(611 days)
Not Found
No
The device description and performance studies focus on the physical components and basic function of a CPR mask, with no mention of AI or ML capabilities.
No.
The device is a CPR mask, which serves as a barrier and assists with ventilation, but it does not directly treat a disease or condition in a therapeutic manner. Its primary function is to facilitate resuscitation efforts.
No
The device is a CPR mask used for ventilation, acting as a physical barrier and aiding in delivering breaths. Its function is to assist in resuscitation, not to analyze or detect medical conditions or diseases.
No
The device description clearly outlines physical components (mask, valve, filter, head strap) and their functions, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for mouth-to-mask ventilation during CPR, providing a physical barrier and facilitating air delivery. This is a therapeutic and protective function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they function to deliver air and protect the rescuer. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis.
The device is clearly intended for use in a medical emergency setting to assist with resuscitation, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use.
The FS-104 CPR mask with oxygen port is intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
CBP
Device Description
(1) The CPR mask with oxygen port is composed of foldable cushion mask with Oxygen Port, one- way valve, disposable filter, and elastic head trap. (2) The CPR mask with oxygen port provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with unknown subject. (3) The CPR mask with oxygen port promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. Proper training in ventilation and CPR should be obtained before using this device. (4) The CPR mask with oxygen port can be functioned in such a way that no any part of device extends into the patient's oral cavity by more than 2 cm. (5) For the device with capability of using oxygen is to sale as prescription device
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth to mask ventilation
Indicated Patient Age Range
adult and child whose weight exceeds 40kg
Intended User / Care Setting
Not Found
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)
Not Found
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
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).
0
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Received
510(K) Summary for CPR Mask
Summary Prepared Date: 07/11/2010
Submitter:
FIRSTAR HEALTHCARE CO., LTD. No.4-5, 2nd Industrial District, Dongshen Cun Dongchong Town, Panyu District Guangzhou, China 511475
Submission Correspondent:
Mr. Leon Lu Director of Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway Dover, DE 19901 USA Tel: 1-877-202-1588 Fax: 1-888-202-8884 Email: info@medeviceservices.com www.medeviceservices.com
General Information:
Common or Usual Name: FS-104 CPR Mask Classification Name: valve, non-rebreathing Product Code: CBP Panel: Anesthesiology Classification: Class II Regulatory Reference: 21 CFR §868.5870 Single Use: Yes Sterile: No
Submission Purpose: New device
Predicate Device:
- . K081516 MedSource CPR Mask with Oxygen Port (Prescription Use) manufactured by MEDSOURCE INTERNATIONAL, LLC
- K042727 POCKET SIZE RESUSCITATOR/MODEL: M16201R AND . M16201A manufactured by FOREMOUNT ENT. CO., LTD.
Indications for Use:
The FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use.
The FS-104 CPR mask with oxygen port is intended for single use only.
FDA CDRH DMC 'JUL 2 2 2010
1
Device Description:
(1) The CPR mask with oxygen port is composed of foldable cushion mask with Oxygen Port, one- way valve, disposable filter, and elastic head trap. (2) The CPR mask with oxygen port provides a physical barrier between the rescuer and victim, eliminating direct contact of the rescuer's lips with unknown subject. (3) The CPR mask with oxygen port promotes an airtight seal to the face allowing ventilation through both the mouth and nose simultaneously. Proper training in ventilation and CPR should be obtained before using this device. (4) The CPR mask with oxygen port can be functioned in such a way that no any part of device extends into the patient's oral cavity by more than 2 cm. (5) For the device with capability of using oxygen is to sale as prescription device
Comparison to the Predicate Devices:
The FS-104 CPR mask with oxygen port is claimed with the same or similar indication for use, operation function, performance and of the predicate devices. The performance is same or similar to the predicate device.
Discussion of Non-Clinical Tests Performed Determination of Substantial Equivalence is as follows:
Compliance to applicable voluntary standards includes ISO 10993-1 for bio-compatibility as well as the specified testing standard of ISO 10993-5 and ISO 10993-10, and ASTM F920 for the performance of device.
Conclusions:
The FS-104 CPR mask with oxygen port is as safe and effective as the predicate devices. It has the same or similar intended uses, indications, technological characteristics, and principles of operation as those of the predicate devices. The minor differences between the FS-104 CPR mask with oxygen port and its predicate devices raise no new issues of safety or effectiveness. Thus, the FS-104 CPR mask with oxygen port is substantially equivalent to its predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Firstar Healthcare Company, Limited C/O Mr. Leon Lu Director of Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901
Re: K083418
Trade/Device Name: FS-104 CPR Mask Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: July 11, 2010 Received: July 14, 2010
Dear Mr. Lu:
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. 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.
3
Page 2- Mr. Lu
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Antinous D. Arata
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K083418
Submitter: FIRSTAR HEALTHCARE CO., LTD.
Device Name: FS-104 CPR Mask
Indications For Use:
The FS-104 CPR mask with oxygen port is indicated for use of mouth to mask ventilation via the ventilation mask with non-rebreathing valve for adult and child whose weight exceeds 40kg. It is for prescription use.
The FS-104 CPR mask with oxygen port is intended for single use only.
Prescription Use J_ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pinto for
(Division Sign-Offic Division of Anesthesiology, General Hospltal Infection Control, Dental Devices
510(k) Number: K083418