(25 days)
Not Found
No
The device description explicitly states it is a "purely mechanical device and contains no electrical or electronic components."
Yes
The device is described as providing "supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe," directly addressing a medical condition and aiming to improve patient health.
No
Explanation: The device is described as an oxygen delivery system intended to provide supplemental oxygen to patients. Its function is to convert liquid oxygen into a gas for patient use, not to diagnose medical conditions or provide information for medical diagnosis.
No
The device description explicitly states that the Helios device is a "purely mechanical device and contains no electrical or electronic components," which is the opposite of a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen directly to patients for breathing difficulties. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a mechanical system for storing and delivering oxygen gas. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is the core function of an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient's home. It is not intended as life sustaining or life supporting device. The device has no contraindications.
Product codes (comma separated list FDA assigned to the subject device)
73 BYJ
Device Description
The Helios portable liquid oxygen system consists of a vacuum insulated cryogenic container and plumbing that includes pressure relief valves, heat exchanger tubes and a pneumatic conserving device. The vacuum insulated container allows oxygen to be stored in its liquid state under pressure where the system pressure is controlled by the relief valve. When the patient opens the flow control valve, the liquid oxygen is withdrawn from the container into a vaporizing coil. Once in the vaporizing coil, ambient heat is absorbed by the liquid oxygen, converting it into a gas and warming it to near room temperature. The gas finally passes through the flow control valve and on to the patient at the prescribed metered rate. The device is intended to be used in conjunction with a larger liquid oxygen reservoir where it is filled by mating it to the fill connection on the top of the larger system. The Helios device is a purely mechanical device and contains no electrical or electronic components.
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
Not Found
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)
The Helios liquid oxygen system successfully passed tests in the following areas;
- Mechanical/Climatic ●
- Device Performance .
In summary, Puritan-Bennett has demonstrated that the Helios portable liquid oxygen system is safe and effective. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
OCT 22 1999
Image /page/0/Picture/2 description: The image shows the word "MALLINCKRODT" in a bold, serif font. The "M" is white and set against a black square. The rest of the letters are black and set against a white background.
510(k) Summary
Puritan-Bennett Helios Portable Liquid Oxygen System
Submitter Information
| Submitter: | Puritan-Bennett Corporation
(a subsidiary of Mallinckrodt Inc.)
3 Missouri Research Park Drive
St. Charles, MO 63304. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tony Keaveney
Regulatory Affairs Manager |
| Tel: | (314) 498 3365 |
| Fax: | (314) 939 5535 |
| Preparation Date: | 24 September 1999 |
Device Name
| Proprietary Name: | Helios Portable Liquid Oxygen System |
|---|---|
| Common Name: | Portable Liquid Oxygen Unit |
| Classification Name: | Portable Liquid Oxygen Unit (73 BYJ) as per 21 CFR 868.5655 |
Predicate Device Equivalence
Puritan-Bennett is claiming substantial equivalence to the Puritan-Bennett Companion 550 Liquid Oxygen (Lox) System, K933930.
1
Device Description
The Helios portable liquid oxygen system consists of a vacuum insulated cryogenic container and plumbing that includes pressure relief valves, heat exchanger tubes and a pneumatic conserving device. The vacuum insulated container allows oxygen to be stored in its liquid state under pressure where the system pressure is controlled by the relief valve. When the patient opens the flow control valve, the liquid oxygen is withdrawn from the container into a vaporizing coil. Once in the vaporizing coil, ambient heat is absorbed by the liquid oxygen, converting it into a gas and warming it to near room temperature. The gas finally passes through the flow control valve and on to the patient at the prescribed metered rate. The device is intended to be used in conjunction with a larger liquid oxygen reservoir where it is filled by mating it to the fill connection on the top of the larger system. The Helios device is a purely mechanical device and contains no electrical or electronic components.
Intended Use
The Helios portable lox system is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. The patient would normally receive the oxygen via a nasal cannula. The device delivers 100% oxygen at 12 different flow settings. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient's home. It is not intended as life sustaining or life supporting device. The device has no contraindications.
Comparison of Technological Characteristics
The intended use of the modified device remains unchanged as does its risk classification. The modified device will continue to be indicated for use for the same patients and will continue to be a prescription only device. Both devices are intended only as sources of supplemental oxygen and are not intended to be life supporting devices. Neither device has any contraindications.
Both the modified and unmodified device include a vacuum insulated cryogenic container and plumbing that includes pressure relief valves, heat exchanger tubes and a pneumatic conserving device. The cryogenic container in the Helios device is smaller than that in the Companion device and the design of the associated valve and heat exchanger assemblies have been optimized. The enclosure has also been changed to accommodate the change in physical dimensions of the modified device. The conservation ratio of the pneumatic conserver has been changed from 2:1 to 4:1 to allow the device to last longer between filling. The Helios device can be used in the horizontal position whereas the Companion device may only be used in the vertical position.
2
Summary of Performance Testing
The Helios liquid oxygen system successfully passed tests in the following areas;
- Mechanical/Climatic ●
- Device Performance .
Conclusions
In summary, Puritan-Bennett has demonstrated that the Helios portable liquid oxygen system is safe and effective. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three wings, symbolizing health, human services, and well-being. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 22 1999
Mr. Tony Keaveney Puritan-Bennett Corporation 3 Missouri Research Park Drive St. Charles, MO 63304
Re: K993220 Helios Portable Liquid Oxygen System Requlatory Class: II (two) Product Code: 73 BYJ September 24, 1999 Dated: September 27, 1999 Received:
Dear Mr. Keaveney:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Tony Keaveney
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Joanne H. Weateober, fec
Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Statement of Indications for Use
| Device name: | Helios Portable Liquid Oxygen System |
|---|---|
| Indications for Use: | The Puritan-Bennett Helios Portable Liquid Oxygen System is intended to provide supplemental oxygen to oxygen therapy patients who may have difficulty extracting oxygen from the air that they breathe. It is intended to be used as an ambulatory source of oxygen both inside and outside the patient's home. It is not intended as life sustaining or life supporting device. The device has no contraindications. |
Prescription Use:
Yes
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
\
or
Over-The-Counter Use:
Premarket Notification 510(k) Number:
KA93220
Tothu.extshos
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number .