The Oxygen Concentrator is intended for the administration of supplemental oxygen. This device is not intended for life supporting nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel, at home, in community health care and medical institutions.

Device Description

The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%). The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power. The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.

AI/ML Overview

The provided document pertains to a 510(k) premarket notification for an Oxygen Concentrator. As such, it describes a medical device, not an AI/ML algorithm. Therefore, many of the requested details regarding acceptance criteria, study design for AI performance, expert adjudication, and ground truth establishment are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

Here's a breakdown of the relevant information from the document, addressing the applicable parts of your request:

1. Table of acceptance criteria and the reported device performance

The document does not present "acceptance criteria" in the typical sense of a target performance metric for an AI algorithm. Instead, it describes compliance with established medical device standards and comparison to a predicate device. The "performance" is demonstrated by meeting these standards and showing similar technical characteristics to the predicate.

Below is a table summarizing the technical characteristics of the proposed device and how they compare to the predicate, which serves as the basis for the substantial equivalence determination. The "acceptance criteria" here are implied by the predicate device's characteristics and relevant standards.

Item	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Proposed Device)
Classification	Class 2	2
Product Code	CAW	CAW
Regulation Number	21 CFR 868.5440	21 CFR 868.5440
Intended Use	Administration of supplemental oxygen; not life-supporting; no patient monitoring; operated by trained personnel.	Administration of supplemental oxygen; not life-supporting; no patient monitoring; operated by trained personnel, at home, in community health care and medical institutions.
Use Environment	Home, hospital, and medical facility	Home, community health care, and medical institutions
Operation Principle	Pressure Swing Adsorption (PSA) technology	Pressure Swing Adsorption (PSA) technology
Oxygen Purity	93% +/- 3%	93% +/- 3%
Flow Type	Continuous flow	Continuous flow
Flow Rate	0.5 - 15 L/min	M30: 0-3 L/min, M40: 0-4 L/min, M50: 0-5 L/min
Sound Level	<70 dBA	≤45 dBA
Oxygen Purity Warning	<85%	<82%
Electrical Requirements	110V/240V, 50Hz/60Hz, Battery	110V/220V, 50Hz/60Hz
Outlet Pressure	10.0 psig	0.05 Mpa ± 10% (7.25 psig roughly)

Note on "Acceptance Criteria" for a non-AI/ML device: For this type of device, "acceptance criteria" are typically defined by compliance with recognized standards (e.g., ISO, IEC, AAMI) and demonstration of substantial equivalence to a legally marketed predicate device. The document explicitly states: "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

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

This is not applicable as there is no "test set" in the context of an AI/ML algorithm's performance evaluation. The "testing" refers to non-clinical bench testing to demonstrate compliance with standards and safety/performance specifications of the physical device.

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

This is not applicable. No expert-established ground truth for an AI/ML algorithm's performance is involved in this 510(k) submission.

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

This is not applicable. No expert adjudication for an AI/ML algorithm's performance is involved.

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

This is not applicable. This submission is for a physical medical device (oxygen concentrator), not an AI-assisted diagnostic or therapeutic tool.

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

This is not applicable. There is no algorithm to evaluate in a standalone manner.

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

This is not applicable. For this type of device, "ground truth" relates to the physical and functional parameters of the device (e.g., oxygen purity, flow rate, pressure) as measured by calibrated equipment and verified against engineering specifications and industry standards. It's not a diagnostic or clinical "ground truth."

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm involved, and thus no training set.

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

This is not applicable. There is no AI/ML algorithm involved, and thus no training set or associated ground truth.

Summary of the Study Proving Device Meets Acceptance Criteria (and Substantial Equivalence):

The "study" refers to non-clinical testing and comparative analysis rather than clinical trials or AI performance evaluations.

Type of Testing: Non-clinical tests were conducted. These typically include bench testing for electrical safety, electromagnetic compatibility, oxygen concentration accuracy, flow rate stability, alarm functions, sound levels, and biocompatibility of patient-contacting materials.
Standards Met: The device demonstrated compliance with several international and US standards, including:
- AAMI / ANSI ES60601-1 (General requirements for basic safety and essential performance of medical electrical equipment)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- ISO 80601-2-69 (Particular requirements for basic safety and essential performance of oxygen concentrator equipment)
- ISO 10993-5 (Biological Evaluation - In Vitro Cytotoxicity)
- ISO 10993-10 (Biological Evaluation - Irritation and Skin Sensitization)
- VOCs and PM2.5 test (per EPA TO 15 and IP-10 method)
Comparison to Predicate Device (K150930): A detailed comparison of technical characteristics (Table 1) was performed against the predicate oxygen generator.
- Similarities were highlighted in classification, product code, regulation number, intended use principle, and oxygen purity.
- Differences in flow rate range, sound level, oxygen purity warning threshold, electrical requirements, and outlet pressure were acknowledged and discussed. The submission argues that these differences do not raise different questions of safety and effectiveness because:
  - The proposed device's flow rate is within the predicate's range.
  - Even with a lower oxygen purity warning level (<82% vs <85%), both comply with ISO 80601-2-69.
  - The outlet pressure, while different, also complies with ISO 80601-2-69.
  - Electrical requirements, though different, comply with the relevant electrical safety and EMC standards.
Conclusion: Based on the non-clinical tests and the comparison, the manufacturer concluded that the proposed device models are substantially equivalent to the predicate device.
Clinical Study: The document explicitly states: "No clinical study is included in this submission." This indicates that the substantial equivalence determination for this device did not require human clinical data.

Summary

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June 1, 2018

SysMed (China) Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K172234

Trade/Device Name: Oxygen Concentrator, Models M30, M40, and M50 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: April 26, 2018 Received: April 30, 2018

Dear Diana Hong:

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. 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 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172234

Device Name Oxygen Concentrator Models M30, M40, and M50

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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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172234

1. Date of Preparation: 05/31/2018
1. Sponsor Identification

SysMed (China) Co., Ltd

11-2-3 No. 17 Wensu Str., Hunnan New Dis., Shenyang, 110171, China

Establishment Registration Number: Not yet registered

Contact Person: Jian Yue Position: Quality Manager Tel: +86-24-24696136 Fax: +86-24-24696137 Email: office02@sysmed.cn

1. Designated Submission Correspondent Ms.
  Diana Hong (Primary Contact Person) Betty Xiao (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: Oxygen Concentrator Common Name: Portable Oxygen Generator Models: M30, M40, M50

Regulatory Information Classification Name: Generator, Oxygen, Portable Classification: 2 Product Code: CAW Regulation Number: 21CFR 868.5440 Review Panel: Anesthesiology

Intended Use Statement:

Device Description

The Oxygen Concentrator adopts the principle of pressure swing adsorption technology. At normal temperature, the device can continuously supply a high concentration of supplemental oxygen (93%±3%).

The main function of the proposed device includes supplying supplemental oxygen. The device also includes alarms for high temperature, low oxygen output, and interruption of power.

The proposed device includes three models, which are M50, M40 and M30. The only difference of the three models is flow rate.

1. Identification of Predicate Devices
  510(k) Number: K150930 Product Name: Deployable Oxygen Generator System - Small (DOGS-S)
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
♪ IEC 60601-1-2:2007/(R)2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests
ISO 80601-2-69 First Edition 2014-07-15, Medical Electrical Equipment - Part 2-69: Particular Requirements For Basic Safety And Essential Performance Of Oxygen Concentrator Equipment.
♪ ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
♪ ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
A VOCs and PM2.5 test per EPA TO 15 andIP-10 method
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

	Table 1 Comparison of Technology Characteristics
Item	Proposed DeviceM30, M40, M50	Predicate DeviceK150930
Classification	2	2
Product Code	CAW	CAW
Regulation Number	21 CFR 868.5440	21 CFR 868.5440
Intended Use	The Oxygen Concentrator is intendedfor the administration ofsupplemental oxygen. This device isnot intended for life supporting nordoes it provide any patientmonitoring capabilities. The systemwill be operated by trained personnel,at home, in community health careand medical institutions.	The Deployable Oxygen GeneratorSystem – Small (DOGS-S) isintended for the administration ofsupplemental oxygen. This deviceis not intended for life support nordoes it provide any patientmonitoring capabilities. Thesystem will be operated by trainedpersonnel.
Use environment	home, community health care andmedical institutions	Home, hospital and medicalfacility
Operation principle	pressure swing adsorption technology(PSA)	pressure swing adsorptiontechnology (PSA)
Oxygen purity	93% +/- 3%	93% +/- 3%

Table 1 Comparison of Technology Characteristics

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Flow type	Continuous flow	Continuous flow
Flow rate	M30: 0-3 L/minM40: 0-4 L/minM50: 0-5 L/min	0.5 - 15 L/min
Sound level	≤45 dBA	<70dBA
Oxygen puritywarning	<82%	<85%
Electricalrequirements	110V/220V, 50Hz/60Hz	110V/240V, 50Hz/60HzBattery
Outlet pressure	0.05 Mpa ± 10%	10.0 psig

Discussion: The intended use environments of both devices are the same. However, the indications for use of the proposed device identifies the intended use environment while the indications for use of the predicate does not.

The flow rate of proposed device is within that of the predicate device. Although the oxygen purity warning level is less than that of the predicate device, and the outlet pressure of proposed device is 0.05Mp, which is equal to 7.25 psig and less than that of predicate device, both of them comply with the requirements of ISO 80601-2-69. The electrical power requirements of the proposed device is different than that of predicate device, but both of them comply with standards AAMI / ANSI ES60601-1 and IEC 60601-1-2. These differences do not raise different questions of safety and effectiveness.

1. Substantially Equivalent (SE) Conclusion
  Based on the comparison and analysis above, the proposed device models are Substantially Equivalent (SE) to the predicate devices.

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).