MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300

K031741 · Alaris Medical Systems, Inc. · CCK · Feb 9, 2004 · Anesthesiology

Device Facts

• Record ID: K031741
• Device Name: MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300
• Applicant: Alaris Medical Systems, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Feb 9, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

Device Story

Medley™ EtCO2 Module integrates into existing Medley™ Medication Safety System; utilizes Oridion Microstream capnography technology. Device measures inspired/expired CO2 and respiratory rate via patient-connected filterline accessories. Used in OR, ICU, NICU, transport, and emergency settings by professional healthcare providers. Provides continuous, non-invasive monitoring data to clinicians to assist in patient respiratory status assessment. Benefits include real-time CO2 monitoring for improved patient safety during clinical care.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing and comparison of technological characteristics to the predicate device.

Technological Characteristics

Capnograph module utilizing Oridion Microstream technology. Integrates with Medley™ Medication Safety System. Measures EtCO2, FiCO2, and respiratory rate. Compatible with various Microstream filterline accessories. Class II device.

Indications for Use

Indicated for continuous, non-invasive monitoring of EtCO2, FiCO2, and respiratory rate in adult, pediatric, and infant/neonate patients, including both intubated and non-intubated individuals, by professional healthcare providers.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• MicroCap/NPB-75 (K964239)

Reference Devices

• Microstream O2/CO2 Oral Nasal Filterline (K011536)
• Microstream Oral Nasal, Cannula Filterline (K011050)
• Microstream Filterline OR/EMS (K980324)
• Microstream Nasal Cannula Filterline (K980325)
• Microstream Filterline ICU (K980327)

Submission Summary (Full Text)

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ALARIS MEDICAL SYSTEMS, INC.

141

# SUMMARY OF SAFETY AND EFFECTIVENESS ALARIS Medical Systems® Medley™ EtCO2 Module

### SUBMITTER INFORMATION

| A. | Company Name: | ALARIS Medical Systems, Inc. |
|----|--------------------------------|-------------------------------------------------------------------------------------------|
| B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 |
| C. | Company Phone:<br>Company Fax: | [phone]<br>[phone] |
| D. | Contact Person: | Renée L. Fluet<br>Principal Regulatory Affairs Specialist<br>ALARIS Medical Systems, Inc. |
| E. | Date Summary Prepared: | June 3, 2003 |

#### DEVICE IDENTIFICATION

| A. | Generic Device Name: | Capnograph / EtCO2 Monitor |
|----|-------------------------|----------------------------------|
| B. | Trade/Proprietary Name: | Medley™ System with EtCO2 Module |
| C. | Classification: | Class II |
| D. | Product Code: | CCK, Capnograph |

#### DEVICE DESCRIPTION

The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239). The current

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### SUMMARY OF SAFETY AND EFFECTIVENESS

#### Page 2

line of Oridion Microstream accessories for use with the Medley™ EtCO2 Module are listed below:

- K011536 Microstream O2/CO2 Oral Nasal Filterline ●
- K011050 Microstream Oral Nasal, Cannula Filterline .
- K980324 Microstream Filterline OR/EMS .
- K980325 Microstream Nasal Cannula Filterline .
- K980327 Microstream Filterline ICU .

### SUBSTANTIAL EQUIVALENCE

The ALARIS Medical Systems® Medley™ System with EtCO2 Module is of comparable type and is substantially equivalent to the following predicate device:

| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|------------------|------------------------------------------------------------------------|------------|--------------|
| MicroCap/NPB-75 | Oridion Medical Ltd.<br>(formally known as<br>Spegas Industries, Inc.) | K964239 | 05/09/97 |

#### INTENDED USE

The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired.

The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

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# SUMMARY OF SAFETY AND EFFECTIVENESS Page 3

# TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the Medley™ System with EtCO2 Module and the predicate device has been performed. The results of this comparison demonstrate that the Medley™ System with EtCO2 Module is equivalent to the marketed predicate device in technological characteristics.

### PERFORMANCE DATA

The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements, and is substantially equivalent to the predicate devices.

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Image /page/3/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" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like extensions.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 2004

Ms. Renee L. Fluet Principal Regulatory Affairs Specialist Alaris Medical Systems, Incorporated Corporate Office 10221 Wateridge Circle San Diego, California 92121-2733

Re: K031741

Trade/Device Name: Medley EtCO2 Module Regulation Number: 868.1400 Regulation Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Regulatory Class: II Product Code: CCK Dated: January 9, 2004 Reccived: January 12, 2004

Dear Ms. Fluet:

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 cnactment 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 - Ms. Rence Fluet

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 (OS) 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,
fthul

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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# INDICATIONS FOR USE

KO3174) ___ (To Be Assigned By FDA) 510(k) Number:

Medley™ System with EtCO2 Module Device Trade Name:

Indications for Use: The Medley EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired.

The Medley "" EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | OR | Over-The-Counter Use | <span style="text-decoration: overline;">_____</span> |
|----------------------|---------------------------------------------------|----|----------------------|-------------------------------------------------------|
| (Per 21 CFR 801.109) | | | | |

signature for HW
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Section Control, Dental Devices
Confidential

| Number: | <span style="text-decoration: overline;">K031741</span> |
|---------|---------------------------------------------------------|
|---------|---------------------------------------------------------|

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