The device provides positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in self breathing patients weighing over 30kg (66lbs). This product can be used in the home as well as in clinical/hospital environments.

Device Description

The proposed device is a non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier. The device is intended to treat obstructive sleep apnea by delivering a flow of positive airway pressure at a level prescribed by a physician to splint open the airway and prevent airway collapse. The proposed device is available in three types, which are Aurora, Resware and Zizmer. Each type is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in four types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T) and Timed (T). The pressure range for the proposed devices is available in three types, which are 4-20cm H2O, 4-25cm H2O and 4-30cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for airway leakage, motor malfunction and high motor temperature. The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (SysMed S/T, a noncontinuous ventilator for treating obstructive sleep apnea). It describes the device, its intended use, and states that non-clinical tests were conducted to demonstrate substantial equivalence to predicate devices based on compliance with various engineering, safety, and biocompatibility standards.

However, this document does NOT describe the acceptance criteria and the study that proves the device meets the acceptance criteria in terms of clinical performance, specifically an AI/ML type of study. The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are typically found in clinical validation reports for AI/ML-driven medical devices.

The provided document focuses on demonstrating substantial equivalence based on physical and functional characteristics, and compliance with well-established performance and safety standards for medical ventilators. It does not involve AI/ML performance evaluation as would be described for an AI/ML-driven diagnostic or therapeutic device.

Therefore, I cannot populate the requested table and answer the study-specific questions based on the provided text. The document confirms that non-clinical tests were done to verify compliance with standards, but not a study demonstrating clinical performance against specific acceptance criteria relevant to AI/ML.

Here's why the document doesn't contain the requested information:

Device Type: The SysMed S/T is a non-continuous ventilator. Its primary function involves delivering positive airway pressure. While it might incorporate some automated features (like therapy modes), the provided document does not indicate it's an AI/ML-driven device that makes diagnostic or treatment recommendations requiring complex clinical validation studies with human readers or AI-specific performance metrics like sensitivity, specificity, or AUC against a ground truth established by experts.
510(k) Process: The 510(k) pathway for medical device clearance primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device. This often involves engineering bench testing, biocompatibility testing, and comparison of technical specifications, rather than a full-scale clinical trial or AI/ML performance study unless the device introduces novel technology or significant changes affecting safety or effectiveness.
Lack of Clinical Data/AI Performance Metrics: The "Non-Clinical Test Conclusion" section lists various industry standards (e.g., IEC, ISO) that the device complies with, relating to electrical safety, electromagnetic compatibility, alarm systems, home healthcare environment use, sleep apnea therapy equipment, humidifying equipment, and biocompatibility. These are typical engineering and safety tests, not clinical performance studies for an AI/ML algorithm.

If this were an AI/ML device, the "Non-Clinical Test Conclusion" or a separate "Clinical Study" section would detail how the AI's performance was measured against a clinically relevant ground truth, including metrics like sensitivity, specificity, or area under the ROC curve, and would address the points in your query.

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 logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 25, 2020

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

Re: K192177

Trade/Device Name: SysMed S/T Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: October 29, 2020 Received: October 30, 2020

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. 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.

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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) 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 medical devices and radiation-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.

for Malvina B. Eydelman, M.D. Director 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) K192177

Device Name SysMed S/T

Indications for Use (Describe)

The device provides positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in seff breathing patients weighing over 30kg (66lbs). This product can be used in the home as well as in clinical/hospital environments.

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 Title 21, CFR Section 807.92.

The assigned 510(k) Number: K192177

1. Date of Preparation: 11/24/2020
1. Sponsor Identification

SysMed (China) Co., Ltd

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

Establishment Registration Number: 3010440667

Contact Person: Yue Jian Position: Quality Manager Tel: +86-24-23970169 Fax: +86-24-23970519 Email: office02@sysmed.cn

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: SysMed S/T Common Name: Bi-Level S/T

Regulatory Information

Classification Name: ventilator, non-continuous (respirator) Classification: II; Product Code: BZD; Regulation Number: 21CFR 868.5905 Review Panel: Anesthesiology;

Indication for Use Statement:

Device Description

The proposed device is available in three types, which are Aurora, Resware and Zizmer. Each type is available in different models designed with different therapy modes and pressure ranges. The therapy modes are available in four types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T) and Timed (T). The pressure range for the proposed devices is available in three types, which are 4-20cm H2O, 4-25cm H2O and 4-30cm H2O. The designated pressure range and therapy mode for each proposed model was provided in following table

Type	Model	Pressure Range	Operating Mode
Aurora-series	Aurora Bi-Level S	4-25 cm H2O	CPAP, S
	Aurora Bi-Level S/T	4-25 cm H2O	CPAP, S, S/T
ZiZmer-series	ZiZ CPAP	4-20 cm H2O	CPAP
Resware-series	BI 20 S	4-20 cm H2O	CPAP, S
	BI 20 S/T	4-20 cm H2O	CPAP, S, S/T, T
	BI 25 S	4-25 cm H2O	CPAP, S

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BI 25 S/T	4-25 cm H2O	CPAP, S, S/T, T
BI 30 S/T	4-30 cm H2O	CPAP, S, S/T, T

Alarm module is incorporated in the device. The device will generate audio and visual alarm for airway leakage, motor malfunction and high motor temperature.

The proposed device is provided non-sterile, and not to be sterilized by the user prior to use. The proposed device can be reused by single patient.

న. Identification of Predicate Device
510(k) Number: K140159 Product Name: S9 WANDA VPAP ST
б. Identification of Reference Device
510(k) Number: K153061 Product Name: Juno VPAP ST-A
1. Non-Clinical Test Conclusion
  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:
A AAMI/ANSI ES60601-1:2005/(R) 2012 And A1:2012, C1:2009/(R) 2012 And A2:2010/(R) 2012 Medical Electrical Equipment-Part 1: General Requirements for Basic Safety and Essential Performance;
A IEC 60601-1-8:2012 Medical Electrical Equipment-Part 1-8: General requirements for basic safety and essential performance-Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60601-1-11:2015 Medical Electrical Equipment-Part 1-11: General requirements for basic safety and essential performance-Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
A IEC 60601-1-2: 2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
ISO 80601-2-70:2015 Medical Electrical Equipment-Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnea Breathing Therapy Equipment;
A ISO 80601-2-74:2017 Medical Electrical Equipment-Part 2-74: Particular Requirements for Basic

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Safety and Essential Performance of Respiratory Humidifying Equipment;

ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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: Test for irritation and skin sensitization;
ISO 10993-12: 2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 18562-2: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
ISO 18562-3: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
ISO 18562-4: 2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate

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Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device	Predicate Device	Reference Device
Classification	II	II	II
Product Code	BZD	BZD	MNS
Regulation Number	21 CFR 868.5905	21 CFR 868.5905	21 CFR 868.5895
Intended Use	The device provides positivepressure therapy for thetreatment of adult obstructivesleep apnea syndrome in selfbreathing patients weighingover 30kg (66lbs). This productcan be used in the home as wellas in clinical/hospitalenvironments.	The S9 WANDA VPAP ST isindicated for the treatment ofObstructive Sleep Apnea (OSA)in patients weighing more than66lb (30kg). It is intended foruse in the hospital and home.	The Juno VPAP ST-A isindicated to providenoninvasive ventilation forpatients weighing more than30lbs (13 kg) withrespiratory insufficiency orobstructive sleep apnoea(OSA).The ¡VAPS mode isindicated for patientsweighing more than 66lbs(30 kg). The Juno VPAPST-A is intended for homeand hospital use.The humidifier is intendedfor single patient use in thehome environment andre-use in ahospital/institutionalenvironment.
Environment of Use	Hospital/Home	Hospital/Home	Hospital/Home
Modes Available	CPAP;S;TS/T;	CPAPSTS/TVAuto	CPAPSTS/TPAC¡VAPS
Pressure Range	CPAP: 4-20cmH2OS, S/T, T: 4-30cmH2O	CPAP: 4-20cmH2OS, S/T, T: 2-25cmH2O	CPAP: 4-20cmH2OS, S/T, T: 3-30cmH2O
Sterile	Non-sterile	Non-sterile	Non-sterile
Single Use	Reuse	Reuse	Reuse
Prescription status	Prescription	Prescription	Prescription
Supplementaloxygen	No	Labeled for use withSupplemental Oxygen	Labeled for use withSupplemental Oxygen
Alarm	Yes	No	Yes
Wireless	Yes	Yes	Yes
Humidifier	Yes	Yes	Yes
Ramp	User selected as “Off” to 45minutes in 5 minute increments	User selected as “Off” to 45minutes in 5 minute increments	User selected as “Off” to 45minutes in 5 minuteincrements.
Transmit data	therapy data, therapy settings,upgrade device software	therapy data, therapy settings,upgrade device software	therapy data, therapysettings, upgrade devicesoftware
Datatransfermedium	SD card, Wireless	SD card, Wireless	SD card, Wireless
Biocompatibility
Cytotoxicity	Comply with ISO 10993-5
Skin Irritation	Comply with ISO 10993-10
Sensitization	Comply with ISO 10993-10
Particulate matter	Comply with ISO 18562-2	Comply with ISO 10993-1, ISO10993-5, ISO 10993-10 and ISO10993-12 standards	Comply with ISO 10993-1,ISO 10993-5, ISO 10993-10and ISO 10993-12 standards
Volatileorganiccompounds(VOCs)	Comply with ISO 18562-3	Comply with ISO 10993-1, ISO10993-5, ISO 10993-10 and ISO10993-12 standards	Comply with ISO 10993-1,ISO 10993-5, ISO 10993-10and ISO 10993-12 standards
Leachables incondensate	Comply with ISO 18562-4
	Comply withIEC 60601-1-8: 2012;AAMI/ANSIES60601-1:2005/(R) 2012 AndA1:2012, C1:2009/(R) 2012And A2:2010/(R) 2012;IEC 60601-1-2: 2014IEC 60601-1-11: 2011ISO 80601-2-70:ISO 80601-2-74	Comply withIEC 60601-1:2005+AMD1:2012IEC 60601-1-2:2014IEC 60601-1-8: 2006IEC 60601-1-11:2010	Comply withIEC 60601-1:2005+AMD1:2012IEC 60601-1-2:2014IEC 60601-1-8: 2006IEC 60601-1-11:2010
Electrical Safetyand EMC

Table 1 Comparison of Technology Characteristics

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

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).