(249 days)
No
The device description and performance studies focus on the physical components and basic functionality of a sampling line for CO2 measurement, with no mention of AI or ML. The submission's main reason is a material change.
No
The device is used to sample exhaled breath for CO2 measurement, which is a diagnostic function to monitor a patient's condition, not a direct treatment or therapy.
No
The device is a sampling line that conducts a patient's breath to a gas measurement device (capnograph) which then measures the percentage of CO2. It does not perform the diagnostic measurement itself.
No
The device description explicitly lists physical components like PVC tubing, airway adapter, and luer connector, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The described device is a sampling line used to transport a sample of the patient's breath (exhaled gas) from the airway to a gas measurement device (capnograph). It is a conduit for a physical sample, not a test performed on a biological sample.
- Intended Use: The intended use is to "conduct a sample of the patient's breathing... to a gas measurement device for measuring the percentage of CO2". This describes a sample delivery function, not a diagnostic test itself.
- Device Description: The components (tubing, adapter, connector) are consistent with a sample transport system, not an IVD test kit or instrument.
- Lack of Biological Sample Testing: There is no mention of the device performing any analysis or testing on a biological sample. The analysis is done by the connected capnograph.
The device is an accessory used in conjunction with a diagnostic device (the capnograph), but it is not an IVD itself. It falls under the category of a medical device used for patient monitoring.
N/A
Intended Use / Indications for Use
Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph.
The device's main components are PVC tubing, airway adapter and a luer connector.
Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.
Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.
An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite.
The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.
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
Adult- Pediatric
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to ensure the devices' performance and to demonstrate similarity to the predicate devices. This bench testing includes mainly pressure drop, tensile strength, and leak tightness.
The results show that the proposed devices are substantially equivalent to their predicates with no different questions of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
Oridion Medical 1987 Ltd. Dalia Givony Regulatory and Clinical Affairs Manager 7 Hamarpe Street P.O. Box 45025 Jerusalem, 9777407 Il
Re: K181467
Trade/Device Name: Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: Class II Product Code: CCK Dated: December 30, 2018 Received: January 2, 2019
Dear Dalia 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Todd D. Courtney -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory,
Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Traditional 510K submission for Intubated CO2 Sampling Lines
001 Indications for Use Statement
Device Name:
Microstream™ Luer Adult-Pediatric Intubated Sampling Line Microstream™ Advance Adult-Pediatric Intubated Filter Line
Indications for Use:
Intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a gas measurement device for measuring the percentage of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use
3
510K Summary
DATE THIS SUMMARY WAS PREPARED
Feb 07, 2019
SUBMITTER NAME AND ESTABLISHMENT ADDRESS:
Oridion Medical 1987 Ltd. 7 HaMarpe Street, P.O. Box 45025, Jerusalem 9777407, Israel
ESTABLISHMENT REGISTRATION NUMBER
8044004
CONTACT PERSON:
Dalia Givony Regulatory & Clinical Affairs Consultant Hativat Golani 2 Modiin, Israel, 7172157 Tel: +972-8-9721157 Dalia@daliag.com
PRODUCTS TRADE NAME
Microstream™ Luer Adult-Pediatric Intubated Sampling Line Microstream™ Advance Adult-Pediatric Intubated Filter Line
COMMON: Intubated CO2 Sampling Lines
CLASSIFICATION:
Product Classification: CCK Class II
This device is a capnograph accessory. It is classified as follows:
21 CFR 868.1400, carbon dioxide gas analyzer.
This device is classified identically to the cleared predicate device K980324 and K980327 (reference device).
4
PREDICATE DEVICE:
Microstream FilterLine OR/EMS cleared under K980324
REFERENCE DEVICE:
Microstream FilterLine ICU cleared under K980327
DEVICE DESCRIPTION:
Similar to their predicates the devices are non-sterile, disposable, single patient use, intended to conduct a sample of the patient's breathing from a ventilator or anesthesia machine to a device for measuring the percentage of CO2 in the patient's exhalation when connected to a capnograph.
The device's main components are PVC tubing, airway adapter and a luer connector.
Microstream™ Advance Adult-Pediatric Intubated Filter Line can be used only with Microstream™ capnography technology.
Microstream™ Luer Adult-Pediatric Intubated Sampling Line can be used with any capnograph with a luer connection.
An Accessory (extension line) to the proposed devices: Microstream™ Advance Filter Line, MRI is composed of PVC tubing and a luer connector. It is Intended to be used when longer tubing is required to allow CO2 sampling for environments such as an MRI suite. The straight tubing is then connected to the FilterLine/ Sampling Line end from one side and from the other side to the monitor, which is placed outside of MRI suite.
The main reason for this submission is the modification of the CO2 tubing to material not made with phthalates.
INDICATIONS FOR USE:
Intended to conduct a sample of the patient's breathing from a ventilator or
5
anesthesia machine to a gas measurement device for measuring the percentage
of CO2 in the patient's exhaled breath. The set is intended for single patient use only. Intended population: Intubated Adult- Pediatric patients.
COMPARISON TO PREDICATE:
| Feature | Microstream™™
FilterLine
OR/EMS -
K980324
(predicate) | Microstream™™
FilterLine ICU-
K980327
(reference
predicate) | Microstream™™ Luer
Adult-Pediatric Intubated
Sampling Line | Microstream™™
Advance
Adult-
Pediatric
Intubated
Filter Line | Accessory:
Microstream™™
Advance Filter
Line, MRI. |
|------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------|
| Mode of
operation | For use with
Microstream
Capnography
technology | For use with
Microstream
Capnography
technology | For use with any
Capnograph with luer
connection | Same as
K980327 | Same as
K980324 |
| Single patient
use | Yes | Yes | Yes | Yes | Yes |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 |
| Tubing Length | 2 m | 2 m | 2m | 2m/4m | 9m |
| Tubing material | Made with
phthalates | Made with
phthalates | Made without
phthalates | Made
without
phthalates | Made without
phthalates |
| Dehumidifier
tubing | N/A | Nafion | N/A | Same as
K980327 | N/A |
| Pressure Drop | Not specified | Not specified | ≤70mBar@180ml/min,
sea level | ≤75[mbar] @
max 4m
length;
50[mL/min],
sea level | ≤75[mbar]
@50[mL/min],
sea level |
| Leak Tightness | 2 mBar/sec
leak rate @
100mBar
under
pressure | 2 mBar/sec
leak rate @
100mBar
under
pressure | Same as K980324 | Same as
K980327 | Same as
K980324 |
| Tensile
Strength | Pull test of at
least 2kg | Pull test of at
least 2kg | Same as K980324 | Same as
K980327 | Same as
K980324 |
6
CLINICAL/ NON-CLINICAL:
The devices are composed from the following main patient contacting components: CO2 tubing (PVC), dehumidifier (Nafion) and air way connector (ABS). Biocompatibility testing, according to ISO 10993 and FDA guidance, which include cytotoxicity, sensitization and irritation as well as risk assessment, were conducted to assess the safe use of the proposed modified devices as externally communicating device with indirect contact with tissue, for prolonged use (>24 hours-30 days).
PERFORMANCE DATA:
Bench testing was conducted to ensure the devices' performance and to demonstrate similarity to the predicate devices. This bench testing includes mainly pressure drop, tensile strength, and leak tightness.
CONCLUSION:
The results show that the proposed devices are substantially equivalent to their predicates with no different questions of safety and effectiveness.