(385 days)
No
The device description and performance studies focus on mechanical components and pressure control, with no mention of AI or ML.
Yes.
The device the SafeT T-Piece Resuscitator is an emergency resuscitator intended to provide respiratory support, which functionally aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition (respiratory distress).
No
This device is a resuscitator, which is a therapeutic device used to provide respiratory support, not to diagnose a condition. While it has a manometer to display pressure (a measurement), its primary function is intervention, not diagnosis.
No
The device description clearly outlines multiple physical components including tubing, valves, a manometer, and a face mask, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide emergency respiratory support by delivering gas to a patient's airway. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a resuscitator, a mechanical device used to assist breathing. It does not involve the analysis of biological samples.
- Lack of IVD characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and related to gas delivery and pressure control.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SafeT 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 10 kg (22 lb).
Product codes
BTL
Device Description
The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb).
It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure.
The T-Piece resuscitator can be connected to the patient via a face mask or tube.
The subject device consists of several components:
- T-Piece patient valve with variable PEEP dial and integrated manometer .
- . Adjustable inspiratory pressure controller
- . 40 cm H2O pressure relief valve
- 7' Oxygen tubing with a red universal (Fits-all) connector .
- 20" x 10 mm circuit tubing .
- Face mask .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's airway
Indicated Patient Age Range
Neonates and infants weighing less than 10 kg (22 lb).
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Persons trained in infant / neonate resuscitation
Hospital, delivery suites, nursery, ICU
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 Performance Testing: The subject and predicate devices were both subjected to the same standards. The subject device met all quantitative and qualitative requirements, as published in the applicable standards. The specifications in the Substantial Equivalency Comparison Table demonstrate that the function and performance are the same or similar between the subject and predicate devices.
The subject device passed the following performance requirements per the applicable performance standards cited above:
- . Delivered Oxygen Concentration
- Resistance to Spontaneous Breathing Inspiratory Resistance ●
- Resistance to Spontaneous Breathing Gas Input Pressure ●
- Resistance to Spontaneous Breathing - Expiratory Resistance
- Inadvertent PEEP ●
- Delivered Volume .
- Pressure Limitation .
- Operation of Manual Trigger ●
- Patient Valve Function after Contamination with Vomitus ●
- Function after Storage Conditions .
- Function During Operating Conditions after Storage Conditions ●
- Function after Drop Test .
- Function after Immersion in Water .
- Inspection of Surfaces, Corners, and Edges ●
- . Size Limitation
- Resuscitation Mass
- Patient Valve with Patient Connection Port Mass .
- Function after Dismantling and Reassembly .
- Legibility and Durability of Markings .
- Flow-Direction-Sensitive Component .
- Pressure Limit Under Single Fault Condition .
- Resuscitator Dead Space .
- . Inadvertent Continuing Expiratory Pressure
- Indication of Use of Function Affecting Performance .
- Indication of Pneumatic Power Rating .
- Durability of Markings ●
- Identification .
- Controls and Indicators ●
- . Indication of Pressure Limiting Device Setting
- Pressure-Limitation Activation Alarm Signal ●
The below performance requirements in the standards require actual values to be stated on instructions for use and does not define acceptance criteria:
- Manometer Accuracy Reading .
- PEEP Flow Range .
- Gas Container Capacity ●
- Protection Against Accidental Adjustments
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Primary – Mercury Medical Neo-Tee™ – K093913
Reference Device(s)
Reference – Fisher & Paykel NeoPuff™ – K892885
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
November 16, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal for the Department of Health & Human Services - USA. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" written in a smaller font size below.
Ventlab, LLC Rob Yamashita Director of Regulatory Affairs 2710 Northridge Drive NW - Suite A Grand Rapids, Michigan 49544
Re: K173373
Trade/Device Name: SafeT T-Piece Resuscitator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL Dated: October 11, 2018 Received: October 17, 2018
Dear Rob Yamashita:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amy K. Levelle -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173373
Device Name Ventilator, Emergency, Powered (Resuscitator)
Indications for Use (Describe)
The SafeT 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 10 kg (22 lb).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Date Prepared: | 10/11/2018 |
|---|---|
| Proprietary or Trade Name: | SafeT T-Piece Resuscitator |
| Common/Usual Name: | Powered emergency ventilator |
| Classification Code/Name: | BTL - Powered emergency ventilator |
| CFR 868.5925 | |
| Proposed Regulatory Class: | Class II |
| Official Contact: | Rob Yamashita |
| Director of Regulatory Affairs | |
| Ventlab, LLC | |
| 2710 Northridge Dr. NW, Suite A | |
| Grand Rapids, MI 49544 USA | |
| Phone: (616) 259-8373 | |
| Predicate Devices: | Primary – Mercury Medical Neo-Tee™ – K093913 |
| Reference – Fisher & Paykel NeoPuff™ – K892885 |
Device Description
The SafeT T-Piece Resuscitator is a single-use, non-sterile, manually operated, gas-powered resuscitator for use with patients less than 10 kg (22 lb).
It is a simple T-Piece resuscitator with a manometer and the ability to adjust Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). It incorporates a pressure relief valve to protect against excessive pressure.
The T-Piece resuscitator can be connected to the patient via a face mask or tube.
The subject device consists of several components:
- T-Piece patient valve with variable PEEP dial and integrated manometer .
- . Adjustable inspiratory pressure controller
- . 40 cm H2O pressure relief valve
- 7' Oxygen tubing with a red universal (Fits-all) connector .
- 20" x 10 mm circuit tubing .
- Face mask .
4
Indications for Use
The SafeT 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 10 kg (22 lb).
Technological Characteristics
The SafeT T-Piece Resuscitator is a circuit intended for emergency resuscitation of neonates and infants. Oxygen or blended gas flows through the circuit, which is composed of an inspiratory pressure controller and a T-Piece patient valve. The inspiratory pressure controller allows adjustment of Peak Inspiratory Pressure (PIP). This inspiratory pressure controller has an integral pressure relief valve, which prevents the inspiratory pressure from exceeding 40 cm H2O.
The T-Piece patient valve has an integral manometer which reads and displays both Peak Inspiratory Pressure (PIP) and Positive End-Expiratory Pressure (PEEP). The T-Piece patient valve consists of a PEEP dial, which allows adjustment of Positive End-Expiratory Pressure (PEEP), and a patient port for attachment to face masks and tubes. The subject device contains a face mask.
Substantial Equivalence Discussion
The following table compares SafeT to the predicate device with respect to its physical state, structure, materials, mechanical properties, indications for use, biocompatibility and performance testing, and provides detailed information regarding the basis for the determination of substantial equivalence. The reference device is also included in this table for comparative purposes.
| | SunMed SafeT | Mercury Medical
Neo-Tee | Fisher & Paykel
NeoPuff | Similarities /
Differences |
|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | SunMed | Mercury Medical | Fisher & Paykel | - |
| 510(k) | Current submission | K093913 | K892885 | - |
| Device Type | Subject Device | Primary Predicate | Reference Device | - |
| Classification | II | II | II | Same |
| Product Code | BTL | BTL | BTL | Same |
| Regulation
Number | 868.5925 | 868.5925 | 868.5925 | Same |
| Applicable
Standards | ISO 10651-5, Lung
Ventilators for
Medical Use -
Particular
Requirements for
Basic Safety and
Essential
Performance | ISO 10651-5,
Lung Ventilators
for Medical Use -
Particular
Requirements for
Basic Safety and
Essential
Performance | ISO 10651-5,
Lung Ventilators
for Medical Use -
Particular
Requirements for
Basic Safety and
Essential
Performance | Same |
| | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical Connectors
ISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical Connectors
ISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | ISO 5356-1, Anaesthetic and Respiratory Equipment – Conical Connectors
ISO 5367, Breathing Tubes Intended for Use with Anaesthetic Apparatus and Ventilators | |
| | BS EN 13544-2, Respiratory Therapy Equipment, Tubing and Connectors
ISO 10651-4, Lung ventilators - Part 4: Particular requirements for operator powered resuscitators | BS EN 13544-2, Respiratory Therapy Equipment, Tubing and Connectors | BS EN 13544-2, Respiratory Therapy Equipment, Tubing and Connectors | |
| Indications of Use | The SafeT 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 Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency 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.) | Manually operated, gas powered resuscitator which provides controlled and accurate resuscitation of newborn babies | The subject and predicate device have the same intended use. |
| Patient Connection | Face Mask & ET Tube | Face Mask & ET Tube | Face Mask & ET Tube | Same |
| Environment of Use | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU | Hospital, delivery suites, nursery, ICU | Same |
| Patient
Population | Infants and
neonates