SysMed S/T

K192177 · Sysmed (China) Co., Ltd. · BZD · Nov 25, 2020 · Anesthesiology

Device Facts

• Record ID: K192177
• Device Name: SysMed S/T
• Applicant: Sysmed (China) Co., Ltd.
• Product Code: BZD · Anesthesiology
• Decision Date: Nov 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5905
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Non-invasive, continuous positive airway pressure (CPAP) ventilator with integrated heated humidifier; treats obstructive sleep apnea by delivering physician-prescribed positive airway pressure to splint airway and prevent collapse. Available in multiple models (Aurora, Resware, ZiZmer series) with varying therapy modes (CPAP, S, S/T, T) and pressure ranges (4-30 cm H2O). Used in home or clinical settings by patients; includes alarm module for airway leakage, motor malfunction, and high motor temperature. Data transfer via SD card or wireless for therapy monitoring and software updates. Healthcare providers use output to adjust therapy settings; benefits patient by maintaining airway patency during sleep.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance verified against electrical safety (IEC 60601-1), alarm systems (IEC 60601-1-8), home healthcare environment (IEC 60601-1-11), electromagnetic compatibility (IEC 60601-1-2), sleep apnea therapy equipment (ISO 80601-2-70), respiratory humidifying equipment (ISO 80601-2-74), and biocompatibility (ISO 10993, ISO 18562).

Technological Characteristics

Non-invasive positive pressure ventilator with integrated heated humidifier. Pressure range 4-30 cm H2O. Modes: CPAP, S, S/T, T. Connectivity: SD card, wireless. Power: AC/DC. Biocompatibility: ISO 10993 and ISO 18562 compliant. Safety: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, ISO 80601-2-70, ISO 80601-2-74.

Indications for Use

Indicated for adult patients (>30kg) with obstructive sleep apnea syndrome who are self-breathing. Intended for home and clinical/hospital use.

Regulatory Classification

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.

Predicate Devices

• S9 WANDA VPAP ST (K140159)

Reference Devices

• Juno VPAP ST-A (K153061)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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:

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. 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

- 7. 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 positive<br>pressure therapy for the<br>treatment of adult obstructive<br>sleep apnea syndrome in self<br>breathing patients weighing<br>over 30kg (66lbs). This product<br>can be used in the home as well<br>as in clinical/hospital<br>environments. | The S9 WANDA VPAP ST is<br>indicated for the treatment of<br>Obstructive Sleep Apnea (OSA)<br>in patients weighing more than<br>66lb (30kg). It is intended for<br>use in the hospital and home. | The Juno VPAP ST-A is<br>indicated to provide<br>noninvasive ventilation for<br>patients weighing more than<br>30lbs (13 kg) with<br>respiratory insufficiency or<br>obstructive sleep apnoea<br>(OSA).<br>The ¡VAPS mode is<br>indicated for patients<br>weighing more than 66lbs<br>(30 kg). The Juno VPAP<br>ST-A is intended for home<br>and hospital use.<br>The humidifier is intended<br>for single patient use in the<br>home environment and<br>re-use in a<br>hospital/institutional<br>environment. |
| Environment of Use | Hospital/Home | Hospital/Home | Hospital/Home |
| Modes Available | CPAP;<br>S;<br>T<br>S/T; | CPAP<br>S<br>T<br>S/T<br>VAuto | CPAP<br>S<br>T<br>S/T<br>PAC<br>¡VAPS |
| Pressure Range | CPAP: 4-20cmH2O<br>S, S/T, T: 4-30cmH2O | CPAP: 4-20cmH2O<br>S, S/T, T: 2-25cmH2O | CPAP: 4-20cmH2O<br>S, S/T, T: 3-30cmH2O |
| Sterile | Non-sterile | Non-sterile | Non-sterile |
| Single Use | Reuse | Reuse | Reuse |
| Prescription status | Prescription | Prescription | Prescription |
| Supplemental<br>oxygen | No | Labeled for use with<br>Supplemental Oxygen | Labeled for use with<br>Supplemental Oxygen |
| Alarm | Yes | No | Yes |
| Wireless | Yes | Yes | Yes |
| Humidifier | Yes | Yes | Yes |
| Ramp | User selected as “Off” to 45<br>minutes in 5 minute increments | User selected as “Off” to 45<br>minutes in 5 minute increments | User selected as “Off” to 45<br>minutes in 5 minute<br>increments. |
| Transmit data | therapy data, therapy settings,<br>upgrade device software | therapy data, therapy settings,<br>upgrade device software | therapy data, therapy<br>settings, upgrade device<br>software |
| Data<br>transfer<br>medium | 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, ISO<br>10993-5, ISO 10993-10 and ISO<br>10993-12 standards | Comply with ISO 10993-1,<br>ISO 10993-5, ISO 10993-10<br>and ISO 10993-12 standards |
| Volatile<br>organic<br>compounds<br>(VOCs) | Comply with ISO 18562-3 | Comply with ISO 10993-1, ISO<br>10993-5, ISO 10993-10 and ISO<br>10993-12 standards | Comply with ISO 10993-1,<br>ISO 10993-5, ISO 10993-10<br>and ISO 10993-12 standards |
| Leachables in<br>condensate | Comply with ISO 18562-4 | | |
| | Comply with<br>IEC 60601-1-8: 2012;<br>AAMI/ANSI<br>ES60601-1:2005/(R) 2012 And<br>A1:2012, C1:2009/(R) 2012<br>And A2:2010/(R) 2012;<br>IEC 60601-1-2: 2014<br>IEC 60601-1-11: 2011<br>ISO 80601-2-70:<br>ISO 80601-2-74 | Comply with<br>IEC 60601-1:2005+AMD1:<br>2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-8: 2006<br>IEC 60601-1-11:2010 | Comply with<br>IEC 60601-1:2005+AMD1:<br>2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-8: 2006<br>IEC 60601-1-11:2010 |
| Electrical Safety<br>and EMC | | | |

## Table 1 Comparison of Technology Characteristics

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- 9. 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.