Pulsehaler
Device Facts
| Record ID | K203378 |
|---|---|
| Device Name | Pulsehaler |
| Applicant | Respinova, Ltd. |
| Product Code | BWF · Anesthesiology |
| Decision Date | Mar 31, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5690 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device. - The use of Pulsehaler™ improves clearance of secretions . - The use of Pulsehaler™ may reduce the need for postural drainage ● - Pulsehaler™ facilitates opening of airways in patients ● - Pulsehaler™ may be used to prevent or reverse atelectasis ● - Pulsehaler™ mav also be useful in the removal of mucus from the lungs ● Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.
Device Story
Handheld PEP device for airway opening and secretion clearance; used by adult patients in home or hospital. System comprises base unit with LCD touch screen and hand unit with rotating disc, connected by air hose and data cable. Patient breathes through mouthpiece while base unit delivers pressurized air; rotating disc interrupts flow to create pressure pulsations (5-50 pulses/sec). Exhalation port restriction induces PEP. Software controls disc rotation speed per pre-set protocol. Treatment duration 20 minutes, up to 3 times daily. Output helps mobilize mucus and prevent atelectasis, potentially reducing need for postural drainage. Patient manages treatment via UI.
Clinical Evidence
Bench testing only. No clinical data provided. Testing included PEP characterization, pressure pulse frequency/amplitude analysis, cleaning/disinfection validation, shelf/use life testing, and biocompatibility (ISO 10993, ISO 18562-3).
Technological Characteristics
Handheld PEP device; base unit (AC power) and hand unit (rotating disc). Materials tested per ISO 10993 and ISO 18562-3. PEP generated via blower, restricted orifice, and disc interruption. Frequencies 6-65 Hz; pressure 9-23 cmH2O. Non-sterile; high-level disinfection (Cidex). Software-controlled. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11.
Indications for Use
Indicated for adult patients as a Positive Expiratory Pressure (PEP) device to improve secretion clearance, reduce need for postural drainage, facilitate airway opening, prevent/reverse atelectasis, and remove mucus from lungs. Intended for home or hospital use.
Regulatory Classification
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.
Predicate Devices
- Aerosure Medic (K140772)
Reference Devices
- Aerobika (K123400)
Submission Summary (Full Text)
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March 31, 2021
Respinova Ltd. % Joel Ironstone President Ironstone Product Development Inc. 250 Carlaw Avenue, Suite 108 Toronto. Ontario M4M 3L1 Canada
Re: K203378
Trade/Device Name: Pulsehaler Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: February 15, 2021 Received: February 22, 2021
Dear Joel Ironstone:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
_ Over-The-Counter Use (21 CFR 801
510(k) Number (if known)
K203378
Device Name
Pulsehaler™
Indications for Use (Describe)
Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device.
- The use of Pulsehaler™ improves clearance of secretions .
- The use of Pulsehaler™ may reduce the need for postural drainage ●
- Pulsehaler™ facilitates opening of airways in patients ●
- Pulsehaler™ may be used to prevent or reverse atelectasis ●
- Pulsehaler™ mav also be useful in the removal of mucus from the lungs ●
Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)
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#### 510(k) SUMMARY
#### Respinova's Pulsehaler™
#### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Respinova Ltd. 8 Hachoshlim St. Herzliya, Israel 4672408 Phone: 1-416-567-1147
Contact Person: Joel Ironstone 250 Carlaw Avenue, Suite 108 Toronto, ON, Canada M4M 3L1 1-416-567-1147
Date Prepared: March 30, 2021
#### Name of Device
Pulsehaler™
## Device Classification and Product Code
Spirometer, Therapeutic (Incentive), 21 CFR 868.5690, Class II, BWF
#### Predicate Devices
Actegy - Aerosure Medic (K140772, Predicate Device) Trudell Medical - Aerobika (K123400, Reference Device)
#### Indications for Use
Pulsehaler™ is indicated for use as a Positive Expiratory Pressure (PEP) Device.
- The use of Pulsehaler™ improves clearance of secretions o
- The use of Pulsehaler™ may reduce the need for postural drainage ●
- Pulsehaler™ facilitates opening of airways in patients ●
- Pulsehaler™ may be used to prevent or reverse atelectasis
- Pulsehaler™ may also be useful in the removal of mucus from the lungs ●
Pulsehaler™ is intended for single patient, adult users in a home or hospital environment.
Pulsehaler™ is a prescription device.
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## Device Description
Pulsehaler™ is a non-invasive handheld treatment device used daily by the patient to promote airway opening and secretion clearance by vibrating the airways at a variety of different frequencies. It consists of Base Unit with an LCD touch screen that provides a pressure source, and a Hand Unit with a rotating disc that periodically interrupts the pressure source to deliver pressure pulsations to the patient. These components are connected by an air hose and an electrical power and data cable.
While sitting in a relaxed position, the patient holds the Hand Unit and breathes normally through its mouthpiece. A steady flow of pressurized air is delivered to the Hand Unit component by the Base Unit and enters the air inlet of the Hand Unit. The pressurized air passes along the internal airflow duct of the Hand Unit through an air filter until it reaches the rotating disc. When it rotates the disc interrupts the continuous flow of air from the Base Unit and then releases the flow in pulses at a rate corresponding to the rotation speed. The rotation speed of the disc is determined by the software using a pre-set protocol.
The exhalation port is restricted in size, which together with the positive pressure generated by the Base Unit, induces PEP.
The patient is treated with the device for 20 minutes at a time, up to three times a day according to the prescribing physician's instructions. During each 20-minute treatment, Pulsehaler™ delivers pulses varying from 5 to 50 pulses per second. The patient may use the User Interface to pause the treatment at any time or resume after a pause.
Pulsehaler™ is intended for single adult patient, multiple reuse, at home or in a healthcare facility and is non-sterile. The instructions for use contain cleaning and high-level disinfection instructions that involve the use of Cidex.
Expected Use Life of the device is 5 years and Shelf Life is 6 Months.
## Summary of Non-Clinical Testing
Non-Clinical testing included the following on the subject device:
- Positive Expiratory Pressure (PEP) characterization and comparison to the predicate device
- Characterization of the pressure pulse frequencies and pressure pulse amplitudes, and comparison to the predicate device
- Cleaning and Disinfection Validation ●
- Shelf Life (6 Months) and Use Life (5 years) Testing
- . Functional Testing and Software Validation to Design Input Requirements
- . Biocompatibility Testing including Volatile Organic Compound (VOC) and Particulate Matter 2.5 Micron Testing - External Communicating, tissue / bone / dentin and Surface contact, Mucosal Membrane, permanent contact duration.
## Standards Compliance
The Pulsehaler has been tested to be compliant with the following FDA recognized standards:
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- Electrical safety testing per IEC 60601-1:2005 (Third Edition) + C1:2006 + C2:2007 + . A1:2012
- Electromagnetic compatibility per IEC 60601-1-2:2014 (4th Edition) ●
- Usability testing per IEC 60601-1-6:2013 (Edition 3.1) .
- Home healthcare environment testing per IEC 60601-1-11:2015 (2nd Edition) .
- Biocompatibility testing per ISO 10993 suite and ISO 18562-3:2002 (1st Edition) ●
- . Software development per IEC 62304:2006
- . Software validation per FDA's Guidance for the Content of Premarket Submission for Software Contained in Medical Devices (May 11, 2005)
## Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.". The software level of concern was moderate.
## Comparison of Technological Characteristics with the Predicate Device
The Pulsehaler™ is substantially equivalent to the Aerosure (K140772). The Pulsehaler™ has the same intended use and indications for use as its predicate device, as well as similar technological characteristics and principles of operation as its predicate device. Both the Pulsehaler™ and the Aerosure deliver vibrating air pressure pulses into the airway to assist in secretion clearance and airway opening. In both devices, air pulses are created by the interruption of the flow of air to and from the patient by a spinning disc.
Both systems apply intermittent pulsating pressure to lung airways. Pulsehaler has similar vibration frequencies and similar levels of positive expiratory pressure (PEP) to its predicate and reference devices.
A summary of substantial equivalence comparison is provided below.
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| Characteristic | Pulsehaler™ | Aerosure (K140772)<br>Predicate Device | Aerobika (K123400)<br>Reference Device | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Pulsehaler™ is<br>indicated for use as a<br>Positive Expiratory<br>Pressure (PEP) Device.<br><br>The use of<br>Pulsehaler™<br>improves clearance<br>of secretions The use of<br>Pulsehaler™ may<br>reduce the need for<br>postural drainage Pulsehaler™<br>facilitates opening<br>of airways in<br>patients Pulsehaler™ may<br>be used to prevent<br>or reverse<br>atelectasis Pulsehaler™ may<br>also be useful in the<br>removal of mucus<br>from the lungs Pulsehaler™ is intended<br>for single patient, adult<br>users in a home or<br>hospital environment. | Aerosure is indicated for<br>use as a Positive<br>Expiratory Pressure<br>(PEP) Device.<br><br>The use of Aerosure<br>improves clearance<br>of secretions The use of Aerosure<br>may reduce the<br>need for postural<br>drainage Aerosure facilitates<br>opening of airways<br>in patients with<br>Cystic Fibrosis,<br>COPD, asthma, and<br>lung diseases with<br>secretory problems Aerosure may be<br>used to prevent or<br>reverse atelectasis Aerosure may also<br>be useful in the<br>removal of mucus<br>from the lungs of<br>patients who have<br>chronic bronchitis or<br>bronchiectasis | The Aerobika*<br>Oscillating Positive<br>Expiratory Pressure<br>device is intended for<br>use as a Positive<br>Expiratory Pressure<br>(PEP device. The<br>Aerobika* Oscillating<br>PEP device may also<br>be used simultaneously<br>with nebulized aerosol<br>drug delivery. The<br>device is intended to be<br>used by patients<br>capable of generating<br>an exhalation flow of 10<br>lpm for 3-4 seconds. | Same as predicate |
| Intended Use<br>Environment | Hospital and Home Use | Hospital and Home Use | Hospital and Home Use | Same as predicate |
| Patient<br>Population | Adult patients | Patients age 21 and<br>above with Cystic<br>Fibrosis, COPD,<br>asthma, and lung<br>diseases with secretory<br>problems, and patients<br>with atelectasis. | Patients capable of<br>generating and<br>exhalation flow of 10 l<br>pm for 3-4 seconds. | Similar to predicate, no<br>specific disease<br>conditions are claimed. |
| Oscillation<br>Mechanism | Rotating Disc | Rotating Disk | Oscillating Lever | Same as predicate |
| Characteristic | Pulsehaler™ | Aerosure (K140772)<br>Predicate Device | Aerobika (K123400)<br>Reference Device | Comparison |
| PEP<br>Mechanism | Flow vs resistance from<br>oscillation mechanism,<br>restricted orifice, and<br>blower | Flow vs resistance from<br>oscillation mechanism,<br>restricted orifice | Flow vs resistance from<br>oscillation mechanism,<br>restricted orifice, and<br>blower | Subject device<br>generates PEP with a<br>blower, however, output<br>PEP pressures,<br>vibration frequencies<br>and amplitudes are<br>equivalent to those<br>produced by predicate<br>and reference device. |
| Operating<br>Modes | Single mode with<br>multiple speeds | Single Speed Mode | 5 levels of resistance | Subject device has<br>multiple speeds. Output<br>PEP pressures,<br>vibration frequencies<br>and amplitudes<br>produced at each<br>speed are equivalent. |
| Software<br>Control | Yes | Yes | No | Same as predicate |
| Mean<br>Frequency | 6 Hz to 65Hz | 30 Hz-52Hz | 7Hz- 22Hz | Mean frequencies<br>generated by subject<br>device are within the<br>range generated by<br>predicate and reference<br>device. |
| Pressure<br>Amplitude | 9-23 cmH2O | 2-32 cmH2O | 1-21 cmH2O | Pressure amplitude<br>generated by subject<br>device is within the<br>range generated by<br>predicate and reference<br>device. |
| Mean<br>Pressure | 7-10 cmH2O | 1-11 cmH2O | 1-25 cmH2O | Mean pressure<br>generated by subject<br>device is within the<br>range generated by<br>predicate. |
| Pressure<br>Limitation | Based on hardware<br>blower limitations | Limited by patient's<br>respiratory effort | Limited by patient's<br>respiratory effort | Output pressure of<br>blower limited during<br>single and multiple<br>faults to <20cmH2O |
| Power Supply | AC Mains connected DC<br>power supply,<br>110~240V 50/60Hz | Charger: AC mains<br>connected DC power<br>supply, 110~240 V /<br>50/60Hz<br>Hand Unit: 3 cell NiMH<br>rechargeable battery<br>(nominal 3.6V). | None (mechanical<br>device) | Wall power to Base<br>Unit - same as<br>predicate; however,<br>Hand Unit is connected<br>and powered by Base<br>Unit, instead of<br>rechargeable batteries |
| Sterility | Used non-sterile | Used non-sterile | Used non-sterile | Same as predicate |
| Characteristic | Pulsehaler™ | Aerosure (K140772)<br>Predicate Device | Aerobika (K123400)<br>Reference Device | Comparison |
| Standards with<br>which the<br>Device<br>Complies | ISO 10993; IEC 60601-<br>1-2; IEC 60601-1, IEC<br>60601-1-6, IEC 60601-<br>1-11, ISO18562 | ISO 10993; IEC 60601-<br>1-2; IEC 60601-1 | ISO 10993 | Additional applicable<br>standards met |
# Substantial Equivalence Table
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## Conclusions
The Pulsehaler™ has the same intended use, indications for use, and similar technological characteristics as its predicate device. Testing demonstrates substantially equivalent performance to the predicate device. Therefore, the Pulsehaler™ is substantially equivalent to its predicate.
