(150 days)
No
The document describes a physical sampling line and its components for CO2 measurement, with no mention of AI or ML technologies.
No.
The device is described as a sampling line intended for CO2 measurement, which is a diagnostic or monitoring function, not a therapeutic intervention.
Yes
The device is intended to provide for CO2 measurement, which is a diagnostic measurement. It enables sampling for monitoring CO2 levels, which aids in assessing a patient's respiratory status.
No
The device description clearly outlines physical components like a sampling line, airway adapter, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, the Carinal VitaLine™ Set is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is intended for CO2 measurement of intubated neonates and infants. This is a measurement taken directly from the patient's airway, not from a sample of bodily fluid or tissue that is analyzed outside the body.
- Device Description: The device is a sampling line that connects to an endotracheal tube and a CO2 monitor. It facilitates the collection of gas from the airway for analysis by the monitor.
- Mechanism of Action: The device's function is to transport gas from the patient's airway to a CO2 monitor. It does not perform any diagnostic testing or analysis on a biological sample itself.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Carinal VitaLine™ Set does not fit this description. It is a component used in conjunction with a CO2 monitor to facilitate the measurement of a physiological parameter (CO2 levels) directly from the patient's airway.
N/A
Intended Use / Indications for Use
The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube. The set is intended for single patient use only.
Product codes
CCK
Device Description
The Carinal VitaLine Set comprises Microstream FilterLine ICU that is modified to enable the clinician to select between central monitoring from the trachea above the carina via the monitoring lumen of the ETT and traditional monitoring with a CO2 sampling airway adapter. The following components are included in the Carinal VitaLine Set:
- sampling line .
- airway adapter with tube and luer connected. .
The Carinal VitaLine Set is designed for use with an infant neonatal size uncuffed endotracheal tube equipped with a monitoring lumen. The endotracheal tube must be supplied by the end user and is not provided by Oridion as part of the Carinal VitaLine. The tubing leading to the CO2 monitor includes two dryer sections to support use in high humidity environments and prevent rapid occlusion of the tubing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, carina
Indicated Patient Age Range
neonates and infants
Intended User / Care Setting
Not Found
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
In order to demonstrate substantial equivalency to the predicate device the following bench tests were performed: Tensile Strength, Leak Tightness, Pressure Drop, Rise Time, and Delay Time.
Key Metrics
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
510(k) Summary of Safety and Effectiveness Information
NOV 2 9 2012
ਉ
DATE THIS SUMMARY WAS PREPARED
Nov 15, 2012
SUBMITTER NAME AND ESTABLISHMENT ADDRESS:
Oridion Medical 1987 Ltd.
7 HaMarpe Street, Har Hotzvim Science Based Industrial Park, POB 45025, 91450 Jerusalem, Israel
ESTABLISHMENT REGISTRATION NUMBER
8044004
CONTACT PERSON:
Dalia Givony, Director of Regulatory Affairs Oridion Medical 1987 Ltd.
Har Hotzvim Science Based Industrial Park
POB 45025, 91450 Jerusalem, Israel
Telephone: +972-2-589 9115
FAX: +972-2-586-6680
DEVICE INFORMATION .
Proprietary Name: Carinal VitaLine™ Set
Common Name: Intubated Infant Neonatal CO2 sampling line
Product Classification: 73CCK Class II
This device is a capnograph accessory. It is classified as follows:
21 CFR 868.1400, carbon dioxide analyzer.
This device is classified identically to the cleared predicate device K980327.
PREDICATE DEVICE
Microstream FilterLine ICU, K980327 manufactured by Oridion Medical 1987 Ltd.
1
DEVICE DESCRIPTION
The Carinal VitaLine Set comprises Microstream FilterLine ICU that is modified to enable the clinician to select between central monitoring from the trachea above the carina via the monitoring lumen of the ETT and traditional monitoring with a CO2 sampling airway adapter. The following components are included in the Carinal VitaLine Set:
- sampling line .
- airway adapter with tube and luer connected. .
The Carinal VitaLine Set is designed for use with an infant neonatal size uncuffed endotracheal tube equipped with a monitoring lumen. The endotracheal tube must be supplied by the end user and is not provided by Oridion as part of the Carinal VitaLine.
The tubing leading to the CO2 monitor includes two dryer sections to support use in high humidity environments and prevent rapid occlusion of the tubing.
INTENDED USE/ INDICATION FOR USE
The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube.
The set is intended for single patient use only.
| Feature | Oridion
MICROSTREAM FILTERLINE
ICU - K980327 | Oridion Carinal VitaLine Set |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The intended use of the
Microstream FilterLine ICU
sample line is conduct a sample
of the patient's breathing from a
ventilator or anesthesia machine
airway to the gas measurement
device for measuring the
percentage of CO2 in the
patient's exhalation | The Carinal VitaLine™ Set sampling
line set is intended to provide for CO2
measurement of intubated neonates
and infants with a Microstream
monitor. It enables either standard
sampling via the airway adapter and
main lumen of an endotracheal tube
or sampling from the carina via the
monitoring lumen of the same tube. |
| Mode of
operation | Used as a Microstream monitor
accessory | Same |
| Intended
population | All Intubated Patients (adult,
pediatric, infant, neonates) | Intubated infant and neonatal patients |
| Patient Interface | Enables CO2 sampling from the
ventilator tubing through an
Airway Adapter which connects | Same
Additionally, enables CO2 sampling
above the carina via the monitoring |
BRIEF COMPARISON TO THE PREDICATE DEVICE
Oridion Medical 1987 Ltd.
Page 2
2
| | from one side to the
endotracheal tube (not supplied
by the company) and from the
other side to the ventilator. | lumen of an endotracheal tube (not
supplied by the company).
User can switch between interfaces. |
|------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Rise time | 215mSec | 240- 280mSec |
| Pressure Drop | 35 mbar Max @ 50ml/min | 33±6mBar at 50 mL/min. |
| Delay Time | 2.7Sec typical @ 50ml/min | 2.8Sec @ 50mL/min |
| Tensile Strength | ≥2kg @30 cm/min | ≥2kg @30 cm/min |
SUMMARY OF TESTING
In order to demonstrate substantial equivalency to the predicate device the following bench tests were performed: Tensile Strength, Leak Tightness, Pressure Drop, Rise Time, and Delay Time.
SUBSTANTIAL EQUIVALENCE
The Carinal VitaLine Set is as safe and effective as the Microstream FilterLine ICU, K980327. It has similar intended use, similar indication for use and similar technological characteristics and principle of operation as its predicate device.
The minor differences between the Carinal VitaLine Set and its predicate device raise no issue of safety and effectiveness. Bench performance data demonstrate that the Carinal VitaLine Set is as safe and effective as the Microstream FilterLine ICU. Thus the Carinal VitaLine Set is substantially equivalent to its predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ms. Dalia Givony Director of Regulatory Affairs Oridion Medical 1987 Limited Har Hotzvim Science Park POB 45025 Jerusalem, Israel 91450
NOV 2 9 2012
Re: K121927
Trade/Device Name: Carinal VitaLine™ Set Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 15, 2012 Received: November 16, 2012
Dear Ms. Givony:
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.
4
Page 2 - Ms. Givony
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); 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/AboutFDA/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Error! Unknown document property name. Set Confidential
1. Statement of Indications for Use
(This document is not confidential)
Nov 15, 2012
Device Name:
Carinal VitaLine™ Set
Indications For Use:
The Carinal VitaLine™ Set sampling line is intended to provide for CO2 measurement of intubated neonates and infants with a Microstream monitor. It enables either standard sampling via the airway adapter and main lumen of an endotracheal tube or sampling from the carina via the monitoring lumen of the same tube.
The set is intended for single patient use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use X (Per 21 CFR 801.109)
Over-The-Counter Use _
Lester W. Schultheis Jr 2012.11.28 15:32:27 -05'00'
(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital
Division of Anesthesional Devices Division of Ancouloonschooloonstal K121927
510(k) Number:
Oridion Medical 1987 Ltd.