I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM

{0}------------------------------------------------ K102454 ## OCT 2 5 2011 ### 510(k) Summary Page 1 of 5 26-Sep-1 l | Respironics Respiratory Drug Delivery (UK) Limited | | |----------------------------------------------------|-----------------------------------------------------| | Chichester Business Park | | | City Fields Way, Tangmere | Tel - +44 800 1300 840 | | Chichester PO20 2FT UK | Fax - +44 800 1300 841 | | Official Contact: | Clare Fripp, Quality and Regulatory Affairs Manager | | Proprietary or Trade Name: | I-neb AAD Systems with TIM and | | | I-neb Insight AAD System | | Common/Usual Name: | Nebulizer (direct patient interface) | | Classification Name: | Nebulizer | | | CAF - 868.5630 | | Predicate Devices: | K062263 – Omron U-22 | | | K870027 - Salter 8900 nebulzier | | | K072019 - Activaero - AKITA2 APIXNEB | | | K042991 - Profile - I-neb AAD | | | K052491 - Profile - I-neb Insight | ### Device Description: The I-neb AAD System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. The I-neb Insight AAD System is an accessory for use with the I-neb AAD system and controls monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. The I-neb AAD system with TIM incorporates a modification of the predicate I-neb AAD system with (tidal breathing mode (TBM)), K042991. While the I-neb Insight incorporates updated software to accommodate the added TIM feature, it is a modification of the predicate I-neb Insight AAD System, K052941. ### Indications for Use: The I-neb AAD system with TIM is a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. The I-neb Insight AAD System is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. It is an accessory to an accessory for use with the I-neb AAD system. ### Patient Population: The I-neb AAD system with TIM is intended for patients > 3 years and older who can coordinate breathing. {1}------------------------------------------------ ### 510(k) Summary Page 2 of 5 26-Sep-1 l ### Environment of Use: Home care, nursing home, sub-acute institution, or hospital environment. ### Contraindications: None ### Performance Testing: I erformed comparative bench testing to demonstrate that the I-neb AAD System with TIM is we performed comparist remotion of System (K042991) in TBM mode, and Omron U22 Courtain'to the production in the comparative testing demonstrates that the proposed device is substantially equivalent to the predicate devices. Previous testing of the I-neb AAD system (K042991) included IEC 60601 and electrical safety, I revious testing of the Photo in the vironmental testing. As the proposed device is a modification Dires, Entil and Moonanteer with TBM (K042991) and 1-neb AAD with Insight (K052491) and no or the predicate i noo in he basic hardware was performed, thus repeating these tests was not required to demonstrate safety. Particle characterization via Cascade Impactor was performed with 3 drugs. This testing was performed at flow rates of 15 lpm and 30 lpm to simulate the intended patient population. Comparative dosing was performed. This testing demonstrated that the TBM and the TIM modes Comparative dosing was perfectived. This and Salter 8900 (K870027) were equivalent. ### Substantial Equivalence: The I-neb AAD System with TIM is viewed as substantially equivalent to the predicate devices because: ### Indications - As a general purpose nebulizer, identical to predicate – Omron U-22 (K062263), Salter 8900 (K870027) and Activaero AKITA2 APIXNEB (K072019) ### Technology - Identical vibrating mesh nebulizer technology to predicates – K042991 – I-neb AAD and K062263 - Omron U-22 Identical breath triggered nebulization technology to predicate - K042991 - I-neb AAD System and K072019 Activaero AKITA2 APIXNEB ### Materials - The materials in the gas and fluid pathway are identical to predicate device - K042991 -- I-neb AAD System. {2}------------------------------------------------ ### 510(k) Summary Page 3 of 5 26-Sep-11 ### Environment of Use - Environment of Ose – Identical to predicate – K062263 – Omron U-22, K072019 - Activaero AKITA² APIXNEB and K042991 - I-neb AAD. ### Patient Population - Faction I o predicates -K062263 - Omron U-22, K042991 - I-neb AAD System and K072019 Activaero AKITA2 APIXNEB. The I-neb Insight AAD System is viewed as substantially equivalent to the predicate devices because: Indications -Identical to predicate - K052491 - I-neb Insight AAD System ### Technology - Identical technology to predicate - K052491 - I-neb Insight AAD system ### Summary of Specific Particle Characterization and Dose testing - Comparison of particle characterization testing included the evaluation of . - MMAD, GSD, Respirable Fraction (%) the predicates and the proposed device o were found to be substantially equivalent. - Comparative Dose for the I-neb AAD system in TBM vs. TIM mode and to the . predicates Omron U22 (K062263) and Salter 8900 (K870027) was performed. - Parameters measured and compared included gravimetric dose, Filter dose and O Treatment time - Results the predicates and the proposed device were substantially equivalent. O {3}------------------------------------------------ | Attribute | Omron<br>U22 nebulizer<br>K062263 | Salter<br>8900<br>K870027 | Activaero<br>AKITA2 APIXNEB<br>K072019 | Profile<br>I-neb AAD<br>K042991 | Proposed<br>I-neb AAD with TIM | |---------------------------------------------------------------------------------------|-----------------------------------|---------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | General purpose use | General purpose use | General purpose use | Specific to a drug | General Purpose use | | Patient population | Adult and pediatric | Adult and Pediatric | 3 and older who can<br>coordinate breathing | 2 and older who can<br>coordinate breathing | 3 and older who can coordinate<br>breathing | | Nebulizer technology | Vibrating Mesh | Jet / venturi | Vibrating Mesh | Vibrating Mesh | Vibrating Mesh | | Accessory mouthpiece | Yes | Yes | N/A | Yes | Yes | | Software driven | Yes | No | Yes | Yes | Yes | | Mode of Operation | Continuous | Continuous | Breathe activated | Breathe activated | Breathe activated | | Synchronized delivery of<br>nebulized drug | No | No | Yes | Yes<br>Inhalation only | Yes<br>Inhalation only | | Drug delivery on demand | No | No | Yes | Yes | Yes | | Drug delivery triggered by | N/A | N/A | Patient inhalation<br>Pressure signal | Patient inhalation<br>Pressure signal | Patient inhalation<br>Pressure signal | | Drug delivery pulse range<br>(seconds) | N/A | N/A | 1 to 7 sec | 0.5 to 5 sec | Up to 7 sec | | Delivers medication | Continuously | Continuously | Up to the last 1 second of<br>the inhalation cycle | Between 50 to 80% of<br>the inhalation cycle | Up to the last 1 second of the<br>inhalation cycle | | Method of guiding patient for<br>Controlled inhalation | None | None | Auxiliary flow is<br>provided from a<br>compressor set at<br>15 Lpm | Use of a flap valve in the<br>mouthpiece in which the<br>patient entrains room air<br>which mixes with the<br>nebulized medication.<br>Approximate flow rate is<br>not controlled in TBM<br>mode | Use of a restrictive flap valve in the<br>mouthpiece to control breathing.<br>Vibration felt by the patient to<br>indicate target time. The patient<br>entrained room air which mixes<br>with the nebulized medication.<br>Approximate flow rate is 15 Lpm<br>for TIM mode | | Method of providing pre-set<br>parameters for nebulizer<br>performance | None | None | Yes<br>Smart Card | Yes<br>RF disc | Yes<br>RF disc | | Accessory for monitoring and<br>recording patient data for review<br>by the clinician | N/A | N/A | N/A | Yes | Yes | 1. {4}------------------------------------------------ ## 510(k) Summary # I-neb Insight with TIM ーーーー - । | Results | Profile | Proposed | |-------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | I-neb Insight<br>(K052491) | I-neb AAD with TIM | | Indications for Use<br>(all have except pentamidine) | Will be used with patients for whom<br>doctors have prescribed medication<br>for nebulization | Will be used with patients for whom<br>doctors have prescribed medication for<br>nebulization | | Accessory to I-neb AAD system with<br>the indications of monitoring and<br>providing patient feedback | The I-neb Insight is monitoring<br>software that provides feedback to the<br>patient recording treatment events,<br>including treatment times and<br>compliance data which is also<br>available to the clinician | The I-neb Insight is monitoring<br>software that provides feedback to the<br>patient recording treatment events,<br>including treatment times and<br>compliance data which is also available<br>to the clinician | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of two parts: the department's seal and the department's symbol. The seal is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. The symbol is a stylized representation of a human figure, with three wavy lines representing the body and head. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Respironics Respiratory Drug Delivery (UK) Limited C/O Mr. Paul Dryden President ProMedic, Incorporated 24301 Woodsage Drive · Bonita Springs, Florida 34134 Re: K102454 Trade/Device Name: I-neb AAD Systems with TIM and I-neb Insight AAD System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: October 6, 2011 Received: October 7, 2011 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. OCT 2 5 2011 {6}------------------------------------------------ ### 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Wh 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 Enclosure {7}------------------------------------------------ ### Indications for Use Statement ### Page 1 of 1 510(k) Number: K102454 Device Name: I-neb AAD system with TIM and I-neb Insight AAD system Indications for Use: The I-neb AAD system with TIM is a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment. The I-neb Insight AAD System is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. It is an accessory to an accessory for use with the I-neb AAD system. The I-neb AAD system with TIM is intended for patients 3 years and older who can coordinate breathing. 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: 4102454