(151 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, the RTC 26-C Inline Aerosol Adapter. The information needed to answer the prompt, particularly regarding acceptance criteria and a study proving the device meets those criteria, is limited and does not align with the typical structure of an AI/ML medical device submission.
This document details the substantial equivalence of a new device (RTC 26-C Inline Aerosol Adapter) to a predicate device (RTC 22-D Metered Dose Inhaler Adapter) based on performance testing and material compatibility, rather than a study proving an AI/ML device meets specific performance metrics against a defined ground truth.
Therefore, many of the requested items (e.g., number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set details) are not applicable to this type of traditional medical device submission.
However, I can extract the relevant information from the provided document as it pertains to the device's performance characteristics and how they compare to a predicate device.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence Evaluation)
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to a predicate device, the RTC 22-D Metered Dose Inhaler Adapter, particularly in terms of safety and effectiveness related to its intended use and functional characteristics. The study presented is a series of performance tests comparing the new device (RTC 26-C) to the predicate device (RTC 22-D).
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Aspect | Implicit Acceptance Criteria (Demonstrates Substantial Equivalence to Predicate) | Reported Device Performance (RTC 26-C vs. RTC 22-D) |
|---|---|---|
| Ease of Setup & Usage | Similar user experience and functionality to predicate device. | "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." Also, the Respimat inhaler was "easily and securely placed." |
| Ventilator Cycling Durability and Integrity | Maintain secure placement, no dislodged caps, proper medication dispersion under prolonged ventilator use and environmental changes. | "Each adapter tested remained secure within the test-set; No caps became dislodged. Every medication dose dispersed properly." |
| Airflow Resistance | Acceptable (ideally lower or comparable) resistance to airflow. | "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 Security/Leakage | Cap provides secure fit and minimal leakage under high pressure and changing conditions. | "the cap of the RTC 26-C adapter fits more securely, and leaks less than the cap of the predicate device" |
| Temperature Extremes Functionality | Device maintains functionality across extreme temperature fluctuations. | "Both new and predicate adapters cycled through extreme low and high temperatures performed equally well." |
| Shipping Durability | Withstand shipping rigors and maintain fit with ventilator components. | "Test results indicate that the RTC 26-C withstands the rigors of shipping and handling, will continue to fit 22mm mating components..." |
| Adapter Cap Tether Strength | Tether maintains integrity under strain. | "No negative consequences were seen after stretching tethers to twice their normal length." |
| PEEP Loss Management | Any potential PEEP loss (if cap is open) is manageable/preventable by the ventilator. | Test determined PEEP loss "is small enough to be entirely prevented by the ventilator." |
| Drop Durability | Materials and design are durable. | "The materials and design of the RTC 26-C are durable and raise no new safety and effectiveness issues." |
| Respimat® Inhaler Attachment Durability | Medication inlet port withstands repeated attachment cycles without damage, and medication dosage dispersion remains successful. | "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 Durability | Adapter ports retain secure fit after repeated connection cycles. | "the adapters retained their secure fit to mating connectors after 25 cycles, fitting as snugly as they did after the first one." |
| Aerosol Performance (Total Delivered Dose) | Delivered dose of medication remains within acceptable range and is comparable to predicate, ideally with better delivery efficiency. | RTC 26-C generally shows better performance or comparable performance for the intended medication (Combivent Respimat®) than the predicate with its MDI counterparts.- Albuterol (RTC 26-C vs. RTC 22-D): Total Delivered Dose (58.1-67.2 µg vs. 50.9-62.3 µg), % Reduction from SMI/MDI alone (27.8% vs. 45.5%).- Ipratropium (RTC 26-C vs. RTC 22-D): Total Delivered Dose (11.4-13.9 µg vs. 10.4-11.9 µg), % Reduction from SMI/MDI alone (34.0% vs. 40.4%). |
| Aerosol Performance (Respirable Particle Mass/Fraction) | Higher respirable fraction is desirable. | - Albuterol (RTC 26-C vs. RTC 22-D): Respirable Particle Mass (24.7-28.5 µg vs. 16.6-20.9 µg), Respirable Fraction (42.4% vs. 33.0%).- Ipratropium (RTC 26-C vs. RTC 22-D): Respirable Particle Mass (5.0-5.9 µg vs. 1.6-3.1 µg), Respirable Fraction (43.7% vs. 21.4%). |
| Biocompatibility | Materials are suitable for prolonged contact in a medical device and do not raise new safety issues. | Materials (thermoplastic elastomer and polystyrene butadiene) are "previously used in the manufacture of medical devices, specifically the predicate device (K991355)." Categorized as "External Communicating Device" with "Prolonged (>24 hours to 30 days)" contact duration. |
2. Sample Size and Data Provenance:
- Placement and Usage Trials: Not specified, but involved "two typical types of ventilator circuits."
- Ventilator Cycling Test: Not specified, but involved "RTC 26-C Adapters and the predicate device."
- Adapter Resistance Test & Cap Pressure/Leak Test: "Every trial run" implies multiple runs, but specific number of samples
or trials not quantified. - Respimat® Inhaler Attachment Trials: 10 samples tested, 500 attachment cycles each.
- Port Connection Trials: "RTC 26-C samples" tested, 25 cycles each.
- Adult Aerosol Performance Comparison Testing:
- RTC 26-C: One Combivent Respimat SMI, three samples of RTC 26-C, three tests per sample = 9 measurements per medication/output variable.
- RTC 22-D: Two drugs (Ventolin HFA and Atrovent), three samples of RTC 22-D, three tests per device sample = 9 measurements per medication/output variable.
- Data Provenance: The tests are described as "laboratory and simulated usage testing." Given the context of a 510(k) submission, this data is prospective and conducted specifically for the submission. No specific country of origin for data is stated beyond the company's location (Pennsylvania, USA).
3. Number of Experts and Qualifications for Ground Truth:
- This is not applicable. The ground truth for this device's performance is established through direct physical/biomedical engineering measurements and comparisons to a known predicate device's performance, not expert-labeled clinical data.
4. Adjudication Method for the Test Set:
- This is not applicable. There is no "test set" in the sense of a set of cases requiring expert review and adjudication. The data are quantitative measurements from instrumental tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is not relevant for this device. The device is a mechanical adapter, not an AI/ML diagnostic tool assisting human readers.
6. Standalone Performance:
- The "standalone" performance is assessed by the device's physical and aerosol delivery characteristics (e.g., resistance, delivered dose, particle size distribution) through the various tests described. This is the direct, unassisted performance of the device artifact itself. The human element comes into play only in administering the associated medication.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance is primarily quantitative physical measurements (e.g., airflow resistance, delivered dose, particle sizes) obtained from standard engineering and aerosolization test methods, compared against established baseline expectations (e.g., historical performance of the predicate device, general principles of fluid dynamics and aerosol mechanics). No clinical outcomes data or pathology reviews are mentioned for establishing device performance.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no training set mentioned for this device.
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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.
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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
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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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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. |
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| Discussion ofSimilarities ofIntended Useof theRTC 26-C andthe PredicateDevice | 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. | ||||||
|---|---|---|---|---|---|---|---|
| TechnologicalCharacteristics | Similarities between the RTC 26-C and the Predicate Device:1. The inlet and outlet end dimensions for both the RTC 26-C and RTC 22-D adapters accommodate 22mm breathing circuit connections.2. Both devices are marked with a molded arrow to indicate direction of flow.3. 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.4. None of the materials making up these devices are manufactured with natural rubber latex.5. Both devices are sold as 'Not Sterile'.Differences between the RTC 26-C and the Predicate Device:1. 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.2. 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. | ||||||
| PerformanceTesting | Specific tests performed upon the RTC 26-C, and their outcomes, include the following:Placement and Usage Trialswithin Two Typical Types ofVentilator 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. |
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| Cap Pressure/Leak Test | Simulated testing with ventilator cycling at highpeak pressures, under both dry and wet circuitconditions, prove that the cap of the RTC 26-Cadapter fits more securely, and leaks less than thecap of the predicate device |
|---|---|
| Temperature ExtremesFunctionality Test | Both new and predicate adapters cycled throughextreme low and high temperatures performedequally well. |
| Shipping Trials | Test results indicate that the RTC 26-C withstandsthe rigors of shipping and handling, will continue tofit 22mm mating components as part of a ventilatorcircuit and is substantially equivalent to thepredicate device. |
| Adapter Cap Tether StrengthTrials | No negative consequences were seen afterstretching tethers to twice their normal length. |
| PEEP Loss Test | This test determined PEEP loss between breathsusing a non-leak-compensated ventilator, comparedto that of a ventilator in leak-compensating mode,to prove that any potential PEEP loss (in the eventof a cap not being replaced) is small enough to beentirely prevented by the ventilator. |
| Drop Test | The materials and design of the RTC 26-C aredurable and raise no new safety and effectivenessissues. |
| Respimat® InhalerAttachment Trials | After 500 attachment cycles, there was no damageto the medication inlet port of any of the 10 samplestested. Medication dosage dispersion testing wasalso successful for every trial. |
| Port Connection Trials | This test of the 22mm OD ports on RTC 26-Csamples proved that the adapters retained theirsecure fit to mating connectors after 25 cycles,fitting as snugly as they did after the first one. |
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Section 5 – 510(k) Summary – revised 2/28/17
Traditional 510(k) Submission Page 4 of 4
| PerformanceTesting,continued | Adult Aerosol Performance Comparison Testing of the RTC 26-C andRTC 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 RTC26-C Adapter (µg) | 58.1 - 67.2 | 50.9 - 62.3 | 11.4 - 13.9 | 10.4 - 11.9 | |
| % Reduction in Total DeliveredDose compared to respectiveSMI/MDI alone | 27.8% | 45.5% | 34.0% | 40.4% | |
| Respirable Particle Mass fromRTC 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 RespirableDose compared to respectiveSMI/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, <4.7µm) | 35.1 - 39.1 | 17.7 - 22.3 | 6.8 - 8.1 | 2.7 - 4.2 | |
| Particle Fraction < 4.7µm | 59.2% | 35.3% | 59.5% | 30.4% | |
| Extra-Fine Particle Dose(µg, <1.0µm) | 17.7 - 20.6 | 2.1 - 19.5 | 3.5 - 4.2 | 1.5 - 2.1 | |
| Particle Fraction <1.0µm | 30.5% | 19.1% | 30.2% | 16.1% | |
| Mass-Median Aerosol Diameter(MMAD) (µm) | 1.4 - 1.7 | 1.8 - 2.1 | 1.4 - 1.7 | 0.9 - 1.4 | |
| Geometric Standard Deviation(GSD) | 3.8 - 4.6 | 2.4 - 3.1 | 3.9 - 4.6 | 3.6 - 5.0 | |
| 95% confidence intervals. Cascade impactor testing conducted at 28.3 lpm. | |||||
| RTC 26-C: Testing done with one Combivent Respimat SMI, three samples of RTC 26-C, three testsper sample, for a total of nine measurements per medication and output variable. | |||||
| RTC 22D: Testing done with two drugs (one canister each of Ventolin HFA and Atrovent), threesamples of RTC 22-D, with three tests per device sample, for a total of nine measurements permedication and output variable. | |||||
| Bio-compatibilityInformation | Materials used in the manufacture of the RTC 26-C Inline Aerosol Adapter,thermoplastic elastomer and polystyrene butadiene, have previously been used in themanufacture of medical devices, specifically the predicate device (K991355). | ||||
| Category: External Communicating Device | |||||
| Contact: Tissue/Bone/DentinContact Duration: Prolonged (>24 hours to 30 days) | |||||
| The RTC 26-C is intended to be installed and remain in the breathing circuit until thebreathing circuit is replaced in accordance with facility guidelines, for a period of timenot to exceed 14 days. | |||||
| Conclusion: | In both laboratory and simulated usage testing, the RTC 26-C has been compared againsta currently marketed device for the determination of substantial equivalency. Thistesting has not raised different issues of safety and effectiveness and the RTC 26-C hasbeen found to be substantially equivalent to the RTC 22-D |
§ 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).