(471 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard CPAP functionalities and therapy modes.
Yes
The device is specifically designed to provide "positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome." This directly indicates it is used for medical treatment, classifying it as a therapeutic device.
No
The device provides positive pressure therapy to treat obstructive sleep apnea, it does not diagnose the condition.
No
The device description clearly outlines hardware components such as a heated respiratory humidifier, motor, and alarm module, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device provides "positive pressure therapy for the treatment of adult obstructive sleep apnea syndrome in self breathing patients". It works by delivering air pressure to the airway within the patient's body.
- No Specimen Analysis: There is no mention of the device collecting or analyzing any biological specimens.
The device is a therapeutic device used to treat a medical condition by directly interacting with the patient's respiratory system.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BZD
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 | |
| 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult
Intended User / Care Setting
Home as well as in clinical/hospital environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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;
- 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
- 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;
- ISO 80601-2-74:2017 Medical Electrical Equipment-Part 2-74: Particular Requirements for Basic 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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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3
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
-
- Date of Preparation: 11/24/2020
-
- 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
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
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
4
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 |
5
| 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 -
- 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:
- Non-Clinical Test Conclusion
-
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
6
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
7
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 | ||
| 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. | The S9 WANDA VPAP ST is | ||
| indicated for the treatment of | |||
| Obstructive Sleep Apnea (OSA) | |||
| in patients weighing more than | |||
| 66lb (30kg). It is intended for | |||
| use in the hospital and home. | The Juno VPAP ST-A is | ||
| indicated to provide | |||
| noninvasive ventilation for | |||
| patients weighing more than | |||
| 30lbs (13 kg) with | |||
| respiratory insufficiency or | |||
| obstructive sleep apnoea | |||
| (OSA). | |||
| The ¡VAPS mode is | |||
| indicated for patients | |||
| weighing more than 66lbs | |||
| (30 kg). The Juno VPAP | |||
| ST-A is intended for home | |||
| and hospital use. | |||
| The humidifier is intended | |||
| for single patient use in the | |||
| home environment and | |||
| re-use in a | |||
| hospital/institutional | |||
| environment. | |||
| Environment of Use | Hospital/Home | Hospital/Home | Hospital/Home |
| Modes Available | CPAP; | ||
| S; | |||
| T | |||
| S/T; | CPAP | ||
| S | |||
| T | |||
| S/T | |||
| VAuto | CPAP | ||
| S | |||
| T | |||
| S/T | |||
| PAC | |||
| ¡VAPS | |||
| Pressure Range | CPAP: 4-20cmH2O | ||
| S, S/T, T: 4-30cmH2O | CPAP: 4-20cmH2O | ||
| S, S/T, T: 2-25cmH2O | CPAP: 4-20cmH2O | ||
| S, S/T, T: 3-30cmH2O | |||
| Sterile | Non-sterile | Non-sterile | Non-sterile |
| Single Use | Reuse | Reuse | Reuse |
| Prescription status | Prescription | Prescription | Prescription |
| Supplemental | |||
| oxygen | No | Labeled for use with | |
| Supplemental Oxygen | Labeled for use with | ||
| Supplemental Oxygen | |||
| Alarm | Yes | No | Yes |
| Wireless | Yes | Yes | Yes |
| Humidifier | Yes | Yes | Yes |
| Ramp | User selected as “Off” to 45 | ||
| minutes in 5 minute increments | User selected as “Off” to 45 | ||
| minutes in 5 minute increments | User selected as “Off” to 45 | ||
| minutes in 5 minute | |||
| increments. | |||
| Transmit data | therapy data, therapy settings, | ||
| upgrade device software | therapy data, therapy settings, | ||
| upgrade device software | therapy data, therapy | ||
| settings, upgrade device | |||
| software | |||
| Data | |||
| transfer | |||
| 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 | |
| 10993-5, ISO 10993-10 and ISO | |||
| 10993-12 standards | Comply with ISO 10993-1, | ||
| ISO 10993-5, ISO 10993-10 | |||
| and ISO 10993-12 standards | |||
| Volatile | |||
| organic | |||
| compounds | |||
| (VOCs) | Comply with ISO 18562-3 | Comply with ISO 10993-1, ISO | |
| 10993-5, ISO 10993-10 and ISO | |||
| 10993-12 standards | Comply with ISO 10993-1, | ||
| ISO 10993-5, ISO 10993-10 | |||
| and ISO 10993-12 standards | |||
| Leachables in | |||
| condensate | Comply with ISO 18562-4 | ||
| Comply with | |||
| IEC 60601-1-8: 2012; | |||
| AAMI/ANSI | |||
| ES60601-1:2005/(R) 2012 And | |||
| A1:2012, C1:2009/(R) 2012 | |||
| And A2:2010/(R) 2012; | |||
| IEC 60601-1-2: 2014 | |||
| IEC 60601-1-11: 2011 | |||
| ISO 80601-2-70: | |||
| ISO 80601-2-74 | Comply with | ||
| IEC 60601-1:2005+AMD1: | |||
| 2012 | |||
| IEC 60601-1-2:2014 | |||
| IEC 60601-1-8: 2006 | |||
| IEC 60601-1-11:2010 | Comply with | ||
| IEC 60601-1:2005+AMD1: | |||
| 2012 | |||
| IEC 60601-1-2:2014 | |||
| IEC 60601-1-8: 2006 | |||
| IEC 60601-1-11:2010 | |||
| Electrical Safety | |||
| and EMC |
Table 1 Comparison of Technology Characteristics
8
-
- 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.
- Substantially Equivalent (SE) Conclusion