(205 days)
Not Found
No
The device description and performance studies focus on mechanical aspects and standard testing for manual resuscitators, with no mention of AI or ML.
Yes
The device is a manual resuscitator used to temporarily augment ventilation in patients during ventilatory insufficiency or ventilator failure, which are therapeutic medical interventions.
No
The device is a manual resuscitator, which is used for temporary ventilation in patients with ventilatory insufficiency or failure. Its function is to support breathing, not to diagnose a condition.
No
The device description clearly outlines physical components such as a resuscitator bag, mask, oxygen tube, and reservoir bag, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The provided description clearly states that this device is a "manual resuscitator" used to "temporarily ventilate a patient during ventilatory insufficiency or ventilator failure." It directly interacts with the patient's respiratory system to assist with breathing.
- Lack of Specimen Analysis: There is no mention of this device analyzing any biological specimens from the patient. Its function is purely mechanical assistance with breathing.
The description focuses on the device's physical characteristics, intended use for ventilation, and performance testing related to its mechanical function and safety for patient use. These are all characteristics of a medical device used for direct patient care, not an IVD.
N/A
Intended Use / Indications for 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
Product codes (comma separated list FDA assigned to the subject device)
BTM
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.
Required Components:
Mask
Resuscitator bag (including intake valve and patient connector)
Reservoir bag
Oxygen tube
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Infant: less than or equal to 10 kg
Child: less than or equal to 23 kg
Adult: greater than 23 kg
Intended User / Care Setting
The product should only be used by persons trained in resuscitation.
Hospital, Transport, emergency and posthospital care
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)
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.
Shelf life testing is conducted based on ASTM F1980:2016 and result is passed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5915 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).
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)
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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, | |
| 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. |
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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
Resuscitator, Model A1
(K170663) | Disposable Manual
Resuscitator | Substantial
Equivalence
Discussion |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Indication for
Use | Single patient use manual
resuscitatorfor use hospital,
transport, emergency, and post
hospital care to temporary
ventilate a patient for the given
body mass ranges of:
Infant: ≤10kg,
Child: ≤23kg,
Adult: >23kg. | Single patient use manual
resuscitator foruse hospital,
transport, emergency, and post
hospital care to temporary
ventilate apatient for the given
body mass ranges of:
Infant: ≤10kg,
Child: ≤23kg,
Adult: >23kg. | Same |
| Target
population | Infant: ≤10kg,
Child: ≤23kg,
Adult: >23kg. | Infant: ≤10kg,
Child: ≤23kg,
Adult: >23kg. | Same |
| Classification | BTM
CFR 868.5915 Ventilator,
Emergency, Manual
(Resuscitator) | BTM
CFR 868.5915 Ventilator,
Emergency, Manual
(Resuscitator) | Same |
| Component | 1. Self-inflating bag
2. Intake valves
3. Oxygen collection bag
4. Oxygen tubing
5. Patient connector
6. Face mask
7. Pressure limiting valve
8.Options-Pop-off,
PEEP valve, Pressure
manometer | 1. Mask
2. Resuscitator bag(Including
intake valveand patient
connector)
3. Reservoir bag
4. Oxygen tube
5. Pressure limiting valve | Different |
| Pressure
Limiting Valve | Pressure limiting valve comprised
of spring, pressure limiting valve
cover, pressure limiting valve
core and spring pad | Pressure limiting valve comprised of
spring, pressure limiting valve
cover, pressure limiting valve core
and spring pad | Same |
| Environment
of Use | Hospital, Transport, emergency
and posthospital care | Hospital, Transport, emergency
and posthospital care | Same |
| Principal of
operation | The patient valve contains a
duckbill valve that directs air
from compression of the
ventilation bag through a patient
connector into the patient
airway duringinspiration and
directs the patient expired air
out to the atmosphere when the
ventilation bag is released
during exhalation. If the patient | The patient valve contains a
duckbill valve that directs air from
compression of the ventilation bag
through a patient connectorinto the
patient airway during inspiration
and directs the patient expired air
out to the atmosphere when the
ventilation bag isreleased during
exhalation. If the patient valve
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 | ||||||||||||||||||||||||||
| 60cmH2O | 40cmH2O | ||||||||||||||||||||||||||
| 60cmH2O | Same | ||||||||||||||||||||||||||
| Duration of use | Single patient, disposable |