The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

Device Description

The Home-Away System, Model 1041 is an accessory to an oxygen concentrator and liquid oxygen (LOX) stroller. It liquefies oxygen that is received from an oxygen nquia entygen (t, and delivers it to a LOX stroller for patient use. While performing these functions, it is also capable of delivering up to 3 L/min of gaseous oxygen directly to the patient. In these respects, the Home-Away System, Model 1041 is the same as its to the payment Home-Away System. The Home-Away System, Model 1041 incorporates prounders from the cleared device that enhance its usability, manufacturability, consistent performance, durability, reliability, and safety.

AI/ML Overview

The provided text is a 510(k) summary for the "Home-Away System, Model 1041." This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting acceptance criteria and detailed study results for a new, standalone medical device, especially one involving AI or diagnostic performance.

Therefore, many of the requested categories related to device performance, ground truth, expert involvement, and AI studies cannot be addressed from this document because it is not designed to provide that information.

Here's how much of the requested information can be extracted or reasonably inferred from the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics in a format suitable for the requested table. Instead, it describes "performance testing" to establish substantial equivalence.

Acceptance Criteria Category (Inferred)	Reported Device Performance/Comparison
Functional Equivalence	The Home-Away System, Model 1041 performs the same functions as the predicate device: liquefies oxygen from a concentrator, delivers it to a LOX stroller, and can deliver up to 3 L/min of gaseous oxygen directly to the patient. Incorporates "improvements from the cleared device that enhance its usability, manufacturability, consistent performance, durability, reliability, and safety."
Oxygen Quality	Compatibility with oxygen concentrators delivering > 5 L/min USP 93% oxygen. Analysis of oxygen for impurities. USP 93% oxygen testing was performed.
Safety	Safety testing was performed. Device is not intended to be life-sustaining or life-supporting. Has no contraindications.
Electromagnetic Compatibility (EMC/EMI)	EMC/EMI testing was performed.
Durability/Environmental	Shock and vibration testing, package testing, environmental testing, and residue testing were performed to demonstrate "consistent performance, durability, reliability, and safety."
Transfill Performance	Transfill testing was performed.
Production Rate	Production rate testing was performed.
Compatibility (Predicate vs. New)	Predicate: Compatible with oxygen concentrators > 5 L/min USP 93% oxygen (approved by In-X Corporation) & any bottom-fill type LOX stroller. New Device (Model 1041): Compatible with oxygen concentrators > 5 L/min USP 93% oxygen (approved by In-X Corporation) & only LOX strollers that utilize a proprietary mating valve. (This is a difference noted, not a performance metric per se).

Study Details (Based on the provided document)

Since this is a 510(k) for substantial equivalence of an oxygen accessory, the study described is a performance testing regimen focused on comparing the new device against its predicate and relevant standards. It is not a clinical study evaluating diagnostic accuracy or a specific medical outcome in human patients.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document mentions "performance testing" of the Home-Away System, Model 1041, which would involve testing of physical units. The number of units tested is not provided.
- Data Provenance: Not specified. Given the company is U.S.-based (Denver, Colorado), it's highly likely the testing was conducted within the U.S.
- Retrospective or Prospective: This type of engineering performance testing is inherently prospective in the sense that the new device (Model 1041) was actively tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This is not a study requiring expert clinical "ground truth" establishment (e.g., for image interpretation or diagnosis). The testing involves objective measurements against engineering specifications and industry standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like "2+1" are relevant for expert consensus in clinical data, which is not the nature of the "performance testing" described here.
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. This device is an accessory to an oxygen concentrator/LOX storage system. It does not involve human readers, diagnostic imaging, or Artificial Intelligence (AI).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is electro-mechanical hardware; it does not involve an algorithm or AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of device and testing would be engineering specifications, industry standards (e.g., USP 93% oxygen purity), and functional performance requirements. For example, the "ground truth" for oxygen purity is the measured oxygen concentration compared to the USP 93% standard.
The sample size for the training set:
- Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
How the ground truth for the training set was established:
- Not applicable. As there is no training set.

Summary

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APR 1 5 2005 510(k) Summary

SUBMITTER:	In-X Corporation6753 E. 47th Ave. Drive, Unit DDenver, CO 80216
CONTACT PERSON:	Douglas Powell, In-X Corporation PresidentPhone: 303-574-3115 ext 103Fax: 303-574-3114
DATE PREPARED:	October 22, 2004
DEVICE TRADE NAME:	Home-Away System, Model 1041
510(K) NUMBER	K042944
PRODUCT CODES	CAW/BYJ
REGULATION NUMBER	868.5440/868.5655
REGULATORY CLASS	Class II (two)
COMMON/USUAL NAME:	Accessory to oxygen concentrator and liquid oxygenstroller
CLASSIFICATION NAME:	Portable Oxygen Generator
	Portable Liquid Oxygen Unit
PREDICATE DEVICE:	The Home-Away System510(k) Number: K004047

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering

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supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON:

The Home-Away System, Model 1041 is substantially equivalent to the cleared Home-Away System (K004047). They are both compatible with oxygen concentrators that deliver > 5 L/min USP 93% oxygen and are approved by In-X Corporation. The Home-Away System is compatible with any bottom-fill type LOX stroller; whereas, the Home-Away System, Model 1041 is only compatible with LOX strollers that utilize a proprietary mating valve.

Substantial equivalence was based on performance testing of the Home-Away System, Model 1041 consisting of analysis of oxygen for impurities, USP 93% oxygen testing, EMC/EMI testing, safety testing, transfill testing, production rate testing, shock and vibration testing, package testing, environmental testing, and residue testing.

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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three overlapping lines, resembling an abstract representation of a human form or a symbol related to health and well-being.

APR 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Douglas Powell President In-X Corporation 6753 East 47th Avenue, Unit D Denver, Colorado 80216

Re: K042944

Trade/Device Name: Home-Away System, Model 1041 Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW, BYJ Dated: April 11, 2005 Received: April 12, 2005

Dear Mr. Powell:

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. Powell

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 (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.

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clive

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: Home-Away System, Model 1041 Indications for Use: The Home-Away System, Model 1041 is intended as an accessory to an oxygen concentrator and liquid oxygen storage system for use as an aid or adjunct to delivering supplemental oxygen therapy in the home. It is intended to be used with both pediatric and adult patients. It is not intended to be a life-sustaining or life-supporting device. The device has no contraindications.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qus LS

nar. Sien-Off) sion of Annsthesiology, General Hospital, Jotion Control, Demai Devices

Number: K042944

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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).