(20 days)
Not Found
No
The summary describes a mechanical adapter for metered dose inhalers and makes no mention of AI or ML technology.
Yes
The device is intended to deliver prescribed aerosol medication to patients, which is a therapeutic intervention.
No
The device is described as an "actuator for intermittent delivery of prescribed aerosol medication." Its purpose is to deliver medication, not to diagnose a condition.
No
The device description clearly states it is an "actuator" and describes physical components and their interaction with ventilator tubing and metered dose inhalers, indicating a hardware device. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers." It's a mechanical device used to administer medication, not to perform tests on biological samples.
- Intended Use: The intended use is to deliver medication to ventilator-dependent patients, not to diagnose or monitor a condition through in vitro testing.
The device is a medical device, but it falls under a different category than IVDs.
N/A
Intended Use / Indications for Use
The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 24-VP 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-VP MDI Adapter is Critical Care and/or long term or short term ventilation.
The RTC 24-VP MDI 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 24-VP metered dose inhaler adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in metered dose inhalers.
Differences:
The RTC 24-VP has a decreased inlet port size of 15 mm OD. The RTC 24-V has an inlet port of 22 mm ID.
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
Not Found
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)
When a range of flow rates is used to ventilate air through both the new RTC 24-VP MDI adapter and the original RTC 24-V MDI adapter, very little difference is seen in peak circuit back pressure. The decreased inlet port size on the RTC 24-VP has no significant impact on the rate of flow through the device or on the circuit back pressure.
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
KC101857
Section 5 – 510(k) Summary Special 510 (k) Submission Page 1 of 2
JUL 2 2 2010
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
ﻟ
nstrumentation
dustries. Inc. We make Respiratory Care Work!
Date Prepared: June 30, 2010 Contact Person/Submitter: Doris F. Walter Official Correspondent for Instrumentation Industries, Inc.: Edward C. Horey
SPECIAL 510(k) SUMMARY
... .. ...
for
RTC 24-VP Metered Dose Inhaler Adapter
| Trade Name | RTC 24-VP Metered Dose Inhaler Adapter | |
|---|---|---|
| Common | ||
| Name | Actuator | |
| Classification | ||
| Name | Nebulizer | |
| Regulation | 21 CFR 868.5630 | |
| Predicate | ||
| Device | Instrumentation Industries, Inc. RTC 24-V (K091111) | |
| Device | ||
| Description | The Instrumentation Industries, Inc. RTC 24-VP metered dose inhaler adapter | |
| is an actuator for intermittent delivery of prescribed aerosol medication | ||
| dispensed in metered dose inhalers. | ||
| Intended Use | ||
| of the Device | ||
| RTC 24-VP | ||
| Metered Dose | ||
| Inhaler Adapter | The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for | |
| intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style | ||
| metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when | ||
| connected to ventilator tubing or tracheal tubes. | ||
| The RTC 24-VP 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-VP MDI Adapter is Critical Care | ||
| and/or long term or short term ventilation. | ||
| The RTC 24-VP MDI Adapter 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 and the materials of both the RTC 24-V predicate device and the | ||
| RTC 24-VP are the same. Both the RTC 24-V and the RTC 24-VP will accept |
1
Special 510 (k) Submission
-
1 - 1 - 1 -
. . . . . . .
| plastic or metal tipped, cylindrically-shaped MDI canisters. All materials are
| latex-free. | |
|---|---|
| Materials - Body – Polystyrene Butadiene | |
| Cap – Thermoplastic Rubber | |
| Functional Dimensions - Outlet – 15mm I.D. / 22 mm O.D. | |
| Markings – Both the RTC 24-V and the RTC 24-VP are marked with a | |
| molded-in arrow defining direction of flow. | |
| Differences: | |
| The RTC 24-VP has a decreased inlet port size of 15 mm OD. The RTC 24-V | |
| has an inlet port of 22 mm ID. | |
| Performance | When a range of flow rates is used to ventilate air through both the new RTC |
| 24-VP MDI adapter and the original RTC 24-V MDI adapter, very little | |
| difference is seen in peak circuit back pressure. The decreased inlet port size | |
| on the RTC 24-VP has no significant impact on the rate of flow through the | |
| device or on the circuit back pressure. | |
| Conclusion: | In laboratory testing the RTC 24-VP MDI adapter is substantially equivalent to the |
| RTC 24-V MDI adapter predicate device. |
. -
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of an abstract symbol, possibly representing the essence of health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
JUL 2.2 2010
Ms. Doris F. Walter Regulatory Affairs/Quality Assurance Manager Instrumentation Industries, Incorporated 2990 Industrial Boulevard Bethel Park, Pennsylvania 15102
Re: K101857
Trade/Device Name: RTC 24-VP Metered Dose Inhaler Adapter Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 30, 2010 Received: July 2, 2010
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.
3
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 (OS) 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Anthony O. Annett
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4 - Indications for Use Special 510(k) Submission Page 1 of 1
Indications for Use
510(k) Number (if known):
Device Name:
RTC 24-VP Metered Dose Inhaler Adapter
Statement of Indications for Use:
RTC 24-VP Metered Dose Inhaler Adapter
The Instrumentation Industries, Inc. RTC 24-VP MDI Adapter is an actuator for intermittent delivery of prescribed aerosol medication dispensed in cylindrical-style metered dose inhalers. The RTC 24-VP MDI Adapter is intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 24-VP 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-VP MDI Adapter is Critical Care and/or long term or short term ventilation.
The RTC 24-VP MDI Adapter is intended for single patient reuse.
This device is intended for sale by or on the order of a physician.
| Prescription Use | √ | And/Or | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
| 510(k) Number: | K101857 |
|---|---|
| ---------------- | --------- |
Concurrence of CDRH, Office of Device Evaluation (ODE)