· The use of Aerosure improves clearance of secretions
· The use of Aerosure may reduce the need for postural drainage
Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
· Aerosure may be used to prevent or reverse atelectasis
· Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis

Aerosure is intended for patients age 21 and above with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy.

Aerosure may be used in hospital as well as the home after a period of training.

Device Description

Aerosure is a small, battery powered device. It produces a rapidly alternating occlusion of airflow as a user breathes through the replaceable valve head (containing the powered rotating vane mechanism) which creates a general increase in resistance to breathing and a vibration of the respiratory tree and the associated structures, including the musculature. Frequency is adjusted by switching modes.

AI/ML Overview

The provided document is a 510(k) summary for the Aerosure Medic device. It focuses on establishing substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for clinical performance.

Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be directly extracted from this document.

However, I can provide the available information based on what is presented:

Acceptance Criteria and Reported Device Performance

The document states that a variety of performance tests were conducted, and the device "functioned as intended" and "met its specifications." It also notes that performance bench test data demonstrated the Aerosure Medic is "substantially equivalent" to predicate devices and has "directly comparable basic characteristics and substantially similar output specifications." Crucially, it highlights that human factors and usability testing concluded the device is "reasonably safe and effective for the intended users, uses and use environments."

General Acceptance Criteria (Implied / Stated):

Acceptance Criteria Category	Reported Device Performance
Biocompatibility (ISO 10993)	Functioned as intended; results observed were as expected.
Electromagnetic Compatibility (IEC 60601-1-2)	Functioned as intended; results observed were as expected.
Medical Device Safety (IEC 60601-1)	Functioned as intended; results observed were as expected.
Cleaning Instructions Support	Cleaning and ingress protection testing demonstrated that reasonably expected cleaning would not affect performance or safety; no depreciation in performance or safety.
Ingress Protection (IP45 [IEC60529])	Testing verified no water ingress and normal device function after exposure to expected in-use water exposure.
Functional Testing	Demonstrated the Aerosure Medic device met its specifications.
Bench Testing (vs. Predicates)	Showed directly comparable basic characteristics and substantially similar output specifications to predicate devices.
Usability Testing / Human Factors	Concluded that Aerosure Medic is reasonably safe and effective for the intended users, uses, and use environments, following FDA's human factors draft guidance.

Missing Information (Not Present in the Document):

Due to the nature of this 510(k) summary, the following specific details are not provided:

Sample size used for the test set and the data provenance: The document mentions "performance data," "functional testing," "bench testing," and "usability testing," but it does not specify sample sizes for any of these tests or the data provenance (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed clinical performance results and ground truth establishment involving human experts are not described in this regulatory submission for substantial equivalence.
Adjudication method for the test set: Not applicable for the type of testing described (which is primarily bench, safety, and usability).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device, and no MRMC study or AI components are mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm-only device; it's a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the tests described would be objective measures against engineering specifications, safety standards, and usability criteria. There is no mention of clinical ground truth (like pathology or outcomes) as a basis for device performance in this submission.
The sample size for the training set: Not applicable, as this is not a machine learned AI device.
How the ground truth for the training set was established: Not applicable.

Summary of Study Information (Based on Document):

Type of Studies: Biocompatibility, Electromagnetic Compatibility, Medical Device Safety, Cleaning & Ingress Protection, Functional Testing, Bench Testing (comparison to predicates), and Usability/Human Factors Testing.
Purpose of Studies: To demonstrate that the Aerosure Medic "functioned as intended," "met its specifications," is "substantially equivalent" to predicate devices, and is "reasonably safe and effective" for its intended users and uses.
Methodology for Usability Testing: Followed FDA's human factors draft guidance for industry entitled, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011)."

The document primarily serves to demonstrate that the Aerosure Medic's technological characteristics and performance are substantially equivalent to existing, legally marketed predicate devices, thereby supporting its 510(k) clearance for marketing.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19,2014

Actegy, Ltd. C/O Dr. John J. Smith Hogan Lovells US LLP Regulatory Counsel Columbia Square 555 13th Street, NW Washington, DC 20004

Re: K140772

Trade/Device Name: Aerosure Medic Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive spirometer Regulatory Class: II Product Code: BWF Dated: December 2, 2014 Received: December 2, 2014

Dear Dr. Smith:

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.

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Page 2 - Dr. Smith

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,

Susan Runno DDS, MA

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known)

Device Name

Aerosure Medic

Indications for Use (Describe)

Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device.

· The use of Aerosure improves clearance of secretions
· The use of Aerosure may reduce the need for postural drainage
Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems
· Aerosure may be used to prevent or reverse atelectasis

· Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis

Aerosure is intended for patients age 21 and above with Cystic Fibrosis. COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis. All patients must be capable of following instructions for Positive Expiratory Pressure Therapy.

Aerosure may be used in hospital as well as the home after a period of training.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Actegy's Aerosure Medic

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

Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE UK

Phone:	+44(0) 1344 636 940
Facsimile:	+44(0) 8452 255 612

Contact Person: Angie Glover Date Prepared: December 18, 2014

Name of Device and Name/Address of Sponsor

Aerosure Medic

Actegy Ltd. 8 Queen Square, Ascot Business Park Lyndhurst Road Ascot Berkshire SL5 9FE UK

Common or Usual Name

Oscillatory positive expiratory pressure devices (OPEP)

Classification Name

Incentive spirometer, 21 C.F.R. §868.5690, Product code BWF

Powered percussor, 21 C.F.R. § 868.5665, Product code BYI

Predicate Devices

Flutter D (Clement Clarke), K972859; Acapella (Smiths Medical), K002768; Roadrunner (DHD), K991561.

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Intended Use / Indications for Use

Aerosure is indicated for use as a Positive Expiratory Pressure (PEP) Device.

· The use of Aerosure improves clearance of secretions
· The use of Aerosure may reduce the need for postural drainage

· Aerosure facilitates opening of airways in patients with Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems

· Aerosure may be used to prevent or reverse atelectasis
• Aerosure may also be useful in the removal of mucus from the lungs of patients who have chronic bronchitis or bronchiectasis

Aerosure may be used in hospital as well as the home after a period of training.

Technological Characteristics

The Aerosure Medic consists of an electrically powered rotary valve mechanism which acts as a means of restricting the user's inhalation and exhalation efforts and generating vibration of the respiratory tree, thus facilitating the removal of mucus from the lungs.

Performance Data

Biocompatibility (ISO 10993), electromagnetic compatibility (IEC 60601-1-2), medical device safety testing (IEC 60601-1), and other performance testing were conducted. In all instances, the Aerosure Medic functioned as intended and the results observed were as expected.

To support the cleaning instructions, cleaning and ingress protection testing was conducted to demonstrate that reasonably expected cleaning of the device would not have an effect of performance or safety. The results verified that there was no depreciation in performance or safety. In addition, in order to verify the Aerosure Medic ingress protection rating of IP45 [IEC60529], testing was conducted to investigate the effects of expected in-use exposure to water. The results verified that there was no water ingress into the device and that the device function was normal after exposure.

Actegy conducted functional testing as part of the design verification process which demonstrated the Aerosure Medic device met its specifications. In addition, the company conducted bench testing comparing the performance characteristics for the Aerosure Medic and the legally marketed predicates. The results showed that all of the devices have directly comparable basic characteristics and substantially similar output specifications.

Finally, Actegy conducted usability testing to demonstrate the safe use of the device in the target user population, i.e., lay persons. The Aerosure Medic summative protocol design, conduct, and analysis followed FDA's human factors draft guidance for industry entitled, Applying Human Factors and Usability Engineering to Optimize Medical Device Design (June 22, 2011). Based on the findings of this study, it was concluded that Aerosure Medic is reasonably safe and effective for the intended users, uses and use environments.

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Substantial Equivalence

The Aerosure Medic is substantially equivalent to the predicated devices.

The Aerosure Medic has substantially equivalent intended uses, indications, technological characteristics and principles of operation as its predicate devices. The Aerosure Medic differs from the predicate devices in terms of certain technological characteristics (minor differences in construction, battery and motor-driven vs. manual power, minor differences in occlusion mechanism, weight and dimensions).

Performance bench test data demonstrate that the Aerosure Medic is substantially equivalent to the predicate devices. Thus, the Aerosure Medic is substantially equivalent.

Conclusion

The Aerosure Medic is substantially equivalent to the predicate devices Flutter D (K.972859), Acapella (K002768) and Roadrunner (K991561).

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Basic Unit characteristics
	Aerosure Medic	Roadrunner	Flutter D	Acapella
510k number	TBD	K991561	K972859	K002768,
Manufacturer	Actegy Ltd.	DHD Healthcare	Clement Clarke(Axcan Scandipharm)	Smiths Medical
Intended use	Aerosure is indicated for use as a PositiveExpiratory Pressure (PEP) Device.• The use of Aerosure improves clearance ofsecretions• The use of Aerosure may reduce the need forpostural drainage• Aerosure facilitates opening of airways inpatients with Cystic Fibrosis, COPD, asthma,and lung diseases with secretory problems• Aerosure may be used to prevent or reverseatelectasis• Aerosure may also be useful in the removal ofmucus from the lungs of patients who havechronic bronchitis or bronchiectasisAerosure is intended for patients age 21 andabove with Cystic Fibrosis, COPD, asthma, andlung diseases with secretory problems, andpatients with atelectasis. All patients must becapable of following instructions for PositiveExpiratory Pressure Therapy.Aerosure may be used in hospital as well as thehome after a period of training.	1 - Purpose:The DHD Roadrunner is indicated for use as aPositive Expiratory Pressure (PEP) Device.2 - Claims:• The use of DHD Roadrunner improvesclearance of secretions• The use of DHD Roadrunner may reducethe need for postural drainage• DHD Roadrunner facilitates opening ofairways in patients with Cystic Fibrosis,COPD, asthma, and lung diseases withsecretory problems• The DHD Roadrunner may be used toprevent or reverse atelectasis3 - Target Patient PopulationPatients with Cystic Fibrosis, COPD, asthma,and lung diseases with secretory problems, andpatients with atelectasis. All patients must becapable of following instructions for PositiveExpiratory Pressure Therapy.4 - Intended Environment for Use• Labeling reflects the statement: "Federal(USA) Law restricts this device to sale byor on the order of a physician."• May be used in hospital as well as thehome after a period of training.	The efficacy of the Flutter 4D as amucus clearance device for cysticfibrosis patients is based on itsability to1) vibrate the airways (whichloosens mucus from the airwaywalls),2) intermittently increaseendobronchial pressure (tomaintain the patency of airwaysduring exhalation, so that mucusdoes not become trapped as itmoves up the airways), and3) accelerate expiratory airflow (tofacilitate the upward movement ofmucus through the airways sothat it can be more easilycoughed out).FlutterD may also be useful in theremoval of mucus from the lungsof patients who have chronicbronchitis or bronchiectasis andin conjunction with a medicalneed for Positive ExpiratoryPressure (PEP) Therapy.	Acapella is intended foruse as a PositiveExpiratory Pressure(PEP) device. It may alsobe used simultaneouslywith nebulized aerosoldrug delivery.
Device	Aerosure is a small, battery powered device. Itproduces a rapidly alternating occlusion of airflow as	Positive Expiratory Pressure and vibrationfeature	The Flutter®D is a small, singleuse, hand held device expiration	Acapella is a small, singleuse, hand held secretion
Description	a user breathes through the replaceable valve head(containing the powered rotating vane mechanism)which creates a general increase in resistance tobreathing and a vibration of the respiratory tree andthe associated structures, including the musculature.Frequency is adjusted by switching modes.	Use when both inhale and exhaleAdjust frequency with knobManually powered device.	resistance device. consisting of ahardened plastic mouthpiece atone end, a plastic cover with anopening at the other end, and avalve on the inside created by ahigh density steel ball resting in aplastic circular cone. Exhalation through the device causesvibrations to loosen mucus fromthe airways. The resistance isincreased by tilting the device	clearance and lungexpansion plasticmechanical device thatcreates vibrating positiveexpiratory pressure whena patient exhales throughthe device via a vibrating orifice mechanism. Theresistance is adjusted viathe rotating dial.
Software/Firmware/Microprocessor control	Yes	No	No	No
Power source	3 cell NiMH rechargeable battery (nominal 3.6V) todrive the motor. The charger operates normally with apower supply range of 110~240 V / 50Hz	Inhalation & Exhalation - manual, mechanicalpowered device	Exhalation - manual, mechanicalpowered device	Inhalation & Exhalation -manual, mechanicalpowered device
CompliancewithVoluntarystandards	ISO 10993; IEC 60601-1-2; IEC 60601-1	Unknown	Unknown	Unknown
Weight	195g	Unknown	86g	89g
Dimensions	45x96x149	Unknown	90x56x44	172x60x58
Housingmaterials andconstruction	Plastic mouldings	Unknown	Plastic mouldings	Plastic mouldings

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Regulation Number and Section

§ 868.5690 Incentive spirometer.

(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).