(129 days)
The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
Here's a breakdown of the acceptance criteria and the study information for the Genuine First Aid CPR Mask, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Device Performance (Genuine First Aid CPR Mask) | Standard/Requirement |
|---|---|---|
| Expiratory resistance | 3 cmH2O (at 50 L/min) | < 5 cmH2O (at 50 L/min) |
| Inspiratory resistance | 2 cmH2O (at 50 L/min) | < 5 cmH2O (at 50 L/min) |
| In vitro cytotoxicity | Passes | Required (ISO10993-1,-5,-10) |
| Skin irritation | Passes | Required (ISO10993-1,-5,-10) |
| Delayed-type hypersensitivity | Passes | Required (ISO10993-1,-5,-10) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the performance tests (expiratory and inspiratory resistance, and biocompatibility). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). However, given that these are physical performance tests for a medical device submitted to the FDA in the US, it's highly likely they were conducted in a controlled laboratory environment to meet regulatory standards, but the specific details are not disclosed.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to this submission. The device is a CPR mask, and the "ground truth" for its performance is based on measurable physical properties (resistance) and established biocompatibility standards, not expert interpretation of medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for assessing discrepancies in expert interpretation, which is not relevant for the type of performance testing performed on this device. The results are based on objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is commonly employed for AI-powered diagnostic devices to assess how AI assistance impacts human reader performance, which is not relevant for a physical medical device like a CPR mask.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is not an algorithm or AI system, but a physical medical device. The "standalone" performance here refers to the device's inherent physical characteristics.
7. The Type of Ground Truth Used
The ground truth used for this device is based on:
- Established industry standards: Specifically, ISO10651-4:2002 for pulmonary resistance measurements and ISO10993-1,-5,-10 for biocompatibility.
- Objective physical measurements: The expiratory and inspiratory resistance values are quantitative measurements of the device's physical properties.
- Laboratory-based biological testing: Biocompatibility tests (cytotoxicity, irritation, hypersensitivity) are conducted in a lab against established biological endpoints.
8. The Sample Size for the Training Set
This information is not applicable. The Genuine First Aid CPR Mask is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8. There is no training set for this device.
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510(k) SUMMARY
Nov. 28. 2011
DEC – 1 2011
Submitter: Genuine First Aid LLC 600 Cleveland Street Suite 400 Clearwater FL 33755, USA Office: (727) 449 2150 Fax: Contact: Desiree Jacques
Contact/Consultant: Gary Lehnus Lehnus & Associates Consulting 150 Cherry Lane Rd East Stroudsburg, PA 18301 USA (570) 620-0198 (570) 620-0199
Trade Name: Genuine First Aid CPR Mask
Common Name: Emergency CPR Mask
Classification Name: Valve, Non-Rebreathing Product Code: CBP Classification: Class II Panel: Anesthesiology Regulatory Classification: 21CFR 868.5870
Predicate Device: Medisource CPR Mask without Oxygen Port - K081516 LIV Medica CPR Face Mask - K052458
Device Description:
Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim.
Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
Specifications:
Dimensions: (122mm x 100mm x 90mm) mask connector 22mm ID oxygen port 6mm OD Inspiratory resistance: < < 5 cmH2O ( at 50 L/min ) Expiratory resistance: < < 5 cmH2O (at 50 L/min)
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Operation Temperature: -18°C~ 40°C
Storage Temperature: -30℃ ~ 50℃
Storage relative humidity: <85%
- Indications For Use: The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a nonbreathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
| Features | Medisource | Genuine First Aid CPR mask |
|---|---|---|
| Configuration | One piece | One piece |
| Use | Single | Single |
| Size | Adult | Adult |
| Material | PVC、silicone、Non-Woven | PVC、silicone、Non-Woven |
| Intended Use | Mouth to mask ventilation | mouth to mask ventilation |
| Ventilation | manual | manual |
| Oxygen port | None | None |
| Connector | Standard 22 mm | Standard 22 mm |
| Expiratory resistance | 1.94 cmH2O ( at 50 L/min) | 3 cmH2O ( at 50 L/min) |
| Inspiratory resistance | 2.04 cmH2O (at 50 L/min) | 2 cmH2O ( at 50 L/min) |
| Includes | Universal breathing tubeOne-way filtered valveHead strapWith or without oxygen port | Universal breathing tubeOne-way filtered valveHead strapWith or without oxygen port |
Substantial Equivalency Summary
PERFORMANCE TESTING
Biocompatibility testing:
| Biocompatibility test | ISO10993-1,-5,-10requirement | Testing results |
|---|---|---|
| vitro cytotoxicity | required | passes |
| skin irritation | required | passes |
| delayed-typehypersensitivity | required | passes |
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Conclusion:
.
The potential for causing irritation is remote for the follow reasons:
- . The raw material and mask have been tested beyond the requirements of ISO10993 for skin contact.
- . The time of contact and percentage of body exposure is very low.
- The injection molding process does not significantly alter the raw material . characteristics
| Patient contact components description | |||
|---|---|---|---|
| Device component | Material of construction | Patient /rescuer contact | Contact time |
| One way valve | K-resin/silicone | mouth (rescuer) | 3-60minutes |
| Face mask | PVC | Skin(Patient) | 3-60minutes |
| Elastic strap | Non-woven | Hair/skin(Patient) | 3-60minutes |
Expiratory resistance and Inspiratory resistance performance testing was done using the test methods described in ISO10651-4:2002, Lung ventilators-Part 4: Particular requirements for operator-powered resuscitators.
| Device tested | Standard requirement | Genuine First Aid CPR mask |
|---|---|---|
| Expiratory resistance | <5 cmH2O ( at 50 L/min) | 3 cmH2O ( at 50 L/min) |
| Inspiratory resistance------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <5 cmH2O ( at 50 L/min) | 2 cmH2O ( at 50 L/min) |
CONCLUSIONS:
The Genuine First Aid CPR mask without oxygen port is as safe and effective as the predicate device. It has the same or similar intended use, indications for use, technological characteristics, and principles of operation as those of the predicate device. The minor differences between the Genuine First Aid CPR mask with oxygen port and its predicate device raise no new issues of safety or effectiveness. Thus, the Genuine First Aid CPR mask without oxygen port is substantially equivalent to its predicate device.
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Public Health Service
DEC - 1 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Genuine First Aid LLC C/O Mr. Gary Lehnus Official Correspondent Lehnus & Associates Consulting 482 Cherry Lane Road East Stroudsburg, Pennsylvania 18301
Re: K112126
Trade/Device Name: Genuine First Aid OTC CPR Face Mask Regulation Number: 21 CFR 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: November 10, 2011 Received: November 16, 2011
Dear Mr. Lehnus:
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. Lehnus
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,
Arthman D. Martin
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):
Device Name: ____ Genuine First Aid OTC CPR Face Mask
Indications For Use:
The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will (vect expired air from the patient away from the user. This device should only be used hy persons who have received adequate training.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
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 (OIVD)
L. Schultheis
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anton, Dental Devices
510(k) Number: K112126
Page _1 of 1
§ 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).