RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC

K091111 · Instrumentation Industries, Inc. · CAF · Dec 2, 2009 · Anesthesiology

Device Facts

• Record ID: K091111
• Device Name: RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
• Applicant: Instrumentation Industries, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Dec 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

The RTC 24-V is an actuator for delivering aerosolized medication from cylindrical metered dose inhalers (MDIs) into ventilator circuits or tracheal tubes. It features an integrated gear mechanism designed to interface with specific MDI brands that include dose counters, allowing for monitoring of remaining medication. The device is used in critical care or ventilation settings by respiratory therapists or clinicians. It is provided as a standalone adapter or as a kit including 22mm tubing and a 15mm/22mm connector. The device facilitates medication delivery to ventilator-dependent patients, potentially improving therapeutic efficiency compared to previous models.

Clinical Evidence

Bench testing only. Laboratory performance compared the RTC 24-V to the RTC 22-D using Ventolin HFA, Atrovent HFA, and QVAR. Metrics included MMAD, GSD, and medication captured on USP throat. Results showed no statistically significant differences in particle size or throat deposition, while the RTC 24-V demonstrated statistically significant improvements in total dose delivered, respirable fraction, and total respirable dose delivered.

Technological Characteristics

Actuator for MDI; materials: Polystyrene Butadiene (body), Thermoplastic Rubber (cap). Dimensions: 15mm I.D. inlet, 15mm I.D./22mm O.D. outlet. Features integrated gear for MDI dose counter compatibility. Flow direction indicated by molded-in arrow. Single patient reuse. Latex-free.

Indications for Use

Indicated for ventilator-dependent patients prescribed aerosol medication via cylindrical-style metered dose inhalers. Used in critical care, long-term, or short-term ventilation settings. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Instrumentation Industries, Inc. RTC 22-D (K991355)

Submission Summary (Full Text)

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X0911111

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Section 5 Page 1 of 3 DEC - 2 2009

2990 Industrial Boulevard • Bethel Park, PA 15102-2536 Phone: [phone] US Toll-Free: 1-800-633-8577 Fax: [phone] 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 Adapter<br>RTC 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 is<br>an actuator for intermittent delivery of prescribed aerosol medication<br>dispensed in metered dose inhalers.<br><br>The RTC 24-V metered dose inhaler adapter kit is comprised of the<br>Instrumentation Industries, Inc. components normally used by respiratory<br>therapists to integrate our existing actuators into a ventilator circuit.<br><br>The kit includes one RTC 24-V MDI adapter, one 4 inch length of 22mm ID<br>tubing and one 15mm ID/22mm OD adapter |
| Intended Use<br>of the Device<br>RTC 24-V<br>Metered Dose<br>Inhaler Adapter | The Instrumentation Industries, Inc. RTC 24-V MDI Adapter is an actuator for<br>intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style<br>metered dose inhalers. The RTC 24-V MDI Adapter is intended for use only when<br>connected to ventilator tubing or tracheal tubes.<br><br>The RTC 24-V MDI Adapter is intended to be prescribed for any patient who is<br>ventilator-dependent and to whom a metered dose inhaler has been prescribed. The<br>expected clinical environment for the RTC 24-V MDI Adapter is Critical Care and/or |
| RTC 24-V<br>Metered Dose<br>Inhaler Adapter<br>Kit<br>(To be sold as<br>model number<br>RTC 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 MDI<br>Adapter actuator for intermittent delivery of prescribed aerosol medication dispensed<br>in cylindrical-style metered dose inhalers. The RTC 24-V KIT is intended for use<br>only when connected to ventilator tubing or tracheal tubes.<br>The RTC 24-V KIT is intended to be prescribed for any patient who is ventilator-<br>dependent and to whom a metered dose inhaler has been prescribed. The expected<br>clinical environment for the RTC 24-V KIT is Critical Care and/or long term or short<br>term ventilation. |
| | The components of the RTC 24-V KIT consist of one RTC 24-V MDI Adapter, one<br>four inch length of 22 mm inner-diameter tubing, and one 15 mm inner-diameter/22<br>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. |
| Technological<br>Characteristics | Similarities: The function, inlet and outlet end dimensions, and the materials of both the<br>RTC 22-D predicate device and the RTC 24-V are the same. Both the RTC<br>22-D and the RTC 24-V will accept plastic or metal tipped, cylindrically-<br>shaped MDI canisters. All materials are latex-free.<br>Materials - Body - Polystyrene Butadiene<br>Cap - Thermoplastic Rubber<br>Functional Dimensions - Inlet - 15mm I.D<br>Outlet - 15mm I.D./22 mm O.D.<br>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 limited<br>number of brands of metered dose inhalers that have an integral dose counter.<br>The interaction of the adapter gear and the dose counter permits accurate |
| | monitoring of the amount of doses remaining in the inhaler device. The RTC<br>22-D does not include a similar gear. |
| | There currently is not a kit version of the RTC 22-D. Users must purchase the<br>MDI adapter, the tubing and the straight connector separately. |
| Aerosol<br>Performance | The RTC 24-V was tested in the laboratory with the following MDI<br>medications:<br>- Ventolin® HFA<br>- Atrovent® HFA<br>- QVAR® |
| | In the tests (shown below) that were performed upon the RTC 24-V and the<br>RTC 22-D predicate device, actual differences were not statistically<br>significant:<br>Particle Size (MMAD)<br>Geometric Standard Deviation (GSD)<br>Medication Captured on USP Throat |
| | In the tests (shown below) that were performed upon the RTC 24-V and the<br>RTC 22-D predicate device, actual differences were statistically significant,<br>with the RTC 24-V out-performing the RTC 22-D.<br>Total Dose Delivered<br>Respirable Fraction<br>Total Respirable Dose Delivered<br>Medication Retained in Device |
| Conclusion: | In laboratory testing the RTC 24-V is substantially equivalent to the RTC 22-D<br>predicate device. |

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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 [phone] or [phone] 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 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 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:

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