(454 days)
Not Found
Not Found
No
The summary does not mention AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The device description is also not provided, which would be a key place to find such information.
No
The device is described as a resuscitator for mouth-to-mask ventilation, which is used to support or restore a physiological function (breathing), but it's not explicitly indicated for treatment or prevention of a disease or condition as typically defined for therapeutic devices. It's a life-sustaining aid.
No
Explanation: The device is a resuscitator indicated for ventilation, which is a therapeutic rather than a diagnostic function. It does not identify or detect diseases or conditions.
No
The device is described as a "Pulmonary Resuscitator" and is indicated for "mouth to mask ventilation". This strongly implies a physical device (mask, potentially with a valve or other components) is involved, not just software. The lack of a device description prevents definitive confirmation, but the intended use points away from a software-only device.
Based on the provided information, the Merlin Medical Limited Merlin E-Mask Air Pulmonary Resuscitator is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "mouth to mask ventilation of a non-breathing adult and child". This describes a device used for direct patient care and resuscitation, not for testing samples taken from the body (which is the definition of an IVD).
- Device Description (Not Found): While the description is missing, the intended use is the primary indicator.
- No mention of biological samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample.
- No mention of diagnostic testing: The device is used for providing ventilation, not for diagnosing a condition.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Merlin E-Mask Air Pulmonary Resuscitator does not fit this description.
N/A
Intended Use / Indications for Use
The Merlin Medical Limited Merlin E-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.
Product codes
CBP
Device Description
Merlin E-Mask
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
adult and child weighing over 30 kgs
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2004
Mr. Robert Steele Director of Technical Development & Quality Merlin Medical Limited The Whitbread Centre Rhymney Gwent NP22 5BF United Kingdom
Re: K031397
Trade/Device Name: Merlin E-Mask Regulation Number: 868.5870 Regulation Name: Nonrebreathing Valve Regulatory Class: II Product Code: CBP Dated: June 25, 2004 Received: June 12, 2004
ﻳﻨﺘﻮ
Dear Mr. Steele:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Steele
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); 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.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use
510(k) Number (if known): K031397
Device Name: Merlin E-Mask
Indication for use:
The Merlin Medical Limited Merlin E-Mask Air Pulmonary Resuscitator is indicated for mouth to mask ventilation of a non-breathing adult and child weighing over 30 kgs.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
lim S
eneral Hospital
510(k) Numbe
Page 1 of 1
Page: 2