The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).

Device Description

The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).

It is a simple T-piece, with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve for excessive pressure.

The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.

AI/ML Overview

The provided document describes the Mercury T-Piece Resuscitator and its substantial equivalence to predicate devices, focusing on non-clinical testing for performance. This is a 510(k) premarket notification summary, which means the device is being compared to an already legally marketed device (predicate device) and does not involve AI or complex analytical studies in the way modern AI/ML medical devices would.

Therefore, many of the requested categories in the prompt are not applicable to this document. I will focus on the information that can be extracted directly from the provided text.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance

The acceptance criteria are generally aligned with the performance requirements outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators. The "Reported Device Performance" column reflects the specifications of the proposed Mercury Medical T-Piece Resuscitator as presented in comparison tables with its predicate devices.

Acceptance Criteria (Derived from Predicate & ISO 10651-5)	Reported Device Performance (Mercury Medical T-Piece Resuscitator)
Indications for Use: Provide emergency respiratory support by face mask or tube; patients > 10kg (>22lbs).	The T-Piece Resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).
Environment of Use: Hospital, sub-acute facilities, and pre-hospital (EMS).	Hospital, sub-acute facilities, and pre-hospital (EMS).
Patient Population: Patients greater than 10 Kg (>22 lbs.).	Patients greater than 10 Kg (>22 lbs.)
Ventilation Frequency: Manually delivered by the user up to 60 BPM.	Manually delivered by the user up to 60 BPM.
Maximum Pressure Relief: Factory set at 40 cm H2O (predicate range 5-80 cm H2O).	60 cm H2O (Factory set at 40 cm H2O).
Delivered Pressure: Up to 60 cm H2O (predicate range 5-80 cm H2O).	Up to 60 cm H2O.
Delivered Volume: (Predicate range 190 - 675 ml with flow rates between 4 - 36 lpm).	60 - 700 ml with flow rates between 5 - 35 lpm.
Inspiratory Resistance: (Predicate: Less than - 5 cm H2O).	2 cm H2O at minimum PEEP setting @ 60 lpm.
Expiratory Resistance: (Predicate: Less than + 5 cm H2O).	2.4 cm H2O at minimum PEEP setting @ 60 lpm.
Oxygen Concentration with optional blender: (Predicate range: 21-100%).	21 - 98% based upon blender setting.
Manometer Range: (Predicate range: -20 to 80 cm H2O).	Up to 60 cmH2O (Cleared under K954486).
Manometer Accuracy: (Predicate: +/- 2 cm H2O).	+/- 3 cm H2O up to 15 cm H2O; +/- 5 cm H2O > 15 cm H2O.
Peak Inspiratory Pressure (PIP): (Predicate range: 5-80 cm H2O).	0-60 cm H2O.
Positive End-Expiratory Pressure (PEEP): (Predicate uses CPAP instead; reference NeoTee has PEEP).	0 to 60 cm H2O.
Operational Gas Flow Rate: (Predicate range: 0-60 lpm).	0 - 35 lpm.
Operational time with 400 L cylinder: (Predicate @ 36 lpm - 10 minutes).	@ 35 lpm - 11 minutes.
Dead space of circuit: (Predicate: < 15 ml).	< 7.5 ml.
Operating Temperature Range: (Predicate range: 10 to 40°C).	-18 to 60°C.
Storage Temperature: (Predicate range: -20 to 60°C).	-40 to 50°C.
Immersion Resistance: Temporary submersion of circuit does not affect functionality.	Temporary submersion of circuit does not affect functionality.
Vomitus Resistance: Meets ISO 10651-5.	Tested per ISO 10651-5.
Water Immersion: Meets ISO 10651-5.	Tested per ISO 10651-5.
Oxygen Concentration: Meets ISO 10651-5.	Tested per ISO 10651-5.
Pressure Limitation: Meets ISO 10651-5.	Tested per ISO 10651-5.
Storage/Operating Conditions: Meets ISO 10651-5.	Tested per ISO 10651-5.
Drop: Meets ISO 10651-5.	Tested per ISO 10651-5.

The study that proves the device meets the acceptance criteria is a series of "Bench testing" performed according to ISO 10651-5 for gas powered resuscitators. The document explicitly states: "We have demonstrated that the T-Piece Resuscitator meets the performance and design specifications requirements as outlined in requirements and specifications as outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators."

Additional Information on the Study:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document describes "bench testing" which implies tests on physical devices rather than patient data. Therefore, details like "country of origin of the data" or "retrospective/prospective" are not applicable. The sample size for the bench tests is not specified in the provided summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable as the study involves bench testing of a physical medical device, not a diagnostic or AI algorithm relying on expert interpretation of data. The ground truth is established by the performance standards outlined in ISO 10651-5.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable to a physical device performance test assessed against engineering standards.
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:
- This is not applicable. This is a physical medical device (resuscitator), not an AI/ML diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's performance is based on engineering and safety standards, specifically ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators.
The sample size for the training set:
- This is not applicable. The device is a physical resuscitator, not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established:
- This is not applicable, as there is no training set for a physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, representing the department's focus on people and health.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 17, 2014

Mercury Medical, Incorporated C/O Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive Bonita Springs, FL 34134-2958

Re: K142096

Trade/Device Name: T-Piece Resuscitator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL Dated: August 14, 2014 Received: August 15, 2014

Dear Mr. Dryden:

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. Dryden

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Image /page/1/Picture/8 description: The image shows the name "Tejashri Purohit-Sheth, M.D." in a stylized font. The text is black and appears to be centered. The letters are thick and have a slight curve to them, giving the text a formal appearance.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K142096

Device Name

T-piece Resuscitator Indications for Use (Describe)

The T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. It is intended for use with patients weighing greater than 10kg (>22lb).

Environment of Use - Hospital, sub-acute facilities, and pre-hospital (EMS)

Type of Use (Select one or both, as applicable)

XX Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (9/13)

PSC Publishing Services (301) 443-6740 EF

Page 1 of 2

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510(k) Summary Page 1 of 6 14-Oct-14

Mercury Medical, Inc.11300 - 49th St. NorthClearwater, FL 33762-4807	Tel – (727) 573-0088Fax – (727) 571-3922
Official Contact:	Jeff Ratner - VP Engineering and Quality Assurance
Proprietary or Trade Name:	T-Piece Resuscitator
Common/Usual Name:	Powered emergency ventilator
Classification Code /Name:	BTL - powered emergency ventilatorCFR 868.5925
Device:	T-Piece Resuscitator
Predicate Devices:	NeoForce – ISPIRA - K092085Mercury - NeoTee™ - K093913

Device Description:

The Mercury T-Piece Resuscitator is manually operated, gas powered resuscitator for use with patients greater than 10 kg (>22 lb).

The T-Piece Resuscitator can be connected to the patient via a face mask, Supraglottic airway or endotracheal tube.

Indications for Use:

Environment of Use: Hospital, sub-acute facilities, and pre-hospital (EMS)

Substantial Equivalence:

The Mercury T-Piece Resuscitator is a similar design T-piece resuscitation system to our own reference device, Mercury NeoTee™ (K093913) and with the NeoForce ISPIRA (K092085) for the indications for use and patient population. We will provide information which demonstrates that the proposed device is substantially equivalent to the predicates.

Table 5.1 lists the similarities and differences of the predicate. NeoForce ISPIRA (K092085) and the proposed device. While Table 5.2 compares the reference device, Mercury NeoTeeTM (K093913) which has the identical design of patient circuit but is indicated for neonate / infant populations and a more limited environment of use.

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510(k) Summary Page 2 of 6 14-Oct-14

Summary of substantial equivalence Table 5.1 - Table of the Similarities and Differences of Proposed Device vs. the Predicate

	ProposedMercury Medical T-PieceResuscitator	PredicateNeoForce ISPIRAK092085
Indications for Use	The T-Piece Resuscitator is a poweredemergency ventilator intended toprovide emergency respiratory supportby means of a face mask or a tubeinserted into a patient's airway. It isintended for use with patients greaterthan 10kg (>22 lbs.).	The NeoForce ISPIRA ResuscitationSystem is a manually operated, gaspowered resuscitator intended forcontrolled and accurate pulmonaryresuscitation and emergency respiratorysupport of pediatric and adult patientswith a body weight of more than 22 lbs.(10 kg) in the hospital, pre-hospital(EMS), and sub-acute / alternate sitefacility environments via face mask,laryngeal mask or endotracheal tube.The device is also intended to provideCPAP to spontaneously breathingpatients in the hospital, pre-hospital(EMS) and sub-acute / alternate sitefacility environments via face mask,laryngeal mask or endotracheal tube.
Environment of use	Hospital, sub-acute facilities, and pre-hospital (EMS)	Hospital, pre-hospital (EMS), and sub-acute / alternate site facilityenvironments
Patient Population	Patients greater than 10 Kg (>22 lbs.)	Patients greater than 10 Kg (>22 lbs.)
Prescriptive	Persons trained in resuscitation	Persons trained in resuscitation
Patient connection	Face maskSupraglottic airwayEndotracheal Tube	Face maskSupraglottic airway (LMA)Endotracheal Tube
Features and Performance Characteristics
Gas flow provided by	Wall gas or cylinder	Wall gas or cylinder
Components	Hand-piece which is a T-piece configuration with Manometer Corrugated tubing and connector Control Panel which allows for PIP and PEEP adjustments Oxygen tubing Masks (optional)	T-piece configuration Manometer part of controller Corrugated tubing and connectors Controller which allows for PIP, PEEP, and CPAP adjustments Tubing to monitor pressure Oxygen delivered via corrugated hose Mask has some CPAP features
Ventilation Frequency	Manually delivered by the user up to60 BPM	Manually delivered by the user up to60 BPM
Maximum pressure relief	60 cm H2OFactory set at 40 cm H2O	5-80 cm H2O.Factory set at 40 cm H2O
	ProposedMercury Medical T-Piece Resuscitator	PredicateNeoForce ISPIRA
		K092085
Delivered Pressure	Up to 60 cm H2O	5 to 80 cm H2O
CPAP	Not offered but offers PEEPIdentical to K093913 – Mercury NeoTee™	5 -15 cm H2O@ 8-12 lpm flow
Delivered Volume	60 - 700 ml with flow rates between5 - 35 lpm	190 - 675 ml with flow rates between4 - 36 lpm
Inspiratory resistance	2 cm H2O at minimum PEEP setting@ 60 lpm	Less than - 5 cm H2O
Expiratory resistance	2.4 cm H2O at minimum PEEP setting@ 60 lpm	Less than + 5 cm H2O
Oxygen concentration withoptional blender	21 - 98% based upon blender setting	21 - 100% based upon blender setting
Manometer range	Up to 60 cmH2OCleared under K954486	-20 to 80 cm H2O
Manometer accuracy	+/- 3 cm H2O up to 15 cm H2O+/- 5 cm H2O > 15 cm H2O	+/- 2 cm H2O
Peak Inspiratory Pressure(PIP)	0-60 cm H2O	5-80 cm H2O
Positive End-ExpiratoryPressure (PEEP)	0 to 60 cm H2O	Not offered. Use CPAP instead
Operational gas flow rate	0 - 35 lpm	0 - 60 lpm
Operational time with 400 Lcylinder	@ 35 lpm - 11 minutes	@ 36 lpm - 10 minutes
Dead space of circuit	< 7.5 ml	< 15 ml
Operating Temperature range	-18 to 60°C	10 to 40°C
Storage Temperature	-40 to 50°C	-20 to 60°C
Immersion resistance	Temporary submersion of circuit does notaffect functionality	Temporary submersion of circuit doesnot affect functionality
Reusable	No	Yes
Standards	ISO 10651.5	ISO 10651.5

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510(k) Summary

Page 3 of 6
14-Oct-14

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510(k) Summary Page 4 of 6

14-Oct-14

Table 5.2 - Table of the Similarities and Differences of Proposed

vs.

	ProposedMercury Medical T-PieceResuscitator	ReferenceMercury NeoTee™K093913
Indications for Use	The T-Piece Resuscitator is a poweredemergency ventilator intended toprovide emergency respiratory supportby means of a face mask or a tubeinserted into a patient's airway. It isintended for use with patients greaterthan 10kg (>22 lbs.).	The Mercury Medical T-PieceResuscitator is a powered emergencyventilator intended to provideemergency respiratory support by meansof a face mask or a tube inserted into apatient's airway. It is intended for usewith neonates and infants weighing lessthan 10kg (<22 lbs.).
Environment of use	Hospital, sub-acute facilities, and pre-hospital (EMS)	Hospital, delivery suites, nursery, ICU
Patient Population	Patients greater than 10 Kg (>22 lbs.)	Patients less than 10 Kg (<22 lbs.)
Prescriptive	Persons trained in resuscitation	Persons trained in infant / neonateresuscitation
Patient connection	Face maskSupraglottic airwayEndotracheal Tube	Face maskEndotracheal Tube
Features and Performance Characteristics
Gas flow provided by	Wall gas or cylinder	Wall gas or cylinder
Components	Hand-piece which is a T-piececonfiguration with Manometer Corrugated tubing and connector Control Panel which allows for PIPand PEEP adjustments Oxygen tubing Masks (optional)	Hand-piece which is a T-piececonfiguration with Manometer Corrugated tubing and connector Control Panel which allows for PIPand PEEP adjustments Oxygen tubing Masks (optional)
Maximum pressure relief	60 cm H2O	40 cm H2O
Delivered Pressure	Up to 60 cm H2O	Up to 40 cm H2O
Delivered Volume	60 - 700 ml with flow rates between5 - 35 lpm	15-200 ml
Manometer range	Up to 60 cmH2O (K954486)	Up to 60 cmH2O ( K954486)
Manometer accuracy	+/- 3 cm H2O up to 15 cm H2O+/- 5 cm H2O > 15 cm H2O	+/- 3 cm H2O up to 15 cm H2O+/- 5 cm H2O > 15 cm H2O
Inspiratory resistance	2 cm H2O at minimum PEEP setting@ 60 lpm	0.4 cm H2O at minimum PEEP setting@ 6 lpm
Expiratory resistance	2.4 cm H2O at minimum PEEP setting@ 60 lpm	0.5 cm H2O at minimum PEEP setting@ 6 lpm
Peak Inspiratory Pressure	0-60 cm H2O	0-40 cm H2O @ 15 Lpm
(PIP)
	ProposedMercury Medical T-PieceResuscitator	ReferenceMercury NeoTee™K093913
Positive End-Expiratory	0-60 cm H2O	2 cmH₂O at 2.5 lpm up to
Pressure (PEEP)		15 cm H2O @ 15 lpm
Operational time with 400 L	@ 35 lpm – 11 minutes w/ 400 L	@ 15 lpm – 26 minutes w/ 400L
cylinder	@ 35 lpm ~ 19 min with 660 L cylinder	@ 15 lpm - 44 minutes w/ 660L
Operational gas flow rate	0 – 35 lpm	0 – 15 lpm
Dead space of circuit	< 7.5 ml	< 3.48 ml

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510(k) Summary Page 5 of 6 14-Oct-14

Substantial Equivalence Rationale

The Mercury T-Piece Resuscitator is viewed as substantially equivalent to the predicate devices because:

Indications - Identical indications for use to our reference device, NeoTee™ (K093913). Similar to the predicate NeoForce (K092085), which are is a gas powered emergency ventilator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway. The environments of use are different as the proposed device as the predicate was specifically designed for neonate use.

Discussion - The differences in indications for use between the reference device, NeoTeeTM (K093913), patient population and environment differences are covered with the NeoForce™ (K092085).

Technology - The technology is identical to the reference NeoTee™ (K093913) which includes all the features and components.

Discussion -The only difference between the proposed T-piece and the reference NeoTee™ is the size of the PEEP cap to accommodate high gas flow for adults. The patient connector for the proposed device is 15mm ID / 22mm OD to allow for connection to standard face mask with 22 mm ID fittings as well as endotracheal tubes with 15 mm OD fittings vs. the reference NeoTee™ (K093913) only has a 15mm ID connector which allows it to connect to endotracheal tubes and face mask with 15 mm OD fittings. These differences do not raise any new safety concerns.

Materials - The materials in patient contact are identical to the NeoTee™ device manufactured by Mercury Medical.

Discussion - The materials are identical and the patient contact is also identical to the reference NeoTee™ (K093913). The manufacturing, handling and processing are identical to the reference device and we can make a certification claim.

Non-clinical Testing

We performed a number of tests to demonstrate the performance of the proposed device to the reference or predicate devices.

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510(k) Summary Page 6 of 6 14-Oct-14

Bench testing - We performed applicable testing per ISO 10651-5 for gas powered resuscitators. These tests included:

Vomitus Resistance
. Water Immersion
Oxygen Concentration
Inspiratory Resistance .
Expiratory Resistance
PEEP Test ●
Delivered Volume
Pressure Limitation ●
Storage/Operating Conditions ●
. Drop

Discussion - We have demonstrated that the T-Piece Resuscitator meets the performance and design specifications requirements as outlined in requirements and specifications as outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator 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).