The JUMAO Oxygen Concentrator is intended 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

JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides high concentration of oxygen directly to patient/user through a nasal cannula or other methods.

The Jumao Oxygen Concentrator is a Pressure Swing Adsorption (PSA) type oxygen concentrator which takes 120V ~ power source as power source. 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 93% oxygen to the patient.

AI/ML Overview

This document is a 510(k) premarket notification for an Oxygen Concentrator (Model: JMC5A Ni) and primarily focuses on demonstrating substantial equivalence to a predicate device. It is not a study report designed to prove a device meets specific acceptance criteria through clinical or large-scale non-clinical performance studies with detailed statistical analysis.

Therefore, many of the requested details about acceptance criteria, study methodologies, sample sizes for test/training sets, expert involvement, and ground truth establishment are not present in this regulatory submission document as they would be in a dedicated performance study report.

The document states, "No clinical testing has been performed." and primarily relies on non-clinical (bench) testing and a usability study to support substantial equivalence. The "acceptance criteria" discussed are more akin to meeting specific established standards and performance specifications for an oxygen concentrator rather than criteria for an AI/algorithm-driven device's performance metrics (like sensitivity, specificity).

Below, I will extract the available information, noting where the requested details are not provided due to the nature of the document.

Device Under Review: JUMAO Oxygen Concentrator (Model: JMC5A Ni)
Device Classification: Class II, Product Code CAW (Portable Oxygen Generator)
Indication for Use: "The JUMAO Oxygen Concentrator is intended 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."

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a "table" format with reported performance against them as one might find for an AI algorithm's metrics (e.g., sensitivity, specificity). Instead, the document discusses compliance with recognized standards and certain performance specifications.

Parameter/Characteristic	Acceptance Criteria (from predicate/standards)	Reported Device Performance (JMC5A Ni)	Notes/Comparison to Predicate
Oxygen Concentration	95.6% to 87% at all flow rates (Predicate)	$93% \pm 3%$ at 0.5 to 5L/min (after turning on 5 minutes)	Similar/Superior: Proposed device has a narrower and higher specified range, suggesting superior performance in this aspect ("superior to the predicate device"). Compliant with ISO80601-2-69.
Oxygen Flow	0.5 – 5 LPM (Predicate)	0.5~5L/min	Same
Outlet Pressure	38kPa±5kPa (Predicate)	38kPa±5kPa	Same
Noise	52 dB(A) (Predicate)	Sound level: ≤ 50.5dB(A); Acoustic power level: 58.5dB (A)	Different/Improved: Proposed device has a lower sound level. Compliant with ANSI AAMI ES60601-1.
Electr. Classification	Class II, Type B (Predicate)	Class II, Type BF	Similar: Both Class II. Type BF is different from Type B, but proposed device compliant with ANSI AAMI ES60601-1. This difference does not affect safety/effectiveness.
Alarms	Oxygen low-flow monitor, Low oxygen purity, Power failure, Compressor 40 psi pressure relief valve, Thermal protection on compressor (Predicate)	Start-up fail alarm, Low oxygen concentration alarm, Power supply failure alarm, Pressure failure alarm (Outlet block, oxygen flowrate below 0.6 Lpm; Compressor stop)	Similar/Same Principle: Different expressions but similar underlying principles. Proposed device's pressure alarm takes into account more specific scenarios and is compliant with IEC 60601-1-8.
Normal Operating Ambient	Temp: 10°C - 35°C; RH: 30-75%; Alt: Up to 7,500 feet (Predicate)	Temp: 5°C ~ 40°C; RH: ≤80%; Pressure: 86kPa ~ 106kPa; Alt: 1828 meter (5997 feet)	Different: Wider temperature and humidity range; lower maximum altitude.
Biocompatibility	Not explicitly detailed for predicate	Evaluated per ISO 10993-1, ISO 18562-1, ISO 18562-2, ISO 18562-3, ISO 10993-5, ISO 10993-10, ISO 10993-23.	Compliance with these standards is the acceptance criterion.
Electrical Safety & EMC	IEC 60601-1:2005, IEC 60601-1-2:2007 (Predicate)	ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, AIM Standard 7351731, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69	Similar/Updated Standards: Compliance with newer/updated versions of standards and additional relevant standards (e.g., for home use, alarms). This demonstrates meeting current safety requirements.
Software Verification & Validation	Not explicitly detailed for predicate	Performed as intended per FDA Guidance for Premarket Submissions for Software Contained in Medical Devices.	Compliance with FDA V&V guidance is the acceptance criterion.
Performance Testing (Bench)	General functional and safety requirements for oxygen concentrators	Appearance, Gas tightness, Sound pressure level, Operation, Accuracy of continuous flowrate, Oxygen yield and oxygen concentration, Oxygen output pressure, Alarm, Error of flowmeter, Leakage current, Dielectric strength.	All bench test results provided in a Performance Test Report (not enclosed). This implies meeting the functional specifications for each.
Use Life Test	Not explicitly detailed for predicate	Accelerated life test and performance test after accelerated life test.	Pass/fail implicit in conclusion of substantial equivalence.
Cleaning & Disinfection Verification	Not explicitly detailed for predicate	Simulated cleaning and disinfection test and performance test after simulated cleaning and disinfection test.	Pass/fail implicit in conclusion of substantial equivalence.
Usability Study	Not explicitly detailed for predicate	15 participants able to understand user manual/labeling and safely/effectively use device.	Demonstrated successful use by an adequate number of participants.

2. Sample size used for the test set and the data provenance

Test Set (for performance/engineering tests): The document doesn't specify a "sample size" in terms of number of devices for specific performance tests (e.g., number of concentrators tested for oxygen concentration). It states "All the bench test results are provided in Performance Test Report," implying that the necessary testing in accordance with the standards was performed on a representative sample of devices.
Data Provenance: Not explicitly stated, but given the manufacturer is based in China, it's highly probable the non-clinical testing was conducted in China or by labs retained by the manufacturer. It's retrospective in the sense that the tests were completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This is not applicable as there is no "ground truth" to be established by experts in the context of human-read images or data for an AI/algorithm. The device is an oxygen concentrator, and its performance is measured against engineering specifications and industry standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for the type of device and testing performed. This typically applies to human reader studies or image interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/algorithm-assisted diagnostic device. No clinical studies were performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/algorithm device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is defined by the technical specifications and requirements outlined in recognized national and international standards for oxygen concentrators (e.g., ISO 80601-2-69, various IEC and ISO biocompatibility and electrical safety standards). Performance data (e.g., oxygen concentration, flow rate, noise level) is measured directly from the device against these established benchmarks.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services - USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top of the word "ADMINISTRATION".

November 9, 2023

Jiangsu Jumao X-Care Medical Equipment Co., Ltd. % Jinghua Zhou Regulation Control Manager Guangzhou Junyi Information Technology Co., Ltd. Room 215, Huaming Building, Chebei Road Guangzhou, Guangdong 511660 China

Re: K230969

Trade/Device Name: Oxygen Generator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: October 10, 2023 Received: October 10, 2023

Dear Jinghua Zhou:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.

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See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230969

Device Name Oxygen Concentrator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 5 - 510(k) Summary

K Number: K230969 Date of Summary Preparation: March 31, 2023 Date of Summary modification: September 28, 2023

1. Submitter's Identifications

Submitter's Name: Jiangsu Jumao X-Care Medical Equipment Co., Ltd. Address: No.36 Danyan Road, Danyang, Jiangsu 212300, China Official Contact Person: Yu Yao Zip code: 212300 Contact Title: General Manager Contact E-mail Address: 541640111@gq.com Tel: +86-511-86197666 Fax: +86-511-86197033

2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 215, Huaming Building, Chebei Road, Guangzhou, P.R. China ZIP Code: 511660 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549

3. Name of the Device

Device Classification Name: Oxygen concentrator, Portable Product Name: Portable oxygen generator Trade Name: Oxygen Concentrator Model: JMC5A Ni Classification Panel: Anesthesiology Product Code: CAW Regulation Number: 21 CFR 868.5440 Device Classification: Class II

4. The Predicate Devices

Predicate device: K090007 Oxygen Concentrator

5. Device Description

JMC5A Ni oxygen concentrator is made up of mainframe and flowmeter. It is an electronically operated device that separates oxygen from ambient air. It provides

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high concentration of oxygen directly to patient/user through a nasal cannula or other methods.

6. Intended Use of Device

7. Summary of Substantial Equivalence
---------------------------------------	--

	Proposed device	Predicate device	Comparison
510kNumber	------	K090007	------
Product Code	CAW	CAW	Same
ProprietaryName	Oxygen Concentrator	Oxygen Concentrator	------
Model	JMC5A Ni	JM-07000Hi,JM-07000i, JM-07000	------
Manufacturer	Jiangsu Jumao X-CareMedical EquipmentCo., Ltd.	Jiangsu Jumao X-CareMedical EquipmentCo., Ltd.	------
Indicationsfor use	The JUMAO OxygenConcentrator isintended to providesupplemental oxygento patients withrespiratory disorders,by separating nitrogen	The intended functionand use of the JumaoOxygen Concentratoris to providesupplemental oxygento patients withrespiratory disorders.	Same

	from room air, by wayof a molecular sieve. Itis not intended tosustain or support life.	by separating nitrogenfrom room air, by wayof a molecular sieve. Itis not intended tosustain or support life.
Intendedpatientpopulation	The device is intendedfor use in adults.	The device is intendedfor use in adults.	Same
Structure andmaincomponents	JMC5A Ni oxygenconcentrator is madeup of mainframe andflowmeter.The front panel of thedevice contains thecontrols andindicators. Theseinclude a standardbarb fitting forattaching the oxygentubing, the adjustableflow meter, a powerlight indicator, anelapsed time meter,and a standard on/offrocker type powerswitch.	The front panel of thedevice contains thecontrols andindicators. Theseinclude a standardbarb fitting forattaching the oxygentubing, the adjustableflow meter, a powerlight indicator, anelapsed time meter,and a standard on/offrocker type powerswitch.	SameSame as JM-07000iand JM-07000 models.
Filters	Cabinet, out HEPA,Compressor inlet	Cabinet, out HEPA,Compressor inlet	Same
HEPA Filter	Same as predicatedevice	Same as proposeddevice	Same
Oxygensensor	Model: OXY-III-B,Gasboard-7500K	DigiFLO ConcentratorANALYZER (clear byFDA, K072469)	DifferentThe oxygen sensorused in proposeddevice does not have aK number, while thesensor used inpredicate device has aK number.The oxygen sensor ofpredicate device hasbeen tested withequipment.Thedifference does not
			and safety of the
			proposed device.
Compressor	Model: 1120-2-1-3,1121-1-2-1(1000460)	GSE-ZW400D2-90Compressor, Thomasbased double wobble	DifferentProposed device andpredicate device usecompressors fromdifferentmanufacturers.The compressor ofpredicate device hasbeen tested withequipment.Thedifference does notaffect the effectivenessand safety of theproposed device.
Material ofmaincomponents	Components andassociated materialswhich contact the gaspathway to the patient:filter-High efficiencyparticulate air (HEPA)filter paper;Compressor- ASM;Heat exchanger-Aluminum; Valveassembly-Aluminum;Molecular sievemodule-$Li2O \cdot A12O3 \cdot (2.2\pm0.2)$SiO2·9/2H2O;Silicone tube-Silicone; Producttank-ABS; Bacillifilter- Non-wovenpolyester fiber; Flowmeter-Acrylic; Checkvalve-Fluororubber;Oxygen outletconnector-Copper;Commute valve-Fluororubber; Muffler,Enclosure, Base-ABS;	Components andassociated materialswhich contact the gaspathway to the patient:filter-High efficiencyparticulate air (HEPA)filter paper;Compressor- ASM;Heat exchanger-Aluminum; Valveassembly-Aluminum;Molecular sievemodule-$Li2O \cdot A12O3 \cdot (2.2\pm0.2)$SiO2·9/2H2O;Silicone tube-Silicone; Producttank-ABS; Bacillifilter- Non-wovenpolyester fiber; Flowmeter-Acrylic; Checkvalve-Fluororubber;Oxygen outletconnector-Copper;Humidifierbottle-( Cupbody-translucent PE,	Same
	Wheel, Control panel; Power cord-ASM; PCB- Flame Retardant Copper Clad Epoxy E Glass Cloth Laminate	Filter tube-transparent PVC); Nasal oxygen cannula-PVC; Commute valve-Fluororubber; Muffler, Enclosure, Base-ABS; Transformer, AC fan, Wheel, Control panel, Power cord-ASM; PCB- Flame Retardant Copper Clad Epoxy E Glass Cloth Laminate
Power supply	AC120V, 60Hz; Current: 3.5A; Power: 450VA	AC115V, 60 Hz, 4.3 A; Power consumption: 4.3 amps average 5L/min (400W)	Different Input voltage, rated current and rated input power of proposed device are different from those of predicate device. Proposed device is complied with safe standards. These difference do not affect the safety and effectiveness of proposed device.
Oxygen concentration	$93% \pm 3%$ at 0.5 to 5L/min (after turning on 5 minutes)	95.6% to 87% at all flow rates	Similar1. The expression of the proposed device is more standardized, and the requirements for oxygen concentration under the conditions of 0.5 to 5L/min are specified.2. The oxygen concentration range of the proposed device is narrower than that of the predicate device. Oxygen concentration of proposed device can reach $93% \pm 3%$ within the oxygen flow range.
			which is superior tothe predicate device.Proposed device iscomplied withISO80601-2-69.The difference doesnot affect theeffectiveness andsafety of the proposeddevice.
Oxygen flow	0.5~5L/min	0.5 – 5 LPM	Same
Outletpressure	38kPa±5kPa	38kPa±5kPa	Same
Noise	Sound level: ≤ 50.5dB(A);Acoustic power level:58.5dB (A)	52 dB(A)	DifferentSound level ofproposed device islower than that ofpredicate device.Acoustic power levelis added to the propseddevice.Proposed device is compliedwith ANSI AAMIES60601-1.The difference does notaffect the effectivenessand safety of theproposed device.
Releasepressure bymachineoperation	250kPa±50kPa	40bsi (275kPa)	DifferentRange of releasepressure of proposeddevice is larger thanthat of predicatedevice.Proposed device iscomplied with safestandards.The difference doesnot affect theeffectiveness andsafety of the proposeddevice.
Net weight	16.1kg	52 pounds (23.6kg)	DifferentNet weight ofproposed device is
			lighter than that of predicate device.Proposed device is complied with ANSI AAMI ES60601-1.The difference does not affect the effectiveness and safety of the proposed device.
Dimension	330×260×540(mm)	28" (710mm)H x 17"(432) W x 15"(381)D	Different Dimension of proposed device is smaller than that of predicate device.Proposed device is complied with ANSI AAMI ES60601-1.The difference does not affect the effectiveness and safety of the proposed device.
ElectricClassification	Class II, Type BF	Class II, Type B	SimilarThey are both Class II.But safety type of applied part is different, proposed device is type BF, predicate device is type B.Proposed device is complied with ANSI AAMI ES60601-1.The difference does not affect the effectiveness and safety of the proposed device.
Alarm	Start-up fail alarm	Oxygen low-flow monitor,	SameDifferent expressions, in fact the same principle

	Low oxygenconcentration alarm	Low oxygen purity(JM-07000Hi,JM-07000i)	SameDifferent expressions, in fact the same principle.
	Power supply failurealarm	Power failure	SameDifferent expressions, in fact the same principle.
	Pressure failure alarm1.Outlet block, oxygenflowrate below 0.6Lpm;2.Compressor stop	Compressor 40 psipressure relief valveThermal protection oncompressor	DifferentProposed devicedesign takes intoaccount compressorstop, outlet block,oxygen flowrate belowresulting in pressurefailure alarm. Thealarm function iscomplied with IEC60601-1-8. Thedifference does notaffect the effectivenessand safety of theproposed device.
Mode ofoperation	Continuous duty	Continuous duty	Same
Normaloperatingambient	Temperature range:5°C ~ 40°C (41°F ~~104°F)Relative humidity:≤80%Atmospheric pressure:86kPa ~ 106kPa(12.47psi~~15.37psi)1828 meter (5997 feet)height above sea level	10 °C - 35 °C30-75% RelativeHumidity(non-condensing)Up to 7,500 feet abovesea level	DifferentThe range of operatingtemperature range andrelative humidity ofproposed device iswider than those ofpredicate device.The height above sealevel of proposeddevice is less than thatof predicate device.
Storage andtransportambient	Temperature Range:0°C~+55°C (32°F~+131°F)Relative HumidityRange: 10%~~90%Atmospheric pressure:70kPa ~ 106kPa(10.2psi~~15.37psi)	-40 °C to 70 °C, 10%to 100% R.H.	DifferentThe temperature rangeand relative humidityrange of proposeddevice are both narrowthan those of predicatedevice. Atmosphericpressure is added to
			proposed device.The range of storageand transport ofproposed device isnarrower than that ofpredicate device.The difference doesnot affect theeffectiveness andsafety of the proposeddevice.
Softwarecontrol	Yes	Yes	Same
Patientinterface type	Visual, direct contacttype patient interface	Visual, direct contacttype patient interface	Same
Standard	IEC 60601-1-2:2014+A1:2020IEC TR60601-4-2:2016AIM Standard7351731:2021ANSI AAMIES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012IEC60601-1-11:2015IEC60601-1-8:2012ISO80601-2-69:2014ISO18562-1:2017ISO18562-2:2017ISO18562-3:2017ISO10993-1:2018ISO10993-5:2009ISO10993-10:2021ISO10993-23:2021	ASTM 1464-93 (2005)ISO 8359:1996IEC 60601-1:2005IEC 60601-1-2:2007UL 1431, 2nd ED.,1996	Similar1. In the test standardsfor proposed deviceand predicate device:basic safety andperformancerequirements formedical electricalequipment(ES/IEC60601-1), andelectromagneticcompatibility(IEC60601-1-2), thetwo standards have thesame number, butdifferent age numbers;2. StandardIEC60601-1-11 andstandard UL 1431 aresimilar.The requirements ofISO80601-2-69supersede ASTM 1464and ISO 8359.3. Proposed deviceadds IEC TR60601-4-2, AIMStandard 7351731,ISO18562-1
DiscussionforSubstantiallyEquivalent(SE)	The proposed device JMC5A Ni oxygen concentrator has the sameindications for use, intended patient population, structure and maincomponents, filters, HEPA filter, material of main components, oxygenflow, outlet pressure, alarm (start-up fail alarm, low oxygen concentrationalarm, power supply failure alarm), mode of operation. The maindifferences are oxygen sensor and compressor used, power supply,oxygen concentration, noise, release pressure by machine operation, netweight, dimension, application types of electrical safety, pressure failurealarm, normal operating ambient, storage and transport ambient, teststandards. These differences are slight and do not affect the effectivenessand safety of the device, through the above comparative analysis.The proposed device JMC5A Ni oxygen concentrator is determined to beSubstantially Equivalent (SE) to the predicate device, JM-07000Hi,JM-07000i, JM-07000 oxygen concentrator in respect of safety andeffectiveness.	ISO18562-2, andISO18562-3 test.4. Proposed deviceadds ISO 10993-5,ISO 10993-10, ISO10993-23 test.Proposed device aretested against currentapplicable standards,and the test resultsmeet the standardrequirements. Thesedifference do notaffect the effectivenessand safety of theproposed device.

Table 1

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Note: The oxygen concentrator can be used with accessories (i.e, nasal cannula, humidifier bottle) available in the market.

8. Non-Clinical Tests Submitted:

The following non-clinical testing was provided in this 510(k) submission:

Biocompatibility Testing

According to ISO 10993-1:2018 and ISO 18562-1:2017, we performed the biocompatibility evaluation and test of the dry breathing gas pathway:

Performed toxicological evaluation according to ISO 18562-1:2017. Performed evaluation of emissions of ozone, carbon monoxide, carbon dioxide per recommendations in ISO 18562-1:2017.
Performed test for emissions of particulate matter according to ISO 18562-2:2017.

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Performed test for emissions of volatile organic compounds according to ISO 18562-3:2017.

According to ISO 10993-1:2018, we performed biocompatibility test for the parts that may directly contact the intact skin of the patient or operator, including in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021.

Electrical Safety and Electromagnetic Compatibility Testing

The Device was tested and complied with the applicable requirements of the following standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC TR 60601-4-2, AIM Standard 7351731, IEC 60601-1-11, IEC 60601-1-8, ISO 80601-2-69, demonstrated that the basic safety and performance of the device met the requirements.

Software Verification and Validation

Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

9. Concise summary for performance testing

From the performance testing - bench, we have a brief summary as follow:

Performance Test (Appearance requirement, Gas tightness, Sound pressure level, Operation, Accuracy of continuous flowrate, Oxygen yield and oxygen concentration, Oxygen output pressure, Alarm, Error of flowmeter, Leakage current, Dielectric strength).
Use Life Test (Accelerated life test, and performance test after accelerated life test).
Cleaning and Disinfection Verification (simulated cleaning and disinfection test, and performance test after simulated cleaning and disinfection test).

All the bench test results are provided in Performance Test Report.

10. Usability Study

The JMC5A Ni oxygen concentrator was performed usability study separately by similar methods.

Testing of 15 participants was conducted showing that the participants were able to understand the user manual and labeling and were able to safely and effectively use the device.

11. Clinical Study

No clinical testing has been performed.

12. Conclusions

After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantially equivalent to the predicate device.

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).