The DigiFLO Concentrator ANALYZER is a tool used by service personnel to measure Oxygen purity, Flow at the outlet of an oxygen concentrator. Also, it measures gas pressure inside and at the outlet of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient. The DigiFLO Concentrator ANALYZER is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.

Device Description

The DigiFLO Concentrator ANALYZER is a lightweight, battery operated device, which measures oxygen concentrator outlet oxygen gas concentration and flow rate by means of ultrasonic wave, which travels from one piezoelectric transducer to another, and Oxygen pressure by means of a piezoresistive pressure transducer. The device is a standalone product and does not have any accessories, power supply adapters and fittings. The device is intended as a tool for use by oxygen concentrator service personnel, to evaluate the output and internal pressures in an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient.

The device connects to an oxygen concentrator through existing therapy tubing presently in use throughout the industry. The device is designed and calibrated for use only on the species gas mixture inherent with the output flow of a concentrator. Information provided by DigiFLO Concentrator ANALYZER is the concentrator's oxygen concentration, flow rate, and pressure. Continuous monitoring of output gas flow between an operating oxygen concentrator and the patient is not possible. Use with any downstream devices or patient accessories is also not possible.

It is further intended that this device be used on clean, dry and unhumidified concentrator output gas. In conjunction with the operating temperature of oxygen concentrators, the ambient temperature range of DigiFLO Concentrator ANALYZER is within +10 to +40 degrees Celsius and should remain in dry indoor environment.

AI/ML Overview

The provided text focuses on the 510(k) summary for the DigiFLO Concentrator ANALYZER, including its description, intended use, and substantial equivalence determination by the FDA. However, it does not contain information about acceptance criteria, the study design (including sample sizes, data provenance, expert ground truth, adjudication methods, or MRMC studies), or how ground truth was established for training data.

The document primarily states the device's technical specifications and how they align with its intended use for servicing oxygen concentrators.

Here's a breakdown of what can be extracted and what cannot based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the expected operational ranges for the device and its accuracy, which can be interpreted as its performance specifications. However, it doesn't explicitly state "acceptance criteria" vs. "reported performance" from a specific validation study that demonstrated it met those criteria. It's more of a declaration of its capabilities.

Performance Metric	Acceptance Criteria (Stated Performance)
Flow Rate
Concentrator outlet	0 to 20 Liters per Minute ±0.2 L/M
Air	0 to 10 Liters per Minute ±0.2 L/M
Oxygen Content	20.8% to 95.7% oxygen ±1.8%
Pressure Range	0 to 35 PSI, ±0.5%
Battery	9V "N" type battery
Temperature	+10°C to +40°C

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

This information is not provided in the document. The 510(k) summary focuses on regulatory approval based on substantial equivalence, not detailed study results.

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)

This information is not provided in the document. The device is a measurement tool, and its "ground truth" would likely be established against calibrated reference instruments, not expert human interpretation.

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

This information is not provided in the document. As a measurement device, adjudication by experts is not applicable in the typical sense for medical imaging or diagnostic devices.

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

This is not applicable and not mentioned in the document. The DigiFLO Concentrator ANALYZER is a standalone measurement tool, not an AI-assisted diagnostic device used by human readers.

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

The document describes the DigiFLO Concentrator ANALYZER as a "standalone product" that measures oxygen concentrator output. While it's a "standalone device" in terms of its physical form and function, the document does not describe a "standalone (algorithm only)" performance study in the context of typical AI/software-as-a-medical-device (SaMD) evaluations. It is a hardware measurement device, and its performance would be evaluated against calibrated standards.

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

The document does not explicitly state the type of ground truth used for validation. However, for a measurement device like an oxygen gas analyzer, the ground truth would typically be established using calibrated reference instruments (e.g., a highly accurate benchtop oxygen analyzer, flow meter, and pressure gauge) that are traceable to national or international standards.

8. The sample size for the training set

This information is not provided in the document. Measurement devices like this are typically calibrated during manufacturing rather than "trained" on a dataset in the way an AI algorithm would be.

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

This information is not provided in the document. As mentioned for point 8, the concept of a "training set" and establishing "ground truth" for it in the context of an AI/machine learning device is not directly applicable to a physical measurement device like the DigiFLO Concentrator ANALYZER. Its accuracy is established through calibration against known standards.

Summary

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510(k) Summary

JAN - 3 2008

K072469

Trade name DigiFLO Concentrator ANALYZER .
Common name DigiHH ●
Classification name Oxygen gas analyzer (Product Code: CCL)

Equivalence claimed to:

Invacare Check O2 Plus K984295 .
PRO2 CHECK OXYGEN INDICATOR K983500. .

description of the device

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The concentrator gas is expected to fall within the following ranges and will be measured with accuracy's listed below.

Flow Range	Concentrator outlet: 0 to 20 Liters per Minute ±0.2 L/MAir: 0 to 10 Liters per Minute ±0.2 L/M
Oxygen Content	20.8% to 95.7% oxygen ±1.8%
Pressure Range	0 to 35 PSI, ±0.5%
Battery	9V "N" type battery
Temperature range	+10°C to +40°C

Intended Use:

The DigiFLO Concentrator ANALYZER is a tool used by service personnel to measure Oxygen purity and Flow at the outlet of an oxygen concentrator. Also, it measures gas pressure inside and at the outlet of an oxygen concentrator. It is not intended to be used by patients who are prescribed oxygen, nor is it intended to continuously monitor or confirm oxygen delivery to a patient.

Intended Environment: The DigiFLO Concentrator ANALYZER is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.

"Caution:

The Federal Law restricts this device to sale by or on order of a physician, or any other practitioner licensed by the law of the state in which he practices to use or order the use of this device."

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and head. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 3 2008

Mr. Michael Stern DigiFLO, Incorporated 6942 96th Avenue, SE Mercer Island, Washington 98040

Re: K072469

Trade/Device Name: DigiFLO Concentrator ANALYZER Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: December 21, 2007 Received: December 28, 2007

Dear Mr. Stern:

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. Stern

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,

Suita y. M. Aain Das
Shih-Hsin, Ph.D.

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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Indication for Use

510(k) Number K072469

Device Name: DigiFLO Concentrator ANALYZER

Indication For Use:

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

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

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

Uing Thaler

Lester W. Clark

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).