The Oxlife Independence Oxygen Concentrator is used on a prescriptive basis by patients requiring supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are nonsterile.

The Oxlife Independence Oxygen Concentrator provides approximately 90% oxygen to the patient on continuous to 3 and on a conserver flow basis at an "equivalent" rate of 1.0 liters per minute to 6.0 liters to minute. The Oxlife Independence Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110-220 VAC, 12-14 VDC or rechargeable batteries.

The Oxlife Independence Oxygen Concentrator uses molecular sieve adsorption technology. Ambient air is drawn thru particle filters by a compressor and forced thru molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from molecular sieve, allowing it to adsorb again during next cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a valve, and timers are used to make the system function.

Oxygen is delivered to the patient on a continuous flow basis in precise amounts during the inhalation part of the breathing cycle. This conserver technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Oxlife Independence Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient.

The design of the Oxlife Independence Oxygen Concentrator has focused on maximizing efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use.

The basic technology of the Oxife Independence Oxygen Concentrator is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the predicate device noted in the submission.

AI/ML Overview

The provided text describes a 510(k) submission for the Oxlife Independence Oxygen Concentrator, seeking substantial equivalency to a predicate device. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a large-scale clinical study in the way an AI/ML device submission might.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable to this documentation. The information provided is primarily related to bench testing for performance specifications and comparison to the predicate device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance
Oxygen output meets specifications (implied to be equivalent to predicate)	Oxygen concentration testing confirmed that the oxygen output of the modified devices meets specifications and is substantially equivalent to the predicate device (SeQual Eclipse Model 1000 K013931).
Adequate power provision from 12 Volt DC source	The inverter provides adequate power to run the devices from a 12 Volt DC power source.
Basic technology and principles of operation are equivalent to predicate.	Basic technology (molecular sieve adsorption) and principles of operation (demand flow delivery, power options) are equivalent to other approved oxygen concentrators and the predicate device.
No new questions of safety and effectiveness compared to predicate.	Technologies utilized by the Oxlife Independence Oxygen Concentrator bring forth no new questions of safety and effectiveness.
Continuous operation in various environments.	Capable of continuous use in a home, institution, vehicles, and various mobile environments.

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

Sample Size: Not explicitly stated. The text refers to "the modified devices" and "bench top performance testing." This suggests laboratory testing on a sample of manufactured devices, but the exact number isn't specified.
Data Provenance: The testing was "bench top performance testing," meaning it was conducted in a laboratory or engineering setting by the manufacturer (OxLife LLC). It is retrospective in the sense that it's testing a finished product against pre-defined engineering and performance specifications, but it's not a clinical study on patient data. Country of origin for data is not explicitly mentioned but implied to be where the company is located (USA).

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

Not Applicable. For a device like an oxygen concentrator, "ground truth" as it relates to expert consensus or clinical outcomes isn't typically established in the same way as for diagnostic AI. The performance criteria are objective engineering specifications (e.g., oxygen concentration, power output). The "truth" is whether the device physically meets these measurable parameters.

4. Adjudication Method for the Test Set

Not Applicable. Since the testing involves objective measurement of physical parameters, there is no need for human adjudication of results in the traditional sense of clinical or image interpretation studies. The measurements are taken by instruments.

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

No. An MRMC study is not relevant for an oxygen concentrator. This type of study is specific to diagnostic imaging or AI-assisted interpretation where human readers are making assessments.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Not Applicable. The Oxlife Independence Oxygen Concentrator is a physical medical device, not an AI algorithm. Its performance is measured directly, not through an algorithm's output.

7. The Type of Ground Truth Used

Objective Engineering Specifications/Measurements: The 'ground truth' for this device's performance is based on measurable, objective physical and chemical parameters related to its function, such as the actual concentration of oxygen produced, power consumption, and flow rates. These are compared directly to the target specifications of the predicate device.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As above, no training set is involved.

Summary

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APR 1 6 2008

OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 12

10.0 510(k) Summary

K080082

10.1 Submitters Name:	OxLife LLC
10.2 Submitters Address:	141 Twin Springs Rd Hendersonville NC28792
10.3 Submitters Phone & Fax:	828-684-7353 ph. 828-684-8990 fx.
10.4 Contact Person:	Margaret K. PoteatGeneral Manager/ManagementRepresentative
10.5 Date Summary Prepared:	January 7, 2008
10.6 Trade/Proprietary Name:	OxLife Independence™ OxygenConcentrators
10.7 Common/Usual Name:	Oxygen Concentrator
10.8 Classification Name:	Portable Oxygen Concentrator
10.9 Comparison to Currently Marketed Devices:The OxLife Independence Oxygen

Concentrator is substantially equivalent to the SeQual Eclipse Model 1000 K013931

10.10 Device Description:

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OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 13

cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series of sieve beds, a valve, and timers are used to make the system function.

10.11 Indications for Use:

Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

10.12 Technological Characteristics:

The Oxlife Independence Oxygen Concentrator utilizes well established technologies. Molecular sieve/pressure swing adsorption technology has been used for many years to produce oxygen. Demand flow delivery systems have been in use on portable oxygen sources for many years. The capability of AC,DC or rechargeable battery power has also been in use.

Technologies utilized by the Oxlife Independence Oxygen Concentrator brings forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device.

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OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 14 Bench top performance testing has demonstrated that the Oxlife Independence Oxygen Concentrator is equivalent to the SeQual Eclipse Model 1000 K013931

10.13 Performance Data:

The results of the oxygen concentration testing confirm that the oxygen output of the modified devices meets specifications and is substantially equivalent to the predicate device. Also, the inverter provides adequate power to run the devices from a 12 Volt DC power source.

10.14 Conclusion:

Based on the design, performance specifications and testing and intended use, the Oxlife Independence Oxygen Concentrator are substantially equivalent to the currently marketed devices.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Margaret K. Poteat General Manager/ Management Representative OxLife LLC 141 Twin Springs Road Hendersonville, North Carolina 28792

APR 1 6 2008

Re: K080082

Trade/Device Name: Oxlife Independence Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: June 21, 2007 Received: January 17, 2008

Dear Ms. Poteat:

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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Image /page/4/Picture/0 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 wings, representing health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Page 2 - Ms. Poteat

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Yutta G.M. Melchior Onda

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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Attachment 2 8.0 Statement of Indications for Use

Indications for Use

510 (k) Number: K080082

Device Name: Oxlife Independence Oxygen Concentrator

Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Min Thul

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

KU40042 510(k) Number:

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).