Disposable Manual Resuscitator

K210288 · Xiamen Compower Medical Tech. Co., Ltd. · BTM · Aug 26, 2021 · Anesthesiology

Device Facts

• Record ID: K210288
• Device Name: Disposable Manual Resuscitator
• Applicant: Xiamen Compower Medical Tech. Co., Ltd.
• Product Code: BTM · Anesthesiology
• Decision Date: Aug 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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

Device Story

Disposable manual resuscitator provides temporary ventilation for patients experiencing respiratory insufficiency or failure. Device consists of a resuscitator bag, non-rebreathing valve with duck-bill mechanism, mask, oxygen reservoir bag, and oxygen tubing. Operated by trained healthcare personnel in hospital, transport, or emergency settings. Manual compression of the ventilation bag forces air through the patient connector into the airway; duck-bill valve directs expired air to the atmosphere during exhalation. Includes a pressure-limiting valve (40 cmH2O for infant/child; 60 cmH2O for adult) to prevent barotrauma. Supplemental oxygen can be delivered via the reservoir system. Output is manual ventilation; clinical decision-making relies on provider assessment of patient respiratory status. Benefits include immediate, portable respiratory support.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 10651-4 and ISO 5356-1, including ventilation volumes, inspiratory/expiratory resistance, pressure limitation, and oxygen delivery. Biocompatibility assessed per ISO 10993 and ISO 18562 series. Usability validated per IEC 62366-1. No clinical data presented.

Technological Characteristics

Materials: PVC, Polycarbonate, Silicone. Principle: Manual self-inflating bag with duck-bill non-rebreathing valve. Connectivity: None. Sterilization: Non-sterile. Standards: ISO 5356-1:2015, ISO 10651-4:2002, ISO 10993-1/5/10/11, ISO 18562-1/2/3. Pressure limiting valve: 40 cmH2O (infant/child), 60 cmH2O (adult).

Indications for Use

Indicated for temporary ventilation of patients in hospital, transport, emergency, and post-hospital care settings. Patient populations include infants (≤10 kg), children (≤23 kg), and adults (>23 kg).

Regulatory Classification

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.

Predicate Devices

• Foremount Disposable PVC Resuscitator Model A1 (K170663)

Submission Summary (Full Text)

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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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 ([e-mail]) or phone [phone] 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

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# 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)

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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,<br>Xiang'An Torch Industrial Zone,<br>Xiamen, Fujian, 361101, CHINA. |
| | Contact person in China:<br>Correspondent) | Lifen Chen, Regulatory Affairs Manager |
| | Address: | Unit 301, No.16, Xianghong Road,<br>Xiang'An Torch Industrial Zone,<br>Xiamen, Fujian, 361101, CHINA. |
| | Phone: | [phone] |
| | FAX: | [phone] |
| | E-mail | [e-mail] |
| | Contact person in the U.S.: | Mingzi Hussey, Regulatory Consultant |
| | Address | Zi-meidcal, Inc.<br>93 Springs Rd,<br>Bedford, MA 01730 US |
| | Phone/Fax: | 206-981-0675 |
| | E-mail | [e-mail] |
| 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. | |

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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

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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 PVC<br>Resuscitator, Model A1<br>(K170663) | Disposable Manual<br>Resuscitator | Substantial<br>Equivalence<br>Discussion |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Indication for<br>Use | Single patient use manual<br>resuscitatorfor use hospital,<br>transport, emergency, and post<br>hospital care to temporary<br>ventilate a patient for the given<br>body mass ranges of:<br>Infant: ≤10kg,<br>Child: ≤23kg,<br>Adult: >23kg. | Single patient use manual<br>resuscitator foruse hospital,<br>transport, emergency, and post<br>hospital care to temporary<br>ventilate apatient for the given<br>body mass ranges of:<br>Infant: ≤10kg,<br>Child: ≤23kg,<br>Adult: >23kg. | Same |
| Target<br>population | Infant: ≤10kg,<br>Child: ≤23kg,<br>Adult: >23kg. | Infant: ≤10kg,<br>Child: ≤23kg,<br>Adult: >23kg. | Same |
| Classification | BTM<br>CFR 868.5915 Ventilator,<br>Emergency, Manual<br>(Resuscitator) | BTM<br>CFR 868.5915 Ventilator,<br>Emergency, Manual<br>(Resuscitator) | Same |
| Component | 1. Self-inflating bag<br>2. Intake valves<br>3. Oxygen collection bag<br>4. Oxygen tubing<br>5. Patient connector<br>6. Face mask<br>7. Pressure limiting valve<br>8.Options-Pop-off,<br>PEEP valve, Pressure<br>manometer | 1. Mask<br>2. Resuscitator bag(Including<br>intake valveand patient<br>connector)<br>3. Reservoir bag<br>4. Oxygen tube<br>5. Pressure limiting valve | Different |
| Pressure<br>Limiting Valve | Pressure limiting valve comprised<br>of spring, pressure limiting valve<br>cover, pressure limiting valve<br>core and spring pad | Pressure limiting valve comprised of<br>spring, pressure limiting valve<br>cover, pressure limiting valve core<br>and spring pad | Same |
| Environment<br>of Use | Hospital, Transport, emergency<br>and posthospital care | Hospital, Transport, emergency<br>and posthospital care | Same |
| Principal of<br>operation | The patient valve contains a<br>duckbill valve that directs air<br>from compression of the<br>ventilation bag through a patient<br>connector into the patient<br>airway duringinspiration and<br>directs the patient expired air<br>out to the atmosphere when the<br>ventilation bag is released<br>during exhalation. If the patient | The patient valve contains a<br>duckbill valve that directs air from<br>compression of the ventilation bag<br>through a patient connectorinto the<br>patient airway during inspiration<br>and directs the patient expired air<br>out to the atmosphere when the<br>ventilation bag isreleased during<br>exhalation. If the patient valve<br>incorporates a pressure limiting | Same |

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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 | 40cmH2O<br>60cmH2O | 40cmH2O<br>60cmH2O | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| Duration of use | Single patient, disposable<24 hours | Single patient, disposable<24 hours<br>Normal use < 1 hr | Same | | | | | | | | | | | | | | | | | | | | | | | | |
| Dimensions | Adult: 445x190mm<br>Child: 350x177mm<br>Infant: 325x165mm | Adult: 212x131mm<br>Child: 177x113mm<br>Infant: 126x93mm | Different | | | | | | | | | | | | | | | | | | | | | | | | |
| Intake valves | External 2 valve design<br>Integrated design | External 2 valve design<br>Integrated 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 ml<br>Child: 500ml<br>Infant: 320ml | Adult: 1500ml<br>Child: 1000ml<br>Infant: 520ml | Different | | | | | | | | | | | | | | | | | | | | | | | | |
| Oxygen collection Bag Volume | Adult: 1000ml<br>Child: 1000ml<br>Infant: 600ml | Adult: 2000ml<br>Child: 1600ml<br>Infant: 1600ml | Different | | | | | | | | | | | | | | | | | | | | | | | | |
| Max Delivered Volume (single hand) | Adult: 650 ml<br>Child: 370 ml<br>Infant: 180 ml | Adult: 500 ml<br>Child: 345 ml<br>Infant: 150 ml | Different | | | | | | | | | | | | | | | | | | | | | | | | |
| Dead Space | ~3.8ml for all sizes | Adult: 7.3<br>Child: 7.1<br>Infant: 6.8 | Different | | | | | | | | | | | | | | | | | | | | | | | | |
| Expiratory resistance<br>Adult@50 lpm<br>Child @5 lpm<br>Infant@5 lpm | Adult: 2.8H2O Child:<br>0.5cmH2OInfant:<br>0.5cmH2O | Adult:1.39cmH2O<br>Child:1.30cmH2O<br>Infant:0.04cmH2O | Different | | | | | | | | | | | | | | | | | | | | | | | | |
| Inspiratory resistance<br>Adult@50 lpm<br>Child @5 lpm<br>Infant@5 lpm | Adult: 3cm H2O Child:<br>0.5cm H2OInfant:<br>0.5cmH2O | Adult:0.98cmH2O<br>Child:0.98 cmH2O<br>Infant: 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 |

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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 | | | | | | | | | |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------|---------|---------|-----------|
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| | | | | | | | | | |
| Supplemental<br>Oxygen% at<br>different flow<br>rates and Tidal<br>Volumes (VT)—<br>Child | | 2L/min | 5L/min | 10L/min | | 2L/min | 5L/min | 10L/min | Different |
| | 200ml/<br>20bpm | 57% | 99% | 98% | 200ml/<br>20bpm | 61% | 96% | 96% | |
| | 300ml/<br>30bpm | 39% | 66% | 98% | 300ml/<br>30bpm | 36% | 57% | 98% | |
| Supplemental<br>Oxygen% at<br>different flow<br>rates and Tidal<br>Volumes (VT)--<br>Adult | | 5L/min | 10L/min | 15L/min | | 5L/min | 10L/min | 15L/min | Different |
| | 600ml/<br>12 bpm | 83% | 99% | 98% | 600ml/<br>12 bpm | 72% | 99% | 99% | |
| | 750ml/<br>12bpm | 57% | 99% | 99% | 750ml/<br>12bpm | 57% | 95% | 99% | |
| | 1000ml/<br>12bpm | 40% | 60% | 70% | 1000ml<br>/12bpm | / | / | / | |
| Operating<br>temperature | | -18°C to 50°C | | | -18°C to 50°C | | | Same | |
| Storage<br>Temperature | | -40°C to 60°C | | | -40°C to 60°C | | | Same | |
| Sterile or<br>Non-sterile | Non-sterile | | | Non-sterile | | | Same | | |
| Single patient<br>use or Reuse | Single patient use | | | Single patient use | | | Same | | |
| Connectors | Non-Rebreathing Valve<br>connector, Bagconnector are<br>conform with ISO 5356-1:2015. | | | Non-Rebreathing Valve<br>connector, Bagconnector are<br>conform with ISO 5356-1:2015. | | | Same | | |
| Trained users | The product should only be<br>used bypersons trained in<br>resuscitation.<br>Use of product is well known to<br>trainedusers. | | | This product must be used by<br>persons who are trained in<br>techniques of pulmonary<br>resuscitation. Use of product is<br>well known to trained users. | | | Same | | |
| Rx only or<br>OTC only | RX only | | | RX only | | | Same | | |
| Compatibility<br>with other<br>devices | The device can compatibility<br>with otherdevices, e.g. face<br>mask, PEEP Valve,<br>Manometer, Filter and<br>Oropharyngeal<br>airways when used. | | | The device can compatibility with<br>other devices, e.g. oropharyngeal<br>airways. Alsoit can be used<br>separately. | | | Same | | |
| Where used | Emergency situations in hospital,<br>transport, emergency, and post<br>hospitalcare. | | | Emergency situations in hospital,<br>transport, emergency, and post<br>hospitalcare. | | | Same | | |

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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 |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Standards<br>met | ISO 5356-1:2015<br>ISO 10651-4:2002<br>ISO 10993-1:2018<br>ISO 10993-5:2009<br>ISO 10993-10:2013<br>ISO 10993-11:2017 | ISO 5356-1:2015<br>ISO 10651-4:2002<br>ISO 10993-5:2009<br>ISO 10993-10:2013<br>ISO 10993-11:2017<br>ISO 18562-1:2017<br>ISO 18562-2:2017<br>ISO 18562-3:2017 | |
| Electrical,<br>thermal or<br>radiation<br>safety | N/A | N/A | Same |
| Shelf life | 5 years | 3 years | Different |
| Biocompatibility | Externally communicating,<br>tissue and Surface Contact,<br>skin Limited durationof use<br>(<24h)<br>Testing - Cytotoxicity,<br>Sensitization, Irritation, Acute<br>Systemic Toxicity, Gas<br>emission VOC, PM2.5,<br>Inorganic gases(Ozone, CO,<br>CO2) | Externally communicating, tissue<br>and Surface Contact, skin Limited<br>duration ofuse (<24h)<br>Testing - Cytotoxicity,<br>Sensitization, Irritation, Acute<br>Systemic Toxicity, Gas<br>emission VOC, PM2.5,<br>Inorganic gases(Ozone, CO,<br>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

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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.