T-PIECE RESUSCITATOR

K142096 · Mercury Medical · BTL · Oct 17, 2014 · Anesthesiology

Device Facts

• Record ID: K142096
• Device Name: T-PIECE RESUSCITATOR
• Applicant: Mercury Medical
• Product Code: BTL · Anesthesiology
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

Gas-powered, manually operated emergency resuscitator; provides respiratory support via face mask, supraglottic airway, or endotracheal tube. Device features T-piece configuration, integrated manometer, and adjustable Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). Includes pressure relief valve for safety. Operated by trained personnel in hospital, sub-acute, or pre-hospital (EMS) environments. User manually delivers ventilation (up to 60 BPM) using wall gas or cylinder source. Output allows healthcare providers to monitor airway pressure and deliver controlled respiratory support, potentially stabilizing patients with respiratory distress. Benefits include portable, adjustable pressure delivery for patients >10kg.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 10651-5 standards, including vomitus resistance, water immersion, oxygen concentration, inspiratory/expiratory resistance, PEEP testing, delivered volume, pressure limitation, storage/operating conditions, and drop testing.

Technological Characteristics

Gas-powered T-piece resuscitator. Materials identical to predicate NeoTee. Features integrated manometer (K954486), pressure relief valve, and adjustable PIP/PEEP. Patient connector: 15mm ID / 22mm OD. Standards: ISO 10651-5. Operational gas flow: 0-35 lpm. Pressure relief: 60 cm H2O (factory set 40 cm H2O).

Indications for Use

Indicated for emergency respiratory support in patients weighing >10kg (>22 lbs) via face mask, supraglottic airway, or endotracheal tube. Intended for use in hospital, sub-acute facilities, and pre-hospital (EMS) settings by trained personnel.

Regulatory Classification

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.

Predicate Devices

• NeoForce – ISPIRA (K092085)
• Mercury - NeoTee™ (K093913)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 [phone] EF

Page 1 of 2

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

| Mercury Medical, Inc.<br>11300 - 49th St. North<br>Clearwater, FL 33762-4807 | Tel – [phone]<br>Fax – [phone] |
|------------------------------------------------------------------------------|------------------------------------------------------------|
| 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 ventilator<br>CFR 868.5925 |
| Device: | T-Piece Resuscitator |
| Predicate Devices: | NeoForce – ISPIRA - K092085<br>Mercury - 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).

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.

#### Indications for Use:

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 (>22 lbs.).

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

| | Proposed<br>Mercury Medical T-Piece<br>Resuscitator | Predicate<br>NeoForce ISPIRA<br>K092085 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The T-Piece Resuscitator is a powered<br>emergency ventilator intended to<br>provide emergency respiratory support<br>by means of a face mask or a tube<br>inserted into a patient's airway. It is<br>intended for use with patients greater<br>than 10kg (>22 lbs.). | The NeoForce ISPIRA Resuscitation<br>System is a manually operated, gas<br>powered resuscitator intended for<br>controlled and accurate pulmonary<br>resuscitation and emergency respiratory<br>support of pediatric and adult patients<br>with a body weight of more than 22 lbs.<br>(10 kg) in the hospital, pre-hospital<br>(EMS), and sub-acute / alternate site<br>facility environments via face mask,<br>laryngeal mask or endotracheal tube.<br>The device is also intended to provide<br>CPAP to spontaneously breathing<br>patients in the hospital, pre-hospital<br>(EMS) and sub-acute / alternate site<br>facility environments via face mask,<br>laryngeal mask or endotracheal tube. |
| Environment of use | Hospital, sub-acute facilities, and pre-<br>hospital (EMS) | Hospital, pre-hospital (EMS), and sub-<br>acute / alternate site facility<br>environments |
| 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 mask<br>Supraglottic airway<br>Endotracheal Tube | Face mask<br>Supraglottic airway (LMA)<br>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 to<br>60 BPM | Manually delivered by the user up to<br>60 BPM |
| Maximum pressure relief | 60 cm H2O<br>Factory set at 40 cm H2O | 5-80 cm H2O.<br>Factory set at 40 cm H2O |
| | Proposed<br>Mercury Medical T-Piece Resuscitator | Predicate<br>NeoForce ISPIRA |
| | | K092085 |
| Delivered Pressure | Up to 60 cm H2O | 5 to 80 cm H2O |
| CPAP | Not offered but offers PEEP<br>Identical to K093913 – Mercury NeoTee™ | 5 -15 cm H2O@ 8-12 lpm flow |
| Delivered Volume | 60 - 700 ml with flow rates between<br>5 - 35 lpm | 190 - 675 ml with flow rates between<br>4 - 36 lpm |
| Inspiratory resistance | 2 cm H2O at minimum PEEP setting<br>@ 60 lpm | Less than - 5 cm H2O |
| Expiratory resistance | 2.4 cm H2O at minimum PEEP setting<br>@ 60 lpm | Less than + 5 cm H2O |
| Oxygen concentration with<br>optional blender | 21 - 98% based upon blender setting | 21 - 100% based upon blender setting |
| Manometer range | Up to 60 cmH2O<br>Cleared under K954486 | -20 to 80 cm H2O |
| Manometer accuracy | +/- 3 cm H2O up to 15 cm H2O<br>+/- 5 cm H2O > 15 cm H2O | +/- 2 cm H2O |
| Peak Inspiratory Pressure<br>(PIP) | 0-60 cm H2O | 5-80 cm H2O |
| Positive End-Expiratory<br>Pressure (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 L<br>cylinder | @ 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 not<br>affect functionality | Temporary submersion of circuit does<br>not 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.

| | Proposed<br>Mercury Medical T-Piece<br>Resuscitator | Reference<br>Mercury NeoTee™<br>K093913 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The T-Piece Resuscitator is a powered<br>emergency ventilator intended to<br>provide emergency respiratory support<br>by means of a face mask or a tube<br>inserted into a patient's airway. It is<br>intended for use with patients greater<br>than 10kg (>22 lbs.). | The Mercury Medical T-Piece<br>Resuscitator is a powered emergency<br>ventilator intended to provide<br>emergency respiratory support by means<br>of a face mask or a tube inserted into a<br>patient's airway. It is intended for use<br>with neonates and infants weighing less<br>than 10kg (<22 lbs.). |
| Environment of use | Hospital, sub-acute facilities, and pre-<br>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 / neonate<br>resuscitation |
| Patient connection | Face mask<br>Supraglottic airway<br>Endotracheal Tube | Face mask<br>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<br>configuration with Manometer Corrugated tubing and connector Control Panel which allows for PIP<br>and PEEP adjustments Oxygen tubing Masks (optional) | Hand-piece which is a T-piece<br>configuration with Manometer Corrugated tubing and connector Control Panel which allows for PIP<br>and 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 between<br>5 - 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<br>+/- 5 cm H2O > 15 cm H2O | +/- 3 cm H2O up to 15 cm H2O<br>+/- 5 cm H2O > 15 cm H2O |
| Inspiratory resistance | 2 cm H2O at minimum PEEP setting<br>@ 60 lpm | 0.4 cm H2O at minimum PEEP setting<br>@ 6 lpm |
| Expiratory resistance | 2.4 cm H2O at minimum PEEP setting<br>@ 60 lpm | 0.5 cm H2O at minimum PEEP setting<br>@ 6 lpm |
| Peak Inspiratory Pressure<br> | 0-60 cm H2O | 0-40 cm H2O @ 15 Lpm |
| (PIP) | | |
| | Proposed<br>Mercury Medical T-Piece<br>Resuscitator | Reference<br>Mercury NeoTee™<br>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.