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.

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.

AI/ML Overview

This document describes the regulatory submission for the Southmedic SMDIA-1000, an adaptor for intermittent delivery of aerosol medications from Metered Dose Inhalers (MDIs) when connected to ventilator or tracheal tubes. The submission aims to demonstrate substantial equivalence to predicate devices, not an AI device. As such, information regarding AI-specific criteria, such as "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone (i.e., algorithm only without human-in-the-loop performance)," and sample sizes/ground truth for training/test sets, is not applicable or present in this document.

Here's the breakdown of the provided information relevant to acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily established through comparative performance testing against predicate devices and adherence to internal pass/fail criteria for various engineering tests.

Acceptance Criteria (What was tested)	Reported Device Performance (Southmedic 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. They are intended for use only when connected to ventilator tubing or tracheal tubes. (Identical to predicate K091111 - RTC-24V)
Technology / Design	Tee design with a port which is capped when not in use. (Identical to predicate K091111 - RTC-24V)
Materials (specifically those in gas or fluid pathway)	Materials in the gas or fluid pathway have been tested per ISO 10993 for Cytotoxicity, Irritation, and Sensitization. (Implies meeting safety standards)
Environment of Use	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. (Substantially equivalent to predicate K091111 - RTC-24V)
Comparative Particle Characterization via Cascade Impactor	3 samples with 3 different drugs MDI burst. Demonstrated that the performance of the proposed device and the predicate were equivalent. (Predicate: 3 drug types, 1 sample each, implying comparable results were expected and achieved)
Simulated Life Cycle Testing	Same sample testing for intra-sample variability. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Environmental Testing	Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Operational Testing	Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Drop Testing	Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Canister Activation Testing	Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Connection Trial Testing	Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Inter- and Intra-sample Variability Testing	Performed. (Details not explicitly provided, but stated that the proposed device met its pass/fail criteria or was found substantially equivalent to the predicate).
Biocompatibility Testing (Cytotoxicity, Irritation, Sensitization)	Tested per ISO 10993. (Implies acceptable results were achieved for these safety parameters).
Other Design Features (e.g., Placed in breathing circuit)	Yes (Identical to predicate).
May attach to a tracheal tube	Yes (Identical to predicate).
Tee with standard 15 mm / 22 mm fittings	Yes (Identical to predicate).
Fitting for adaption to MDI	Yes (Identical to predicate).
Cap when not in use	Yes (Identical to predicate).
Single patient use, disposable	Yes (Identical to predicate).

2. Sample Size Used for the Test Set and Data Provenance

Particle Characterization via Cascade Impactor: 3 samples with 3 different drugs were tested for the proposed device (SMDIA-1000). The predicate used 3 drug types, 1 sample each.
Other Performance Testing (Simulated life cycle, environmental, operational, drop, canister activation, connection trial, inter- and intra-sample variability): Not explicitly stated, but the document mentions "same sample testing for intra-sample variability" for simulated life cycle, implying repeated tests on the same units. The exact number of units or test cycles for these other tests is not provided.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device, these tests would typically be laboratory-based prospective engineering/performance studies rather than clinical studies with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. This is a submission for a physical medical device (an MDI adaptor), not an AI device or diagnostic tool that relies on expert interpretation for ground truth. The "ground truth" for this device's performance is objective measurements (e.g., particle size distribution, durability under stress, material biocompatibility) and comparison to established predicate device functionality, not expert consensus on diagnostic images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as the tests are objective engineering and performance evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers are interpreting images or data. This document pertains to a physical medical device where effectiveness is demonstrated through engineering performance and substantial equivalence to a predicate.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the SMDIA-1000 appears to be:

Objective Engineering Measurements: Particle size distribution (via Cascade Impactor), durability (simulated life cycle, drop tests), functional integrity (operational, canister activation, connection trials).
Biocompatibility Testing: Adherence to ISO 10993 standards for cytotoxicity, irritation, and sensitization.
Predicate Device Performance: The performance of the predicate devices (K991355 - RTC-22-D and K091111 - RTC-24V) served as the benchmark for demonstrating substantial equivalence. The predicate performance would also have been established through similar objective engineering and biocompatibility tests.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

Summary

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K101953

JAN - 7 2011

Southmedic, Inc.50 Alliance Blvd.Barrie, ONT	Tel – (705) 720-1902 x 342Fax – (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 – nebulizerCFR 868.5630
Device:	Southmedic SMDIA 1000
Predicate Devices:	Instrumentation IndustriesK991355 - RTC-22-DK091111 - RTC-24V

Device Description:

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.

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510(k) SummaryPage 2 of 324-Dec-10	PredicateK991355 - R
A-1000

Summary of substantial equivalence	Southmedic SMDIA-1000	Predicate - Instrumentation IndustriesK991355-RTC-22-D & K091111 - RTC-24V
Indications for Use	The SMDIA-1000 MDI adaptor is intended to be used with anMDI for intermittent delivery of prescribed aerosolmedications dispensed in MDIs. They are intended for useonly when connected to ventilator tubing or tracheal tubes.	The RTC series MDI adapters are actuators for intermittentdelivery of prescribed aerosol medications dispensed in meterdose inhalers. The RTC series MDI adapters are intended foruse 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 inhospitals, 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 towhom a MDI has been prescribed.	For any patient who is ventilator dependent and to whoma 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 / 22mm 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 viaCascade Impactor	3 samples with 3 different drugsMDI burst	3 drug types1 sample each
Simulated life cycle and	Same sample testing for intra-sample variabilityEnvironment, operational, drop, canister activation and	Not listed

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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.

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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. .

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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

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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 single patient use, disposable.

Prescription Use XX (Part 21 CFR 801 Subpart D)

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

Regulation Number and Section

§ 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).