manifold Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuos Ventilator Regulatory Class: II Product Code: BZD Dated: July 19, 2011 Received: July 20, 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 l'ederal 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/AboutiFDA/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

hu 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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Image /page/4/Picture/0 description: The image shows the logo for A Plus Medical. The logo features a stylized letter "A" with a person figure above it. Next to the "A" is the text "A Plus Medical" in a bold font. Below the company name is the text "Solutions for Respiratory Care" in a smaller font.

# Indications for Use Statement

| 510(k) Number: | K110383 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | <b>Babi.Plus</b> Pressure Limitation Manifold |
| Indications for Use: | Single patient use device intended for neonate, infant or child with a body mass of less than 10 Kg requiring a pressure limitation system to eliminate excessive pressure should an obstruction occur between gas supply and exhalation port during continuous gas flow therapy up to 12 liters per minute in hospital critical care unit. |

Prescription Use X or (Part 21 CFR 801 Subpart D)

Over-the-counter use __ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

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

510(k) Number: K1110383