(203 days)
No
The description focuses on the mechanical and pneumatic operation of a standard Pressure Swing Adsorption (PSA) oxygen concentrator. There is no mention of AI, ML, or any computational analysis of data for decision-making or control.
Yes
The device is intended to provide supplemental oxygen to patients with respiratory disorders, which is a therapeutic function.
No
The device is an oxygen concentrator, which provides supplemental oxygen to patients. Its intended use explicitly states it is "not intended to sustain or support life," and its description focuses on the physical process of separating oxygen from air, not on diagnosing medical conditions.
No
The device description clearly details physical components like a compressor, sieve beds, valves, filters, and a flow meter, indicating it is a hardware device.
Based on the provided text, the Jumao Oxygen Concentrator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide supplemental oxygen to patients with respiratory disorders by separating nitrogen from room air. This is a therapeutic function, not a diagnostic one.
- Device Description: The description details a mechanical process of air filtration and separation using a molecular sieve. This is a physical process applied to air, not a test performed on biological samples (like blood, urine, or tissue) to diagnose a condition.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of biological samples.
The device is clearly intended for direct patient therapy by providing oxygen, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The intended function and use of the Jumao Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Product codes (comma separated list FDA assigned to the subject device)
CAW
Device Description
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used with the JM-07000i/ JM-07000 models, if desired.
The JM-07000Hi model incorporates the Humidifier to provide humidified oxygen to the user. The Humidiflow attaches to the inlet of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas. The Humidifier has been cleared by FDA (K062091).
The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.
The basic technology of the JuMao oxygen concentrator is equivalent to the other approved oxygen concentrator. The principles of operation are equivalent to the noted predicate device, Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k) K020386.
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)
Safety and Performance Testing: The Jumao Oxygen Concentrator has been tested in accordance with the following standards:
ASTM 1464-93(2005): Standard Specification for Oxygen Concentrators for Domiciliary Use.
ISO 8359:1996 Oxygen Concentrator for Medical Use-Safety Requirements IEC60601-1. 2005 Medical Electrical Equipment, Part 1 : General requirements for basic safety and essential performance
Medical Electrical Equipment-part 1-2: General requirements for IEC60601-1-2, 2007 safety - collateral standard: Electromagnetic compatibility
FDA Reviewer's Guide: 1993 Reviewer Guidance for Premarket Notifications, November 1993
UL 1431, 2nd ED., 1996 UL Standard for Safety for personal Hygiene and Health Care Appliances Equipment
The safety and performance data found in this submission shows that the Jumao Oxygen Concentrator performs as intended and in a manner that is substantially equivalent to the predicate device.
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.
K020386, K033405, K080391, K071608
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.
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
Image /page/0/Picture/1 description: The image contains a sequence of handwritten digits. The digits appear to be '1090007'. The numbers are written in black ink on a white background. The handwriting is somewhat stylized.
Appendix S2-4 Revised 510(k) Summary
510(K) SUMMARY CHAPTER 1.
This 510(k) summary of safety and effectiveness for Jumao Oxygen Concentrator is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Applicant: | Danyang Jumao Healthcare Equipment Co., Ltd. |
|---|---|
| Address: | No.89 Shuangfeng Road, Jiepai town, Danyang, Jiangsu, P.R.China |
| Contact Person: | Qing Wang |
| Telephone: | (86 511)- 86379811 |
| Fax: | (86-511)-86379811 |
| Email: | kenwqing@gmail.com |
| Date of Preparation: | August 10, 2008 |
| Device Name: | JUMAO OXYGEN CONCENTRATOR |
| Model No. JM-07000Hi, JM-07000i, JM-07000 | |
| Classification Name: | Portable Oxygen Concentrator |
| Classification Number: | 868.5440 |
| Device Class: | Class II |
| Product Code: | CAW |
| Classification Panel | Anesthesiology |
| Type of submission | Traditional 510K |
Table 5-1 General Information
Intended use:
The intended function and use of the Jumao Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Indications for Use:
The intended function and use of the Jumao Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Device Description
60
1
The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator. The output of oxygen is 0.5 to 5 liter per minute. Room air enters the piston type compressor via a series of filters for removing dust particles. The output compressed air is directed by a pneumatic valve into one of the two sieve beds which is full of adsorption material - molecular sieve. Nitrogen is adsorbed by the molecular sieve as the pressure increases; oxygen flows through the molecular sieve and concentrates at the sieve bed bottom. The enriched oxygen is divided into two streams; one stream enters a storage tank. The pressurized oxygen is regulated down to the suitable pressure, an adjustable flow meter and out to the patient At the same time the second bed is in exhausted status, the molecular sieve desorbs nitrogen as the pressure decreases; another oxygen stream from first bed enters the bottom of the second bed, promotes purging the nitrogen and is exhausted into the atmosphere. Two sieve beds exchange the role of oxygen concentration and continue to produce 90% oxygen to the patient.
Oxygen is delivered to the user by means of standard oxygen supply tubing and a standard nasal cannula, which are not supplied with the device. A standard humidifier bottle may be used with the JM-07000i/ JM-07000 models, if desired.
The JM-07000Hi model incorporates the Humidifier to provide humidified oxygen to the user. The Humidiflow attaches to the inlet of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas. The Humidifier has been cleared by FDA (K062091).
The front panel of the device contains the controls and indicators. These include a standard barb fitting for attaching the oxygen tubing, the adjustable flow meter, a power light indicator, an elapsed time meter, and a standard on/off rocker type power switch.
The basic technology of the JuMao oxygen concentrator is equivalent to the other approved oxygen concentrator. The principles of operation are equivalent to the noted predicate device, Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k) K020386.
Predicate Devices:
:
- Invacare Platinum 5 Oxygen Concentrator by Invacare Corporation, 510(k) ، K020386.
- LONGFEILFY-I-5 OXYGEN CONCENTRATOR by Zhejiang longfei industrial : co., ltd, K033405
- Drive solstice oxygen concentrator, by Medical depot, K080391 "
- A&J poca01 oxygen concentrator, by Zhongshan A&J medical equip-ment co., । ltd, K071608
Substantial Equivalence Information:
2
| Substantial Equivalence Comparison Table | ||||
|---|---|---|---|---|
| Dan Yang JuMao Healthcare Equipment CO., Ltd | Invacare Corporation | |||
| Product name | JuMao Oxygen Concentrator | JuMao Oxygen Concentrator | JuMao Oxygen Concentrator | Invacare Platinum XL 5-Liter O2 Concentrator with Sens O2 |
| IRC5LX02 | ||||
| Model No | JM-07000Hi | JM-07000i | JM-07000 | IRC5LX02 |
| 510(K) | ||||
| Number | TBD | TBD | TBD | K020386 |
| Concentration levels | same | same | same | 95.6% to 87% at all flow rates |
| Delivery rate | same | same | same | 0.5 to 5 LPM |
| Outlet pressure | same | same | same | 5 psi +/-0.5 psi |
| Alarms | Thermal protection on compressor | |||
| same | ||||
| Low oxygen purity | Thermal protection on compressor | |||
| same | ||||
| Low oxygen purity | Thermal protection on compressor | |||
| same | ||||
| N/A | N/A | |||
| oxygen monitor, low-flow | ||||
| N/A | ||||
| same | ||||
| compressor 40 psi pressure relief valve | same | |||
| compressor 40 psi pressure relief valve | same | |||
| compressor 40 psi pressure relief valve | Power failure | |||
| compressor 35 psi pressure relief valve | ||||
| Electrical rating | same | same | same | 115v 60Hz |
| Power consumption | same | same | same | 4.3 amps average @5L/min(400w) |
| Filters | same | same | same | Cabinet, out HEPA, Compressor inlet |
| dimensions | 17"W x 28"H x 15"D | 17"W x 28"H x 15"D | 17"W x 28"H x 15"D | 18-3/8"W x 26-3/8"H x 14-3/8"D |
| Weight (lbs) | same | same | same | 52 |
| Operating system | same | same | same | PSA(Pressure swing adsorption) |
| Sound level | 52dBA average | 52dBA average | 52dBA average | 50dBA average |
| Compressor | GSE-ZW400D2-90 | |||
| Compressor | ||||
| (Same as K080391) | GSE-ZW400D2-90 | |||
| Compressor | ||||
| (Same as K080391) | GSE-ZW400D2-90 | |||
| Compressor | ||||
| (Same as K080391) | Thomas based double wobble | |||
| Humidifier | Humidiflow humidifier | same | same | Bottle humidifier |
| (Cleared by | ||||
| FDA, K062091) | ||||
| Oxygen sensor | DigiFLO | |||
| Concentrator | ||||
| Analyzer | ||||
| (Cleared by | ||||
| FDA, K072469) | DigiFLO | |||
| Concentrator | ||||
| Analyzer | ||||
| (Cleared by | ||||
| FDA, K072469) | N/A | Yes | ||
| HEPA Filter | Same | Same | Same | Yes |
| Intended use | same | same | same | It is to provide |
| supplemental | ||||
| oxygen to patient | ||||
| with respiratory | ||||
| disorders. It is not | ||||
| intended to | ||||
| sustain or support | ||||
| life |
Substantial Equivalence Comparison Table
.
62
3
Table 5-1 Substantial Equivalence Comparison Table
As the chart above show, Jumao Oxygen Concentrator is comparable to its predicate. All devices have the same intended use for the same patient population, extract oxygen from air using the same methodology, provide comparable oxygen purity and are powered in the same manner. There are some small differences in the size, sound level, and compressor pressure between the Jumao Oxygen Concentrator and the predicate device, which do not affect the safety and effectiveness of the device.
Safety and Performance Data:
Safety and Performance Testing: The Jumao Oxygen Concentrator has been tested in accordance with the following standards:
ASTM 1464-93(2005): Standard Specification for Oxygen Concentrators for Domiciliary Use.
ISO 8359:1996 Oxygen Concentrator for Medical Use-Safety Requirements IEC60601-1. 2005 Medical Electrical Equipment, Part 1 : General requirements for basic safety and essential performance
Medical Electrical Equipment-part 1-2: General requirements for IEC60601-1-2, 2007 safety - collateral standard: Electromagnetic compatibility
FDA Reviewer's Guide: 1993 Reviewer Guidance for Premarket Notifications, November 1993
UL 1431, 2nd ED., 1996 UL Standard for Safety for personal Hygiene and Health Care Appliances Equipment
The safety and performance data found in this submission shows that the Jumao Oxygen Concentrator performs as intended and in a manner that is substantially equivalent to the predicate device.
4
All the components/materials/process used in the Jumao Oxygen Concentrator's gas path and patient contacting portion are identical to those of the Predicate Devices, see Table S2-1. Therefore, the Jumao Oxygen Concentrator meets biocompatibility standards in accordance with FDA Guidance Document FDA's Blue Book Memorandum #G95-1, "Use of international Standard ISO-10993, Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing" (G95-1).
Conclusion:
The data submitted in this 510(K) Premarket Notification supports the finding that this device is substantially equivalent with respect to the intended use, technology, functionality, and safety features to the legally marketed Predicate Device. Therefore, we believe that this device meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(K) guidelines.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Danyang Jumao Healthcare Equipment Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313
JUL 24 2009
Re: K090007
Trade/Device Name: Jumao Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Oximeter Regulatory Class: II Product Code: CAW Dated: July 7, 2009 Received: July 8, 2009
Dear Mr. Job:
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.
2000 - 11.00
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
6
Page 2 - Mr. Job
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
for.
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
7
INDICATIONS FOR USE CHAPTER 4.
090007 510(k) Number (if known):
Device Name: Jumao Oxygen Concentrator
Indications for Use:
The intended function and use of the Jumao Oxygen Concentrator is to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve. It is not intended to sustain or support life.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schulte
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K 090067