GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM

K040862 · Caradyne, Ltd. · BZD · Jun 30, 2004 · Anesthesiology

Device Facts

• Record ID: K040862
• Device Name: GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM
• Applicant: Caradyne, Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg body weight with RDS or which are recovering from RDS (Respiratory Distress Syndrome). May or may not include humidification capabilities.

Device Story

Guardian Neonate CPAP/Humidification System provides non-invasive respiratory support for neonates/infants <5kg. Device mixes air and oxygen (21-100%) and delivers flow (1-20 L/min) at CPAP pressures (2-10 cm H2O). Humidification provided via Vapotherm microporous membrane. System includes patient circuits, accessories, and interfaces for single-patient use. Operated by hospital staff; monitors circuit pressure, FiO2, and gas temperature (33-41°C) via integrated displays. Alarms alert clinicians to high/low pressure, FiO2, or temperature deviations. Pressure relief valve set at 18 cm H2O ensures safety. Device supports patient recovery from RDS by maintaining airway patency through continuous positive airway pressure.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by bench testing and technical performance specifications.

Technological Characteristics

Non-invasive CPAP system; provides 2-10 cm H2O pressure; 21-100% O2 concentration; 1-20 L/min flow. Humidification via Vapotherm microporous membrane. Gas temperature range 33-41°C. Features pressure relief valve (18 cm H2O), AC/battery power, and visual bar graph/window displays for pressure, O2, and temperature. Alarms for pressure, FiO2, and temperature. Single-patient use circuits.

Indications for Use

Indicated for newborns and infants < 5kg body weight with Respiratory Distress Syndrome (RDS) or recovering from RDS, requiring non-invasive CPAP respiratory support in a hospital setting.

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

• EME - Infant Flow systems (K011516)
• Vapotherm - 2000I (K000401)

Submission Summary (Full Text)

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K040862

## Summary of Safety and Effectiveness

## Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 29 June 2004

| Official Contact: | John O'Dea, Ph.D. - General Manager | |
|----------------------------|--------------------------------------------------------------------|--|
| Proprietary or Trade Name: | Guardian Neonatal CPAP / Humidification System | |
| Common/Usual Name: | CPAP system | |
| Classification Name: | Ventilator, non-continuous (Respirator) | |
| Predicate Devices: | EME - Infant Flow systems - K011516<br>Vapotherm - 2000I - K000401 | |

# Device Description

The Guardian Neonate CPAP / Humidification systems is non-invasive respiratory support device for neonatal patients

| Intended Use and Environments | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use -- | Intended to provide CPAP for use in hospitals to<br>treat newborns and infants less than 5kg body weight with<br>RDS or which are recovering from RDS (Respiratory<br>Distress Syndrome). May or may not include humidification<br>capabilities. |
| Environment of Use -- | Hospital |

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### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 29-Jun-04

General Technical Characteristics

| Attribute | Guardian CPAP System |
|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Intended to provide CPAP for neonates and infants < 5kg body weight with RDS or recovering from RDS (Respiratory Distress Syndrome) | Yes |
| Humidification of gases | Yes |
| Environment of Use - Hospital | Yes |
| Single patient use circuits and accessories including patient interfaces | Yes |
| Design Features and Specifications | |
| CPAP – Range of pressure | 2 to 10 cm H2O |
| Air / Oxygen mixture | Yes |
| % O2 range | 21 – 100% |
| Range of Flow delivered | 1 to 15 Lpm (Flow Mode)<br>1 to 20 L/min (CPAP Mode) |
| Humidification method | Vapotherm microporous membrane |
| Range of temperature of gas delivered | 33 to 41 °C |
| Measured Data | |
| Circuit Pressure (bar graph display) Range | 0-12 cm H2O |
| % O2 (window display) - Range | 21-100% |
| Gas temperature - Range | 10-50 °C |
| Flow (bar graph) | Indicator |
| Power | AC and Battery |
| Pressure Relief Valve | 18 cmH2O |
| Alarms | High and Low Pressure<br>High and Low FIO2<br>High and Low Temperature |
| Supply Gases Failure | Air and Oxygen |

## Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed device when compared to the predicate device is safe and effective and is substantially equivalent.

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 3 0 2004

Mr. John O'Dea General Manager Caradyne, Limited Parkmore Business Centre Parkmore West Galway. IRELAND

Re: K040862

Trade/Device Name: Guardian Neonate CPAP / Humidification System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: June 11, 2004 Received: June 14, 2004

Dear Mr. O'Dea:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. O'Dea

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely vours.

Chi-Lien, Ph.D.

Chiu Lin, Ph.D. 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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K040862 510(k) Number:

Guardian Neonate CPAP / Humidification system Device Name:

Indications for Use:

Intended to provide CPAP for use in hospitals to treat newborns and infants less than 5kg Intended to provide of provish are recovering from RDS. (Respiratory Distress Syndrome) May or may not include humidification capabilities

or Over-the-counter use __ Prescription Use XX (Per CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quu Suliom

(Division Sigh-Off) (Division Sigh-Off))
Division of Anesthesiology, General Hospital, Division of Anesthoolonsis.

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510(k) Number: K040862

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