(134 days)
No
The description focuses on mechanical and software-controlled pressure delivery based on a pre-set protocol, with no mention of learning, adaptation, or data-driven decision making characteristic of AI/ML.
Yes
The device is indicated for use as a Positive Expiratory Pressure (PEP) Device to clear secretions, open airways, prevent/reverse atelectasis, and remove mucus, all of which are therapeutic actions aimed at treating respiratory conditions.
No
Explanation: The device description and intended use clearly state that Pulsehaler™ is a treatment device used to improve clearance of secretions, open airways, and prevent/reverse atelectasis by delivering positive expiratory pressure and vibrations. It does not mention any function for diagnosing conditions.
No
The device description clearly outlines physical hardware components including a Base Unit with an LCD touch screen, a Hand Unit with a rotating disc, an air hose, and electrical cables, in addition to the software.
Based on the provided information, the Pulsehaler™ device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Pulsehaler™ Function: The description clearly states that Pulsehaler™ is a non-invasive handheld treatment device that delivers pressurized air and vibrations to the patient's airways. It is used to improve secretion clearance, open airways, and prevent/reverse atelectasis.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is purely mechanical/physical therapy applied externally to the respiratory system.
Therefore, the Pulsehaler™ falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BWF
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.
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
Adult
Intended User / Care Setting
single patient, adult users in a home or hospital environment.
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)
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.
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.
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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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.
4
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:
5
- 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)
Predicate Device | Aerobika (K123400)
Reference Device | Comparison |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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™ 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. | 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 | The Aerobika*
Oscillating Positive
Expiratory Pressure
device is intended for
use as a Positive
Expiratory Pressure
(PEP device. The
Aerobika* Oscillating
PEP device may also
be used simultaneously
with nebulized aerosol
drug delivery. The
device is intended to be
used by patients
capable of generating
an exhalation flow of 10
lpm for 3-4 seconds. | Same as predicate |
| Intended Use
Environment | Hospital and Home Use | Hospital and Home Use | Hospital and Home Use | Same as predicate |
| Patient
Population | Adult patients | Patients age 21 and
above with Cystic
Fibrosis, COPD,
asthma, and lung
diseases with secretory
problems, and patients
with atelectasis. | Patients capable of
generating and
exhalation flow of 10 l
pm for 3-4 seconds. | Similar to predicate, no
specific disease
conditions are claimed. |
| Oscillation
Mechanism | Rotating Disc | Rotating Disk | Oscillating Lever | Same as predicate |
| Characteristic | Pulsehaler™ | Aerosure (K140772)
Predicate Device | Aerobika (K123400)
Reference Device | Comparison |
| PEP
Mechanism | Flow vs resistance from
oscillation mechanism,
restricted orifice, and
blower | Flow vs resistance from
oscillation mechanism,
restricted orifice | Flow vs resistance from
oscillation mechanism,
restricted orifice, and
blower | Subject device
generates PEP with a
blower, however, output
PEP pressures,
vibration frequencies
and amplitudes are
equivalent to those
produced by predicate
and reference device. |
| Operating
Modes | Single mode with
multiple speeds | Single Speed Mode | 5 levels of resistance | Subject device has
multiple speeds. Output
PEP pressures,
vibration frequencies
and amplitudes
produced at each
speed are equivalent. |
| Software
Control | Yes | Yes | No | Same as predicate |
| Mean
Frequency | 6 Hz to 65Hz | 30 Hz-52Hz | 7Hz- 22Hz | Mean frequencies
generated by subject
device are within the
range generated by
predicate and reference
device. |
| Pressure
Amplitude | 9-23 cmH2O | 2-32 cmH2O | 1-21 cmH2O | Pressure amplitude
generated by subject
device is within the
range generated by
predicate and reference
device. |
| Mean
Pressure | 7-10 cmH2O | 1-11 cmH2O | 1-25 cmH2O | Mean pressure
generated by subject
device is within the
range generated by
predicate. |
| Pressure
Limitation | Based on hardware
blower limitations | Limited by patient's
respiratory effort | Limited by patient's
respiratory effort | Output pressure of
blower limited during
single and multiple
faults to