(105 days)
The Neo-Tee™ 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 neonates and infants weighing less than 10kg (22 lb).
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants < 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 Mercury Medical T-Piece Resuscitator (Neo-Tee™) can be connected to the patient via a face mask or endotracheal tube.
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) underwent performance testing to demonstrate its substantial equivalence to predicate devices and adherence to industry standards, specifically ISO 10651:2006.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Test requirements) | Reported Device Performance |
|---|---|---|
| Vomitus Resistance | Must subsequently pass Oxygen Concentration, Inspiratory Resistance, Expiratory Resistance, PEEP, Delivered Volume and Pressure Limitation tests | Met the requirements |
| Water Immersion | Resuscitator must continue to function within the tolerances for normal use | Continued to function within normal use tolerances |
| Oxygen Concentration | Volumetric concentration of oxygen must be > 85% | Met the requirements (> 85% oxygen concentration) |
| Inspiratory Resistance | Pressure at patient connection port must be > -6 cm H2O with inspiratory airflow of 6 L/min | Met the requirements (> -6 cm H2O) |
| Expiratory Resistance | Pressure at patient connection port must be < 6 cm H2O with expiratory airflow of 6 L/min | Met the requirements (< 6 cm H2O) |
| PEEP Test | PEEP must be < 2 cm H2O during Oxygen Concentration Test | Met the requirements (< 2 cm H2O) |
| Delivered Volume | Delivered volume must be <20 mL @ C1, R200 and > 3.75 mL @ C10, R20 | Met the requirements (<20 mL and > 3.75 mL) |
| Pressure Limitation | Pressure must not exceed 60 cm H2O @ 60 L/min | Met the requirements (not exceeding 60 cm H2O) |
| Storage/Operating Conditions | Must subsequently pass Delivered Volume and Pressure Limitation tests | Subsequently passed Delivered Volume and Pressure Limitation tests |
| Drop | Resuscitator must continue to function within the tolerances for normal use | Continued to function within normal use tolerances |
2. Sample size used for the test set and the data provenance:
The summary does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described refers to bench tests performed on the device itself. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not applicable or provided in this 510(k) summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for these performance tests is defined by the technical specifications outlined in the industry standard ISO 10651:2006 and the pre-established performance characteristics of the predicate devices. Expert clinical consensus or data annotation by medical professionals is not part of this type of engineering performance testing.
4. Adjudication method for the test set:
Not applicable, as this was a series of bench tests against defined engineering standards and predicate device performance, not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The submission focuses on device performance against engineering standards and comparison to predicate device specifications.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The Mercury Medical T-Piece Resuscitator is a mechanical gas-powered device, not an algorithm or AI system. Its performance evaluation is inherently "standalone" in the sense that it refers to the device's physical and functional capabilities, not an algorithm's output.
7. The type of ground truth used:
The ground truth for this device's performance evaluation is based on:
- Industry Standard: ISO 10651:2006 (for "Manually operated resuscitators").
- Predicate Device Specifications: The performance characteristics of the GE Giraffe and Panda (K070210) and Fisher & Paykel NeoPuff (K892885) devices served as benchmarks for substantial equivalence.
8. The sample size for the training set:
Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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510(k) Summary Page 1 of 5 30-Mar-10
APR - 3 2010
| Mercury Medical, Inc. | |
|---|---|
| 11300 - 49th St. North | Tel - (727) 573-0088 |
| Clearwater, FL 33762-4807 | Fax - (727) 571-3922 |
| Official Contact: | Jeff Ratner - VP Engineering and Quality Assurance |
| Proprietary or Trade Name: | Mercury Medical T-Piece Resuscitator (Neo-Tee™) |
| Common/Usual Name: | Infant T-Piece Resuscitator |
| Classification Name/Code: | BTL - powered emergency ventilatorCFR 868.5925 |
| Device: | Mercury Medical T-Piece Resuscitator |
| Predicate Devices: | GE - Giraffe and Panda - K070210Fisher & Paykel - NeoPuff - K892885 |
Device Description:
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants < 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 Mercury Medical T-Piece Resuscitator (Neo-Tee™) can be connected to the patient via a face mask or endotracheal tube.
Indications for Use:
The (Neo-Tee™) 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 neonates and infants weighing less than 10kg (22 1b).
Environment of Use: Hospital, delivery suites, ICU and Nursery settings
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510(k) Summary
Summary of substantial equivalence
.
| Indications for Use | |||
|---|---|---|---|
| ProposedMercury Medical T-PieceResuscitator (Neo-TeeTM) | PredicateK070210 GE Giraffe and Panda | PredicateK892885 F&P NeoPuff | |
| The Neo-TeeTM T-Piece Resuscitator isa gas powered emergency resuscitatorintended to provide emergencyrespiratory support by means of a facemask or a tube inserted into a patient'sairway. It is intended for use withneonates and infants weighing less than10kg (22 lb). | Provides the basic equipment requiredfor pulmonary resuscitation of infants.Pulmonary resuscitation includespractices necessary to establish a clearairway and provide oxygen andair/oxygen mixtures and/or manualventilation to the infant. These areclinical practices that represent theestablished standard or care.Resuscitation may be required wheneveran infant fails to establish effective,adequate breathing patterns necessary tomeet tissue oxygen demands and/or torid the body of carbon dioxide. As stated in collaborative guidelineswritten by the American HeartAssociation (AHA) and the AmericanAcademy of Pediatrics (AAP) in theTextbook of Neonatal Resuscitation, 5thEdition. | Manually operated, gas poweredresuscitator which provides controlledand accurate resuscitation of newbornbabies | |
| Environment of use | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU |
| Patient Population | Infant and neonates < 10 kg | Infant < 10 kg | Infant < 10 kg |
| Prescriptive | Persons trained in infant / neonateresuscitation | For professional use only, by trainedclinicians. | Persons trained in infant resuscitation |
| ProposedMercury Medical T-PieceResuscitator (Neo-Tee™) | PredicateK070210 GE Giraffe and Panda | PredicateK892885 F&P NeoPuff | |
| Patient connection | Face maskET tube | Face maskET tube | Face maskET tube |
| Features and Performance Characteristics | |||
| Gas flow provided byComponents | Wall gas or cylinderT-piece configurationManometerAdjustable PIPAdjustable PEEPMasks | Wall gas or cylinderT-piece configurationManometerAdjustable PIPAdjustable PEEPMasks | Wall gas or cylinderT-piece configurationManometerAdjustable PIPAdjustable PEEPMasks |
| Manometer range | Up to 60 cmH2OCleared under K032593 | -10 to 80 cm H2O | -20 to 80 cm H2O |
| Manometer accuracy | +/- 3 cm H2O up to 15 cm H₂O+/- 5 cm H2O > 15 cm H₂O | +/- 5% of full scale | Not specified |
| Peak Inspiratory Pressure(PIP) | 0-40 cm H2O @ 15 Lpm | Maximum PIP 45 +/- 5 cm H2O | @ 8 Lpm – 2 to 73 cm H2O@ 10 Lpm – 2 to 80 cm H2O |
| Positive End-ExpiratoryPressure (PEEP) | @ 5 Lpm - $<2.1$ cm H2O@ 8 Lpm - $<5.0$ cm H2O@ 10 Lpm - $<7.2$ cm H2O@ 15 Lpm - $<14.6$ cm H2O | @ 5 Lpm - $<5$ cm H2O@ 8 Lpm - $<5$ cm H₂O@ 10 Lpm - $<5$ cm H2O@ 15 Lpm - $<6$ cm H2O | @ 5 Lpm – 1 to 5 cm H2O@ 8 Lpm – 1 to 9 cm H2O@ 10 Lpm – 2 to 15 cm H₂O@ 15 Lpm – 3 to 25 cm H2O |
| Operating time based one-cylinder | @ 15 Lpm ~ 44 minutes | @ 5 Lpm - 121 minutes@ 10 Lpm - 77 minutes@ 15 Lpm - 54 minutes | 5 to 50 Lpm – 50 minutes |
| Maximum pressure relief | 40 cm H2O @ 15 Lpm | 40 cm H2O | |
| Air / Oxygen mixture | Up to 100% O2 | 21 to 100% O2 | Not specified |
| Maximum gas flow rate | 15 Lpm | 15 Lpm | 15 Lpm |
| Warnings | ProposedMercury Medical T-PieceResuscitator (Neo-TeeTM) | PredicateK070210 GE Giraffe and Panda | PredicateK892885 F&P NeoPuff |
| 1. Incorrect operation of this device can be hazardous.2. Do not use in the presence of flammable materials and ensure that no sources of ignition are present while the device is in use. Fire hazards are possible in oxygen enriched environments.3. Users should release the T-piece (manual control) as soon as the breath is delivered. Failure to do so will result in an extended breath, which may prevent exhalation.4. Do not leave patient unattended when device is in use.5. The recommended gas flow range is from 1-15 LPM. DO NOT EXCEED 15 LPM. | Not available | 1. Ensure no smoking, naked flames or sources of ignition are present while the unit is in use.2. Recommended operating gas flow range 5 to 15 Lpm. Do not attempt to use a higher flow than 15 Lpm. |
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510(k) Summary
.
Page S1.18
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510(k) Summary
It is our view that there are no significant differences that affect the safety or effectiveness of the intended device as compared to the
predicate device.
Page S1.19
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510(k) Summary Page 5 of 5 30-Mar-10
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is viewed as substantially equivalent to the predicate devices because:
Indications -
- Similar to predicate F&P NeoPuff K892885 .
Technology -
Materials -
- The materials in patient contact are identical to predicate devices manufactured by . Mercury Medical.
Environment of Use -
Performance Testing -
The following performance / bench tests were performed and shown to demonstrate that the Mercury Medical T-piece Resuscitator (Neo-Tee™) either met the requirements of industry standard, ISO 10651:2006 or were substantially equivalent to the predicate devices.
| Test | Test requirements |
|---|---|
| Vomitus Resistance | Must subsequently pass Oxygen Concentration, Inspiratory Resistance,Expiratory Resistance, PEEP, Delivered Volume and Pressure Limitation tests |
| Water Immersion | Resuscitator must continue to function within the tolerances for normal use |
| OxygenConcentration | Volumetric concentration of oxygen must be > 85% |
| InspiratoryResistance | Pressure at patient connection port must be > -6 cm H2O with inspiratory airflow of 6L/min |
| ExpiratoryResistance | Pressure at patient connection port must be < 6 cm H2O with expiratory airflow of 6L/min |
| PEEP Test | PEEP must be < 2 cm H2O during Oxygen Concentration Test |
| Delivered Volume | Delivered volume must be <20 mL @ C1, R200 and > 3.75 mL @ C10, R20 |
| Pressure Limitation | Pressure must not exceed 60 cm H2O @ 60 L/min |
| Storage/OperatingConditions | Must subsequently pass Delivered Volume and Pressure Limitation tests |
| Drop | Resuscitator must continue to function within the tolerances for normal use |
The (Neo-Tee™) T-piece resuscitator met all the performance requirements as outline above and thus can be found to either comply with ISO 10651:2006 or is equivalent to the predicates.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mercury Medical, Incorporated C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
APR - 3 2010
Re: K093913
Trade/Device Name: Mercury Medical T-Piece Resuscitator (Neo-Tee™) Regulation Number: 21CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: December 19, 2009 Received: December 22, 2009
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 go to
h11p://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm forthe Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
h for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use Statement
Page 1 of 1
K093913 510(k) Number:
Device Name:
Mercury Medical T-Piece Resuscitator (Neo-Tee™)
Indications for Use:
The Neo-Tee™ 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 neonates and infants weighing less than 10kg (22 lb).
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultze
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093913
§ 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).