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K Number
K213169
Device Name
BPAP System
Manufacturer
BMC Medical Co., Ltd.
Date Cleared
2022-12-05

(433 days)

Product Code
MNS
Regulation Number
868.5895
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.
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 or respiratory insufficiency 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 different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O. Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. 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 and multi-patients
More Information

K153061

K201620

No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard ventilation modes and alarm systems.

Yes
The device is described as a "Bi-level PAP (Bi-level Positive Airway Pressure) device" intended to "provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency" and to "treat obstructive sleep apnea or respiratory insufficiency by delivering a flow of positive airway pressure". This clearly indicates its therapeutic purpose.

No

This device is described as a treatment device, specifically a Bi-level PAP device intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency by delivering positive airway pressure. It is not described as gathering or analyzing data to diagnose a condition.

No

The device description explicitly states it is a "non-invasive, continuous positive airway pressure ventilator, incorporating a heated respiratory humidifier," which are hardware components. The performance studies also reference standards related to electrical equipment and physical devices.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Function of the Device: The description clearly states that this device is a BPAP system intended to provide noninvasive ventilation by delivering positive airway pressure to treat conditions like Obstructive Sleep Apnea and Respiratory Insufficiency. It directly interacts with the patient's airway to provide therapy.
  • Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely therapeutic and supportive of breathing.

Therefore, based on the provided information, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

Product codes

MNS

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 or respiratory insufficiency 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 different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O. The designated pressure range and therapy mode for each proposed model was provided in following table

Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. 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 and multi-patients

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 patients weighing more than 66lbs (30 kg)

Intended User / Care Setting

Home environment and multi-patient re-use in the hospital/institutional environment.

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. The test results demonstrated that the proposed device complies with the following standards:

  • AAMI/ANSI/ES60601-1: 2005/(R)2012 And A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
  • IEC 60601-1-8:2006+A1: 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 reguirements for the basic safety and essential performance of sleep apnoea 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 80601-2-79: 2018 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
    No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K153061

Reference Device(s)

K201620

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).

0

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December 5, 2022

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

Re: K213169

Trade/Device Name: BPAP System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: Class II Product Code: MNS Dated: December 5, 2022 Received: November 4, 2022

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.

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

1

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 (QS) 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,

Ethan ㄴ. Nyberg -S

for James 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) K213169

Device Name BPAP System

Indications for Use (Describe)

The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide noninvasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

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: _K213169

    1. Date of Preparation: 12/05/2022
    1. Sponsor Identification

BMC Medical Co., Ltd.

Room 901, Building 1, No.28 Pingguoyuan Road, Shijingshan, Beijing 100041, CHINA

Establishment Registration Number: 3008566132

Contact Person: Fang Zheng Position: Director of Regulatory Affairs & Quality Assurance Tel: +86-10-5166 3880 Fax: +86-10-5166 3880-810 Email: zhengfang@bmc-medical.com

    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: 360-925-3199 Email: info@mid-link.net

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4. Identification of Proposed Device

Trade Name: BPAP System Common Name: Continuous ventilator

Regulatory Information Classification Name: Continuous Ventilator Classification: II Product Code: MNS Regulation Number: 21 CFR 868.5895 Review Panel: Anesthesiology

Indication for Use Statement:

The BPAP System is a Bi-level PAP (Bi-level Positive Airway Pressure) device, which is intended to provide non-invasive ventilation for patients with Obstructive Sleep Apnea (OSA) or Respiratory Insufficiency. The integrated humidifier is indicated for the humidification and warming of air from the flow generator device. The device is intended for adult patients weighing more than 66lbs (30 kg) by prescription. The device is intended for single patient use in the home environment and multi-patient re-use in the hospital/institutional environment.

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 or respiratory insufficiency 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 different models designed with different therapy modes and pressure ranges. The therapy modes are available in six types, which are CPAP, Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), Auto CPAP and Auto S. The pressure range for the proposed devices is available in two types, which are 4-25cm H2O and 4-30 cm H2O. The designated pressure range and therapy mode for each proposed model was provided in following table

ModelWork ModePressure Range
G3 B25VTCPAP, S, T, S/T4-25 cm H2O
G3 B30SVCPAP, S/T
G3 B30VTCPAP, S, T, S/T4-30 cm H2O
G3 LABCPAP, Auto CPAP, S,

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Auto S, T, S/T
------------------

Alarm module is incorporated in the device. The device will generate audio and visual alarm for any abnormal conditions. 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 and multi-patients

  • ર. Identification of Predicate Device
    510(k) Number: K153061 Product Name: Juno VPAP ST-A

  • Identification of Secondary Predicate Device 6.
    510(k) Number: K201620 Product Name: Luna®G3 BPAP 25A

    1. Non-Clinical Test Conclusion
      Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:

  • AAMI/ANSI/ES60601-1: 2005/(R)2012 And A1: 2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;

  • IEC 60601-1-8:2006+A1: 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 reguirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment

  • A ISO 80601-2-74: 2017 Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment

  • ISO 80601-2-79: 2018 Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

    1. Clinical Test Conclusion

6

No clinical study is included in this submission.

7

9. Substantially Equivalent (SE) Comparison

Table 1 General Comparison
ItemProposed DevicePredicate DeviceSecondary Predicate DeviceRemark
K153061K201620
Product CodeMNSMNSBZDSame
Regulation Number21 CFR 868.589521 CFR 868.589521 CFR 868.5905Same
Indication for UseThe BPAP System is a Bi-level
PAP (Bi-level Positive Airway
Pressure) device, which is intended
to provide non-invasive ventilation
for patients with Obstructive Sleep
Apnea (OSA) or Respiratory
Insufficiency. The integrated
humidifier is indicated for the
humidification and warming of air
from the flow generator device.
The device is intended for adult
patients weighing more than 66lbs
(30 kg) by prescription. The device
is intended for single patient use in
the home environment and
multi-patient re-use in the
hospital/institutional environment.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 iVAPS 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.The luna® G3 BPAP 25A is a Bi-level
PAP (Bi-level Positive Airway Pressure)
device designed for the treatment of
adult obstructive Sleep Apnea (OSA).
The integrated humidifier is indicated
for the humidification and warming of
air from the flow generator device.
These devices are intended for
single-patient use by prescription in the
home or hospital/institutional
environment on adult patients. It is to
be used on patients >66lbs/30kg for
whom CPAP therapy has been
prescribed. The system can deliver
bi-level therapy or auto bi-level therapy.Analysis 1
Environment of UseHospital/HomeHospital/HomeHospital/HomeSame
Supplemental oxygenYesYesYesSame
SterileNon-sterileNon-sterileNon-sterileSame
Single UseReuseReuseReuseSame
Prescription statusPrescriptionPrescriptionPrescriptionSame
AlarmYesYesNoSame
Humidifier
IntegratedYesYesYesSame
Humidity Output$\ge 15$ mg/L, as required by ISO80601-2-74$\ge 10$ mg/L$\ge 15$ mg/L, as required by ISO80601-2-74Analysis 2
Humidifier Setting1-5 (95 to 154.4°F/35 to 68°C)1-81-5 (95 to 154.4°F/35 to 68°C)Analysis 2
DelayYesYesYesSame
Physical specification
Dimensions265 x 145x114 mm (with integrated humidifier)153 mm x 172 mm x 86 mm265 x 145x114 mm (with integrated humidifier)Analysis 3
Weight1.7kg (with integrated humidifier)1.04kg1.7kg (with integrated humidifier)Analysis 3
AC Power100-240V, 50/60Hz,100-240V, 50-60Hz100-240V, 50/60HzSame
Accessory
Air filterYesYesYesSame
Non-heated tubingYesYesYesSame
Heated tubingYesYesYesSame

Table 1 General Comparison

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Analysis 1-Indication for Use

The indication for use for the proposed device is not exactly same as the predicate device. Firstly, the intent weight for the proposed device does not include the population whose weight larger than 301bs. The adult patiended for the adult patients whose weight is larger than 66ths and this population was also covered by predicate device, it can be concluded that the intended population can be covered in the population range of predicate device. In addition, the intended for single patient and multi-patients re-use, while the predicate device is intended for single patient re-use. However, whent reuse or multi-patient reuse, the device shall be cleaned and disinfected prior to subsequent use, and the cleaning and disinfection method for the been validated per FDA recognized standard, the test result is

9

acceptable.

Analysis 2- Humidity Output and humidifier setting

The humidity output and humidifier setting for the proposed device, however, it is same as the secondary predicate device.

Analysis 3-Dimension and Weight

The dimension and weight for the proposed device. The difference in weight and dimension will not affect the intended use and this difference will not raise any safety and in addition to the predicate device, a secondary predicate device was cited, it can be noted that the weight and dimension for the proposed device is same as the secondary predicate device.

| Item | Proposed Device | Predicate Device
K153061 | Secondary Predicate Device
K201620 | Remark |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------|------------|
| Modes Available | CPAP;
S;
T
S/T;
Auto CPAP
Auto S | CPAP
S
T
S/T
PAC
iVAPS | Auto CPAP
Auto S
S
CPAP | Analysis 4 |
| Pressure Range | CPAP: 420cmH2O
Auto CPAP: 420cmH2O
S: 425cmH2O for G3B25VT,
430cmH2O for G3 B30SV, G3 B30VT, G3 LAB;
T: 425cmH2O for G3B25VT, | CPAP: 4-20cmH2O
S, S/T, T: 3-30cmH2O | For CPAP and Auto CPAP mode:
4.020.0 cmH2O
For Auto S and S mode: 4.0~25.0
cmH2O | Analysis 5 |

Table 2 Performance and Safety Comparison
-----------------------------------------------------

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| | 430cmH2O for G3 B30SV, G3
B30VT,G3 LAB;
S/T:425cmH2O for G3B25VT,
430cmH2O for G3 B30SV, G3
B30VT, G3 LAB;
Auto S: 430cmH2O | | | |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Pressure regulation | ±0.5 cmH2O | ±0.5 cmH2O | ±0.5 cmH2O | Same |
| Automatic adjusting
CPAP algorithm | Yes | No | Yes | Analysis 6 |
| Ramp | 0-60 | User selected as “off” to 45minutes in
5 minutes increments
Max ramp time set at clinician’s
driscretion | 0-60 | Analysis 7 |
| Expiratory Pressure
Relief | Reslex® function Level 1-3 | Yes | Reslex® function Level 1-3 | Analysis 8 |
| Cellular module | Yes | No | Yes | Analysis 9 |
| iCode® | iCode,
iCode QR,
iCode QR +
A feature that is intended to give
access to compliance and therapy
management information. The
iCode consists of six separate
codes displayed in the Patient
Menu, each code is a sequence of
numbers. The “iCode QR” and
“iCode QR+” display | No | iCode,
iCode QR,
iCode QR +
A feature that is intended to give
access to compliance and therapy
management information. The iCode
consists of six separate codes
displayed in the Patient Menu, each
code is a sequence of numbers. The
“iCode QR” and “iCode QR+”
display two-dimensional codes | Analysis 10 |
| | two-dimensional codes. | | | |
| iCodeConnect®
Software | Yes | No | Yes | Analysis 11 |
| Transmit data | therapy data, therapy settings, upgrade device software | therapy data, therapy settings, upgrade device software | therapy data, therapy settings, upgrade device software | Same |
| Data transfer medium | SD card, Cellular module | SD card, Wireless | SD card, Cellular module | Analysis 12 |
| Smart A | Yes | No | Yes | Same |
| Smart B | Yes | No | Yes | Same |
| Smart C | Yes | No | Yes | Same |
| Respiratory
event
detection function | Yes | Yes | Yes | Same |
| Biocompatibility | | | | |
| Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-1, ISO
10993-5, ISO 10993-10 and ISO
10993-12 standards | Comply with ISO 10993-5 | Same |
| Skin Irritation | Comply with ISO 10993-10 | | Comply with ISO 10993-10 | |
| Sensitization | Comply with ISO 10993-10 | | Comply with ISO 10993-10 | |
| Particulate matter | Comply with ISO 18562-2 | Comply with ISO 18562-2 | | |
| Volatile
organic
compounds (VOCs) | Comply with ISO 18562-3 | Comply with ISO 18562-3 | | |
| Leachables
in
condensate | Comply with ISO 18562-4 | Comply with ISO 18562-4 | | |
| Electrical Safety | 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 60601-1-11: 2011 | Comply with
IEC 60601-1:2005+AMD1: 2012
IEC 60601-1-8: 2006
IEC 60601-1-11:2010 | 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 60601-1-11: 2011 | Same |
| | ISO 80601-2-74 | | ISO 80601-2-74 | |
| EMC | IEC 60601-1-2: 2014 | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | Same |

11

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Analysis 4-Working Mode

The working mode for the proposed device is not same as the predicate device. The CPAP, S. T and ST mode can be covered by the predicate device. The working mode Auto CPAP and Auto S were not covered by the predicate device. These modes were assessed against the secondary predicate device.

Analysis 5-Pressure Range

The pressure range for the proposed CPAP, S, T, ST mode can be covered by the predicate device. The working mode Auto S were not covered by the predicate device. Based on the discussion in analysis 4, these two additional working modes were compared to the secondary predicate device. The presure range for proposed Auto S is larger than the secondary predicate device, this difference was caused by the proposed device was available in a series model and the largest pressure range of secondary predicate device. Although the largest pressure range for Auto CPAP and Auto S exceed the predicate device, but it does not exceed the pressure range of predicate device.

Analysis 6-Automatic Adjusting CPAP Algorithm

The automatic adjusting CPAP algorithm is not contained by the predicate device. This difference was caused by the working mode, since the predicate device does not have the Auto working mode. Therefore, the predicate device does not have automatic adjusting function. However, in addition to the predicate device, a secondary predicate device was ctechnology characteristics which were not covered by the predicate device, it can be noted that this function can be covered by the secondary predicate device.

Analysis 7-Ramp

The ramp function for proposed device is not exactly same as the predicate device. In addition to the predicate device, a secondary predicate device was cited to compare some technology characteristics which were not covered by the predicate device, it can be noted that this function is same as

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the secondary predicate device.

Analysis 8-Expiratory Pressure Relief

The relef function for proposed device is not exactly same as the predicate device. in addition to the predicate device, a secondary predicate device was cited to compare some technology characteristics which were not covered by the predicate device, it can be noted that this function is same as the secondary predicate device.

Analysis 9-Celluar Module

The cellular module is not contained by the predicate device. This module is used for the data transfer. In addition to the predicate device, a secondary predicate device was cited to compare some technology characteristics which were not covered that the cellular module is same as the secondary predicate device.

Analysis 10-iCode

The iCode function is not contained by the predicate device, in addition to the predicate device, a secondary predicate device was cited to compare some technology characteristics which were not covered by the predicate that this finction is same as the secondary predicate device.

Analysis 11-iCodeConnection Software

The iCode connection software is not contained by the predicate device, in addition to the predicate device, a secondary predicate device was cited to compare some technology characteristics which were not covered by the predicate this connection software is same as the secondary predicate device.

Analysis 12-Data Transfer Medium

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The data transfer medium for the proposed device is not exactly same as predium can be covered by the predicate device. Cellular module is not included by the predicate device, in addition to the predicate device, a secondary predicate device was cited to compare some technology characteristics which were not covered by the predicate device, it can be noted that cellular module is covered by the secondary predicate device. In addition, the electrical safety and EMC test has been conducted on the cellular module can work normally in interference environment.

    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.