(62 days)
Not Found
No
The device description and performance studies focus on electromechanical components and oxygen delivery mechanisms, with no mention of AI/ML technologies.
Yes
The device is intended to provide supplemental oxygen to patients, which is a therapeutic function.
No
The device is described as providing supplemental oxygen and filling gas cylinders; it does not mention any diagnostic capabilities.
No
The device description clearly outlines multiple hardware components including an oxygen concentrator, compressor module, and portable oxygen cylinder. It is an electromechanical 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 to patients and fill oxygen cylinders for personal use. This is a therapeutic and medical device function, not a diagnostic one.
- Device Description: The description details an oxygen concentrator, compressor, and oxygen cylinder with a conserver. These are all components related to delivering oxygen to a patient, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases or conditions, or providing information for diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device operates in vivo (on the patient's body) by delivering oxygen.
N/A
Intended Use / Indications for Use
The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.
Product codes
CAW
Device Description
The Invacare Venture Home Fill II with oxygen conserver is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. It consists primarily of a 5 liter per minute (1pm) oxygen concentrator, a compressor module, and a portable oxygen cylinder with specially adapted cylinder fitting that includes an oxygen conserver. The oxygen conserver delivers oxygen to the user at the beginning of each breath instead of on a continuous basis.
The concentrator provides continuous flow of oxygen at concentrations of 87% to 96%, at flow rates of 0 to 51pm. The compressor fills the cylinder with oxygen concentrations of 90% to 96%. and the cylinder regulator allows flow rates of 0 to 6 lpm. The oxygen supplied by the oxygen concentrator is supplemental and is not considered to be life susporting or life sustaining. The system is not sold or labeled as sterile.
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
Home / patients that require supplemental oxygen
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
A number of mechanical and electrical tests were conducted on the Invacare Model HomeFill II with oxygen conserver and the oxygen conserver to demonstrate that the device performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K02)685
510(k) SUMMARY
Invacare Corporation's Model Venture HomeFill II With Oxygen Conserver
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared.
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Contact Person:
Edward A. Kroll Director, Regulatory Affairs
Date Prepared: May 21, 2002
Name of Device and Name/Address of Sponsor
Invacare Model Venture HomeFill II with Oxygen Conserver
Invacare Corporation One Invacare Way Elyria, Ohio 44036 Phone: (440) 329-6000 Facsimile: (440) 365-4558
Common or Usual Name
Oxygen Concentrator
Classification Name
Portable Oxygen Generator
Predicate Devices
Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939),
Intended Use
The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.
1
Technological Characteristics and Substantial Equivalence
A. Device Description
The Invacare Venture Home Fill II with oxygen conserver is an electromechanical, prescription device designed for use in the home, by patients that require supplemental oxygen. It consists primarily of a 5 liter per minute (1pm) oxygen concentrator, a compressor module, and a portable oxygen cylinder with specially adapted cylinder fitting that includes an oxygen conserver. The oxygen conserver delivers oxygen to the user at the beginning of each breath instead of on a continuous basis.
The concentrator provides continuous flow of oxygen at concentrations of 87% to 96%, at flow rates of 0 to 51pm. The compressor fills the cylinder with oxygen concentrations of 90% to 96%. and the cylinder regulator allows flow rates of 0 to 6 lpm. The oxygen supplied by the oxygen concentrator is supplemental and is not considered to be life susporting or life sustaining. The system is not sold or labeled as sterile.
B. Substantial Equivalence
The Invacare Model Venture HomeFill II with oxygen conserver is substantially equivalent to the Invacare Model HomeFill II Complete home Oxygen System (K003939)
Performance Data
A number of mechanical and electrical tests were conducted on the Invacare Model HomeFill II with oxygen conserver and the oxygen conserver to demonstrate that the device performs as intended.
2
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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three stylized profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 3 2002
Mr. Edward A. Kroll Director, Regulatory Affairs Invacare Corporation One Invacare Way Elyria, Ohio 44036-2125
Re: K021685
Trade/Device Name: Invacare Model Venture HomeFill II with Oxygen Conserver Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: May 21, 2002 Received: May 22, 2002
Dear Mr. Kroll:
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.
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.
3
Page 2 - Mr. Kroll
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours
Timothy A. Ulatowski
Timo A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
:510(k) Number (if known): fBB K021685
Device Name: Invacare Model Venture HomeFill II with Oxygen Conserver
Indications For Use:
The intended function and use of the Invacare Model Venture HomeFill II with oxygen conserver is to provide supplemental oxygen to patients in the home and to supply pressurized oxygen to fill gas cylinders for the patient's personal ambulatory use. It is not intended to sustain or support life.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices 510(k) Number __
(Optional Format 1-2-96)