MD Turbo is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized pressurized metered dose inhalers (pMDI). MD Turbo is also intended for use by patients to count the number of doses remaining in their pMDI.

Device Description

The Respirics Inc. MD Turbo™ is a prescription accessory device designed for use with specific pressurized metered dose inhalers (pMDI). The MD Turbo™ is comprised of a triggering mechanism and dose counter. In addition to its primary function of assisting with the delivery of medications from pMDIs, the secondary function monitors the quantity of medication remaining in the pMDI canister. MD Turbo™ is designed to work with a number of different style pMDIs, without modification. The entire pMDI, i.e., canister and plastic actuator, is inserted into the MD Turbo™. If necessary, the pMDI can be removed for cleaning or if the MD Turbo™ becomes inoperable. Once the pMDI has been placed into the MD Turbo™, the device is prepared for use by the depression of a loading lever. After the loading lever is depressed, the pMDI can be triggered to deliver the prescribed medication through either breath-actuation or manual actuation. For breathactuation, the patient inhales through the pMDI actuator mouthpiece that has been inserted into the MD Turbo™. When the inspiratory flow of the patient reaches the target inspiratory flow rate, the device mechanism is triggered to actuate the pMDI canister and the medication is delivered to the patient. Alternatively, the patient can trigger MD Turbo™ to actuate the pMDI canister by depressing a recessed button on the back of the device. The MD Turbo™ also functions as a dose counter. Once a pMDI has been inserted into MD Turbo™, the patient selects the number of doses contained in the pMDI canister. The number is displayed on an LCD on the side of the device. Every time the MD Turbo™ is activated, the counter decrements appropriately. When the counter reaches 20 or fewer doses, the number display will start to flash.

AI/ML Overview

The MD Turbo is a metered dose inhaler accessory. The available documentation does not contain information on specific quantitative acceptance criteria for the device's performance related to its primary function (assisting with medication delivery) or its secondary function (dose counting). The submission focuses on demonstrating substantial equivalence to predicate devices through comparative testing of physical characteristics.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance:

Feature	Acceptance Criteria (Implied/Compared to Predicate)	Reported Device Performance
Medication Delivery:
Total Dose Output	Similar to Pocket Spacer™ with pMDI, and pMDI alone	Results from HPLC analysis were used for comparison. (Specific values not provided, conclusion is "similar performance characteristics")
Particle Size Distribution	Similar to Pocket Spacer™ with pMDI, and pMDI alone	Results from Cascade Impaction tests were used for comparison. (Specific values not provided, conclusion is "similar performance characteristics")
Dose Counting:
Dose Counter Accuracy	Similar to Meditrack Products Doser™	MD Turbo™ functions as a dose counter, decrementing appropriately and flashing when 20 or fewer doses remain. (No specific accuracy metrics provided for comparison, but implied to be equivalent to predicate)
Biocompatibility:	Meet ISO 10993 standards (implied by tests)	Cytotoxicity, Sensitization, Irritation/Intracutaneous, Bioburden tests performed on patient-contacting and airway-continuity materials, with results documented in Appendix 3. (Specific pass/fail criteria and results not detailed, but submission implies they met accepted standards).
Technological Characteristics:	No significant change in design, materials, energy source, or other technological characteristics compared to predicate devices.	MD Turbo™ is functionally similar to predicate devices, combining features previously separate.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the sample sizes used for the cascade impaction tests or HPLC analysis.
Data Provenance: The studies were performed by Respirics Inc. The country of origin and whether the studies were retrospective or prospective are not explicitly stated, but they appear to be laboratory-based performance tests rather than clinical studies on patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the studies described are laboratory performance tests comparing physical characteristics, not diagnostic or clinical efficacy studies requiring expert ground truth establishment.

4. Adjudication method for the test set:

This information is not applicable for the reasons stated above.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC comparative effectiveness study was done. The device, MD Turbo, is a mechanical accessory for metered dose inhalers and a dose counter, not an AI-assisted diagnostic or decision-support tool. Therefore, the concept of "human readers improving with AI assistance" is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone performance was done in the sense that the device's mechanical functions (medication delivery and dose counting) were evaluated in a laboratory setting without human intervention beyond operating the device for the tests. However, it's important to clarify that this is not an "algorithm-only" performance as would be relevant for an AI device. The MD Turbo is primarily a mechanical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the medication delivery performance (total dose output and particle size distribution), the "ground truth" was established by comparing the MD Turbo™ in conjunction with a pMDI to a predicate device (Pocket Spacer™ with pMDI) and to the pMDI alone. This is a comparative performance study against established methods/devices. The inherent performance of the pMDI alone and the predicate spacer serve as the reference.
For the dose counting function, the ground truth would be the actual number of doses actuated, measured directly, and compared to the device's counter display. No specific details about this "ground truth" establishment are given, but it would likely be through direct observation of manual actuations.
For biocompatibility, the ground truth is adherence to established biocompatibility standards (e.g., ISO 10993 series), for which the specified tests (Cytotoxicity, Sensitization, Irritation/Intracutaneous, Bioburden) provide the evidence.

8. The sample size for the training set:

Not applicable. The MD Turbo is an accessory device that does not use machine learning or AI algorithms requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. (See point 8).

Summary

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Ko5/284

510(k) SUMMARY

Respirics Inc. MD Turbo™

Submitter's Name, Contact Person, Address, Telephone Number, and Date Prepared

Gilbert S. Mott, Jr. Chief Executive Officer Respirics Inc. 6008 Triangle Drive, Suite 101 Raleigh, NC 27617 Telephone: (919) 789-4220 Facsimile: (919) 789-4254

Date Prepared:

January 31, 2005

Name of Device and Name/Address of Sponsor

Respirics Inc. MD Turbo™

Gilbert S. Mott. Jr. Chief Executive Officer Respirics Inc. 6008 Triangle Drive, Suite 101 Raleigh, NC 27617

Common Name

Metered dose inhaler accessory

Classification Name

Accessory to a Nebulizer/Metered Dose Inhaler, Spacer. Actuator Class II - 868.5630

Predicate Devices

1. Ferraris Medical Inc. Pocket Spacer™ (K992038)
(Ka32955) 2. Medtrack Products, LLC. - Doser™
1. Aradigm Corporation SmartMist™ (K960593)

Device Description

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MD Turbo™ is designed to work with a number of different style pMDIs, without modification. The entire pMDI, i.e., canister and plastic actuator, is inserted into the MD Turbo™. If necessary, the pMDI can be removed for cleaning or if the MD Turbo™ becomes inoperable.

Once the pMDI has been placed into the MD Turbo™, the device is prepared for use by the depression of a loading lever. After the loading lever is depressed, the pMDI can be triggered to deliver the prescribed medication through either breath-actuation or manual actuation. For breathactuation, the patient inhales through the pMDI actuator mouthpiece that has been inserted into the MD Turbo™. When the inspiratory flow of the patient reaches the target inspiratory flow rate, the device mechanism is triggered to actuate the pMDI canister and the medication is delivered to the patient. Alternatively, the patient can trigger MD Turbo™ to actuate the pMDI canister by depressing a recessed button on the back of the device.

The MD Turbo™ also functions as a dose counter. Once a pMDI has been inserted into MD Turbo™, the patient selects the number of doses contained in the pMDI canister. The number is displayed on an LCD on the side of the device. Every time the MD Turbo™ is activated, the counter decrements appropriately. When the counter reaches 20 or fewer doses, the number display will start to flash.

Intended Use

MD Turbo™ is intended to assist with the delivery of aerosolized medications when used in conjunction with commercialized pressurized metered dose inhalers (pMDI). MD Turbo™ is also intended for use by patients to count the number of doses remaining in their pMDI.

Technological Characteristics and Substantial Equivalence

The MD Turbo™ has no significant change in design, materials, energy source or other technological characteristics compared to the predicate devices. MD Turbo™ is similar in function to these predicate devices. MD Turbo™ combines features that have in the past only been available as separate commercialized devices. The MD Turbo™ is therefore compared to three predicate devices: the pMDI medication delivery function is compared to the Ferraris Medical Pocket Spacer™; the counter function is compared to the Meditrack Products Doser™; and the actuation mechanism is compared to the Aradigm Corporation SmartMist™ Asthma Management System.

As an accessory to pMDI medication delivery, MD Turbo™ differs from the predicate Pocket Spacer™ in that MD Turbo™ is an active mechanical device rather than a passive mechanical device. As an accessory to pMDI dose counting, both the MD Turbo™ and the predicate Doser™ use

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electromechanical mechanisms. With regard to the breath-actuation mechanism, the MD Turbo™ uses a mechanical mechanism and the predicate SmartMist™ uses an electromechanical mechanism.

Performance Data

Respirics performed cascade impaction tests for particle size comparison, and an HPLC analysis for total dose output comparing MD Turbo™ with pMDI to the Pocket Spacer™ with pMDI and to pMDI alone.

1. Total dose output (HPLC): MD Turbo™ with MDI, Pocket Spacer™ with pMDI, and pMDI alone
1. Particle size distribution (Cascade Impaction): MD Turbo™ with pMDI, Pocket Spacer™ with pMDI, and pMDI alone

Conclusions

The MD Turbo™ has similar intended use and similar performance characteristics to the predicate devices. Furthermore, the results of the testing raise no new issues of safety and effectiveness. Therefore, the MD Turbo™ is substantially equivalent to the predicate devices.

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Table 1. Biocompatibility of Materials in Contact with Patient or Air Flow Path / K051284

Part Name	Diagram#	Part#	Material	Patient Contact	Airway Continuity	Biocompatibility Test	Page Ref
Case Half, Side A	1	1	GE Lexan 144-112	Yes	No	CytotoxicitySensitizationIrritation/IntracutaneousBioburden	Appendix 3, pg 1-pg 5Appendix 3, pg 6-pg 7Appendix 3, pg 6-pg 7Appendix 3, pg 8
Pushlink	1	5	GE Lexan 144-112	Yes	Yes	CytotoxicitySensitizationIrritation/IntracutaneousBioburden	Appendix 3, pg 1-pg 5Appendix 3, pg 6-pg 7Appendix 3, pg 6-pg 7Appendix 3, pg 8
Vane	1	7	GE Lexan 144-112	Yes	Yes	CytotoxicitySensitizationIrritation/IntracutaneousBioburden	Appendix 3, pg 1-pg 5Appendix 3, pg 6-pg 7Appendix 3, pg 6-pg 7Appendix 3, pg 8
Vane Lock	1	8	GE Lexan 144-112	Yes	Yes	CytotoxicitySensitizationIrritation/IntracutaneousBioburden	Appendix 3, pg 1-pg 5Appendix 3, pg 6-pg 7Appendix 3, pg 6-pg 7Appendix 3, pg 8
Case Half, Side B	2	1	GE Lexan 144-122	Yes	No	CytotoxicitySensitizationIrritation/IntracutaneousBioburden	Appendix 3, pg 1-pg 5Appendix 3, pg 6-pg 7Appendix 3, pg 6-pg 7Appendix 3, pg 8
Bezel, Counter	2	3	GE Lexan 144-112	Yes	No	CytotoxicitySensitizationIrritation/IntracutaneousBioburden	Appendix 3, pg 1-pg 5Appendix 3, pg 6-pg 7Appendix 3, pg 6-pg 7Appendix 3

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted with three lines forming the staff and snakes, giving it a modern and abstract appearance. The text is in all capital letters and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 2 2005

Respirics, Incorporated C/O Mr. Edwards M. Basile King & Spalding LLP 1700 Pennsylvania Avenue, N.W. Washington, D.C. 20006-4706

Re: K051284 Trade/Device Name: MD Turbo Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: May 12, 2005 Received: May 13, 2005

Dear Mr. Basile:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 micrstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to devrees that nortic Act (Act) that do not require approval of a premarket the Fouchar Food, Drug, that Connects , therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the From 2007 , 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 If your device is existere to such additional controls. Existing major regulations affecting (1 MA), it may of subject to back adam and regulations, Title 21, Parts 800 to 898. In your device can be found in the be as nouncements concerning your device in the Federal Register.

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Public Health Service

Page 2 - Mr. Basile

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA 3 issualled of a basecan its with other requirements
mean that FDA has made a determination that your device the Forders assession mean that FDA has made a decornmances and regulations administered by other Federal agencies. of the Act of ally rederal statutes and regularents, including, but not limited to: registration
You must comply with all the Act's requirements, including who heavy in You must colliply with an the Fec 3 requirements art 801); good manufacturing practices
and listing (21 CFR Part 807); labeling (21 CFR Part 801); gEP Bact 800); and i and listing (21 CFR I all 807), laocime (21 CFR Part 820); and if 51 CFR Part 820); and if requirements as set form in the quality Systems (SB) regains (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will anow you to ocgain mationing of substantial equivalence of your device to a premarket notification. The I Dr Imaling of backance for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your de recognize. Also, please note the regulation prease contact the Other or Ochiphants and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general micrimational and Consumer Assistance at its toll-free Division of 011-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jenette Y. Michini Oms.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

MD Turbo Device Name:

Indications for Use:

Indications for Use.
MD Turbo is intended to assist with the delivery of aerosolized medications when MD Turbo is intended to assist writt the connectical metered dose inhalers
used in conjunction with commercialized pressurized meters of count the number of used in conjunction with commendation proboch 2011 11:12 PMD In 1997
(pMDI). MD Turbo is also intended for use by patients to count the number of doses remaining in their pMDI.

Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1of 1

Cainy Sule

(Division Sign-Off) (Division Sign-Off)
Division of Anesthestiony, General Hospital,
Division Ourtmi, Dental Devices Division of Anesthesions of Anestical Devices KOS1284

510(k) Number: _______________________________________________________________________________________________________________________________________________________________

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).