(433 days)
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.
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
The provided text describes a 510(k) premarket notification for a BPAP System, stating that "No clinical study is included in this submission." Therefore, there is no information in the provided document about acceptance criteria, device performance, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone performance. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical tests and feature comparison.
However, I can extract the non-clinical test conclusions and how they "prove the device meets acceptance criteria" in that context.
Here's a breakdown of what the document does provide:
Non-Clinical Test Data and Compliance
The document states that non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated compliance with various international standards, which serve as the "acceptance criteria" for these non-clinical aspects.
1. A table of acceptance criteria (standards) and the reported device performance (compliance):
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| AAMI/ANSI/ES60601-1: 2005/(R)2012 And A1: 2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Complied |
| IEC 60601-1-8:2006+A1: 2012 (Alarm systems in medical electrical equipment) | Complied |
| IEC 60601-1-11:2015 (Medical electrical equipment - Home healthcare environment) | Complied |
| IEC 60601-1-2: 2014 (Electromagnetic disturbances - Requirements and tests) | Complied |
| ISO 80601-2-70: 2015 (Sleep apnoea breathing therapy equipment) | Complied |
| ISO 80601-2-74: 2017 (Respiratory humidifying equipment) | Complied |
| ISO 80601-2-79: 2018 (Ventilatory support equipment for ventilatory impairment) | Complied |
| ISO 10993-5 (Cytotoxicity) | Complied |
| ISO 10993-10 (Skin Irritation, Sensitization) | Complied |
| ISO 18562-2 (Particulate matter) | Complied |
| ISO 18562-3 (Volatile organic compounds (VOCs)) | Complied |
| ISO 18562-4 (Leachables in condensate) | Complied |
Additionally, the device's specific technical performance attributes were compared to predicate devices, demonstrating substantial equivalence rather than meeting independent clinical acceptance criteria:
| Acceptance Criteria (Attribute) | Proposed Device Performance |
|---|---|
| Humidity Output | ≥ 15 mg/L, as required by ISO80601-2-74 |
| Humidifier Setting | 1-5 (95 to 154.4°F/35 to 68°C) |
| Pressure regulation | ±0.5 cmH2O |
| Ramp (time) | 0-60 minutes |
| Expiratory Pressure Relief | Reslex® function Level 1-3 |
| Material Properties | (All relevant biocompatibility tests per ISO 10993 standards and material emissions tests per ISO 18562 standards were complied with.) Cleaning and disinfection methods for multi-patient reuse were validated per FDA recognized standards and found acceptable. |
| Pressure Range | CPAP: 4 |
2. Sample size used for the test set and the data provenance:
No clinical study test set or data provenance is mentioned as "No clinical study is included in this submission." The "test set" in this context refers to the physical device prototypes undergoing non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical study or expert-driven ground truth establishment is described. The "ground truth" for non-clinical tests is based on engineering specifications and adherence to international standards.
4. Adjudication method for the test set:
Not applicable, as no clinical study is conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done:
No. As explicitly stated: "No clinical study is included in this submission." Therefore, no MRMC study or effect size for human reader improvement with AI assistance was performed or reported here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device (BPAP system), not an AI algorithm. Its performance is inherent to the device itself, as demonstrated through non-clinical testing against standards.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the requirements and specifications of the cited international standards (e.g., IEC 60601 series, ISO 80601 series, ISO 10993 series, ISO 18562 series) and the manufacturer's internal design specifications.
8. The sample size for the training set:
Not applicable, as "No clinical study is included in this submission." This is a hardware device cleared based on substantial equivalence, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable for the same reason as above.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
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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
-
- Date of Preparation: 12/05/2022
-
- 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
-
- 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: 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
| Model | Work Mode | Pressure Range |
|---|---|---|
| G3 B25VT | CPAP, S, T, S/T | 4-25 cm H2O |
| G3 B30SV | CPAP, S/T | |
| G3 B30VT | CPAP, S, T, S/T | 4-30 cm H2O |
| G3 LAB | CPAP, 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 -
- 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:
- Non-Clinical Test Conclusion
-
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
-
- Clinical Test Conclusion
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No clinical study is included in this submission.
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9. Substantially Equivalent (SE) Comparison
| Table 1 General Comparison | ||||
|---|---|---|---|---|
| Item | Proposed Device | Predicate Device | Secondary Predicate Device | Remark |
| K153061 | K201620 | |||
| Product Code | MNS | MNS | BZD | Same |
| Regulation Number | 21 CFR 868.5895 | 21 CFR 868.5895 | 21 CFR 868.5905 | Same |
| Indication for Use | The BPAP System is a Bi-levelPAP (Bi-level Positive AirwayPressure) device, which is intendedto provide non-invasive ventilationfor patients with Obstructive SleepApnea (OSA) or RespiratoryInsufficiency. The integratedhumidifier is indicated for thehumidification and warming of airfrom the flow generator device.The device is intended for adultpatients weighing more than 66lbs(30 kg) by prescription. The deviceis intended for single patient use inthe home environment andmulti-patient re-use in thehospital/institutional environment. | The Juno VPAP ST-A is indicated toprovide noninvasive ventilation forpatients weighing more than 30lbs (13kg) with respiratory insufficiency orobstructive sleep apnoea (OSA).The iVAPS mode is indicated forpatients weighing more than 66lbs (30kg). The Juno VPAP ST-A is intendedfor home and hospital use.The humidifier is intended for singlepatient use in the home environmentand re-use in a hospital/institutionalenvironment. | The luna® G3 BPAP 25A is a Bi-levelPAP (Bi-level Positive Airway Pressure)device designed for the treatment ofadult obstructive Sleep Apnea (OSA).The integrated humidifier is indicatedfor the humidification and warming ofair from the flow generator device.These devices are intended forsingle-patient use by prescription in thehome or hospital/institutionalenvironment on adult patients. It is tobe used on patients >66lbs/30kg forwhom CPAP therapy has beenprescribed. The system can deliverbi-level therapy or auto bi-level therapy. | Analysis 1 |
| Environment of Use | Hospital/Home | Hospital/Home | Hospital/Home | Same |
| Supplemental oxygen | Yes | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Single Use | Reuse | Reuse | Reuse | Same |
| Prescription status | Prescription | Prescription | Prescription | Same |
| Alarm | Yes | Yes | No | Same |
| Humidifier | ||||
| Integrated | Yes | Yes | Yes | Same |
| Humidity Output | $\ge 15$ mg/L, as required by ISO80601-2-74 | $\ge 10$ mg/L | $\ge 15$ mg/L, as required by ISO80601-2-74 | Analysis 2 |
| Humidifier Setting | 1-5 (95 to 154.4°F/35 to 68°C) | 1-8 | 1-5 (95 to 154.4°F/35 to 68°C) | Analysis 2 |
| Delay | Yes | Yes | Yes | Same |
| Physical specification | ||||
| Dimensions | 265 x 145x114 mm (with integrated humidifier) | 153 mm x 172 mm x 86 mm | 265 x 145x114 mm (with integrated humidifier) | Analysis 3 |
| Weight | 1.7kg (with integrated humidifier) | 1.04kg | 1.7kg (with integrated humidifier) | Analysis 3 |
| AC Power | 100-240V, 50/60Hz, | 100-240V, 50-60Hz | 100-240V, 50/60Hz | Same |
| Accessory | ||||
| Air filter | Yes | Yes | Yes | Same |
| Non-heated tubing | Yes | Yes | Yes | Same |
| Heated tubing | Yes | Yes | Yes | Same |
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
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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 DeviceK153061 | Secondary Predicate DeviceK201620 | Remark |
|---|---|---|---|---|
| Modes Available | CPAP;S;TS/T;Auto CPAPAuto S | CPAPSTS/TPACiVAPS | Auto CPAPAuto SSCPAP | Analysis 4 |
| Pressure Range | CPAP: 4 | CPAP: 4-20cmH2OS, S/T, T: 3-30cmH2O | For CPAP and Auto CPAP mode:4.0 | Analysis 5 |
| Table 2 Performance and Safety Comparison | |||||
|---|---|---|---|---|---|
| -- | ------------------------------------------- | -- | -- | -- | -- |
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| 4 | ||||
|---|---|---|---|---|
| Pressure regulation | ±0.5 cmH2O | ±0.5 cmH2O | ±0.5 cmH2O | Same |
| Automatic adjustingCPAP algorithm | Yes | No | Yes | Analysis 6 |
| Ramp | 0-60 | User selected as “off” to 45minutes in5 minutes incrementsMax ramp time set at clinician’sdriscretion | 0-60 | Analysis 7 |
| Expiratory PressureRelief | 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 giveaccess to compliance and therapymanagement information. TheiCode consists of six separatecodes displayed in the PatientMenu, each code is a sequence ofnumbers. The “iCode QR” and“iCode QR+” display | No | iCode,iCode QR,iCode QR +A feature that is intended to giveaccess to compliance and therapymanagement information. The iCodeconsists of six separate codesdisplayed in the Patient Menu, eachcode 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 |
| Respiratoryeventdetection function | Yes | Yes | Yes | Same |
| Biocompatibility | ||||
| Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-1, ISO10993-5, ISO 10993-10 and ISO10993-12 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 | ||
| Volatileorganiccompounds (VOCs) | Comply with ISO 18562-3 | Comply with ISO 18562-3 | ||
| Leachablesincondensate | Comply with ISO 18562-4 | Comply with ISO 18562-4 | ||
| Electrical Safety | Comply withIEC 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 withIEC 60601-1:2005+AMD1: 2012IEC 60601-1-8: 2006IEC 60601-1-11:2010 | Comply withIEC 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 |
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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.
-
- 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
§ 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).