The Longfian Oxygen Concentrator, Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

Device Description

The Longfian Oxygen Concentrator, Model JAY-5AW adopts pressure swing adsorption principle, which can separate oxygen, nitrogen and other gas from the air, at constant temperature. As soon as power is connected, the air is taken in and compressed by oilless air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The device is capable of providing oxygen flow up to 5 LPM. The concentration of supplied oxygen is from 90%-96%. The weight of Jay-5AW is around 16kg (~351bs). There is no influence on indoor oxygen percent during the generator operating.

The biocompatibility contact classification of the device is as permanent contact externally communicating with dry and humified gas pathway.

The life-time/use life of the oxygen concentrator is set at 5 years or 20.000 hours after the product is sold, whichever comes first.

The reusable components:

Intake air filter (two pieces, part number:GL-01)
Secondary filter (one piece, part number:GL-02)
nasal oxygen tube and
humidifier.

JAY-5AW medical oxygen concentrator contains the following items:

One (1) JAY-5AW Oxygen Concentrator Unit
One (1) AC Power Supply
One (1) Nasal Oxygen Tube
One (1) Firesafe Cannula Valve
One (1) Humidifier
One (1) Operation Manual

AI/ML Overview

The provided document is a 510(k) premarket notification for an Oxygen Concentrator, Model JAY-5AW. It details the device's technical specifications, indications for use, and a comparison to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria related to AI or a "human-in-the-loop" performance study of the type usually associated with the questions asked.

The document discusses "acceptance criteria" and "device performance" in the context of non-clinical bench testing for safety and performance (e.g., biocompatibility, electrical safety, EMC, software verification, and oxygen concentration/flow performance), not for an AI-driven diagnostic or assistive device that would involve human readers, ground truth establishment by experts, or MRMC studies.

Therefore, I cannot populate the table or answer the specific questions related to AI-driven device performance, sample sizes for test sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment in that context.

The document focuses on demonstrating substantial equivalence to a predicate device through engineering and safety testing of a physical medical device (an oxygen concentrator), not a software-based AI system.

Here's what can be extracted regarding the "acceptance criteria" and "device performance" as presented in this document for the Oxygen Concentrator:

Acceptance Criteria and Reported Device Performance (Based on the provided document for an Oxygen Concentrator):

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported Device Performance (from document)
Oxygen Concentration	93% ± 3% (at 0-5 L/min flow)	93% ± 3% (Consistent with predicate device. Performance testing confirmed oxygen production capacity meets design requirements after 8 hours continuous max output.)
Oxygen Flow	0-5 L/min	0-5 L/min (Consistent with predicate device. Performance testing confirmed oxygen production capacity meets design requirements after 8 hours continuous max output.)
Input Power	Predicate: 500W	Subject Device: 460W (Difference noted, but validated for safety and effectiveness through testing.)
Outlet Pressure	40-70 kPa	40-70 kPa (Consistent with predicate device)
Noise	≤ 53 dB(A)	≤ 53 dB(A) (Consistent with predicate device)
Fuse	Predicate: T6.3AL/250V	Subject Device: F5AL/250V (Difference noted, but electrical safety testing conducted.)
Operating Temperature	10-40 ℃	10-40 ℃ (Meets specified conditions)
Operating Relative Humidity	30%-85%	30%-85% (Meets specified conditions)
Operating Atmospheric Pressure	700-1060 hPa	700-1060 hPa (Meets specified conditions)
Transportation/Storage Temperature	Predicate: -20-45 ℃	Subject Device: -40-45 ℃ (Broader range, but within acceptable limits.)
Transportation/Storage Relative Humidity	≤ 95%	≤ 95% (Meets specified conditions)
Transportation/Storage Atmospheric Pressure	Predicate: 500-1060 hPa	Subject Device: 700-1060 hPa (Different range, but implied to be acceptable.)
Biocompatibility	Compliance with ISO18562-1, -2, -3, ISO10993-5, -10, -17	Testing conducted in accordance with specified ISO standards.
Electrical Safety	Compliance with IEC 60601-1, -1-2, -1-8, -1-11, and ISO 80601-2-69	System complies with specified IEC and ISO standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	System complies with specified IEC standard.
Software Verification & Validation	Adherence to FDA Guidance ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Moderate Level of Concern.	Testing conducted, and documentation provided as recommended. (No specific performance metrics for software stated, just compliance with V&V process).
Basic Safety & Essential Performance	Based on ISO 80601-2-69	Evaluated based on ISO 80601-2-69.

Responses to Specific Questions (based on the provided document and its scope):

A table of acceptance criteria and the reported device performance: See table above.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document describes bench testing of a physical device (oxygen concentrator prototypes/production samples), not a study involving patient data or AI algorithm validation with a "test set" in the common sense of AI/diagnostic imaging.
- Therefore, no information on sample sizes of patient data or data provenance (country, retrospective/prospective) is provided or relevant to the type of testing detailed in this document. The testing describes electrical, functional, and biocompatibility tests performed on the physical device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. This document is for an oxygen concentrator, not an AI diagnostic device. There is no concept of "ground truth" derived from expert interpretation of medical images or data from a patient population, nor a need for radiologists or similar experts in this context. The "truth" for this device's performance is determined by meeting engineering and safety standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no "adjudication method" involved as there are no expert interpretations to be reconciled.
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. No MRMC study was performed as this is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (oxygen concentrator), not an algorithm. The software mentioned (software verification and validation) pertains to the embedded control software of the device itself, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC 60601 series, ISO 80601 series, ISO 18562 series, ISO 10993 series) and its stated design specifications (e.g., oxygen concentration, flow rate). These are technical performance metrics, not clinical diagnostic "ground truth."
The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning/AI model.
How the ground truth for the training set was established:
- Not applicable. No training set exists for this type of device submission.

Summary

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December 8, 2022

Longfian Scitech Co., Ltd. % Jun Peng Principal Consultant P&L Scientific, Inc. 1430 S. Dixie Hwy Suite 105 Coral Gables, Florida 33146

Re: K213210

Trade/Device Name: Oxygen Concentrator, Model JAY-5AW Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: November 3, 2022 Received: November 7, 2022

Dear Jun Peng:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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. 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,

James J. Lee -S

James J. Lee, Ph.D. Division 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) K213210

Device Name Oxygen Concentrator, Model JAY-5AW

Indications for Use (Describe)

The Longfian Oxygen Concentrator. Model JAY-5AW is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

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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510(k) Summary

510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based:

K213210

1. Submitter Information:

●

Sponsor/510(K) Owner: LONGFIAN SCITECH CO., LTD. 2F&3F, East Section, Building 12, Power Valley Pioneer Park, No.369 Huiyang Street, Baoding 071051, China

Contact: Mr. Shi Lei Technical Manager Phone: +86-312-5909505

Date: October 28, 2022

Contact Name: ●

Mr. Jun Peng P&L SCIENTIFIC, INC. 1430 S. Dixie Hwy STE 105, Coral Gables, FL 33146 Phone: (305) 345 6018 Fax: (305) 397 0289 Email: jpeng@plscientificinc.com

2. Device Name

Oxygen Concentrator, Model JAY-5AW Trade Name: Common Name: Oxygen concentrator; Classification Name: Oxygen concentrator, portable;

3. Classification :

Classification:	21 CFR 868.5440; Class II
Product Code:	CAW;

4. Predicate Devices:

Oxygen(Model: JAY-5)	Concentrator	K131968,September 5, 2014	Cleared	LONGFIANCO., LTD.	SCITECH
--------------------------	--------------	-------------------------------	---------	-----------------------	---------

5. Description of Device

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air compressor through filtering, then the compressed air goes through the cooler and it is cooled. After that, the air is taken into absorption tower by control valve and the oxygen can be separated in the absorption tower. At the same time, the high purity oxygen is collected into the oxygen tank, and it goes through the flow meter and humidifier, finally the oxygen that meets medical standards can be supplied. Oxygen is generated by pure physical method.

The biocompatibility contact classification of the device is as permanent contact externally communicating with dry and humified gas pathway.

The life-time/use life of the oxygen concentrator is set at 5 years or 20.000 hours after the product is sold, whichever comes first.

The reusable components:

· Intake air filter (two pieces, part number:GL-01)
· Secondary filter (one piece, part number:GL-02)
nasal oxygen tube and
humidifier.

JAY-5AW medical oxygen concentrator contains the following items:

· One (1) JAY-5AW Oxygen Concentrator Unit
One (1) AC Power Supply
· One (1) Nasal Oxygen Tube
· One (1) Firesafe Cannula Valve
One (1) Humidifier
· One (1) Operation Manual

6. Intended Use

The Longfian Oxygen Concentrator, Model JAY-5AW, is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or healthcare environments. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.

Summary of Comparison in to Technological Characteristics Predicate Device 7.

Name	Predicate device	Subject device
K number	K131968	K213210

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Device Trade Name	JAY-5 Medical Molecular Sieve Oxygen Concentrator	The Longfian Oxygen Concentrator, Model JAY-5AW
Common Name	Oxygen concentrator	Oxygen concentrator
Classification Name	Oxygen concentrator, Portable	Oxygen concentrator, Portable
Indications for use	The Longfian Oxygen Concentrator, Model Jay-5 is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model Jay-5 can be used in a home, institution, vehicle, and various mobile environments. The Longfian Oxygen Concentrator, Model Jay-5 does not nor is it intended to sustain or support life.	The Longfian Oxygen Concentrator, Model JAY-5AW, is intended to be used by patients with respiratory disorders who require supplemental oxygen. A high concentration of supplemental oxygen is supplied and a nasal cannula is used to channel oxygen from the concentrator to the patient. The Longfian Oxygen Concentrator, Model JAY-5AW, can be used at home or an institution. The Longfian Oxygen Concentrator, Model JAY-5AW, does not nor is it intended to sustain or support life. The device is intended for use in adults.
Classification	21 CFR 868.5440	21 CFR 868.5440
Feature
Power supply	AC 220±22V, 50±1Hz	AC 230±23V, 50±1Hz
Input power	500W	460W
Oxygen concentration	93%±3%	93%±3%
Oxygen flow	0~5L/min	0~5L/min
Outlet pressure	40~70kPa	40~70kPa
Noise	≤53dB(A)	≤53dB(A)
Fuse	T6.3AL/250V	F5AL/250V
Operating system	Pressure Swing Adsorption	Pressure Swing Adsorption
Electrical classification	Class II Type B	Class II Type B
Dimensions	365×375×600mm(14.37"×14.76"×23.62")	280×3485×510mm(14.37"×14.76"×23.62")
Net weight	26Kg	16Kg
Alarm	Low & high pressure	Low & high pressure;Power failure
LCD display	Accumulating timing;present timing;timing	Accumulating timing;present timing;timing
Accessories	Nasal oxygen tubeHumidifier	Nasal oxygen tubeHumidifier
Materials
Sieve Bed	Synthetic Zeolite	Synthetic Zeolite
Nasal Oxygen Tube	PVC	PVC
Principles of operation
Operating system	Time cycle/ Pressure Swing Adsorption	Time cycle/ Pressure Swing Adsorption
Electronic safetySoftware/Hardware	Electrical Safety per IEC-60601Analog and digital electronicswith microprocessor	Electrical Safety per IEC-60601Analog and digital electronics withmicroprocessor
Operating , transportation and storage environment
Operating conditions	Ambient temperature : 10~40 ℃Relative humidity:30%~85%Atmospheric pressure:7001060hPa	Ambient temperature : 10~40 ℃Relative humidity:30%~85%Atmospheric pressure:700 1060hPa
Transportation andstorage Conditions	Ambient temperature :-20~45 ℃Relative humidity: ≤95%Atmospheric pressure 500-1060hPa	Ambient temperature :-40~45 ℃Relative humidity: ≤95%Atmospheric pressure 700-1060hPa

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The Longfian Oxygen Concentrator, Model JAY-5AW is similar to the predicate devices:

Has the same intended use and indications for use ●
Utilizes the same operating principle ●
Incorporates the same basic design
Incorporates the same technological characteristics ●
Tested to the same electrical and electromagnetic safety standards for medical ● electrical equipment
Manufactured under a quality system ●

The differences are:

JAY-5AW has different enclosure shape comparing to JAY-5; ●
The two models use different power of compressor, but compressor principle is the . same, the electronical safety and performance testing has validate the safety and effectiveness of JAY-5AW:
The differences in dimensions and weight do not raise any issues in safety and ● effectiveness.

8. Assessment of Non-Clinical Testing:

Non-clinical testing of the Longfian Oxygen Concentrator, Model JAY-5AW has been performed against requirements for performance, physical attributes, environmental conditions, materials and safety, and to provide objective evidence that the device's intended use is met.

9. Test Summary:

The device has been evaluated the safety and performance by lab bench testing as following:

Biocompatibility testing:

The biocompatibility evaluation for the Longfian Oxygen Concentrator, Model JAY-5AW was conducted in accordance with the ISO18562-1, ISO 18562-2, ISO18562-3, ISO10993-5, ISO10993-10, ISO10993-17.

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Electrical safety and electromagnetic compatibility (EMC):

Electrical safety and EMC testing were conducted on the Longfian Oxygen Concentrator, Model JAY-5AW. The system complies with the IEC 60601-1. IEC 60601-1-2, IEC 60601-1-8, IEC60601-1-11, and ISO 80601-2-69 standards for electrical safety and the IEC60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Level of Concern: The software for this device was considered as a moderate level of concern, because the subject device is a supplement to a patient's normal oxygen intake. If a failure of operation or latent design flaw could directly result in minor injury to the patient or operator. The device is not intended to be life supporting or life sustaining.

Performance Bench Testing

The basic safety and essential performance Test were evaluated based on ISO 80601-2-69. And Oxygen concentration and maximum flow performance testing was also conducted to verify that oxygen production capacity of the oxygen generator can meet the design requirements after working continuously at the maximum output for 8 hours

10. Conclusion

The subject device and the predicate device have the same intended use. The technological differences do not raise different questions of safety and effectiveness

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).