MERLIN E-MASK

K031397 · Merlin Medical Limited · CBP · Jul 29, 2004 · Anesthesiology

Device Facts

• Record ID: K031397
• Device Name: MERLIN E-MASK
• Applicant: Merlin Medical Limited
• Product Code: CBP · Anesthesiology
• Decision Date: Jul 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Merlin E-Mask is a nonrebreathing valve device used for manual pulmonary resuscitation. It facilitates mouth-to-mask ventilation for non-breathing patients. Operated by clinicians or trained rescuers in emergency or clinical settings to deliver rescue breaths. The device acts as an interface between the rescuer and the patient, ensuring one-way airflow to prevent cross-contamination and facilitate effective ventilation. Benefits include providing life-saving respiratory support to patients in respiratory arrest.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Nonrebreathing valve device (Product Code: CBP). Class II medical device. Mechanical design for airway management.

Indications for Use

Indicated for mouth to mask ventilation of non-breathing adults and children weighing over 30 kg.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Submission Summary (Full Text)

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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

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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)

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eneral Hospital

510(k) Numbe

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