(167 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and gas handling processes without mentioning any computational or learning components.
Yes
The device is described as providing supplemental oxygen to patients and filling gas cylinders for their personal ambulatory use, which directly addresses a medical need.
No
Explanation: The device is designed to provide supplemental oxygen and fill oxygen cylinders for patient use, not to diagnose medical conditions or provide patient monitoring.
No
The device description explicitly states it consists of a compressor module and a portable oxygen cylinder, which are hardware components. It also describes the physical process of pressurizing and filling oxygen cylinders.
Based on the provided text, 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 ambulatory use. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details a system for pressurizing and delivering oxygen. It does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a core characteristic of IVDs.
- Lack of IVD Keywords: The text does not contain keywords commonly associated with IVDs, such as "in vitro," "diagnostic," "assay," "test," "sample," "analyte," etc.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This oxygen concentrator and filling system does not perform any such analysis.
N/A
Intended Use / Indications for Use
The Oxygen Concentrators with the Oxygen Filling accessory are indicated 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. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Profill Q601 series home oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities. The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it is split into two streams. The first stream flows to the outlet on the control panel. The patients can use this as their source of supplemental oxygen while they are filling their cylinders. The second stream flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are 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
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)
Verification testing has confirmed the product meets its specifications.
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
§ 868.5440 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
SUMMARY OF SAFETY AND EFFECTIVENESS 9.0
"510(k) SUMMARY"
| 9.1 Manufacturer: | Merits Health Products Co., LTD. |
|---|---|
| 9, Road 36, | |
| Taichung Industrial Park | |
| Taichung, Taiwan R.O.C | |
| 9.2 Submitted By: | Contact - P/L Biomedical |
| Lee Leichter | |
| 7690 Cameron Circle | |
| Fort Myers, FL 33912 | |
| Tel - 239-768-1118 | |
| Fax - 815-550-0162 | |
| Prepared - April 26, 2005 | |
| 9.1 Trade/Proprietary Name: | Merits Health Products Oxygen Tank Filling Accessory |
| 9.2 Common/Usual Name: | Oxygen Concentrator (Accessory) |
| 9.3 Classification Name: | Portable Oxygen Generator |
Comparison to Currently Marketed Devices 9.4
The modified Oxygen Concentrators are substantially equivalent to the currently marketed Invacare Corporation Model HomeFill II Complete Home Oxygen System (K003939).
1
Device Description 9.5
The Profill Q601 series home oxygen filling machines are prescription devices designed for use in home by patients that require supplemental oxygen. It is intended to pressurize oxygen from an oxygen concentrator to fill gas cylinders for the patient's personal ambulatory use. It is not intended for life support nor does it provide any patient monitoring capabilities.
The device consists of a compressor module and a portable oxygen cylinder with a specially adapted cylinder fitting. It is compatible with available standard oxygen concentrators as the source of oxygen. The oxygen generated by the oxygen concentrator is inducted into a buffer tank. Then it is split into two streams. The first stream flows to the outlet on the control panel. The patients can use this as their source of supplemental oxygen while they are filling their cylinders. The second stream flows to the compressor where the oxygen is pressurized and filled into the cylinder. The devices are not sold or labeled as sterile
Indications for Use વે.રે
The Oxygen Concentrators with the Oxygen Filling accessory are indicated 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. The device is not intended for life support nor does it provide any patient monitoring capabilities
Technological Characteristics 9.7
The technological characteristics are the same as the predicate devices.
ರಿ 8 Performance Data
Verification testing has confirmed the product meets its specifications.
Conclusion ರಿ.ಡಿ. ಇದರ ಕಾರಿ ಕಾರಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾಡಿ ಮಾ
Based on the design, performance specifications, testing and intended use, the Oxygen Filling Accessories are substantially equivalent to the currently marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 4 - 2005
Merits Health Products Company c/o Mr. Lee Leichter P/L Biomedical 7690 Cameron Circle Fort Myers, Florida 33912
Re: K050430
Trade/Device Name: Merits Health Products Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: July 8, 2005 Received: July 8, 2005
Dear Mr. Leichter:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, de vices that have been recuire approval of a premarket approval application (PMA). and Costiette Tec (110) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions 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 If your device is enabilitional controls. Existing major regulations affecting your device can may be subject to sater additions, Title 21, Parts 800 to 898. In addition, FDA may be found inther announcements concerning your device in the Federal Register.
3
Page 2 - Mr Leichter
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issumes of a babbidents with other requirements of the Act that I DA has made a decommandia in administered by other Federal agencies. You must of ally if edital statures und regulations . including, but not limited to: registration and listing (21 Comply with an the Act 3 requirements) on the manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (Declobs your device as described in your Section 510(k) This letter will anow you to begin marketing your device of your device to a legally premits in the month. The PDF mining of casions 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 If you ucate specific acries ion your at (240) 276-0120. Also, please note the regulation entitled, Coniation of Compunisor market notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
Sinute y. Michino m-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
4
INDICATIONS FOR USE STATEMENT
510(k) File Number:
Merits Health Products Oxygen Concentrator Device Name: The Oxygen Concentrators with the Oxygen Filling accessory are Indications For Use: indicated 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. The device is not intended for life support nor does it provide any patient monitoring capabilities.
Prescription Use ✔ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cum Aubrom
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: