(80 days)
Not Found
No
The device description and intended use describe a simple mechanical connector for airway management, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device facilitates the connection of airway tubes to a ventilator or suction system and assists in secretion removal, but it does not directly treat a disease or condition itself.
No
The Trach-Assist is described as an airway connector for ventilatory tubing and secretion removal, not for diagnosing conditions.
No
The device description clearly describes a physical connector with standard fittings, indicating it is a hardware device, not software.
Based on the provided information, the Trach-Assist 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.
- Trach-Assist Function: The Trach-Assist is a device used to connect components of a breathing circuit and assist in removing secretions from the airway. It interacts directly with the patient's airway and breathing system, not with samples taken from the body for analysis.
- Intended Use: The intended use clearly describes a mechanical function related to airway management and secretion removal, not diagnostic testing.
Therefore, the Trach-Assist falls under the category of a medical device used for patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Trach-Assist is an airway connector intended to comect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
Product codes
BZA
Device Description
Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with an endotracheal tube or tracheostomy tube and the patient wye of a breathing circuit.
The Trach-Assist H has a port for insertion of a suction catheter to remove secretions while Trach-Assist-I uses Closed Suction Catheter system to remove secretions.
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
Not Found
Intended User / Care Setting
Hospitals, health care facilities, homes
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K850964, K833373, K770771, K063125
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5810 Airway connector.
(a)
Identification. An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
0
510(k) Summary · Page 1 of 4
2-Mar-09
MAR 5 2009
Mergenet Medical, Inc. 6601 Lyons Rd. Suite B1-B4
Tel - 561-208-6886 Coconut Creek, FL 33073 Fax - 561-423-3181 Official Contact: Robert Landis - Director R&D Proprietary or Trade Name: Trach-Assist Common/Usual Name: Airway (extension) Connector Classification Name: Airway (extension) Connector BZA - 868.5810 Predicate Devices: K850964 - Sheridan (Teleflex) Double Swivel K833373 - Sontek Bodai Swivel K770771 - Hudson RCI (Teleflex) Water Trap K063125 - ARC Medical HME
Device Description:
Trach-Assist is a simple connector with standard 15 mm fittings permitting connection with an endotracheal tube or tracheostomy tube and the patient wye of a breathing circuit.
The Trach-Assist H has a port for insertion of a suction catheter to remove secretions while Trach-Assist-I uses Closed Suction Catheter system to remove secretions.
Indications for Use:
The Trach-Assist is an airway connector intended to comect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
Patient Population:
Patients with tidal volumes > 200 ml
Environment of Use:
Hospitals, health care facilities, homes
Contraindications:
None
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0(k) Summa
Page 2 of 4
2-Mar-09
Page 19
K083702
0.20f4
2
| Features | Proposed Device | Predicate Sheridan Double Swivel K850964 | Predicate Sontek Bodai Double Swivel K833373 | Predicate Hudson RCI Water trap K770771 |
|---|---|---|---|---|
| Performance and Design Features (continued) | ||||
| Permits direct suctioning of patient secretions | Yes | |||
| Via a port and use of a standard suction catheter (Trach-Assist H) | ||||
| Allows direct connections of a Closed suction catheter system (Trach-Assist I) | Yes | |||
| Via a port and use of a standard suction catheter | Yes | |||
| Via a port and use of a standard suction catheter | N/A | |||
| Has a reservoir for collection of secretions | Yes within the housing | No | No | Yes but for water which rains out in the tubing |
| Standard 15 mm / 22 mm fittings | Yes | Yes | Yes | Yes - 22mm as it fittings in the tubing only |
| Internal Volume | 36 ml - “T” | |||
| 29.6 ml - “H” | Not available | Not available | N/A as it is not located where it is considered dead space | |
| Resistance to flow | 0.12 cm H2O @ 30 Lpm | |||
| 0.60 cm H2O @ 50 Lpm | ||||
| 0.93 cm H2O @ 70 Lpm | ||||
| Trach-Assist-H highest resistance values | Not available | 0.17 cm H2O @ 30 Lpm | ||
| 0.66 cm H2O @ 50 Lpm | ||||
| 0.95 cm H2O @ 70 Lpm | ||||
| Predicate ARC Medical HME K063125 | N/A | |||
| Duration of use | Single patient use up to 24 hours | Single patient use, not specified | Single patient use, not specified | Single patient use, not specified |
| Provided clean, non-sterile | Yes | Yes | Yes | Yes |
510(k) Summary
Page 20
K083702
P. 3 of 4
3
510(k) Summary Page 4 of 4 2-Mar-09
Differences Between Other Legally Marketed Predicate Devices:
- The Trach-Assist is designed with a reservoir where secretions may collect . instead of staying within the patient circuit. This feature is similar to an in-line water trap which keeps water from collecting in the patient circuit and increasing resistance. Except in this case we are collecting secretions.
- We do not believe that this difference is significant and raises any no new patient · ● safety issues.
The proposed device is viewed as substantially equivalent to the predicate devices, K850964, K833373, K770771, and K063125.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that create the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.
5 2009 MAR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mergenet Medical C/o Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
Re: K083702
Trade/Device Name: Trach-Assist Regulation Number: 21 CFR 868.5810 Regulation Name: Airway Connector Regulatory Class: I Product Code: BZA Dated: December 12, 2008 Received: December 15, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
5
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address . http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sadie y. Michael Inrs.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
Page 1 of 1
510(k) Number:
(To be assigned)
Device Name:
Indications for Use:
The Trach-Assist is an airway connector intended to connect between an endotracheal tube or tracheostomy tube and the ventilator circuit or closed suction system. It can assist in removal of patient secretions that may collect in ventilatory tubing.
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)
Zin 72
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: _______________________________________________________________________________________________________________________________________________________________