TRACH-ASSIST

K083702 · Mergenet Medical · BZA · Mar 5, 2009 · Anesthesiology

Device Facts

• Record ID: K083702
• Device Name: TRACH-ASSIST
• Applicant: Mergenet Medical
• Product Code: BZA · Anesthesiology
• Decision Date: Mar 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5810
• Device Class: Class 1

Intended 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.

Device Story

Trach-Assist is an airway connector placed between an endotracheal/tracheostomy tube and a ventilator circuit. It features a built-in reservoir to collect patient secretions, preventing accumulation in the ventilator tubing. Two versions exist: Trach-Assist H (includes a port for standard suction catheters) and Trach-Assist I (connects to closed suction catheter systems). Used in hospitals, healthcare facilities, and homes; operated by clinicians or caregivers. By diverting secretions into the reservoir, the device maintains circuit patency and reduces potential for increased flow resistance. It is a single-patient-use device intended for up to 24 hours.

Clinical Evidence

Bench testing only. Performance data provided includes internal volume (36 ml for 'T' model, 29.6 ml for 'H' model) and resistance to flow measurements (0.12 cm H2O at 30 Lpm, 0.60 cm H2O at 50 Lpm, 0.93 cm H2O at 70 Lpm).

Technological Characteristics

Airway connector with 15 mm/22 mm fittings. Features a secretion collection reservoir. Single-patient use, non-sterile. Flow resistance: 0.12-0.93 cm H2O depending on flow rate (30-70 Lpm).

Indications for Use

Indicated for patients with tidal volumes > 200 ml requiring connection between an endotracheal or tracheostomy tube and a ventilator circuit or closed suction system to assist in secretion removal.

Regulatory Classification

Identification

An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

Predicate Devices

• Sheridan Double Swivel (K850964)
• Sontek Bodai Swivel (K833373)
• Hudson RCI Water Trap (K770771)
• ARC Medical HME (K063125)

Submission Summary (Full Text)

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K083102

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

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| 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<br>Via a port and use of a standard suction catheter (Trach-Assist H)<br>Allows direct connections of a Closed suction catheter system (Trach-Assist I) | Yes<br>Via a port and use of a standard suction catheter | Yes<br>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”<br>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<br>0.60 cm H2O @ 50 Lpm<br>0.93 cm H2O @ 70 Lpm<br>Trach-Assist-H highest resistance values | Not available | 0.17 cm H2O @ 30 Lpm<br>0.66 cm H2O @ 50 Lpm<br>0.95 cm H2O @ 70 Lpm<br>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

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## 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.

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### 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.

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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); 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 [phone]. 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 [phone] or [phone] 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

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# 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: _______________________________________________________________________________________________________________________________________________________________