The LIV 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. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall! be rah Uized or otherwise secured to prevent falling and rolling.

Device Description

The Linde Integrated Valve™ ("LIV") is a portable oxyqen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of user-selectable flow settings is available, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50psig oxygen delivery, while an optional bed hanger allows the LIV to be readily attached to a bed. The LIV is suitable for use in all healthcare settings, including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.

AI/ML Overview

The Linde Integrated Valve (LIV) is a portable oxygen delivery system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way one might for a novel AI/software device.

Here's the breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the LIV primarily relies on demonstrating substantial equivalence to a predicate device (MEDICYL-E-Lite K033897) rather than setting specific quantitative acceptance criteria for novel performance, as one would for an AI/software device. The "acceptance criteria" here are implicitly met by showing the device's technical characteristics are substantially similar and that it conforms to relevant standards.

Acceptance Criteria (Implicit)	Reported Device Performance
Technological Characteristics Substantially Similar to Predicate Device (K033897)	The LIV shares key features with the MEDICYL-E-Lite, including: - Flowrate Selector and Flow Outlet (yes)- Cylinder On/Off (yes)- Filling Port (active; w/ non-return valve)- Excess Flow Device (yes)- Residual Pressure Valve (yes)- Burst Disk (yes)- Single stage piston style (yes)- Guard (2 grip, Access Ports, green color)- Cylinder Sizes (D, E)- Materials/construction (Aluminum)- MRI Compatibility (yes; tested up to 3.0T)
Compliance with 21CFR49 § 178.46	Aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders.
MRI Compatibility (ASTM standard 2503-05 and CDRH document)	Evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, "A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems," dated February 7, 1997. MR-conditional (per ASTM standard 2503-05). Intended for use during MR imaging for MRI systems up to 3.0T.
Safety and Effectiveness (Implicit)	The manufacturer believes that the LIV is substantially equivalent to the predicate device and "does not raise any new questions of safety or effectiveness" based on safety and performance testing and compliance with voluntary standards.
Intended Use Alignment with Predicate	Both devices are portable oxygen delivery systems. The LIV's indications for use: "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. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only."
Additional Features (no new safety/effectiveness concerns)	The LIV includes features not in the predicate: Pressure Outlet (yes) and Contents Gauge (active), which are implicitly deemed not to raise new safety or effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of this 510(k) summary. This document does not describe a "test set" or data provenance in the way one would for a clinical study comparing AI performance against ground truth. The evaluation is primarily based on engineering design, materials, and compliance with standards, along with a comparison of technological characteristics to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a medical device (hardware) submission, not an AI/software device submission requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as above.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The LIV is a hardware device for oxygen delivery, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for this type of device submission revolves around engineering specifications, material properties, and functionality meeting established standards and being comparable to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No AI/machine learning training set is involved.

9. How the ground truth for the training set was established

Not applicable. No AI/machine learning training set is involved.

In summary:

The provided document is a 510(k) summary for a physical medical device (an oxygen delivery system). It demonstrates the device's safety and effectiveness by establishing substantial equivalence to an already legally marketed predicate device, rather than through a standalone performance study with clinical endpoints or AI-specific validation metrics. The "study" implicitly referenced is the "safety and performance testing and compliance with voluntary standards" conducted by the manufacturer, which is deemed sufficient to demonstrate this equivalence. The "acceptance criteria" are met by matching or exceeding the predicate's characteristics and complying with relevant engineering and safety standards.

Summary

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Image /page/0/Picture/0 description: The image shows the word "Linde" in a stylized, cursive font. The word is white against a black background, creating a strong contrast. The "L" has a large, sweeping curve that extends over the rest of the word, adding a touch of elegance to the design. The overall impression is clean and modern.

510(k) Summary LIV (Linde Integrated Valve) 510(k) Number: _ K 0 6 335 4

APR 17 2007

Submitted in accordance with the requirements of SMDA 1990 and 21CFR807.92.

1.0 APPLICANT'S INFORMATION

Edward W. Siurek III Dir., Operational Quality Institutional Business Division Linde Gas Therapeutics PH: +1 216 525 6917 Mobile: +1 216 269 3368 E: ed.siurek@us.Linde-gas.com Medical Establishment Registration No .: 3003900188

2.0 SUBMITTER'S INFORMATION

James Jochen Rogers General Manager Coastal Consulting Group, Ltd. P.O. Box 470218 Broadview Heights, OH 44147 PH/FX: +1 440.546.4936 Mobile: +1 724.713.2298 E: coastalcg@earthlink.net http://www.coastalcg.com

3.0 DATE

October 31, 2006

4.0 DEVICE INFORMATION

Trade/Proprietary Name:

Trade/Proprietary Name:	LIV (Linde Integrated Valve)
Common Name:	LIV (Linde Integrated Valve)
DEVICE NAME:	Cylinder, Compressed Gas, and Valve
Classification Panel:	Cardiovascular and Respiratory Devices
Classification Number:	868.2700
Product Nomenclature:	Regulator, Pressure, Gas Cylinder
Product Code(s):	CAN

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Classification Number:	868.2610
Product Nomenclature:	Gauge, Gas Pressure, Cylinder/Pipeline
Product Code(s):	BXH
Classification Number:	unclassified
Product Nomenclature:	Cylinder, Compressed Gas, and Valve
Product Code(s):	ECX
Classification Number:	unclassified
Product Nomenclature:	Cylinder, Gas (Empty)
Product Code(s):	KGA

5.0 DEVICE CLASSIFICATION

Empty compressed gas cylinders and compressed gas cylinder with valve assemblies are unclassified devices, and reviewed by the Anesthesiology and Respiratory Devices Branch, Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices.

Gas cylinder pressure requlators and gas pressure gauges are Class I devices and exempted from pre-market notification.

PREDICATE DEVICE(s) 6.0

K033897 MEDICYL-E-Lite Portable Oxygen System

7.0 DEVICE DESCRIPTION

8.0 INDICATIONS FOR USE

The LIV 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. For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.

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9.0 TECHNOLOGICAL CHARACTERISTICS

A summary comparison of technological characteristics, including design and materials is provided in the table below:

Parameter	LIV (Linde Integrated Valve)	MEDICYL-E-LiteK033897
Valve/Regulator
Flowrate Selector and FlowOutlet	yes	yes
Pressure Outlet	yes	no
Cylinder On/Off	yes	yes
Filling Port	active;w/ non-return valve	active;w/ non-return valve
Contents Gauge	active	non-active
Excess Flow Device	yes	yes
Residual Pressure Valve	yes	yes
Burst Disk	yes	yes
Single stage piston style	yes	yes
Guard
Hand grip	2 grip	2 grip
Access Ports	yes	yes
Color	green	green
Cylinder
Sizes	D, E	D, E
Materials/construction	Aluminum	Aluminum
MRI Compatibility	yes; tested up to 3.0T	yes; tested up to 3.0T

The manufacturer believes that the technological characteristics of the IV (Linde Integrated Valve) is substantially similar to those of the predicate device.

10.0 PERFORMANCE DATA

The aluminum cylinders conform to the requirements of 21CFR49 § 178.46, Specification SAL seamless aluminum cylinders.

The LIV (Linde Integrated Valve) has been evaluated in accordance with the draft CDRH Magnetic Resonance Working Group document, A Primer on Medical Device Interactions with Magnetic Resonance Imaging Systems, dated February 7, 1997.

11.0 STATEMENT OF SUBSTANTIAL EQUIVALENCE

Based upon the safety and performance testing and compliance with voluntary standards, the manufacturer believes that the LV (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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is a stylized image of three human figures in profile, arranged in a row.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Linde Gas Therapeutics C/O Mr. James J. Rogers General Manager Coastal Consulting Group, Limited P.O. Box 470218 Broadview Heights, Ohio 44147

APR 1 7 2007

Re: K063354

Trade/Device Name: LIV (Linde Integrated Valve) Regulation Number: None Regulation Name: Cylinder, Compressed Gas and Valve Regulatory Class: Unclassified Product Code: ECX Dated: March 19, 2007 Received: March 20, 2007

Dear Mr. Rogers:

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.

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 - Mr. Rogers

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 (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.

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sylitte Y. Michlew Omd

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

510(k) Number (if known):

Device Name: LIV (Linde Integrated Valve

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND

Over-the-Counter Use _ X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

18 051-399 sion of Anesthesiology, General Hospital, Joseon Control, Dental Devices

C(k) Number: K 06

Page 12/164

Regulation Number and Section

§ 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.