(263 days)
Not Found
No
The device description and summary of performance studies focus on the mechanical and regulatory aspects of an oxygen delivery system, with no mention of AI or ML.
Yes
The device is described as an oxygen delivery system intended to provide supplemental oxygen, which is a therapeutic intervention for patients.
No
The device is described as an "integrated portable oxygen delivery system intended to provide supplemental oxygen." It does not mention any function for diagnosing medical conditions.
No
The device description clearly states it consists of a fully integrated cylinder, valve, regulator, flow meter, and shock-absorbing guard, which are all hardware components.
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 LIV is described as a "portable oxygen delivery system." Its function is to provide supplemental oxygen directly to the patient.
- Intended Use: The intended use is to "provide supplemental oxygen to pediatrics and adults." This is a therapeutic function, not a diagnostic one.
- No Mention of Samples or Testing: The description does not mention any analysis of biological samples or any diagnostic testing.
Therefore, the LIV falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LIV is an inteqrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MR1 systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Product codes (comma separated list FDA assigned to the subject device)
ECX
Device Description
The Linde Integrated Valve® ("LIV") is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of userselectable flow settings is available, inclúding low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50 psig oxygen delivery, while an optional bed hanger allows the LV to be readily attached to a bed. The LV is suitable for use in all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
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
pediatrics and adults
Intended User / Care Setting
all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
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)
Not Found
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.
Not Found
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
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
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Image /page/0/Picture/1 description: The image shows the logo for The Linde Group. The logo is white text on a black background. The words "THE LINDE GROUP" are in all caps and are located at the top left of the image. Below that is a white swoosh and the word "Linde" in cursive.
Section 6 - 510(k) Summary
MAR 1 8 2011
Contact Persons for this submission:
MICHAEL C. PIACENZA
Medical and FDA Compliance Manager Linde North America, Inc. 575 Mountain Avenue, Murray Hill, NJ 07974, USA Office: 908-508-2729 Fax: 908-771-1203 Mobile: 908-720-0200
Date prepared: June 25, 2010
Trade Names
LIV (Linde Integrated Valve)
-
- LIV Portable Oxygen System - with a 2000 psi service pressure rating
-
- LIV Portable Oxygen System - with a 3000 psi service pressure rating
Device Classification
| Common Name | Classification
Number | Class | Regulation Number |
|---------------------------------|--------------------------|-------|-------------------|
| Portable Oxygen Delivery System | unclassified | | |
Predicate Device Identification
| Legally marketed devices to which equivalence is being claimed | 510(k) # |
|---|---|
| LIV | K063354 |
| Medicyl-E-lite | K033897 |
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Image /page/1/Picture/0 description: The image shows the logo for The Linde Group. The words "THE LINDE GROUP" are in white text in the upper left corner of the image. The word "Linde" is in a stylized white font in the lower right corner of the image.
Device Description:
The Linde Integrated Valve® ("LIV") is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of userselectable flow settings is available, inclúding low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50 psig oxygen delivery, while an optional bed hanger allows the LV to be readily attached to a bed. The LV is suitable for use in all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
Intended Use of the Device:
The UV is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MRI systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling
Comparison to Predicate Devices:
A summary comparison of technological characteristics, including design and materials is provided in the table below.
| Parameter | Medicyl-E-lite (K033897) | LIV
(Linde Integrated Valve) |
|---------------------------------|--------------------------|-------------------------------------------|
| Flow selector and flow outlet | yes | yes |
| Fixed pressure outlet | no | yes |
| Cylinder On/Off | yes | yes (with optional open close indication) |
| Contents Gauge | non-active | Active |
| Excess Flow Device | No | No |
| MR Compatibility | yes; tested up to 3.0T | yes; tested up to 3.0T |
| Cylinder Sizes | D,E | D,E |
| Cylinder materials construction | Aluminium | Aluminium |
| Guard colour | green | green |
| Guard hand grip | 2 grips | 2 grips |
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Image /page/2/Picture/0 description: The image shows the logo for The Linde Group. The words "THE LINDE GROUP" are in white, block letters in the upper left corner of the image. The word "Linde" is written in a stylized, cursive font in the lower right corner of the image.
Based on the Medicyl-E-lite - K033897, the new LIV valves have been revised to comply with ISO 10524-3 (valid standard for Medical Valve Integrated Pressure Requiator - ratified April 2006). The modified devices also have the same intended use and indications for use as the aforementioned predicate device. Linde believes that the technological characteristics of the LIV (Linde Integrated Valve) is substantially similar to those of the predicate device.
Non-Clinical Performance Summary:
In terms of operating and safety specification the device conforms to applicable standards including
-
- ISO 10524-3:2005 Pressure requlators for use with medical gases -- Part 3: Pressure requlators integrated with cylinder valves
-
- 150 15996:2005 Gas cylinders -- Residual pressure valves -- General requirements and type testing
-
- BS EN 1789:2007 Medical vehicles and their equipment. Road ambulances
-
- ISO 9227:2006 Corrosion tests in artificial atmospheres -- Salt spray tests
-
- DOT 49 CFR 178.46. Specification SAL seamless aluminum cylinder (Aluminium cylinders)
-
- CE marking; Council Directive 93/42/EEC of 14.June 1993, concerning medical devices.
-
- ISO 11117:2008 Gas cylinders-valve protection caps and valve quards for industrial and medical gas cylinder- Design, construction and tests
Conclusion:
Based upon the safety and performance testing and compliance with voluntary standards, the manufacturer believes that the LIV (Linde Integrated Valve) is substantially equivalent to the predicate device, and does not raise any new questions of safety or effectiveness.
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare. The symbol is composed of three wavy lines that converge at the bottom and extend upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael Piacenza Medical and FDA Compliance Manager Linde Gas North America LLC 575 Mountain Avenue Murray Hill, New Jersey 07974
MAR 1 8 201
Re: K101792
Trade/Device Name: Linde Integrated Valve - LIV Regulatory Class: II Product Code: ECX Dated: February 4, 2011 Received: February 7, 2011
Dear Mr. Piacenza:
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- Mr. Piacenza
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 (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.
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/ReportalProblem/default.htmr.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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Wh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows a logo for The Linde Group. The words "THE LINDE GROUP" are in a sans-serif font at the top left of the image. Below that is a white streak that appears to be a stylized representation of a gas or vapor. The word "Linde" is written in a cursive font at the bottom right of the image.
Section 5 - Indications for Use Statement
510(k) Number: K101792
Device Name: Linde Integrated Valve - LIV
Indications for Use:
The LIV is an inteqrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MR1 systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
Prescription Use
AND / OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number:
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anest Stantal Devices Division of Ansol.
Infection Control, Dental Devices
W/01-
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