(267 days)
Not Found
No
The device description and performance studies focus on mechanical and electrical function, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
The device is used to improve clearance of secretions, open airways, and remove mucus for patients with various lung diseases, which directly addresses medical conditions.
No
The device is indicated for therapeutic use (clearing secretions, opening airways, preventing/reversing atelectasis) by producing a physical effect (vibration and increased resistance to breathing), not for diagnosing conditions.
No
The device description explicitly states it is a "small, battery powered device" with a "powered rotating vane mechanism," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for physical therapy and airway clearance, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a mechanical device that affects airflow and creates vibrations within the respiratory system. This is a physical intervention, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information based on laboratory analysis.
The device falls under the category of a therapeutic device used for respiratory conditions.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
BWF, BYI
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.
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
21 and above
Intended User / Care Setting
hospital as well as the home after a period of training.
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)
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.
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.
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
§ 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).
0
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.
1
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
2
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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3
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.
4
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 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.
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.
5
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).
6
| 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 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. | 1 - Purpose:
The DHD Roadrunner is indicated for use as a
Positive Expiratory Pressure (PEP) Device.
2 - Claims:
• The use of DHD Roadrunner improves
clearance of secretions
• The use of DHD Roadrunner may reduce
the need for postural drainage
• DHD Roadrunner facilitates opening of
airways in patients with Cystic Fibrosis,
COPD, asthma, and lung diseases with
secretory problems
• The DHD Roadrunner may be used to
prevent or reverse atelectasis
3 - Target Patient Population
Patients 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.
4 - Intended Environment for Use
• Labeling reflects the statement: "Federal
(USA) Law restricts this device to sale by
or on the order of a physician."
• May be used in hospital as well as the
home after a period of training. | The efficacy of the Flutter 4D as a
mucus clearance device for cystic
fibrosis patients is based on its
ability to
- vibrate the airways (which
loosens mucus from the airway
walls), - intermittently increase
endobronchial pressure (to
maintain the patency of airways
during exhalation, so that mucus
does not become trapped as it
moves up the airways), and - accelerate expiratory airflow (to
facilitate the upward movement of
mucus through the airways so
that it can be more easily
coughed out).
FlutterD may also be useful in the
removal of mucus from the lungs
of patients who have chronic
bronchitis or bronchiectasis and
in conjunction with a medical
need for Positive Expiratory
Pressure (PEP) Therapy. | Acapella is intended for
use as a Positive
Expiratory Pressure
(PEP) device. It may also
be used simultaneously
with nebulized aerosol
drug delivery. |
| Device | Aerosure is a small, battery powered device. It
produces a rapidly alternating occlusion of airflow as | Positive Expiratory Pressure and vibration
feature | The Flutter®D is a small, single
use, hand held device expiration | Acapella is a small, single
use, 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 to
breathing and a vibration of the respiratory tree and
the associated structures, including the musculature.
Frequency is adjusted by switching modes. | Use when both inhale and exhale
Adjust frequency with knob
Manually powered device. | resistance device. consisting of a
hardened plastic mouthpiece at
one end, a plastic cover with an
opening at the other end, and a
valve on the inside created by a
high density steel ball resting in a
plastic circular cone. Exhalation through the device causes
vibrations to loosen mucus from
the airways. The resistance is
increased by tilting the device | clearance and lung
expansion plastic
mechanical device that
creates vibrating positive
expiratory pressure when
a patient exhales through
the device via a vibrating orifice mechanism. The
resistance is adjusted via
the rotating dial. |
| Software/
Firmware/
Microprocess
or control | Yes | No | No | No |
| Power source | 3 cell NiMH rechargeable battery (nominal 3.6V) to
drive the motor. The charger operates normally with a
power supply range of 110~240 V / 50Hz | Inhalation & Exhalation - manual, mechanical
powered device | Exhalation - manual, mechanical
powered device | Inhalation & Exhalation -
manual, mechanical
powered device |
| Compliance
with
Voluntary
standards | ISO 10993; IEC 60601-1-2; IEC 60601-1 | Unknown | Unknown | Unknown |
| Weight | 195g | Unknown | 86g | 89g |
| Dimensions | 45x96x149 | Unknown | 90x56x44 | 172x60x58 |
| Housing
materials and
construction | Plastic mouldings | Unknown | Plastic mouldings | Plastic mouldings |
7