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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the I-neb AAD Systems with TIM and I-neb Insight AAD System. The primary method for demonstrating substantial equivalence is through comparative bench testing against predicate devices. The document does not describe a study in the context of AI/ML device performance, as it is a medical device from 2011, long before the widespread use of AI in medical imaging. Therefore, many of the questions related to AI device performance are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to existing predicate devices (K062263 – Omron U-22, K870027 - Salter 8900 nebulzier, K072019 - Activaero - AKITA2 APIXNEB, K042991 - I-neb AAD, K052491 - I-neb Insight). The "acceptance criteria" are not explicitly stated as numerical thresholds but rather as the proposed device exhibiting comparable performance characteristics to the predicates in specific areas.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (I-neb AAD with TIM & I-neb Insight AAD)
Particle Characterization (MMAD, GSD, Respirable Fraction %) comparable to predicates.	"Comparison of particle characterization testing included the evaluation of MMAD, GSD, Respirable Fraction (%) the predicates and the proposed device were found to be substantially equivalent."
Comparative Dosing (gravimetric dose, Filter dose, Treatment time) equivalent to predicates.	"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 Treatment time. Results the predicates and the proposed device were substantially equivalent."
Indications for Use for general purpose nebulization (I-neb AAD with TIM) and monitoring accessory (I-neb Insight AAD).	I-neb AAD with TIM: "General Purpose use." "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." I-neb Insight AAD: "monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician."
Technology: Vibrating mesh nebulizer and breath-triggered nebulization.	"Identical vibrating mesh nebulizer technology to predicates." "Identical breath triggered nebulization technology to predicate."
Materials: Gas and fluid pathway materials identical to predicate I-neb AAD.	"The materials in the gas and fluid pathway are identical to predicate device - K042991 -- I-neb AAD System."
Environment of Use: Home care, nursing home, sub-acute institution, or hospital environment.	"Identical to predicate."
Patient Population: 3 years and older who can coordinate breathing.	"Identical to predicates."
I-neb Insight Technology/Indications: Monitoring software and feedback.	"Identical technology to predicate - K052491 - I-neb Insight AAD system." "The I-neb Insight 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."

Study Details:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "3 drugs" were used for particle characterization.
- The testing was "performed at flow rates of 15 lpm and 30 lpm."
- The sample sizes for "comparative dosing" are not explicitly stated, but it was done between the I-neb AAD system in TBM vs. TIM mode and compared to Omron U22 and Salter 8900.
- This was bench testing, not human clinical data. Therefore, the concept of "country of origin for data" or "retrospective/prospective" human data does not apply here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission relies on bench testing, not expert-adjudicated ground truth from human data for AI/ML performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was bench testing, not a human consensus or adjudication study.
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. This is a 2011 submission for a nebulizer, not an AI/ML diagnostic tool. An MRMC study was not conducted, nor would it be relevant for this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a nebulizer system, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the performance specifications and characteristics of the predicate devices, against which the proposed device's bench test results (e.g., MMAD, GSD, gravimetric dose) were compared to demonstrate substantial equivalence.
The sample size for the training set
- Not applicable. This device does not involve an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established
- Not applicable. This device does not involve an AI/ML algorithm.

Summary

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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:

Indications for Use:

Patient Population:

The I-neb AAD system with TIM is intended for patients > 3 years and older who can coordinate breathing.

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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.

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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

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Attribute	OmronU22 nebulizerK062263	Salter8900K870027	ActivaeroAKITA2 APIXNEBK072019	ProfileI-neb AADK042991	ProposedI-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 cancoordinate breathing	2 and older who cancoordinate breathing	3 and older who can coordinatebreathing
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 ofnebulized drug	No	No	Yes	YesInhalation only	YesInhalation only
Drug delivery on demand	No	No	Yes	Yes	Yes
Drug delivery triggered by	N/A	N/A	Patient inhalationPressure signal	Patient inhalationPressure signal	Patient inhalationPressure signal
Drug delivery pulse range(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 ofthe inhalation cycle	Between 50 to 80% ofthe inhalation cycle	Up to the last 1 second of theinhalation cycle
Method of guiding patient forControlled inhalation	None	None	Auxiliary flow isprovided from acompressor set at15 Lpm	Use of a flap valve in themouthpiece in which thepatient entrains room airwhich mixes with thenebulized medication.Approximate flow rate isnot controlled in TBMmode	Use of a restrictive flap valve in themouthpiece to control breathing.Vibration felt by the patient toindicate target time. The patiententrained room air which mixeswith the nebulized medication.Approximate flow rate is 15 Lpmfor TIM mode
Method of providing pre-setparameters for nebulizerperformance	None	None	YesSmart Card	YesRF disc	YesRF disc
Accessory for monitoring andrecording patient data for reviewby the clinician	N/A	N/A	N/A	Yes	Yes

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510(k) Summary

I-neb Insight with TIM

ーーーー -

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Results	Profile	Proposed
	I-neb Insight(K052491)	I-neb AAD with TIM
Indications for Use(all have except pentamidine)	Will be used with patients for whomdoctors have prescribed medicationfor nebulization	Will be used with patients for whomdoctors have prescribed medication fornebulization
Accessory to I-neb AAD system withthe indications of monitoring andproviding patient feedback	The I-neb Insight is monitoringsoftware that provides feedback to thepatient recording treatment events,including treatment times andcompliance data which is alsoavailable to the clinician	The I-neb Insight is monitoringsoftware that provides feedback to thepatient recording treatment events,including treatment times andcompliance data which is also availableto the clinician

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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

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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/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

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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 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

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).