The GoLox USP is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside and outside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

Device Description

The GoLox is a double walled vacuum insulated cryogenic vessel designed to hold approximately 1 pound of liquid oxygen at a pressure of 22 psig with heat exchange tubing, relief valves and a pneumatic conserving device housed in a plastic enclosure. Oxygen is stored under low pressure in its liquid state where the pressure is limited by the pressure relief valve. The liquid oxygen is converted to near ambient temperature gaseous oxygen through a system of tubes and warming coils for delivery to patients requiring supplemental oxygen by a single lumen cannula. The device is not intended as life support or life sustaining. The GoLox USP s designed to be refilled from industry standard liquid oxygen stationary units already cleared and in the marketplace.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "GoLox USP" portable liquid oxygen unit. It asserts substantial equivalence to a predicate device, the "Respironics PLOX (K050414)", based on comprehensive testing. However, the document does not contain explicit acceptance criteria or a detailed study report with specific performance metrics for the GoLox USP device against such criteria.

Therefore, I cannot populate the table or answer most of the questions about acceptance criteria and detailed study design. The document focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly define acceptance criteria or provide specific numerical performance results for the GoLox USP. It states that "Comprehensive testing was performed to determine equivalence between the GoLox and PLOX (K050414). Testing included connection/disconnection of proprietary connector, purity and flowrates in stated environmental conditions." This implies that the GoLox USP's performance in these areas was deemed equivalent to the predicate device, but no specific values or thresholds are given.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not mentioned in the document.

3. 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 a medical device performance study, not one requiring expert interpretation of data to establish ground truth in the way AI/ML algorithms often do.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device. The "comprehensive testing" would have involved the device itself performing to its intended specifications.

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

Not explicitly stated. For a physical device like this, "ground truth" would likely refer to established engineering and performance standards for oxygen delivery units. The testing focused on "equivalence" to a predicate device, meaning its performance in areas like "purity and flowrates" demonstrated results comparable to or within acceptable limits of the previously cleared PLOX.

8. The sample size for the training set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/2 description: The image shows a handwritten string of characters and numbers. The string begins with the letters 'K0', followed by the numbers '72723'. After the numbers, there is a forward slash '/' and then the letter 'S' with a superscript '2'. Below the numbers '72723' is the word 'GoLox'.

Date of Submission	February 5, 2008
Official Contact	Zita A. YurkoDirector Regulatory AffairsRespironics, Inc.1740 Golden Mile HighwayMonroeville, PA 15146zita.yurko@respironics.com
	724-387-4120 t724-882-4120 с724-387-7490f
Classification Reference	21 CFR 868.5655
Product Code	BYJ - Portable Liquid Oxygen Unit
Common/Usual Name	Portable Liquid Oxygen Unit
Proprietary Name	Respironics GoLox USP
Predicate Device(s)	Respironics PLOX (K050414)

Substantial Equivalence

The GoLox has the following similarities to the previously cleared predicate device:

□ Same intended use.
O Same operating principle.
□ Same technology.
□ Same manufacturing process.

The PLOX was cleared in K050414 for delivering oxygen to patients after being filled with USP 99% oxygen from stationary liquid vessels.

02/06/08

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Comprehensive testing was performed to determine equivalence between the GoLox and PLOX (K050414). Testing included connection/disconnection of proprietary connector, purity and flowrates in stated environmental conditions.

Intended Use

The GoLox is intended to provide supplemental oxygen to patients who have difficulty extracting oxygen from the air that they breathe. The patients would normally receive oxygen via a nasal cannula. It is intended for ambulatory use inside of the home. It is not intended to be life supporting or life sustaining. The device has no contraindications.

Device Description

(End of Tab.)

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the bird. The text is in all capital letters.

MAR 2 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Respironics, Incorporated C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K072723

Trade/Device Name: GoLox USP Regulation Number: 21 CFR 868.5655 Regulation Name: Portable Liquid Oxygen Unit Regulatory Class: II Product Code: BYJ Dated: March 7, 2008 Received: March 11, 2008

Dear Mr. Devine:

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/3/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Page 2 - Mr. Devine

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) 276-0120. 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,

Sutta Y. Michael Davis

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: GoLox USP

Prescription Use ____________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vivi Thule

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

K072723 510(k) Number:

Page

Regulation Number and Section

§ 868.5655 Portable liquid oxygen unit.

(a)
Identification. A portable liquid oxygen unit is a portable, thermally insulated container of liquid oxygen that is intended to supplement gases to be inhaled by a patient, is sometimes accompanied by tubing and an oxygen mask. An empty portable liquid oxygen unit is a device, while the oxygen contained therein is a drug.(b)
Classification. Class II (performance standards).