(77 days)
Mercury NeoTee™ (K093913)
No
The device description and performance studies focus on mechanical and pressure-based functionalities, with no mention of AI or ML.
Yes
The device is intended to provide emergency respiratory support, which is a therapeutic intervention for patients.
No
The device is a resuscitator providing respiratory support, not a diagnostic device that identifies or characterizes a disease or condition.
No
The device description clearly outlines a physical, gas-powered resuscitator with mechanical components (T-piece, manometer, valves) and mentions bench testing related to physical performance characteristics (resistance, volume, pressure limitation, drop). There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The T-Piece Resuscitator is a mechanical device used to provide respiratory support directly to a patient's airway. It does not analyze any biological samples.
- Intended Use: The intended use is to provide emergency respiratory support, not to diagnose a condition based on in vitro analysis.
- Device Description: The description focuses on the mechanical aspects of the device (gas powered, T-piece, manometer, pressure adjustments).
- Performance Studies: The performance studies are bench tests evaluating the mechanical function and safety of the device, not the accuracy of diagnostic results from biological samples.
Therefore, the T-Piece Resuscitator falls under the category of a medical device used for direct patient care, not an In Vitro Diagnostic device.
N/A
Intended Use / 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 (>22lb).
Product codes
BTL
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.
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
Patients weighing greater than 10kg (>22lb).
Intended User / Care Setting
Environment of Use - Hospital, sub-acute facilities, and pre-hospital (EMS)
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)
Bench testing was performed 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
The results demonstrated that the T-Piece Resuscitator meets the performance and design specifications requirements as outlined in ISO 10651-5 - Particular Requirements for Basic Safety and Essential Performance for Gas Powered Resuscitators.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
NeoForce – ISPIRA - K092085, Mercury - NeoTee™ - K093913
Reference Device(s)
Mercury NeoTee™ (K093913)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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).
0
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.
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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. North
Clearwater, FL 33762-4807 | Tel – (727) 573-0088
Fax – (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 ventilator
CFR 868.5925 |
| Device: | T-Piece Resuscitator |
| Predicate Devices: | NeoForce – ISPIRA - K092085
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
Mercury Medical T-Piece
Resuscitator | Predicate
NeoForce ISPIRA
K092085 |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The T-Piece Resuscitator is a powered
emergency ventilator 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 greater
than 10kg (>22 lbs.). | The NeoForce ISPIRA Resuscitation
System is a manually operated, gas
powered resuscitator intended for
controlled and accurate pulmonary
resuscitation and emergency respiratory
support of pediatric and adult patients
with a body weight of more than 22 lbs.
(10 kg) in the hospital, pre-hospital
(EMS), and sub-acute / alternate site
facility environments via face mask,
laryngeal mask or endotracheal tube.
The device is also intended to provide
CPAP to spontaneously breathing
patients in the hospital, pre-hospital
(EMS) and sub-acute / alternate site
facility 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 facility
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
Supraglottic airway
Endotracheal Tube | Face mask
Supraglottic 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 to
60 BPM | Manually delivered by the user up to
60 BPM |
| Maximum pressure relief | 60 cm H2O
Factory set at 40 cm H2O | 5-80 cm H2O.
Factory set at 40 cm H2O |
| | Proposed
Mercury Medical T-Piece Resuscitator | Predicate
NeoForce ISPIRA |
| | | K092085 |
| Delivered Pressure | Up to 60 cm H2O | 5 to 80 cm H2O |
| CPAP | Not offered but offers PEEP
Identical to K093913 – Mercury NeoTee™ | 5 -15 cm H2O@ 8-12 lpm flow |
| Delivered Volume | 60 - 700 ml with flow rates between
5 - 35 lpm | 190 - 675 ml with flow rates between
4 - 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 with
optional blender | 21 - 98% based upon blender setting | 21 - 100% based upon blender setting |
| Manometer range | Up to 60 cmH2O
Cleared 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-Expiratory
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
cylinder | @ 35 lpm - 11 minutes | @ 36 lpm - 10 minutes |
| Dead space of circuit | 22 lbs.). | The Mercury Medical T-Piece
Resuscitator is a powered emergency
ventilator 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 neonates and infants weighing less
than 10kg (22 lbs.) | Patients less than 10 Kg ( 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) | | |
| | Proposed
Mercury Medical T-Piece
Resuscitator | Reference
Mercury 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 |