(151 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of an aerosol adapter for ventilators, with no mention of AI or ML technologies.
Yes.
The device facilitates the delivery of medication to a patient, which directly contributes to a therapeutic outcome.
No
This device is designed to assist in the delivery of medication to mechanically-ventilated patients by providing an access port in the ventilator circuit; it does not diagnose any condition.
No
The device description and performance studies clearly indicate that the RTC 26-C Inline Aerosol Adapter is a physical hardware component designed to be inserted into a ventilator circuit. There is no mention of software as a component of this device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed to assist in the delivery of medication (Combivent®) from an inhaler to a mechanically-ventilated patient. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description reinforces the intended use, stating it provides an access port in a ventilator circuit for medication administration.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to diagnose a disease or condition.
- Performance Studies: The performance studies focus on the device's ability to function within a ventilator circuit, deliver medication effectively, and withstand various conditions. These are related to the device's mechanical and functional performance in a therapeutic setting, not its diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information for diagnosis, monitoring, or screening. This device facilitates the delivery of medication into the body.
N/A
Intended Use / Indications for Use
The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing.
The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse.
This device is intended for sale by or on the order of a physician.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Instrumentation Industries, Inc. RTC 26-C Inline Aerosol Adapter is a single-patient reuse device intended to provide an access port in a ventilator circuit to facilitate the administration of Combivent® (ipratropium bromide and albuterol) Respimat® medication to mechanically ventilated patients.
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
Adult
Intended User / Care Setting
The expected clinical environment for the RTC 26-C Inline Aerosol Adapter is Critical Care and/or long term or short term ventilation.
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)
Specific tests performed upon the RTC 26-C, and their outcomes, include the following:
-
Placement and Usage Trials within Two Typical Types of Ventilator Circuits: The set-up and usage of the RTC 26-C was no more difficult than that of the predicate in its typical circuit set-up. The Respimat inhaler was able to be easily and securely placed into the medication port to deliver a properly dispersed dose of medication.
-
Ventilator Cycling Test: RTC 26-C Adapters and the predicate device were put through 18 days of high pressure ventilator cycling with circuit conditions changes that included heat, cold, low and high humidification, and an HME set-up. Each adapter tested remained secure within the test-set; No caps became dislodged. Every medication dose dispersed properly.
-
Adapter Resistance Test: The RTC 26-C Adapter had less resistance than that of the predicate device for every trial run at both 60 and 80 lpm peak flow settings.
-
Cap Pressure/Leak Test: Simulated testing with ventilator cycling at high peak pressures, under both dry and wet circuit conditions, prove that the cap of the RTC 26-C adapter fits more securely, and leaks less than the cap of the predicate device.
-
Temperature Extremes Functionality Test: Both new and predicate adapters cycled through extreme low and high temperatures performed equally well.
-
Shipping Trials: Test results indicate that the RTC 26-C withstands the rigors of shipping and handling, will continue to fit 22mm mating components as part of a ventilator circuit and is substantially equivalent to the predicate device.
-
Adapter Cap Tether Strength Trials: No negative consequences were seen after stretching tethers to twice their normal length.
-
PEEP Loss Test: This test determined PEEP loss between breaths using a non-leak-compensated ventilator, compared to that of a ventilator in leak-compensating mode, to prove that any potential PEEP loss (in the event of a cap not being replaced) is small enough to be entirely prevented by the ventilator.
-
Drop Test: The materials and design of the RTC 26-C are durable and raise no new safety and effectiveness issues.
-
Respimat® Inhaler Attachment Trials: After 500 attachment cycles, there was no damage to the medication inlet port of any of the 10 samples tested. Medication dosage dispersion testing was also successful for every trial.
-
Port Connection Trials: This test of the 22mm OD ports on RTC 26-C samples proved that the adapters retained their secure fit to mating connectors after 25 cycles, fitting as snugly as they did after the first one.
-
Adult Aerosol Performance Comparison Testing of the RTC 26-C and RTC 22-D Predicate Device:
- Albuterol (RTC 26-C vs. RTC 22-D): Total Delivered Dose (58.1 - 67.2 µg vs. 50.9 - 62.3 µg), % Reduction in Total Delivered Dose (27.8% vs. 45.5%), Respirable Particle Mass (24.7 - 28.5 µg vs. 16.6 - 20.9 µg), Respirable Fraction (42.4% vs. 33.0%), % Reduction in Respirable Dose (47.5% vs. 55.7%), Coarse Particle Dose (22.3 - 28.8 µg vs. 31.8 - 41.4 µg), Particle Fraction > 4.7µm (40.8% vs. 64.7%), Fine Particle Dose (35.1 - 39.1 µg vs. 17.7 - 22.3 µg), Particle Fraction 4.7µm (40.5% vs. 68.8%), Fine Particle Dose (6.8 - 8.1 µg vs. 2.7 - 4.2 µg), Particle Fraction
§ 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).
0
Image /page/0/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem consists of three stylized human profiles facing right, layered on top of each other to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2017
Instrumentation Industries, Inc. % Doris Walter Regulatory Affairs/Quality Assurance Manager 2990 Industrial Blvd. Bethel Park, Pennsylvania 15102
Re: K162753
Trade/Device Name: RTC 26-C Inline Aerosol Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: January 17, 2017 Received: January 19, 2017
Dear Ms. Walter:
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.
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 devicerelated 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.
1
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/ResourcesforYou/Industry/default.htm. 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 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,
Lori A. Wiggins -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) K162753
Device Name RTC 26-C Inline Aerosol Adapter
Indications for Use (Describe)
Indications for Use:
The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing.
The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse.
This device is intended for sale by or on the order of a physician.
| 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
Image /page/3/Picture/0 description: The image shows the logo for Instrumentation Industries, Inc. The logo consists of a stylized icon with three columns of squares inside of a rounded rectangle. The text "Instrumentation Industries, Inc." is written in bold, followed by the tagline "We make Respiratory Care Work!"
2990 Industrial Boulevard • Bethel Park, PA 15102-2536 Phone: 412-854-1133 US Toll-Free: 1-800-633-8577 Fax: 412-854-5668 www.iiimedical.com
Date Prepared: 2/28/2017 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
510(k) SUMMARY of the RTC 26-C Inline Aerosol Adapter
| Trade Name | RTC 26-C Inline Aerosol Adapter |
|---|---|
| Common Name | Adapter |
| Classification Name | Accessory to a Nebulizer |
| Regulation | 21 CFR 868.5630 |
| Predicate Device | Instrumentation Industries, Inc. RTC 22-D (K991355) Metered Dose Inhaler Adapter |
| Device Description | The Instrumentation Industries, Inc. RTC 26-C Inline Aerosol Adapter is a single-patient reuse device intended to provide an access port in a ventilator circuit to facilitate the administration of Combivent® (ipratropium bromide and albuterol) Respimat® medication to mechanically ventilated patients. |
| Indications for Use | The RTC 26-C Inline Aerosol Adapter is designed to assist in the delivery of Combivent® (ipratropium bromide and albuterol) medication from a Respimat® inhaler as prescribed to an adult, mechanically-ventilated patient. The RTC 26-C Inline Aerosol Adapter is intended for use only when connected to ventilator tubing. |
| The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. | |
| This device is intended for sale by or on the order of a physician. | |
| Intended Use of the Device | The RTC 26-C Inline Aerosol Adapter is intended to be prescribed for any adult patient who is ventilator-dependent and for whom a Combivent® (ipratropium bromide and albuterol) Respimat® has been prescribed. The expected clinical environment for the RTC 26-C Inline Aerosol Adapter is Critical Care and/or long term or short term ventilation. |
| The RTC 26-C Inline Aerosol Adapter is intended for single patient reuse. "Single patient reuse" means that this adapter can be used to deliver Combivent® (ipratropium bromide and albuterol) Respimat® medication multiple times to a single patient while installed in a breathing circuit, for a period of time not to exceed 14 days. | |
| This device is intended for sale by or on the order of a physician. |
4
| Discussion of
Similarities of
Intended Use
of the
RTC 26-C and
the Predicate
Device | 1. Both devices are intended for use in a ventilator circuit when ordered by a physician.
2. Both devices remain in the circuit once installed, and are discarded with the circuit upon circuit change.
3. Both devices are intended for a single patient. Neither device is intended to be reprocessed after use.
4. Both devices allow certain medications from a metered dose inhaler, specifically albuterol sulfate and ipratropium bromide, to be delivered to a ventilated patient after a medical professional determines the need for them.
5. Both devices must be capped after the MDI device is removed. | | | | | | |
|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| Technological
Characteristics | Similarities between the RTC 26-C and the Predicate Device:
- The inlet and outlet end dimensions for both the RTC 26-C and RTC 22-D adapters accommodate 22mm breathing circuit connections.
- Both devices are marked with a molded arrow to indicate direction of flow.
- Both devices include a molded body and a molded cap. Each of the bodies, and each of the caps, are molded of the same respective materials.
- None of the materials making up these devices are manufactured with natural rubber latex.
- Both devices are sold as 'Not Sterile'.
Differences between the RTC 26-C and the Predicate Device:
- The RTC 22-D serves as an actuator for a metered dose inhaler. The RTC 26-C is not an actuator: Its function is to allow access to a breathing circuit for the purpose of the introduction of the prescribed medication.
- The RTC 22-D can be used with MDI medication canisters which have standard cylindrical stem outlets. The RTC 26-C is intended to be used only with Combivent® (ipratropium bromide and albuterol) bronchodilator medication dispensed from a Respimat® inhaler which has an elliptical mouthpiece outlet. | | | | | | |
| Performance
Testing | Specific tests performed upon the RTC 26-C, and their outcomes, include the following:
Placement and Usage Trials
within Two Typical Types of
Ventilator Circuits The set-up and usage of the RTC 26-C was no more difficult than that of the predicate in its typical circuit set-up. The Respimat inhaler was able to be easily and securely placed into the medication port to deliver a properly dispersed dose of medication. Ventilator Cycling Test RTC 26-C Adapters and the predicate device were put through 18 days of high pressure ventilator cycling with circuit conditions changes that included heat, cold, low and high humidification, and an HME set-up. Each adapter tested remained secure within the test-set;
No caps became dislodged. Every medication dose dispersed properly. Adapter Resistance Test The RTC 26-C Adapter had less resistance than that of the predicate device for every trial run at both 60 and 80 lpm peak flow settings. | | | | | | |
5
| Cap Pressure/Leak Test | Simulated testing with ventilator cycling at high
peak pressures, under both dry and wet circuit
conditions, prove that the cap of the RTC 26-C
adapter fits more securely, and leaks less than the
cap of the predicate device |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Temperature Extremes
Functionality Test | Both new and predicate adapters cycled through
extreme low and high temperatures performed
equally well. |
| Shipping Trials | Test results indicate that the RTC 26-C withstands
the rigors of shipping and handling, will continue to
fit 22mm mating components as part of a ventilator
circuit and is substantially equivalent to the
predicate device. |
| Adapter Cap Tether Strength
Trials | No negative consequences were seen after
stretching tethers to twice their normal length. |
| PEEP Loss Test | This test determined PEEP loss between breaths
using a non-leak-compensated ventilator, compared
to that of a ventilator in leak-compensating mode,
to prove that any potential PEEP loss (in the event
of a cap not being replaced) is small enough to be
entirely prevented by the ventilator. |
| Drop Test | The materials and design of the RTC 26-C are
durable and raise no new safety and effectiveness
issues. |
| Respimat® Inhaler
Attachment Trials | After 500 attachment cycles, there was no damage
to the medication inlet port of any of the 10 samples
tested. Medication dosage dispersion testing was
also successful for every trial. |
| Port Connection Trials | This test of the 22mm OD ports on RTC 26-C
samples proved that the adapters retained their
secure fit to mating connectors after 25 cycles,
fitting as snugly as they did after the first one. |
6
Section 5 – 510(k) Summary – revised 2/28/17
Traditional 510(k) Submission Page 4 of 4
| Performance
Testing,
continued | Adult Aerosol Performance Comparison Testing of the RTC 26-C and
RTC 22-D Predicate Device | | | | Page 4 of 4 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|-------------|-------------|-------------|
| | Albuterol | | Ipratropium | | |
| | RTC 26-C | RTC 22-D | RTC 26-C | RTC 22-D | |
| | Total Delivered Dose from RTC
26-C Adapter (µg) | 58.1 - 67.2 | 50.9 - 62.3 | 11.4 - 13.9 | 10.4 - 11.9 |
| | % Reduction in Total Delivered
Dose compared to respective
SMI/MDI alone | 27.8% | 45.5% | 34.0% | 40.4% |
| | Respirable Particle Mass from
RTC 26-C (µg, 0.5-5µm) | 24.7 - 28.5 | 16.6 - 20.9 | 5.0 - 5.9 | 1.6 - 3.1 |
| | Respirable Fraction
(0.5-5µm) | 42.4% | 33.0% | 43.7% | 21.4% |
| | % Reduction in Respirable
Dose compared to respective
SMI/MDI alone | 47.5% | 55.7% | 50.4% | 68.8% |
| | Coarse Particle Dose
(µg, >4.7µm) | 22.3 - 28.8 | 31.8 - 41.4 | 4.0 - 6.3 | 7.1 - 8.3 |
| | Particle Fraction > 4.7µm | 40.8% | 64.7% | 40.5% | 68.8% |
| | Fine Particle Dose
(µg, 24 hours to 30 days) | | | | |
| | The RTC 26-C is intended to be installed and remain in the breathing circuit until the
breathing circuit is replaced in accordance with facility guidelines, for a period of time
not to exceed 14 days. | | | | |
| Conclusion: | In both laboratory and simulated usage testing, the RTC 26-C has been compared against
a currently marketed device for the determination of substantial equivalency. This
testing has not raised different issues of safety and effectiveness and the RTC 26-C has
been found to be substantially equivalent to the RTC 22-D | | | | |