(205 days)
Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg Adult: greater than 23 kg
Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient. Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of: Infant - Less than or equal to 10 kg Child - less than or equal to 23 kg Adult - Greater than 23 kg.
The provided text is a 510(k) premarket notification for a medical device (Disposable Manual Resuscitator). This document outlines the manufacturer's claim of "substantial equivalence" of their device to a legally marketed predicate device.
Crucially, this document is NOT a study report for an AI/ML powered medical device, nor does it contain information about establishing ground truth, multi-reader multi-case studies, or training sets in the context of AI/ML.
The "Performance Data" and "Summary of Device Testing" sections refer to the physical and functional performance of the manual resuscitator as per established medical device standards (e.g., ISO 10651-4, ISO 5356-1, ISO 10993). These are tests for mechanical and material properties, not an AI algorithm.
Therefore, I cannot extract the information required for bullet points 1 through 9 from the provided text, as those points are specific to the validation of AI/ML systems.
Here's a breakdown of why the requested information cannot be found in this document:
- Acceptance Criteria for AI/ML and Reported Device Performance (Table 1): The document's "Performance Data" section in Table 1 refers to physical characteristics of a manual resuscitator (e.g., "Ventilation Bag Volume," "Max Delivered Volume," "Expiratory resistance," "Supplemental Oxygen%"). These are not acceptance criteria or performance metrics for an AI/ML algorithm.
- Sample Size for Test Set and Data Provenance: This pertains to data used to evaluate AI. The document describes testing of physical products, not data sets.
- Number of Experts and Qualifications for Ground Truth: No AI is involved, so no ground truth established by experts is mentioned.
- Adjudication Method: Not applicable for a non-AI physical device.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: This is for evaluating changes in human performance with AI assistance. Not relevant here.
- Standalone (Algorithm Only) Performance: Not applicable as it's not an algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set & How Ground Truth for Training Set was Established: These concepts are central to AI/ML model development. The document describes product manufacturing and testing processes, not AI training.
In summary, the provided document details the regulatory submission for a physical medical device (a manual resuscitator) and demonstrates its substantial equivalence to a predicate device based on physical and functional testing. It does not involve any artificial intelligence or machine learning components, and thus the requested details regarding AI/ML acceptance criteria and validation studies are not present.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 26, 2021
Xiamen Compower Medical Tech. Co., Ltd. % Mingzi Hussey Regulatory Consultant Zi-medical, Inc. 93 Springs Rd Bedford, Massachusetts 01730
Re: K210288
Trade/Device Name: Disposable Manual Resuscitator Regulation Number: 21 CFR 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: Class II Product Code: BTM Dated: May 11, 2021 Received: July 29, 2021
Dear Mingzi Hussey:
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}------------------------------------------------
Page 2
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 (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 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 Brandon Blakely, Ph.D. Acting Assistant Director DHT1C: Division of ENT, 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210288
Device Name Disposable Manual Resuscitator
Indications for Use (Describe)
Single patient use manual resuscitator for use in hospital, transport, emergency, and post-hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10 kg Child: less than or equal to 23 kg
Adult: greater than 23 kg
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for Compower. The logo consists of a stylized letter "C" above the word "Compower". The "C" is formed by two curved lines that do not quite meet, creating an open shape. The word "Compower" is written in a bold, sans-serif font, and there is a registered trademark symbol to the right of the word.
GENERAL INFORMATION
| 1 | Type of Submission | |
|---|---|---|
| Traditional 510(k) Submission | ||
| Date Prepared: | 08/26/2021 | |
| 2 | Submitter | |
| Name: | XIAMEN COMPOWER MEDICAL TECH. CO., LTD | |
| Address: | Unit 301, No.16, Xianghong Road,Xiang'An Torch Industrial Zone,Xiamen, Fujian, 361101, CHINA. | |
| Contact person in China:Correspondent) | Lifen Chen, Regulatory Affairs Manager | |
| Address: | Unit 301, No.16, Xianghong Road,Xiang'An Torch Industrial Zone,Xiamen, Fujian, 361101, CHINA. | |
| Phone: | +86-13306000572 | |
| FAX: | +86-592-5796765 | |
| dcc@cpmedi.com | ||
| Contact person in the U.S.: | Mingzi Hussey, Regulatory Consultant | |
| Address | Zi-meidcal, Inc.93 Springs Rd,Bedford, MA 01730 US | |
| Phone/Fax: | 206-981-0675 | |
| mingzi@zi-medical.com | ||
| 3 | Establishment Registration Number | |
| 3008261717 | ||
| 4 | Common Name or Classification Name | |
| Manual emergency ventilator (Resuscitator) (CFR 868.5915, Product Code BTM) | ||
| 5 | Trade Name | |
| Disposable Manual Resuscitator | ||
| 6 | Device Classification | |
| This is a Class II device | ||
| 7 | Reason for Premarket Notification | |
| Introducing a (finished) device into commercial distribution (marketing) in the U.S. for the first time. |
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for Compower. The logo consists of a stylized letter 'C' that is formed by two overlapping shapes. Below the symbol is the word "Compower" in a bold, sans-serif font. To the right of the word is the registered trademark symbol.
8 Legally Marketed Predicate Device
Foremount Disposable PVC Resuscitator Model A1
K170663 Code BTM
9 Predicate Device Company
Foremount Enterprise Co., Ltd.
10 Device Description
Disposable manual resuscitator is disposable, medical device, which temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure. Disposable manual resuscitator uses a duck-bill valve in the non-rebreathing valve assembly, attaches the non-rebreathing valve directly onto the resuscitation bag and includes an oxygen enrichment (reservoir) system. Disposable manual resuscitator may be used in hospital, transport, emergency, and post hospital care to temporary ventilate a patient.
Disposable manual resuscitator is for single patient used. It comprises of mask, oxygen tube, reservoir bag and resuscitator bag. It is used to temporary ventilate a patient for the given body mass ranges of:
- . Infant - Less than or equal to 10 kg
- . Child - less than or equal to 23 kg
- . Adult - Greater than 23 kg.
Models:
There are three device models subject to this 510(k) premarket notification including:
- NPVC-001/RTMA--Adult disposable manual resuscitator .
- . NPVC-002/RTMA--Child disposable manual resuscitator
- NPVC-003/RTMA1--Infant disposable manual resuscitator .
The ventilation bags are available in three sizes based upon the intended patient population. They are provided with three different sizes of masks.
Intended Use Statement 11
Single patient use manual resuscitator for use hospital, transport, emergency, and post hospital care to temporary ventilate a patient for the given body mass ranges of: Infant: less than or equal to 10Kg. Child: less than or equal to 23 Kg. Adult: greater than 23 Kg.
12 Required Components
Mask
Resuscitator bag (including intake valve and patient connector) Reservoir bag Oxygen tube
13 Summary Table of Comparison
Table 1 outlines the predicate device functions comparing with Compower Disposable Manual Resuscitator
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for Compower. The logo consists of a stylized, abstract shape resembling two overlapping ellipses, positioned above the word "Compower" in a bold, sans-serif font. A registered trademark symbol is placed to the right of the word "Compower".
Comparison with Foremount Disposable PVC Resuscitator (K170663)
| Foremount Disposable PVCResuscitator, Model A1(K170663) | Disposable ManualResuscitator | SubstantialEquivalenceDiscussion | |
|---|---|---|---|
| Indication forUse | Single patient use manualresuscitatorfor use hospital,transport, emergency, and posthospital care to temporaryventilate a patient for the givenbody mass ranges of:Infant: ≤10kg,Child: ≤23kg,Adult: >23kg. | Single patient use manualresuscitator foruse hospital,transport, emergency, and posthospital care to temporaryventilate apatient for the givenbody mass ranges of:Infant: ≤10kg,Child: ≤23kg,Adult: >23kg. | Same |
| Targetpopulation | Infant: ≤10kg,Child: ≤23kg,Adult: >23kg. | Infant: ≤10kg,Child: ≤23kg,Adult: >23kg. | Same |
| Classification | BTMCFR 868.5915 Ventilator,Emergency, Manual(Resuscitator) | BTMCFR 868.5915 Ventilator,Emergency, Manual(Resuscitator) | Same |
| Component | 1. Self-inflating bag2. Intake valves3. Oxygen collection bag4. Oxygen tubing5. Patient connector6. Face mask7. Pressure limiting valve8.Options-Pop-off,PEEP valve, Pressuremanometer | 1. Mask2. Resuscitator bag(Includingintake valveand patientconnector)3. Reservoir bag4. Oxygen tube5. Pressure limiting valve | Different |
| PressureLimiting Valve | Pressure limiting valve comprisedof spring, pressure limiting valvecover, pressure limiting valvecore and spring pad | Pressure limiting valve comprised ofspring, pressure limiting valvecover, pressure limiting valve coreand spring pad | Same |
| Environmentof Use | Hospital, Transport, emergencyand posthospital care | Hospital, Transport, emergencyand posthospital care | Same |
| Principal ofoperation | The patient valve contains aduckbill valve that directs airfrom compression of theventilation bag through a patientconnector into the patientairway duringinspiration anddirects the patient expired airout to the atmosphere when theventilation bag is releasedduring exhalation. If the patient | The patient valve contains aduckbill valve that directs air fromcompression of the ventilation bagthrough a patient connectorinto thepatient airway during inspirationand directs the patient expired airout to the atmosphere when theventilation bag isreleased duringexhalation. If the patient valveincorporates a pressure limiting | Same |
{6}------------------------------------------------
Image /page/6/Picture/1 description: The image shows the logo for Compower. The logo consists of a stylized letter 'C' shape above the word "Compower". The 'C' shape is formed by two overlapping ovals, with the top oval being slightly larger than the bottom oval. The word "Compower" is written in a bold, sans-serif font, and there is a registered trademark symbol to the right of the word.
| valve (40 cmH2Ofor infant and child and 60 cmH2O for adult), excessive pressure will be exhausted to atmosphere to prevent pressure trauma. | valve (40 cmH2O for infant and child and 60 cmH2O for adult), excessive pressure will be exhausted to atmosphere to prevent pressure trauma. | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient Connector | 15ID/22OD | 15ID/22OD | Same | ||||||||||||||||||||||||
| Pressure Limit | 40cmH2O60cmH2O | 40cmH2O60cmH2O | Same | ||||||||||||||||||||||||
| Duration of use | Single patient, disposable<24 hours | Single patient, disposable<24 hoursNormal use < 1 hr | Same | ||||||||||||||||||||||||
| Dimensions | Adult: 445x190mmChild: 350x177mmInfant: 325x165mm | Adult: 212x131mmChild: 177x113mmInfant: 126x93mm | Different | ||||||||||||||||||||||||
| Intake valves | External 2 valve designIntegrated design | External 2 valve designIntegrated design | Same | ||||||||||||||||||||||||
| Can provide supplemental oxygen | Yes | Yes | Same | ||||||||||||||||||||||||
| Material | PVC, Polycarbonate, Silicone | PVC, Polycarbonate, Silicone | Same | ||||||||||||||||||||||||
| Energy used/ delivered | N/A | N/A | Same | ||||||||||||||||||||||||
| Performance Data | |||||||||||||||||||||||||||
| Ventilation Bag Volume | Adult: 1700 mlChild: 500mlInfant: 320ml | Adult: 1500mlChild: 1000mlInfant: 520ml | Different | ||||||||||||||||||||||||
| Oxygen collection Bag Volume | Adult: 1000mlChild: 1000mlInfant: 600ml | Adult: 2000mlChild: 1600mlInfant: 1600ml | Different | ||||||||||||||||||||||||
| Max Delivered Volume (single hand) | Adult: 650 mlChild: 370 mlInfant: 180 ml | Adult: 500 mlChild: 345 mlInfant: 150 ml | Different | ||||||||||||||||||||||||
| Dead Space | ~3.8ml for all sizes | Adult: 7.3Child: 7.1Infant: 6.8 | Different | ||||||||||||||||||||||||
| Expiratory resistanceAdult@50 lpmChild @5 lpmInfant@5 lpm | Adult: 2.8H2O Child:0.5cmH2OInfant:0.5cmH2O | Adult:1.39cmH2OChild:1.30cmH2OInfant:0.04cmH2O | Different | ||||||||||||||||||||||||
| Inspiratory resistanceAdult@50 lpmChild @5 lpmInfant@5 lpm | Adult: 3cm H2O Child:0.5cm H2OInfant:0.5cmH2O | Adult:0.98cmH2OChild:0.98 cmH2OInfant: 0.04cmH2O | Different | ||||||||||||||||||||||||
| Supplemental Oxygen% at different flow rates and Tidal Volumes (VT) | 2L/min 5L/min 10L/min 70ml/ 20bpm 90% 98% 98% 70ml/ 30bpm 87% 99% 98% | 2L/min 5L/min 10L/min 70ml/ 20bpm 76% 82% 83% 70ml/ 30bpm 80% 87% 90% | Different |
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image shows the logo for Compower. The logo consists of a stylized letter 'C' that is formed by two overlapping curved shapes. Below the symbol is the word "Compower" in a bold, italicized font, followed by the registered trademark symbol.
| Infant | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| SupplementalOxygen% atdifferent flowrates and TidalVolumes (VT)—Child | 2L/min | 5L/min | 10L/min | 2L/min | 5L/min | 10L/min | Different | ||
| 200ml/20bpm | 57% | 99% | 98% | 200ml/20bpm | 61% | 96% | 96% | ||
| 300ml/30bpm | 39% | 66% | 98% | 300ml/30bpm | 36% | 57% | 98% | ||
| SupplementalOxygen% atdifferent flowrates and TidalVolumes (VT)--Adult | 5L/min | 10L/min | 15L/min | 5L/min | 10L/min | 15L/min | Different | ||
| 600ml/12 bpm | 83% | 99% | 98% | 600ml/12 bpm | 72% | 99% | 99% | ||
| 750ml/12bpm | 57% | 99% | 99% | 750ml/12bpm | 57% | 95% | 99% | ||
| 1000ml/12bpm | 40% | 60% | 70% | 1000ml/12bpm | / | / | / | ||
| Operatingtemperature | -18°C to 50°C | -18°C to 50°C | Same | ||||||
| StorageTemperature | -40°C to 60°C | -40°C to 60°C | Same | ||||||
| Sterile orNon-sterile | Non-sterile | Non-sterile | Same | ||||||
| Single patientuse or Reuse | Single patient use | Single patient use | Same | ||||||
| Connectors | Non-Rebreathing Valveconnector, Bagconnector areconform with ISO 5356-1:2015. | Non-Rebreathing Valveconnector, Bagconnector areconform with ISO 5356-1:2015. | Same | ||||||
| Trained users | The product should only beused bypersons trained inresuscitation.Use of product is well known totrainedusers. | This product must be used bypersons who are trained intechniques of pulmonaryresuscitation. Use of product iswell known to trained users. | Same | ||||||
| Rx only orOTC only | RX only | RX only | Same | ||||||
| Compatibilitywith otherdevices | The device can compatibilitywith otherdevices, e.g. facemask, PEEP Valve,Manometer, Filter andOropharyngealairways when used. | The device can compatibility withother devices, e.g. oropharyngealairways. Alsoit can be usedseparately. | Same | ||||||
| Where used | Emergency situations in hospital,transport, emergency, and posthospitalcare. | Emergency situations in hospital,transport, emergency, and posthospitalcare. | Same |
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the logo for ComApower. The logo consists of a stylized, abstract shape resembling two overlapping ovals or circles, creating a dynamic and interconnected design. Below the shape, the word "ComApower" is written in a bold, sans-serif font, with the registered trademark symbol (®) positioned to the right of the word.
| Compower | |||
|---|---|---|---|
| Standardsmet | ISO 5356-1:2015ISO 10651-4:2002ISO 10993-1:2018ISO 10993-5:2009ISO 10993-10:2013ISO 10993-11:2017 | ISO 5356-1:2015ISO 10651-4:2002ISO 10993-5:2009ISO 10993-10:2013ISO 10993-11:2017ISO 18562-1:2017ISO 18562-2:2017ISO 18562-3:2017 | |
| Electrical,thermal orradiationsafety | N/A | N/A | Same |
| Shelf life | 5 years | 3 years | Different |
| Biocompatibility | Externally communicating,tissue and Surface Contact,skin Limited durationof use(<24h)Testing - Cytotoxicity,Sensitization, Irritation, AcuteSystemic Toxicity, Gasemission VOC, PM2.5,Inorganic gases(Ozone, CO,CO2) | Externally communicating, tissueand Surface Contact, skin Limitedduration ofuse (<24h)Testing - Cytotoxicity,Sensitization, Irritation, AcuteSystemic Toxicity, Gasemission VOC, PM2.5,Inorganic gases(Ozone, CO,CO2) | Same |
Table 1 Comparison Table
14 Summary of Device Testing
The following practices were followed and monitored for development of the Disposable Manual Resuscitators:
- The device was developed and tested according to GMP Standard Operating Procedures for Medical Devices.
- Risk Analysis of the device was performed according to ISO 14971. .
- Human Factors/Usability Engineering validation according to IEC 62366-1 ● demonstrated the safety and efficacy of the device.
- Biocompatibility was evaluated in accordance with ISO 10993-1 and ISO . 18562-1.
- Biocompatibility tests was conducted according to ISO 10993-5, ISO 10993-10, . ISO 10993-11, ISO 18562-2 and ISO 18562-3.
- Performance test is conducted according to ISO 10651-4 and ISO 5356-1. ●
- . Shelf life test is conducted according to ASTM F1980.
15 Comparison Summary
The Disposable Manual Resuscitators are viewed as substantially equivalent to the predicate device because:
Indications for use
The proposed indications for use are the same as predicate.
Patient Population
The patient population is the same as predicate. Xiamen Compower Medical Tech. Co., Ltd. Disposable Manual Resuscitator
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the logo for Compower. The logo consists of a stylized letter 'C' formed by two overlapping curved shapes. Below the symbol, the word "Compower" is written in a bold, italicized font, with the registered trademark symbol '®' to the right of the word.
Components
Similar as the predicate device without peep valve and pressure manometer. Those two items are optional accessories which won't impact product safety and effectiveness.
Environment of Use
The environment of use is the same as predicate.
Technological Characteristics
The design and principle of operation is similar to the predicate. The configuration and functionality is similar. The differences in specification, e.g. maximum delivered volume, dead space and ventilation bag volume do not raise new safety or effectiveness concerns related to substantial equivalence as ISO 10651-4 and ISO 5356-1 specifies the minimum requirements and the subject device and the predicate both meet the minimum requirements as listed in the standard. The operating principle of the Compower Resuscitator is the same as the identified predicate devices.
Shelf life
Shelf life testing is conducted based on ASTM F1980:2016 and result is passed. The shorter of shelf life does not raise any safety or efficacy issue.
Biocompatibility
Biocompatibility test conducted for Cytotoxicity, sensitization, irritation and acute systemic toxicity study, emissions of VOC and aldehydes, gas emission of CO, CO2, Ozone, PM2.5, PM10 has demonstrate the substantial equivalence.
No new issues of biocompatibility raised with regard to the Disposable Manual Resuscitator.
Non-clinical data
Performance test is conducted according to ISO 10651-4 and ISO 5356-1 for Appearance, dimension measurement, expiratory resistance, inspiratory resistance, patient valve malfunction, max delivered volume (single hand), pressure limitation, dead space, supplementary oxygen and delivered oxygen concentration, patient valve function after contamination with vomitus, drop test, immersion in water, storage and operation conditions, method of test for strength nipple to demonstrate the substantial equivalence.
Risk management report according to ISO14971:2019 and Usability test according to IEC 62366-1:2015 has been conducted and no new issues raised.
16 Conclusion
There are no differences between the proposed device and the predicates, which raise different safety or effectiveness concerns. Based on the device design, risk assessment and non-clinical tests data generated from biocompatibility test and performance test, we can conclude that the proposed device and accessory components can be considered substantially equivalent. Based upon the testing the sponsor has demonstrated the equivalence of the subject device compared to the legally marketed predicate device.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).