The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or long term or short term ventilation. The RTC 24-V MDI 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 24-V KIT includes the RTC 24-V MDI Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation. The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22 mm outer-diameter adapter. The RTC 24-V KIT is intended for single patient reuse. This device is intended for sale by or on the order of a physician.

Device Description

The Instrumentation Industries, Inc. RTC 24-V metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers. The RTC 24-V metered dose inhaler adapter kit is comprised of the Instrumentation Industries, Inc. components normally used by respiratory therapists to integrate our existing actuators into a ventilator circuit. The kit includes one RTC 24-V MDI adapter, one 4 inch length of 22mm ID tubing and one 15mm ID/22mm OD adapter.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called the "RTC 24-V MDI Adapter and RTC 24-V MDI Adapter Kit." This summary details the device's characteristics, intended use, and a comparison to a predicate device (RTC 22-D). It also includes information about aerosol performance testing.

Here's an analysis of the acceptance criteria and the study based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as strict pass/fail thresholds with numerical values in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device (RTC 22-D) in terms of aerosol performance. The reported device performance is a comparison of the new device (RTC 24-V) to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (RTC 24-V vs. RTC 22-D)
Aerosol Performance Equivalence to Predicate Device
Particle Size (MMAD)	Actual differences were not statistically significant.
Geometric Standard Deviation (GSD)	Actual differences were not statistically significant.
Medication Captured on USP Throat	Actual differences were not statistically significant.
Superiority in Specific Aerosol Performance Metrics (Optional but shown)
Total Dose Delivered	Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D.
Respirable Fraction	Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D.
Total Respirable Dose Delivered	Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D.
Medication Retained in Device	Actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D.

Study Proving Acceptance Criteria:

The study described is a laboratory performance test comparing the new RTC 24-V MDI adapter to its predicate device, the RTC 22-D.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a number of devices or number of tests. The text mentions testing with "the following MDI medications: Ventolin® HFA, Atrovent® HFA, QVAR®." It implies a set of tests were performed for each medication type, comparing the RTC 24-V and RTC 22-D.
Data Provenance: The study was conducted "in the laboratory." There is no information about the country of origin or whether it was retrospective or prospective. Given it's a lab performance test of physical devices, it's inherently prospective in nature for the performance data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This type of information is not applicable to this study. The study focuses on objective, measurable physical parameters (aerosol performance) of the device, not a subjective interpretation requiring expert consensus on a "ground truth" like in imaging studies. The "ground truth" here is the measured physical performance.

4. Adjudication Method for the Test Set

This is not applicable as there is no subjective assessment being made that would require 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

This is not applicable. This is a device performance study, not an AI or diagnostic imaging study involving human readers.

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

This is not applicable. This is a physical device performance study, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this study is objective physical measurements of aerosol performance parameters. These measurements are assumed to be accurate representations of the device's output under controlled laboratory conditions.

8. The Sample Size for the Training Set

This is not applicable. This is a device performance study, not a machine learning study that would typically involve a "training set."

9. How the Ground Truth for the Training Set was Established

This is not applicable for the same reason as point 8.

Summary

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X0911111

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Image /page/0/Picture/1 description: The image shows the logo for Instrumentation Industries, Inc. The logo consists of a rounded rectangle with six smaller rectangles inside, arranged in two rows of three. Below the logo is the company name, "Instrumentation Industries, Inc." The tagline "We make Respiratory Care Work!" is printed below the company name.

Section 5 Page 1 of 3 DEC - 2 2009

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: April 10, 2009 Revised: November 23, 2009 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey

510(k) SUMMARY

for

RTC 24-V MDI Adapter and RTC 24-V MDI Adapter Kit

Trade Name	RTC 24-V Metered Dose Inhaler AdapterRTC 24-V Metered Dose Inhaler Adapter Kit
Common Name	Actuator
Classification Name	Nebulizer
Regulation	21 CFR 868.5630
Predicate Device	Instrumentation Industries, Inc. RTC 22-D (K991355)
Device Description	The Instrumentation Industries, Inc. RTC 24-V metered dose inhaler adapter isan actuator for intermittent delivery of prescribed aerosol medicationdispensed in metered dose inhalers.The RTC 24-V metered dose inhaler adapter kit is comprised of theInstrumentation Industries, Inc. components normally used by respiratorytherapists to integrate our existing actuators into a ventilator circuit.The kit includes one RTC 24-V MDI adapter, one 4 inch length of 22mm IDtubing and one 15mm ID/22mm OD adapter
Intended Useof the DeviceRTC 24-VMetered DoseInhaler Adapter	The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator forintermittent delivery of prescribed aerosol medication dispensed in cylindrical-stylemetered dose inhalers. The RTC 24-V MDI Adapter is intended for use only whenconnected to ventilator tubing or tracheal tubes.The RTC 24-V MDI Adapter is intended to be prescribed for any patient who isventilator-dependent and to whom a metered dose inhaler has been prescribed. Theexpected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or
RTC 24-VMetered DoseInhaler AdapterKit(To be sold asmodel numberRTC 24-V KIT)	long term or short term ventilation.
	The RTC 24-V MDI 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 24-V KIT includes the RTC 24-V MDIAdapter actuator for intermittent delivery of prescribed aerosol medication dispensedin cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for useonly when connected to ventilator tubing or tracheal tubes.The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expectedclinical environment for the RTC 24-V KIT is Critical Care and/or long term or shortterm ventilation.
	The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, onefour inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22mm outer-diameter adapter.
	The RTC 24-V KIT is intended for single patient reuse.
	This device is intended for sale by or on the order of a physician.
TechnologicalCharacteristics	Similarities: The function, inlet and outlet end dimensions, and the materials of both theRTC 22-D predicate device and the RTC 24-V are the same. Both the RTC22-D and the RTC 24-V will accept plastic or metal tipped, cylindrically-shaped MDI canisters. All materials are latex-free.Materials - Body - Polystyrene ButadieneCap - Thermoplastic RubberFunctional Dimensions - Inlet - 15mm I.DOutlet - 15mm I.D./22 mm O.D.Markings - Both the RTC 24-D and the RTC 22-D are marked with a molded-in arrow defining direction of flow.
	Differences: The RTC 24-V design includes a gear that is designed to mate with a limitednumber of brands of metered dose inhalers that have an integral dose counter.The interaction of the adapter gear and the dose counter permits accurate
	monitoring of the amount of doses remaining in the inhaler device. The RTC22-D does not include a similar gear.
	There currently is not a kit version of the RTC 22-D. Users must purchase theMDI adapter, the tubing and the straight connector separately.
AerosolPerformance	The RTC 24-V was tested in the laboratory with the following MDImedications:- Ventolin® HFA- Atrovent® HFA- QVAR®
	In the tests (shown below) that were performed upon the RTC 24-V and theRTC 22-D predicate device, actual differences were not statisticallysignificant:Particle Size (MMAD)Geometric Standard Deviation (GSD)Medication Captured on USP Throat
	In the tests (shown below) that were performed upon the RTC 24-V and theRTC 22-D predicate device, actual differences were statistically significant,with the RTC 24-V out-performing the RTC 22-D.Total Dose DeliveredRespirable FractionTotal Respirable Dose DeliveredMedication Retained in Device
Conclusion:	In laboratory testing the RTC 24-V is substantially equivalent to the RTC 22-Dpredicate device.

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and the comments of

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing right. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Doris Walter Regulatory Affairs/Quality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102

DEC - 2 2009

Re: K091111

Trade/Device Name: RTC 24-V Metered Dose Inhaler Adapter and RTC 24-V Metered Dose Inhaler Adapter Kit Regulation Number: 868.5630 Regulation Name: Nebulizer Regulatory Class: Il Product Code: CAF Dated: November 23, 2009 Received: November 25, 2009

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.

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- Ms. Walter

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

for

Susan Runner, D.D.S., M.A. Acting Division 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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Section 4 Page 1 of 2 Revised Nov. 23, 2009

Indications for Use

510(k) Number (if known):

K091111

Device Name:

RTC 24-V Metered Dose Inhaler Adapter

Statement of Indications for Use:

RTC 24-V Metered Dose Inhaler Adapter

The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style. metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes.

The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is ventilator-dependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or long term or short term ventilation.

And/Or

The RTC 24-V MDI Adapter is intended for single patient reuse.

This device is intended for sale by or on the order of a physician.

Prescription Use (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schult

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: KO 9

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Section 4 Page 2 of 2 Revised Nov. 23, 2009

Indications for Use

510(k) Number (if known):

K091111

Device Name:

RTC 24-V Metered Dose Inhaler Adapter Kit (To be sold as model number RTC 24-V KIT)

Statement of Indications for Use:

The RTC 24-V KIT is intended to be prescribed for any patient who is ventilatordependent and to whom a metered dose inhaler has been prescribed. The expected clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short term ventilation.

The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22 mm outer-diamcter adapter.

And/Or

The RTC 24-V KIT is intended for single patient reuse.

This device is intended for sale by or on the order of a physician.

V Prescription Use (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) L. Ahelt

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

коч////

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).