MD TURBO

• K Number: K051284
• Device Name: MD TURBO
• Manufacturer: RESPIRICS, INC.
• Date Cleared: 2005-06-22 ( 40 days)
• Product Code: CAF
• Regulation Number: 868.5630

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.

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.

Predicate Devices

K992038, K032955, K960593

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical triggering mechanisms and a simple dose counter, with no mention of AI/ML terms or functionalities.

Therapeutic

No.
The device assists in the delivery of medication; it does not directly provide therapeutic action itself.

Diagnostic

No

The device assists with the delivery of medication and counts remaining doses; it does not diagnose any medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a triggering mechanism, dose counter, loading lever, recessed button, and an LCD display. It also describes the physical interaction with a pMDI canister. This indicates a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the MD Turbo is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use is to assist with the delivery of aerosolized medications and count the remaining doses in a pMDI. This is a mechanical function related to drug delivery, not the examination of specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
• Device Description: The description details a mechanical device with a triggering mechanism and dose counter. It does not involve any reagents, test strips, or analysis of biological samples.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analysis of biological specimens (blood, urine, tissue, etc.)
  • Detection or measurement of analytes
  • Providing information for diagnosis, monitoring, or screening of diseases or conditions.

The MD Turbo is an accessory device for drug delivery, specifically for use with pressurized metered dose inhalers.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

CAF

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.

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)

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
2. Particle size distribution (Cascade Impaction): MD Turbo™ with pMDI, Pocket Spacer™ with pMDI, and pMDI alone

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.

K992038, K032955, K960593

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

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).

Summary

0

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: [phone] Facsimile: [phone]

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™
• 3. Aradigm Corporation SmartMist™ (K960593)

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.

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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

2

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
• 2. 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	Cytotoxicity
Sensitization
Irritation/Intracutaneous
Bioburden	Appendix 3, pg 1-pg 5
Appendix 3, pg 6-pg 7
Appendix 3, pg 6-pg 7
Appendix 3, pg 8
Pushlink	1	5	GE Lexan 144-112	Yes	Yes	Cytotoxicity
Sensitization
Irritation/Intracutaneous
Bioburden	Appendix 3, pg 1-pg 5
Appendix 3, pg 6-pg 7
Appendix 3, pg 6-pg 7
Appendix 3, pg 8
Vane	1	7	GE Lexan 144-112	Yes	Yes	Cytotoxicity
Sensitization
Irritation/Intracutaneous
Bioburden	Appendix 3, pg 1-pg 5
Appendix 3, pg 6-pg 7
Appendix 3, pg 6-pg 7
Appendix 3, pg 8
Vane Lock	1	8	GE Lexan 144-112	Yes	Yes	Cytotoxicity
Sensitization
Irritation/Intracutaneous
Bioburden	Appendix 3, pg 1-pg 5
Appendix 3, pg 6-pg 7
Appendix 3, pg 6-pg 7
Appendix 3, pg 8
Case Half, Side B	2	1	GE Lexan 144-122	Yes	No	Cytotoxicity
Sensitization
Irritation/Intracutaneous
Bioburden	Appendix 3, pg 1-pg 5
Appendix 3, pg 6-pg 7
Appendix 3, pg 6-pg 7
Appendix 3, pg 8
Bezel, Counter	2	3	GE Lexan 144-112	Yes	No	Cytotoxicity
Sensitization
Irritation/Intracutaneous
Bioburden	Appendix 3, pg 1-pg 5
Appendix 3, pg 6-pg 7
Appendix 3, pg 6-pg 7
Appendix 3

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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.

5

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 [phone] 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: _______________________________________________________________________________________________________________________________________________________________