(229 days)
Not Found
No
The description focuses on the mechanical function of the device as an actuator for delivering medication from a metered dose inhaler and does not mention any computational or learning capabilities.
No
The device is an adapter or actuator for delivering prescribed aerosol medication, but it does not directly treat a condition itself. It facilitates the delivery of medication which is therapeutic.
No
Explanation: The device is described as an "actuator for intermittent delivery of prescribed aerosol medication." Its primary function is to help administer medication from a metered dose inhaler, not to diagnose a medical condition.
No
The device description explicitly lists physical components (adapter, tubing) and describes it as an "actuator," indicating a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The RTC 24-V MDI Adapter and Kit are designed to deliver aerosol medication from a metered dose inhaler directly into a patient's respiratory system via ventilator tubing or tracheal tubes.
- Intended Use: The intended use clearly states it's for delivering prescribed aerosol medication to ventilator-dependent patients. It does not involve testing or analyzing biological specimens.
The device is a medical device used for drug delivery, specifically in a respiratory support setting.
N/A
Intended Use / 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 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CAF
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
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
Not Found
Intended User / Care Setting
Expected clinical environment for the RTC 24-V MDI Adapter and RTC 24-V KIT is Critical Care and/or long term or short term ventilation. Device is intended for sale by or on the order of a physician.
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)
The RTC 24-V was tested in the laboratory with the following MDI medications:
- Ventolin® HFA
- Atrovent® HFA
- QVAR®
In the tests performed upon the RTC 24-V and the RTC 22-D predicate device, actual differences were not statistically significant:
Particle Size (MMAD)
Geometric Standard Deviation (GSD)
Medication Captured on USP Throat
In the tests performed upon the RTC 24-V and the RTC 22-D predicate device, actual differences were statistically significant, with the RTC 24-V out-performing the RTC 22-D.
Total Dose Delivered
Respirable Fraction
Total Respirable Dose Delivered
Medication Retained in Device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
X0911111
iş
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 Adapter
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
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 |
| Intended Use
of the Device
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 |
| RTC 24-V
Metered Dose
Inhaler Adapter
Kit
(To be sold as
model number
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
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. |
| Technological
Characteristics | Similarities: The function, inlet and outlet end dimensions, and the materials of both the
RTC 22-D predicate device and the RTC 24-V are the same. Both the RTC
22-D and the RTC 24-V will accept plastic or metal tipped, cylindrically-
shaped MDI canisters. All materials are latex-free.
Materials - Body - Polystyrene Butadiene
Cap - Thermoplastic Rubber
Functional Dimensions - Inlet - 15mm I.D
Outlet - 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 limited
number 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 RTC
22-D does not include a similar gear. |
| | There currently is not a kit version of the RTC 22-D. Users must purchase the
MDI adapter, the tubing and the straight connector separately. |
| Aerosol
Performance | The RTC 24-V was tested in the laboratory with the following MDI
medications:
- Ventolin® HFA
- Atrovent® HFA
- QVAR® |
| | In the tests (shown below) that were performed upon the RTC 24-V and the
RTC 22-D predicate device, actual differences were not statistically
significant:
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 the
RTC 22-D predicate device, actual differences were statistically significant,
with the RTC 24-V out-performing the RTC 22-D.
Total Dose Delivered
Respirable Fraction
Total Respirable Dose Delivered
Medication Retained in Device |
| Conclusion: | In laboratory testing the RTC 24-V is substantially equivalent to the RTC 22-D
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.
4
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
5
Section 4 Page 1 of 2 Revised Nov. 23, 2009
Indications for Use
510(k) Number (if known):
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
6
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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