(283 days)
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No
The summary describes a mechanical adapter for metered dose inhalers and contains no mention of AI, ML, or related concepts.
No
The device is described as an "actuator" for delivering medication, not the medication itself or a device that directly treats a condition. It facilitates the delivery of therapeutic agents.
No
Explanation: The device is described as an "actuator for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers," indicating it is used for drug delivery, not diagnosis.
No
The device is described as "actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers" and "intended for use only when connected to ventilator tubing or tracheal tubes." This description clearly indicates a physical, hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "actuator for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers." This describes a device used to administer medication to a patient, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing diagnostic information
Therefore, the RTC Series Metered Dose Inhaler (MDI) Adapters fall under the category of a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes. The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use. The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.
Product codes
73 CAF
Device Description
Metered Dose Inhaler Adapter
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 27 2000
Ms. Tricia Wood Instrumentation Industries, Inc. 2990 Industrial Boulevard Bethel Park, PA 15102
Re: K991355 Metered Dose Inhaler Adapter Regulatory Class: II (two) Product Code: 73 CAF November 9, 1999 Dated: Received: November 15, 1999
Dear Ms. Wood:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Tricia Wood
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
foran AWesterhausen for,
elia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) NUMBER (IF KNOWN): K991355
DEVICE NAME:
Metered Dose Inhaler Adapter
INDICATION FOR USE:
The RTC Series Metered Dose Inhaler (MDI) Adapters are actuators for intermittent delivery of prescribed aerosol medications dispensed in metered dose inhalers. The RTC Series MDI Adapters are intended for use only when connected to ventilator tubing or tracheal tubes.
The RTC 15-D, RTC 22-D, and RTC 23-D models are intended for single patient use.
The RTC 22-A and RTC 23-A models are reusable and may be reprocessed.
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use (Per 21 CFR 801.109) | |
| OR | |
| Over-The-Counter-Use (Optional Format 1-2-96) | |
| (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices |
510(k) Number _