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.

AI/ML Overview

This document is a 510(k) premarket notification for the RespiConnect Adapter. It aims to demonstrate substantial equivalence to a predicate device. The information provided does not describe a study involving a particular device that requires the detailed acceptance criteria and study design requested. Instead this is a 510(k) submission for a non-AI medical device for which the following information is provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of performance thresholds with numerical values for a specific study. Instead, it describes general non-clinical tests performed and concluded that the device performs "satisfactorily" and "does not raise any new safety or efficacy related issues."

Non-Clinical Test Summary:

Test Type	Acceptance Criteria / Performance Conclusion
Mechanical Testing	"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." (Specific leakage values or thresholds are not provided in this summary.)
Biocompatibility	"materials of construction were tested for biocompatibility and do meet the requirements of ISO 10993-1:2009, Biological evaluation of medical devices." (Specific results of cytotoxicity, sensitization, and irritation/intracutaneous reactivity are not provided in this summary, only the conclusion of meeting the standard.)
Aerosol Testing	"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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical testing of a device rather than a study with a "test set" of patient data. Therefore, this information is not applicable in the context of the provided document. The tests seem to be performed on the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there is no "test set" of patient data requiring expert ground truth in this submission. The tests were for device performance characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as there is no "test set" of patient data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a submission for a non-AI medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a submission for a non-AI medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable in the sense of medical diagnosis. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles for mechanical leakage, biocompatibility standards (e.g., ISO 10993-1), and aerosol delivery characteristics.

8. The sample size for the training set

Not applicable. This is a non-AI medical device; there is no AI algorithm to train.

9. How the ground truth for the training set was established

Not applicable. This is a non-AI medical device; there is no AI algorithm to train.

Summary

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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.

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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

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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

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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.

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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.

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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 forRespimat™	ACE Aerosol Cloud EnhancerK926301
Single Patient Use	Yes	Yes
For use in aventilator circuit	Yes	Yes
Delivery of aerosolmedication	Yes	Yes
Built in actuator	No	Yes
Sold non-sterile	Yes	Yes
22mm ISO fittings	Yes	Yes
DeviceClassification:	Class II - Accessory to anebulizer	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

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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

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.

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

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.

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

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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

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).