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

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.

AI/ML Overview

The provided text describes the JUMAO OXYGEN CONCENTRATOR and its submission for 510(k) clearance, asserting substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a study proving those criteria are met for a novel AI/software device.

Therefore, many of the requested categories are not applicable to this document. However, I can extract the information that is present.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in terms of specific thresholds for oxygen concentration or delivery rate. Instead, it leverages "substantial equivalence" to predicate devices. The performance is presented as being "same" or comparable to the predicate.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (Jumao Oxygen Concentrator)
Oxygen Concentration Levels	95.6% to 87% at all flow rates (Invacare Platinum XL 5-Liter O2 Concentrator)	Same (as predicate)
Delivery Rate	0.5 to 5 LPM (Invacare Platinum XL 5-Liter O2 Concentrator)	Same (as predicate)
Outlet Pressure	5 psi +/- 0.5 psi (Invacare Platinum XL 5-Liter O2 Concentrator)	Same (as predicate)
Sound Level	50dBA average (Invacare Platinum XL 5-Liter O2 Concentrator)	52dBA average
Intended Use	Provide supplemental oxygen to patients with respiratory disorders; not intended to sustain or support life.	Same

Note: The "acceptance criteria" here are implied by the attributes of the predicate device to which the JUMAO device claims substantial equivalence. The document states, "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." This suggests that the measured sound level of 52dBA, while higher than the predicate's 50dBA, was deemed acceptable in the context of substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document describes a medical device (oxygen concentrator) and compares its technical specifications to predicate devices. It does not involve a "test set" of patient data in the way an AI/software device would. The testing mentioned is related to engineering standards (e.g., ASTM, ISO, IEC, UL).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided and is not applicable. The device is hardware-based, and its performance evaluation for 510(k) clearance is based on engineering specifications and adherence to recognized standards, not on expert-adjudicated ground truth from a test set.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive AI/software devices involving human readers. The JUMAO Oxygen Concentrator is a hardware device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

No, a "standalone" study in the context of an algorithm's performance was not done. The performance evaluation is based on the physical device's specifications and adherence to engineering standards.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to AI/software devices (e.g., pathology, outcomes data) is not applicable here. The "ground truth" for this device's performance is its measured physical characteristics and output (e.g., oxygen concentration, flow rate, pressure) as assessed against engineering standards and compared to a predicate device's established performance.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a hardware oxygen concentrator, not an AI/software algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

This information is not provided and is not applicable.

Summary

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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 CONCENTRATORModel 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:

Indications for Use:

Device Description

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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:

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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 O2IRC5LX02
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 compressorsameLow oxygen purity	Thermal protection on compressorsameLow oxygen purity	Thermal protection on compressorsameN/A	N/Aoxygen monitor, low-flowN/A
	samecompressor 40 psi pressure relief valve	samecompressor 40 psi pressure relief valve	samecompressor 40 psi pressure relief valve	Power failurecompressor 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-ZW400D2-90Compressor(Same as K080391)	GSE-ZW400D2-90Compressor(Same as K080391)	GSE-ZW400D2-90Compressor(Same as K080391)	Thomas based double wobble
Humidifier	Humidiflow humidifier	same	same	Bottle humidifier
	(Cleared byFDA, K062091)
Oxygen sensor	DigiFLOConcentratorAnalyzer(Cleared byFDA, K072469)	DigiFLOConcentratorAnalyzer(Cleared byFDA, K072469)	N/A	Yes
HEPA Filter	Same	Same	Same	Yes
Intended use	same	same	same	It is to providesupplementaloxygen to patientwith respiratorydisorders. It is notintended tosustain or supportlife

Substantial Equivalence Comparison Table

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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.

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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.

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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.

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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

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INDICATIONS FOR USE CHAPTER 4.

090007 510(k) Number (if known):

Device Name: Jumao Oxygen Concentrator

Indications for Use:

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

Regulation Number and Section

§ 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).