K Number

Device Name

RESPICONNECT ADAPTER

Manufacturer

TRUDELL MEDICAL INT'L

Date Cleared

2014-08-15

(127 days)

Product Code

CAF

Regulation Number

868.5630

Intended Use

Device Description

The RespiConnect Adapter is a single-patient use device intended to provide a self-sealing access port in a ventilator circuit to facilitate the administration of Respimat™ Soft Mist inhaler medication to mechanically ventilated patients.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K926301

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical and aerosol delivery characteristics, with no mention of AI or ML.

Therapeutic

Yes.
The device facilitates the delivery of bronchodilator aerosol medication to mechanically ventilated patients, which is a therapeutic intervention.

Diagnostic

No
The device is described as an adapter to facilitate the delivery of medication, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description and performance studies clearly indicate that the RespiConnect Adapter is a physical hardware device designed to be inserted into a ventilator circuit.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to facilitate the delivery of medication to mechanically ventilated patients. This is a therapeutic or drug delivery function, not a diagnostic one.
Device Description: The description focuses on providing an access port for medication administration within a ventilator circuit. This aligns with a drug delivery device, not a device used to examine specimens from the human body.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly designed to interact with a patient's respiratory system to deliver medication, which falls under the category of a medical device used for treatment, not diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

CAF

Device Description

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

mechanically ventilated patients

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)

Mechanical testing was conducted to characterize the operating parameters (leakage) of the RespiConnect Adapter device. The results (in Section 11, Attachment 4) demonstrate that the RespiConnect Adapter device performs satisfactorily, and does not raise any new safety or efficacy related issues.

Aerosol testing was performed to characterize cascade impactor performance data for total delivered dose, respirable fraction and respirable particle mass using the subject device. Review of the performance results indicate no new safety or efficacy issues were raised as a result of the testing. Expected performance results have been added to the instructions for the RespiConnect Adapter for user reference.

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.

K926301

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.

Not Found

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

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on health and well-being. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15, 2014

Trudell Medical International Mr. Darryl Fischer Associate Director, Global Regulatory Affairs 725 Third Street London, Ontario N5V 5G4 CANADA

Re: K140919

Trade/Device Name: RespiConnectTM Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer (Direct Patient Interface) Regulatory Class: II Product Code: CAF Dated: July 14, 2014 Received: July 16, 2014

Dear Mr. Fischer:

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.

Page 2 - Mr. Fischer

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

K140919 510(k) Number:

Device Name:

Indications for Use:

Prescription Use:
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Image /page/2/Picture/9 description: The image shows the FDA logo. The logo is in white and consists of the letters "FDA" in a stylized font. The letters are connected and have a thick, outlined appearance. The logo is simple and recognizable.

Anya C. Harry -S 2014.08.15 10:43:33 -04'00'

Page 1 of 1

Trade marks and registered trademarks of Trudell Medical International

510k No. K140919 as amended 14 July 2014

Section 5 – 510(k) Summarv

Prepared: 21 March 2014 / Amended 15 Aug 2014

Trudell Medical International 510(k) Owner 725 Third Street London, Ontario N5V 5G4 CANADA Contact Person Darryl Fischer Associate Director, Global Regulatory Affairs 1-519-455-7060 ext 2140 Phone 1-519-455-6329 Fax e-mail dfischer@trudellmed.com

Device Name

Proprietary	RespiConnect Adapter
Common/Classification	Accessory to a nebulizer

Product Code CAF

Classification Regulation 868.5630

| Predicate Device(s)

510(k) Number	Trade/Model Name	Manufacturer
K926301	Ace Cloud Enhancer	DHD Diemolding,
Healthcare Division

Device Description

Intended Use

The RespiConnect Adapter is designed to be used with RESPIMAT™ SOFT MIST INHALERS to facilitate the delivery of bronchodilator aerosol medication to mechanically ventilated patients. The single patient use adapter is intended to be left in the inspiratory limb of a 22 mm ventilator circuit. The intended use does not differ significantly from that of the predicate device detailed below. The predicate device below is designed to assist with the delivery of aerosolized medications from metered dose inhaler canisters to a mechanically ventilated patient.

Section 5 – 510(k) Summary

Ace Aerosol Cloud Enhancer, K926301

Manufactured from plastic
. 22mm OD and ID fittings to accommodate 22 mm breathing circuit connections
Used to administer aerosolized . medication to a mechanically ventilated patient

Image /page/4/Picture/7 description: The image shows a medical device used for respiratory therapy. The device is made of clear plastic and has a mouthpiece on one end and a bulb-shaped chamber in the middle. There is a white knob on the side of the chamber, which is likely used to adjust the resistance of the device. The device is designed to help people with respiratory problems improve their lung function.

Section 5 - 510(k) Summary

Technological Characteristic Comparison to Predicate Device

The table below presents some of the common device characteristics exhibited by the Class II device and the predicate device.

Common Device Characteristics

Characteristic	RespiConnect Adapter for
Respimat™	ACE Aerosol Cloud Enhancer
K926301
Single Patient Use	Yes	Yes
For use in a
ventilator circuit	Yes	Yes
Delivery of aerosol
medication	Yes	Yes
Built in actuator	No	Yes
Sold non-sterile	Yes	Yes
22mm ISO fittings	Yes	Yes
Device
Classification:	Class II - Accessory to a
nebulizer	Class II - Accessory to a nebulizer

Relevant differences in the operating principles of the Adapter for Respimat™ and the predicate device;

RespiConnect Adapter is used only with the Respimat™ Soft Mist Inhaler (SMI) device. ●
. RespiConnect Adapter has a self-sealing port to maintain circuit integrity once the Respimat™ device is removed. The ACE device must be capped to prevent circuit leakage if it remains in the circuit after use.
RespiConnect Adapter remains in the circuit once installed, and is discarded with the circuit upon circuit change. The ACE device is not recommended to remain in the circuit once in place, and may be removed after each use.
RespiConnect Adapter has a molded arrow to indicate direction of air flow. The ACE device is not labeled with the direction of air flow.

510k No. K140919 as amended 15 Aug 2014

Trademarks and registered trademarks of Trudell Medical International

Section 5 – 510(k) Summarv

RespiConnect Adapter is not patient-orientation sensitive while medication is being delivered. The ACE device and pMDI is patient-orientation sensitive during aerosol delivery, as the pMDI must be oriented in the upright position during firing to ensure the labeled dosage of drug is properly delivered.

Non-Clinical Test Summary

There are no direct patient contacting components of the RespiConnect Adapter device. However, the materials of construction were tested for biocompatibility and do meet the requirements of ISO 10993-1:2009, Biological evaluation of medical devices.

Biological evaluation of the RespiConnect Adapter device was classified according to the requirements within ISO 10993-1 as follows;

Category: Surface device
Contact: Mucosal membranes
. Contact Duration: B - Prolonged Exposure (24hrs to 30 days)
Evaluation Testing for Biological Effect ●
- o Cytotoxicity according to ISO 10993-5
- Sensitization according to ISO 10993-10 о
- Irritation or Intracutaneous Reactivity according to ISO 10993-10 o

Clinical Performance Summary

Not applicable, the determination of substantial equivalence is not based on Clinical Performance Data.

Conclusions from Testing

The RespiConnect Adapter device has been compared against a currently marketed (predicate) device for the determination of substantial equivalency. The RespiConnect Adapter device and the predicate device share:

510k No. K140919 as amended 15 Aug 2014

Trademarks and registered trademarks of Trudell Medical International

Section 5 – 510(k) Summary

common indications for use for mechanically ventilated patients
. usage environments
. both devices are single patient use
. both devices are sold non-sterile

The RespiConnect Adapter device raises no new issues regarding safety or efficacy.

Trademarks and registered trademarks of Trudell Medical International

510k No. K140919 as amended 15 Aug 2014