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.

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

AI/ML Overview

The provided text is a 510(k) Summary for a CPR Mask (FS-104 CPR Mask). The document discusses the device's substantial equivalence to predicate devices based on non-clinical testing. It does not describe a study involving humans or AI to set and meet acceptance criteria for device performance as a diagnostic or analytical tool.

Therefore, I cannot fulfill the request to provide information based on the specific numbered points (1-9) as they relate to such a study. The document focuses on demonstrating that the new CPR mask is as safe and effective as pre-existing, legally marketed predicate devices through compliance with voluntary standards and similar functional characteristics.

Here's what I can extract regarding the assessment of the device, aligning it as much as possible with the spirit of your request, but highlighting that it's not a clinical AI performance study:

Summary of Device Assessment (Not an AI/Diagnostic Performance Study):

The assessment described in this document is a demonstration of substantial equivalence of the FS-104 CPR Mask to predicate devices, focusing on:

Indications for Use: Same or similar.
Technological Characteristics: Same or similar.
Principles of Operation: Same or similar.
Performance: Same or similar, as demonstrated by compliance to voluntary standards.

Explanation of Acceptance Criteria and the "Study":

The "study" here is the non-clinical testing performed to establish compliance with recognized voluntary standards and compare the device's performance to predicate devices. The acceptance criteria are implicit in meeting these standards and demonstrating similarity.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion / Standard	Reported Device Performance
ISO 10993-1 (Biocompatibility)	Compliant
ISO 10993-5 (Biocompatibility - In vitro cytotoxicity)	Compliant
ISO 10993-10 (Biocompatibility - Skin irritation & sensitization)	Compliant
ASTM F920 (Performance of device)	Compliant (Similar to predicate devices)
Functional Performance (e.g., airtight seal, barrier, 2cm oral cavity limit)	Functions as described, similar to predicate devices

Sample size used for the test set and the data provenance: Not applicable. This was non-clinical (laboratory/bench) testing against standards, not a clinical trial with a test set of patient data. The "data provenance" would be the accredited laboratories or internal testing facilities where the standards were applied.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic performance, is not established by experts for this type of device submission. Compliance with standards and functional equivalence are the "ground truth."
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. No MRMC study was mentioned; this device is a mechanical CPR mask, not an AI-powered diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used: For this submission, the "ground truth" is defined by:
- Compliance with established voluntary standards (ISO 10993-1, ISO 10993-5, ISO 10993-10, ASTM F920).
- Demonstrated performance characteristics that are "same or similar" to legally marketed predicate devices.
The sample size for the training set: Not applicable. This device is not an AI model, so there is no training set.
How the ground truth for the training set was established: Not applicable.

In conclusion, this document describes a regulatory submission for a Class II medical device (CPR Mask) seeking substantial equivalence to predicate devices, based on non-clinical testing and comparison of characteristics. It does not involve AI, clinical diagnostic performance studies, or the methodologies typically associated with establishing performance for such tools.

Summary

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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 intended for single use only.

FDA CDRH DMC 'JUL 2 2 2010

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Device Description:

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.

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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.

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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

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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 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

Regulation Number and Section

§ 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).