INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

K031745 · Sensor Medics Corp. · BZD · Feb 13, 2004 · Anesthesiology

Device Facts

• Record ID: K031745
• Device Name: INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
• Applicant: Sensor Medics Corp.
• Product Code: BZD · Anesthesiology
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of a Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in hospitals, hospital-type facilities and intra-hospital transport environments and is indicated for the treatment of newborn and infant patients.

Device Story

Infant Flow Plus System provides Bi-Level CPAP (SiPAP) to newborn and infant patients. Device consists of driver, generator, nasal prongs, and masks. Operates by modifying existing air/oxygen mixer and CPAP flow control; adds ancillary manual flow control with electronic control solenoid valve for timed delivery of augmented flow and pressure. Housed in enclosure designed to attach to existing Infant Flow Driver Unit. Used in hospitals and intra-hospital transport environments by clinicians. Output allows delivery of sigh breaths to support respiratory function. Benefits include non-invasive respiratory support for neonates.

Clinical Evidence

Bench testing only. The device was verified for compliance with IEC 60601-1 (General safety), IEC 60601-1-2 (Electromagnetic compatibility), IEC 60601-1-4 (Programmable electrical medical systems), and UL 2601-1.

Technological Characteristics

Bi-level nasal CPAP system. Includes driver, generator, prongs, and masks. Features electronic control solenoid valve for timed flow/pressure delivery. Designed as a modular add-on to existing Infant Flow Driver units. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, and UL 2601-1 standards.

Indications for Use

Indicated for the treatment of newborn and infant patients requiring Bi-Level CPAP (SiPAP) to produce a sigh.

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

• Star Sync (K840865 & K884521)
• Infant Flow System (K011516)
• Model IV-100B Infant Ventilator (K833982)
• Infant Flow System (K991972)

Submission Summary (Full Text)

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510(k) Notification Infant Flow Plus System June 2003

#### 510(k) SUMMARY

031745

#### Date Summary Prepared

May 1st, 2002

COMPANY NAME AND ADDRESS

SensorMedics Corporation 22705 Savi Ranch Parkway Yorba Linda, CA 92887 USA

# CONTACT PERSON

Earl W. Draper Director QS/RA Telephone [phone] [phone] Fax:

DEVICE TRADE NAME

Infant Flow Plus ™

COMMON NAME

Bi-level Nasal CPAP

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510(k) Notification Infant Flow Plus System June 2003

#### PREDICATE DEVICES

- Star Sync 1. Device Name: Classification: Class II Manufacturer: Infrasonics, Inc. 3911 Sorrento Valley Blvd. San Diego CA 92121-1402 K840865 & K884521 510(k) #:
- 2. Device Name: Infant Flow System Classification: Class II Manufacturer: EME (Electro Medical Equipment) Ltd 60 Gladstone Place Brighton Sussex, BN2 3QD United Kingdom 510(k) #: K011516
- 3. Device Name: Model IV-100B Infant Ventilator Classification: Class II Manufacturer: Sechrist 510(k)# K833982
- 4. Device Name: Infant Flow System Classification: Class II Manufacturer Manufactured for SensorMedics by EME (Electro Medical Equipment) Ltd 60 Gladstone Place Brighton Sussex, BN2 3QD United Kingdom 510(k)# K991972

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When compared to the predicate devices, the Infant Flow Plus System does not incorporate any significant change in intended use, method of operation, material or design that could affect the safety or effectiveness of the subject device.

## DEVICE DESCRIPTION

The Infant Flow Plus System is a factory-installed modification to the Infant Flow Plus System. It uses the existing manually operated air / oxygen mixer and CPAP flow control. An ancillary manual flow control with electronic control solenoid valve allows timed delivery of augmented flow and pressure. The modification is housed in a robust enclosure that is designed to "piggy back" on to the existing Infant Flow Driver Unit.

## INTENDED USE

The Infant Flow Plus System consisting of a Driver and Generator plus NCPAP Prongs and Masks, is intended for the provision of a Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in hospitals, hospital-type facilities and intra-hospital transport environments and is indicated for the treatment of newborn and infant patients.

# PERFORMANCE DATA

The Infant Flow Plus System has been verified to be compliant with the requirements of the following standards:

- IEC60601-1, Medical Electrical Equipment. Part 1; General requirements . for safety, Second Edition, 1998; Amendment 1, 1991-11; Amendment 2, 1995-03
- IEC60601-1-2, Second Edition, 2001, Medical Electrical Equipment, Part 1; . General Requirements for Safety; Electromagnetic Compatibility -Requirements for Tests.
- IEC60601-1-4: 1996. Medical Electrical Equipment Part 1: General . requirements for safety: 4. Collateral Standard: Programmable electrical medical systems.
- UL 2601-1: Medical Electrical Equipment: General Requirements for . Safety,

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#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FFB 1 3 2004

SensorMedics, Incorporated c/o Mr. Tom Gutierrez P.E. VIASYS Healthcare GmbH 1100 Bird Center Drive Palm Springs, California 92262

Re: K031745

Trade/Device Name: Infant Flow Plus Infant CPAP System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 11, 2003 Received: December 16, 2003

Dear Mr. Gutierrez:

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 111 (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 Fedcral 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.

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Page 2 - Mr. Tom Gutierrez P.E.

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 yours.

Susan Runn

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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510(k) Notification Infant Flow Plus System June 2003

## INDICATIONS FOR USE STATEMENT

Applicant:

SensorMedics Corporation

510(k) Number:

K021745

Infant Flow Plus System Device Name:

The Infant Flow Plus System consisting of a Driver and Indications for Use: Generator plus NCPAP Prongs and Masks, is intended for the provision of Bi-Level CPAP (SiPAP) to produce a sigh. The system is for use in Hospitals, Hospital-type facilities and intra-Hospital transport environments and is indicated for the treatment of Newborn and Infant patients.

Yes (Per 21 CFR 801.109) Prescription Use:

Please Do Not WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

Prescription Use

or

OTC Use

Kthun

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number K031745