MD TURBO

K051284 · Respirics, Inc. · CAF · Jun 22, 2005 · Anesthesiology

Device Facts

• Record ID: K051284
• Device Name: MD TURBO
• Applicant: Respirics, Inc.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

MD Turbo is a prescription accessory for pMDIs; assists medication delivery; monitors remaining doses. Device accepts pMDI canister/actuator assembly. Operation: user depresses loading lever; device triggers via breath-actuation (inspiratory flow) or manual button. Dose counting: user selects total doses; LCD displays remaining count; flashes when 20 or fewer doses remain. Used by patients in home/clinic settings. Benefits: improved delivery consistency; medication tracking. Healthcare providers use output to monitor patient adherence/medication usage.

Clinical Evidence

Bench testing only. Performance evaluated via cascade impaction tests for particle size distribution and HPLC analysis for total dose output. Compared MD Turbo + pMDI against Pocket Spacer + pMDI and pMDI alone. Results demonstrated equivalent performance characteristics.

Technological Characteristics

Materials: GE Lexan 144-112 and 144-122 (polycarbonate). Sensing/Actuation: Mechanical breath-actuation mechanism. Energy: Battery-powered (implied by LCD/electromechanical counter). Form factor: Handheld pMDI accessory. Connectivity: None. Sterilization: Not specified. Software: Embedded firmware for dose counting/LCD display.

Indications for Use

Indicated for patients requiring assistance with aerosolized medication delivery via pressurized metered dose inhalers (pMDI) and for tracking remaining medication doses.

Regulatory Classification

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.

Predicate Devices

• Ferraris Medical Inc. Pocket Spacer™ (K992038)
• Medtrack Products, LLC. Doser™ (K032955)
• Aradigm Corporation SmartMist™ (K960593)

Submission Summary (Full Text)

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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: [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

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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
- 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<br>Sensitization<br>Irritation/Intracutaneous<br>Bioburden | Appendix 3, pg 1-pg 5<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 8 |
| Pushlink | 1 | 5 | GE Lexan 144-112 | Yes | Yes | Cytotoxicity<br>Sensitization<br>Irritation/Intracutaneous<br>Bioburden | Appendix 3, pg 1-pg 5<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 8 |
| Vane | 1 | 7 | GE Lexan 144-112 | Yes | Yes | Cytotoxicity<br>Sensitization<br>Irritation/Intracutaneous<br>Bioburden | Appendix 3, pg 1-pg 5<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 8 |
| Vane Lock | 1 | 8 | GE Lexan 144-112 | Yes | Yes | Cytotoxicity<br>Sensitization<br>Irritation/Intracutaneous<br>Bioburden | Appendix 3, pg 1-pg 5<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 8 |
| Case Half, Side B | 2 | 1 | GE Lexan 144-122 | Yes | No | Cytotoxicity<br>Sensitization<br>Irritation/Intracutaneous<br>Bioburden | Appendix 3, pg 1-pg 5<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 8 |
| Bezel, Counter | 2 | 3 | GE Lexan 144-112 | Yes | No | Cytotoxicity<br>Sensitization<br>Irritation/Intracutaneous<br>Bioburden | Appendix 3, pg 1-pg 5<br>Appendix 3, pg 6-pg 7<br>Appendix 3, pg 6-pg 7<br>Appendix 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 [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: _______________________________________________________________________________________________________________________________________________________________