(242 days)
The intended use of this device is to provide manual, bag mask/tube pulmonary resuscitation.
The Mercury Medical Reusable CPR Bag uses the same technology as the Mercury CPR, Puntan Bennett PMR and most other manual resuscitators in the market. The bag is compressed by hand to move air into the patient. When released the bag re-expands with air flowing through the intake valve. Supplemental oxygen tubing may be connected to an oxygen source to allow intake of oxygen enriched air.
The provided text describes a 510(k) submission for the Mercury Medical Reusable CPR Bag. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than a detailed performance study with acceptance criteria often seen for novel devices or those with higher risk. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not directly addressed in this document.
Here's an attempt to extract the closest relevant information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria. Instead, it relies on a comparison to predicate devices and adherence to external standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Design Similarity to predicate devices (K911622 Mercury Medical single patient use CPR Bag, Puntan Bennett PMR, Laerdal Bag Mask Resuscitator). | The device is "similar in design" to the Mercury Medical single patient use CPR Bag. The "Table of Technological Comparison in Section 5 indicates that this device and predicate device are similarly designed with identical materials." It uses "the same technology as the Mercury CPR, Puntan Bennett PMR and most other manual resuscitators in the market." |
| Performance Characteristics similar to predicate devices and exceeding ASTM standards. | The "Table of Performance Comparison in Section 5 also demonstrates that this and the predicate devices all have similar performance characteristics exceeding the ASTM standards." (Specific ASTM standard not mentioned, and specific performance characteristics/metrics are not detailed in this summary). |
| Intended Use Equivalence | "The intended use of this device is to provide manual, bag mask/tube pulmonary resuscitation," which is directly comparable to the stated function of manual resuscitators. |
2. Sample size used for the test set and the data provenance
Not applicable. The submission is based on engineering design comparison and performance data against standards, not a clinical test set from human or simulated patients in the usual sense. The data provenance would be laboratory testing against ASTM standards and comparison to specifications of predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a clinical test set is not established in this type of submission. Performance is assessed against engineering standards and comparison to predicate devices, presumably by the manufacturer's internal engineering team and later reviewed by FDA.
4. Adjudication method for the test set
Not applicable, as there is no specific clinical test set described that would require expert adjudication.
5. 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. This device is a manual resuscitator, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical, human-operated medical device, not an algorithm.
7. The type of ground truth used
For the performance comparison, the "ground truth" would be the established performance specifications of the predicate devices and the requirements of the relevant ASTM standards. These standards themselves are developed through expert consensus and scientific principles for medical device safety and efficacy.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or an "AI" component, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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OCT 31 1997
SECTION 10 510(k) SUMMARY
Prepared: February 21, 1997
- Submitter: Mercury Medical 11300 49th St. No. Clearwater, Florida 34622-4800 Phone: (813) 573-0088 Fax: (813) 573-6040 Contact: Arthur J. Ward 1024404 (Registration Number)
roprietary Name: Mercury Medical Reusable CPR Bag
Common Name: Manual Resuscitator
Classification Name: Ventilator, Emergency Manual (Resuscitator)
Substantial Equivalence: This device is similar in design to the Mercury Medical single patient use CPR Bag (K911622) except manufactured with reusable materials similar to the Puntan Bennett PMR and Laerdal Bag Mask Resuscitator both of which are pre-amendment devices.
Description: The Mercury Medical Reusable CPR Bag uses the same technology as the Mercury CPR, Puntan Bennett PMR and most other manual resuscitators in the market. The bag is compressed by hand to move air into the patient. When released the bag re-expands with air flowing through the intake valve. Supplemental oxygen tubing may be connected to an oxygen source to allow intake of oxygen enriched air.
Intended Use: The intended use of this device is to provide manual, bag mask/tube pulmonary resuscitation.
Technology Comparison: The Table of Technological Comparison in Section 5 indicates that this device and predicate device are similarly designed with identical materials.
Performance Comparison: The Table of Performance Comparison in Section 5 also demonstrates that this and the predicate devices all have similar performance characteristics exceeding the ASTM standards.
Summary Conclusion: Based upon the review of this information we have submitted this 510(k) request as the information indicates these devices are substantially equivalent.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's head, body, and wings. The logo is simple and elegant, and it effectively communicates the department's mission of protecting the health of all Americans.
OCT 31 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.
Mr. Arthur J. Ward Mercury Medical 11300-49th Street North Clearwater, Florida 34622-4800
Re: K970756 Mercury Medical Reusable CPR Bag Regulatory Class: II (two) Product Code: 73 BTM August 18, 1997 Dated: August 19, 1997 Received:
. Dear Mr. Ward:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. .
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Page 2 - Mr. Arthur J. Ward
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 2 INTENDED USE
The intended use of this device is to provide manual, bag masklube pulmonary resuscitation. This bag is
similar in design and function to the Massury ODB Reased Bell RMB BMD similar in design and function to the Mercury CPR Bag and Punitan Bennett PMR.
Chant. C. M. L. M. C.
(Division Sign-Off) Division of Cardiovascula Re and Neurological Device 510(k) Number
OTC.
prescriptions use
§ 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).