(105 days)
No
The device description and performance studies focus on mechanical and pressure-based functionalities, with no mention of AI or ML terms or capabilities.
Yes
The device is described as an "emergency resuscitator" intended to provide "emergency respiratory support" to neonates and infants, which directly addresses a health condition.
No
The device is described as an emergency resuscitator intended to provide respiratory support, adjusting inspiratory and expiratory pressures, but not to determine the nature or cause of a disease or condition.
No
The device description clearly outlines a physical, gas-powered resuscitator with hardware components like a manometer, pressure adjustment mechanisms, and a pressure relief valve. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Neo-Tee™ T-Piece Resuscitator is a device that provides mechanical respiratory support by delivering gas directly to a patient's airway. It is used for emergency resuscitation.
- Lack of Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is to deliver gas and manage pressure within the airway.
Therefore, the Neo-Tee™ 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 Neo-Tee TM 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).
Product codes (comma separated list FDA assigned to the subject device)
BTL
Device Description
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants 85%
- Inspiratory Resistance: Pressure at patient connection port must be > -6 cm H2O with inspiratory airflow of 6 L/min
- Expiratory Resistance: Pressure at patient connection port must be 3.75 mL @ C10, R20
- Pressure Limitation: Pressure must not exceed 60 cm H2O @ 60 L/min
- Storage/Operating Conditions: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
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 ventilator |
| CFR 868.5925 | |
| Device: | Mercury Medical T-Piece Resuscitator |
| Predicate Devices: | GE - Giraffe and Panda - K070210 |
| Fisher & Paykel - NeoPuff - K892885 |
Device Description:
The Mercury Medical T-Piece Resuscitator (Neo-Tee™) is a gas power resuscitator for use with neonates / infants 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-Expiratory
Pressure (PEEP) | @ 5 Lpm - $ 85% |
| Inspiratory
Resistance | Pressure at patient connection port must be > -6 cm H2O with inspiratory airflow of 6
L/min |
| Expiratory
Resistance | Pressure at patient connection port must be 3.75 mL @ C10, R20 |
| Pressure Limitation | Pressure must not exceed 60 cm H2O @ 60 L/min |
| Storage/Operating
Conditions | 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.
5
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.
6
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
7
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