(250 days)
No
The summary describes a capnograph module that measures standard physiological parameters (EtCO2, FiCO2, RR) using established technology. There is no mention of AI, ML, image processing, or any other indicators of advanced algorithmic processing.
No
The device is a monitoring device that measures physiological parameters (EtCO2, FiCO2, RR) and does not provide therapy or treatment.
Yes
The device continuously monitors physiological parameters (EtCO2, FiCO2, and RR) to provide information that assists healthcare providers in assessing a patient's respiratory status, which is a key function of a diagnostic device.
No
The device description explicitly states that the Medley™ EtCO2 Module incorporates "currently marketed Oridion capnograph technology and accessories," which are hardware components used to measure CO2 and respiration rate.
Based on the provided information, the Medley™ EtCO2 Module is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro - "in glass"). This device directly monitors physiological parameters on the patient (in vivo - "in the living").
- The intended use and device description clearly state it monitors parameters like EtCO2, FiCO2, and respiratory rate continuously and non-invasively on the patient. This is a direct measurement of physiological function, not an analysis of a biological sample.
Therefore, the Medley™ EtCO2 Module falls under the category of a patient monitoring device, not an IVD.
N/A
Intended Use / 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.
Product codes
CCK
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 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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults, pediatrics and infant/neonates
Intended User / Care Setting
professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. Used in the operating room, ICU, NICU, transport and emergency treatment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements, and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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 |
| San Diego, CA 92121-2733 | ||
| C. | Company Phone: | |
| Company Fax: | (858) 458-7563 | |
| (858) 458-6114 | ||
| D. | Contact Person: | Renée L. Fluet |
| Principal Regulatory Affairs Specialist | ||
| 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
1
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. | ||
| (formally known as | |||
| 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.
2
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.
3
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.
4
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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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
5
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ | OR | Over-The-Counter Use | _____ |
|---|---|---|---|---|
| (Per 21 CFR 801.109) |
signature for HW
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Section Control, Dental Devices
Confidential
| Number: | K031741 |
|---|---|
| --------- | --------------------------------------------------------- |
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