(179 days)
Not Found
No
The device description and performance studies focus on the mechanical function of an adaptor for delivering medication, with no mention of AI or ML capabilities.
No.
The device is an adaptor for aerosol medication delivery and does not itself treat or prevent a disease or condition.
No
The device is an adaptor for delivering aerosol medications, not for diagnosing conditions. Its function is to facilitate the delivery of drugs, not to identify or monitor medical states.
No
The device description clearly states it is an "adaptor which acts as an actuator" and is a physical component intended to be connected to ventilator tubing or tracheal tubes and an MDI. This indicates a hardware device, not software only.
Based on the provided information, the SMDIA-1000 MDI adaptor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for the "intermittent delivery of prescribed aerosol medications dispensed in MDIs." This is a therapeutic purpose, delivering medication to a patient.
- Device Description: The description reinforces its function as an "actuator for intermittent delivery of prescribed aerosol medications."
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The SMDIA-1000 does not interact with or analyze any biological specimens.
Therefore, the SMDIA-1000 MDI adaptor is a medical device used for drug delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. They are intended for use only when connected to ventilator tubing or tracheal tubes. The SMDIA-1000 MDI adaptor is single patient use, disposable.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
The Southmedic SMDIA-1000 is an adaptor which acts as an actuator for intermittent delivery of prescribed aerosol medications dispensed by meter dose inhalers (MDI). The SMDIA-1000 is connected to ventilator tubing and the MDI connected when drug delivery into the circuit is required. The SMDIA-1000 adaptor may also be connected to the endotracheal tube.
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
The expected clinical environment is critical care and / or long or short term ventilation, which can occur in hospitals, ICU, sub-acute centers, and home settings.
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)
Comparative Particle characterization testing via Cascade Impactor demonstrated that the performance of the proposed device and the predicate were equivalent. Additional performance testing included Simulated life cycle, environmental, operational, drug, canister activation and connection trial testing, inter- and intra-sample testing for variability. For which the proposed device met its pass / fail criteria or was found substantially equivalent to the predicate.
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
K101953
JAN - 7 2011
| Southmedic, Inc.
50 Alliance Blvd.
Barrie, ONT | Tel – (705) 720-1902 x 342
Fax – (705) 728-9537 |
|------------------------------------------------------|-----------------------------------------------------------------------|
| Official Contact: | Tish Anger - VP Quality & Regulatory Assurance |
| Proprietary or Trade Name: | SMDIA-1000 |
| Common/Usual Name: | Accessory to a nebulizer |
| Classification Name/Code: | CAF – nebulizer
CFR 868.5630 |
| Device: | Southmedic SMDIA 1000 |
| Predicate Devices: | Instrumentation Industries
K991355 - RTC-22-D
K091111 - RTC-24V |
Device Description:
The Southmedic SMDIA-1000 is an adaptor which acts as an actuator for intermittent delivery of prescribed aerosol medications dispensed by meter dose inhalers (MDI). The SMDIA-1000 is connected to ventilator tubing and the MDI connected when drug delivery into the circuit is required. The SMDIA-1000 adaptor may also be connected to the endotracheal tube.
Indications for Use:
The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDI's. They are intended for use only when connected to ventilator tubing or tracheal tubes.
Environment of Use:
The expected clinical environment is critical care and / or long or short term ventilation, which can occur in hospitals, ICU, sub-acute centers, and home settings.
Patient Population:
The SMDIA-1000 is intended to be prescribed for any patient who is ventilator dependent and to whom a MDI has been prescribed.
1
| 510(k) Summary
Page 2 of 3
24-Dec-10 | Predicate
K991355 - R |
|--------------------------------------------|--------------------------|
| A-1000 | |
| Summary of substantial equivalence | Southmedic SMDIA-1000 | Predicate - Instrumentation Industries
K991355-RTC-22-D & K091111 - RTC-24V |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The SMDIA-1000 MDI adaptor is intended to be used with an
MDI for intermittent delivery of prescribed aerosol
medications dispensed in MDIs. They are intended for use
only when connected to ventilator tubing or tracheal tubes. | The RTC series MDI adapters are actuators for intermittent
delivery of prescribed aerosol medications dispensed in meter
dose inhalers. The RTC series MDI adapters are intended for
use only when connected to ventilator tubing or tracheal tubes. |
| Environment of use | The expected clinical environment is critical care and /
or long or short term ventilation, which can occur in
hospitals, ICU, sub-acute centers, and home settings. | The expected clinical environment is critical care and /
or long or short term ventilation. |
| Patient Population | For any patient who is ventilator dependent and to
whom a MDI has been prescribed. | For any patient who is ventilator dependent and to whom
a MDI has been prescribed. |
| Prescriptive | Yes | Yes |
| Design | | |
| Placed in the breathing circuit | Yes | Yes |
| May attach to a tracheal tube | Yes | Yes |
| Tee with standard 15 mm / 22
mm fittings | Yes | Yes |
| Fitting for adaption to MDI | Yes | Yes |
| Cap when not in use | Yes | Yes |
| Single patient use, disposable | Yes | Yes |
| Performance Testing | | |
| Particle characterization via
Cascade Impactor | 3 samples with 3 different drugs
MDI burst | 3 drug types
1 sample each |
| Simulated life cycle and | Same sample testing for intra-sample variability
Environment, operational, drop, canister activation and | Not listed |
2
510(k) Summary Page 3 of 3 24-Dec-10
In summarizing the above comparative table the SMDIA-1000 is viewed as substantially equivalent to the predicate devices because:
Indications -
- Intended to be used with an MDI for intermittent delivery of prescribed aerosol medications . dispensed in MDIs. They are intended for use only when connected to ventilator tubing or tracheal tubes. These indications for use are identical to the predicate - K091111 - RTC-24V
Technology -
- The tee design with a port which is capped when not in used is identical to the predicate -. K091111 - RTC-24V
Materials -
- . The materials in the gas or fluid pathway have been tested per ISO 10993 for Cytotoxicity, Irritation, and Sensitization
Environment of Use -
- The expected clinical environment is critical care and / or long or short term ventilation, � which can occur in hospitals, ICU, sub-acute centers, and home settings in substantially equivalent to the predicate - K091111 -- RTC-24V
Comparative Performance -
- . Comparative Particle characterization testing via Cascade Impactor demonstrated that the performance of the proposed device and the predicate were equivalent
- Additional performance testing included Simulated life cycle, environmental, operational, . drop, canister activation and connection trial testing, inter- and intra-sample testing for variability. For which the proposed device met its pass / fail criteria or was found substantially equivalent to the predicate.
Differences -
There are no significant differences between the proposed device and the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MID 20993-0002
Southmedic, Incorporated C/O Mr. Paul E. Dryden President Promedic, Incorporated 24301 Woodsage Drive Bonita Springs, Florida 34134
JAN - 7 2011
Re: K101953
Trade/Device Name: SMDIA-1000 Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: December 24, 2010 Received: December 27, 2010
Dear Mr. Dryden:
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. .
4
Page 2- Mr. Dryden
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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
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
5
JAN - 7 2011
Indications for Use Statement
Page 1 of 1
510(k) Number: K101953
Device Name: SMDIA - 1000
Indications for Use:
The SMDIA-1000 MDI adaptor is intended to be used with an MDI for intermittent delivery of prescribed aerosol medications dispensed in MDIs. It is intended for use only when connected to ventilator tubing or tracheal tubes.
The SMDIA-1000 MDI adaptor is single patient use, disposable.
Prescription Use XX (Part 21 CFR 801 Subpart D)
or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101953