(121 days)
Not Found
No
The device description focuses on physical measurement technologies (ultrasonic waves, piezoresistive transducers) and does not mention any AI/ML terms or capabilities. The intended use is a simple measurement tool for service personnel.
No.
The device is a tool for service personnel to analyze oxygen concentrators and is explicitly stated not to be used by patients or for continuous monitoring of oxygen delivery to a patient.
No
The device is described as a tool for service personnel to measure the output and internal pressures of an oxygen concentrator, not to diagnose a patient's medical condition. It explicitly states 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."
No
The device description explicitly states it is a "lightweight, battery operated device" that measures parameters using "ultrasonic wave" and "piezoresistive pressure transducer," indicating it is a hardware device with integrated sensors.
Based on the provided information, the DigiFLO Concentrator ANALYZER is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is explicitly stated to be a tool for service personnel to measure parameters of an oxygen concentrator. It is not intended for use by patients, nor for monitoring or confirming oxygen delivery to a patient.
- Device Description: The description reinforces its use as a tool for evaluating the output and internal pressures of an oxygen concentrator. It connects to the concentrator's tubing, not directly to a patient.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The DigiFLO Concentrator ANALYZER analyzes the gas output of a machine, not a biological sample.
The device's function is to assess the performance of a medical device (the oxygen concentrator), not to diagnose or monitor a patient's health condition based on biological samples.
N/A
Intended Use / Indications for 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.
Product codes
CCL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Service personnel / Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(k) Summary
JAN - 3 2008
- Trade name DigiFLO Concentrator ANALYZER .
- Common name DigiHH ●
- Classification name Oxygen gas analyzer (Product Code: CCL)
Equivalence claimed to:
description of the device
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.
1
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:
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.
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