(134 days)
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.
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.
The provided document is a 510(k) premarket notification for the Pulsehaler™ device, which is a Positive Expiratory Pressure (PEP) Device. The document details the device, its indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.
Based on the provided text, the Acceptance Criteria and the Study that proves the device meets the Acceptance Criteria are primarily focused on non-clinical testing and comparison to predicate devices, rather than a clinical study with human subjects, especially not a multi-reader, multi-case (MRMC) comparative effectiveness study of an AI-powered device. The device is a mechanical PEP device, not an AI-powered diagnostic or therapeutic device that would typically involve AI-specific performance metrics like sensitivity, specificity, or AUC, or human reader improvement studies.
Therefore, the requested information regarding AI device acceptance criteria, MRMC studies, ground truth establishment for AI models, and training/test set sizes for AI data are not applicable to this specific submission. The submission relies on demonstrating substantial equivalence to a legally marketed predicate device (K140772) through technical and functional comparisons, and non-clinical testing.
Here's an attempt to answer the questions based only on the provided document, noting the limitations of the document for an AI-focused query:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for performance in the way one might see for an AI device (e.g., "Sensitivity must be >X%"). Instead, the device's "performance" is demonstrated by its functional characteristics being similar or equivalent to its predicate device. The document summarizes non-clinical testing and then provides a comparison table.
| Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Pulsehaler™) |
|---|---|---|
| Indications for Use | Must be same as or similar to predicate (Aerosure, K140772): Improves clearance of secretions, reduces need for postural drainage, facilitates opening of airways, prevents/reverses atelectasis, aids mucus removal. Intended for single patient, adult users in home or hospital. | Same: Improves clearance of secretions, may reduce need for postural drainage, facilitates opening of airways, may be used to prevent or reverse atelectasis, may also be useful in the removal of mucus from the lungs. Intended for single patient, adult users in home or hospital environment. |
| Intended Use Environment | Must be Hospital and Home Use. | Hospital and Home Use. |
| Patient Population | Similar to predicate (patients age 21 and above with various lung conditions susceptible to secretion problems/atelectasis). | Adult patients. (Note in comparison table: "Similar to predicate, no specific disease conditions are claimed.") |
| Oscillation Mechanism | Similar to predicate (Rotating Disk). | Rotating Disc. |
| PEP Mechanism | Output PEP pressures, vibration frequencies, and amplitudes are equivalent to predicate and reference device. | Flow vs resistance from oscillation mechanism, restricted orifice, and blower. (Note in comparison table: "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 | Output PEP pressures, vibration frequencies and amplitudes produced at each speed are equivalent to predicate. | Single mode with multiple speeds. (Note in comparison table: "Subject device has multiple speeds. Output PEP pressures, vibration frequencies and amplitudes produced at each speed are equivalent.") |
| Software Control | Similar to predicate (Yes). | Yes. |
| Mean Frequency | Within range of predicate (30-52 Hz) and reference (7-22 Hz). | 6 Hz to 65 Hz. (Note in comparison table: "Mean frequencies generated by subject device are within the range generated by predicate and reference device.") |
| Pressure Amplitude | Within range of predicate (2-32 cmH2O) and reference (1-21 cmH2O). | 9-23 cmH2O. (Note in comparison table: "Pressure amplitude generated by subject device is within the range generated by predicate and reference device.") |
| Mean Pressure | Within range of predicate (1-11 cmH2O). | 7-10 cmH2O. (Note in comparison table: "Mean pressure generated by subject device is within the range generated by predicate.") |
| Pressure Limitation | Output pressure during single and multiple faults must be <20 cmH2O. | Based on hardware blower limitations. (Note in comparison table: "Output pressure of blower limited during single and multiple faults to <20cmH2O.") |
| Power Supply | Similar to predicate (AC Mains connected DC power supply). | AC Mains connected DC power supply, 110~240V 50/60Hz. (Note in comparison table: "Wall power to Base Unit - same as predicate; however, Hand Unit is connected and powered by Base Unit, instead of rechargeable batteries.") |
| Sterility | Used non-sterile. | Used non-sterile. |
| Standards Compliance | Compliant with relevant medical device standards shown by predicate (e.g., IEC 60601-1-2, ISO 10993). | ISO 10993; IEC 60601-1-2; IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, ISO18562. (Note: "Additional applicable standards met.") |
| Cleaning & Disinfection | Validated cleaning and disinfection methods. | Validation done, involving Cidex. |
| Shelf/Use Life | Validated shelf and use life. | Shelf Life (6 Months) and Use Life (5 years) Testing completed. |
| Biocompatibility | Compliant with relevant biocompatibility standards. | Testing including VOC and Particulate Matter 2.5 Micron Testing - External Communicating, tissue / bone / dentin and Surface contact, Mucosal Membrane, permanent contact duration, per ISO 10993 suite and ISO 18562-3:2002. |
| Functional/Software Testing | Functional and Software validation to Design Input Requirements; Software V&V per FDA guidance. | Functional Testing and Software Validation to Design Input Requirements. Software verification and validation testing conducted, documentation provided as recommended by FDA's Guidance. Software level of concern: moderate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes non-clinical testing and comparison to predicate devices, not typically "test sets" of data for algorithmic performance. The testing involved physical devices. There is no mention of "data provenance" in terms of patient data or clinical images from specific regions or whether it was retrospective/prospective, as this is not a data-driven AI device.
3. 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. There is no "ground truth" establishment in the context of expert review of images or clinical data, as this is a mechanical device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication required for this type of non-clinical device test.
5. 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 not an AI-assisted diagnostic or therapeutic device. No MRMC study was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. Its performance is inherent to its mechanical and software design, tested physically.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of clinical "ground truth" for diagnostic accuracy. The "ground truth" for this device's performance is its physical measurements (e.g., pressure, frequency) and safety characteristics, confirmed through engineering tests and adherence to recognized standards. For the purpose of substantial equivalence, the "ground truth" is also the performance and characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI-based device.
9. How the ground truth for the training set was established
Not applicable. See point 8.
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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
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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)
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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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)Predicate Device | Aerobika (K123400)Reference Device | Comparison |
|---|---|---|---|---|
| Indications forUse | Pulsehaler™ isindicated for use as aPositive ExpiratoryPressure (PEP) Device.The use ofPulsehaler™improves clearanceof secretions The use ofPulsehaler™ mayreduce the need forpostural drainage Pulsehaler™facilitates openingof airways inpatients Pulsehaler™ maybe used to preventor reverseatelectasis Pulsehaler™ mayalso be useful in theremoval of mucusfrom the lungs Pulsehaler™ is intendedfor single patient, adultusers in a home orhospital environment. | Aerosure is indicated foruse as a PositiveExpiratory Pressure(PEP) Device.The use of Aerosureimproves clearanceof secretions The use of Aerosuremay reduce theneed for posturaldrainage Aerosure facilitatesopening of airwaysin patients withCystic Fibrosis,COPD, asthma, andlung diseases withsecretory problems Aerosure may beused to prevent orreverse atelectasis Aerosure may alsobe useful in theremoval of mucusfrom the lungs ofpatients who havechronic bronchitis orbronchiectasis | The Aerobika*Oscillating PositiveExpiratory Pressuredevice is intended foruse as a PositiveExpiratory Pressure(PEP device. TheAerobika* OscillatingPEP device may alsobe used simultaneouslywith nebulized aerosoldrug delivery. Thedevice is intended to beused by patientscapable of generatingan exhalation flow of 10lpm for 3-4 seconds. | Same as predicate |
| Intended UseEnvironment | Hospital and Home Use | Hospital and Home Use | Hospital and Home Use | Same as predicate |
| PatientPopulation | Adult patients | Patients age 21 andabove with CysticFibrosis, COPD,asthma, and lungdiseases with secretoryproblems, and patientswith atelectasis. | Patients capable ofgenerating andexhalation flow of 10 lpm for 3-4 seconds. | Similar to predicate, nospecific diseaseconditions are claimed. |
| OscillationMechanism | Rotating Disc | Rotating Disk | Oscillating Lever | Same as predicate |
| Characteristic | Pulsehaler™ | Aerosure (K140772)Predicate Device | Aerobika (K123400)Reference Device | Comparison |
| PEPMechanism | Flow vs resistance fromoscillation mechanism,restricted orifice, andblower | Flow vs resistance fromoscillation mechanism,restricted orifice | Flow vs resistance fromoscillation mechanism,restricted orifice, andblower | Subject devicegenerates PEP with ablower, however, outputPEP pressures,vibration frequenciesand amplitudes areequivalent to thoseproduced by predicateand reference device. |
| OperatingModes | Single mode withmultiple speeds | Single Speed Mode | 5 levels of resistance | Subject device hasmultiple speeds. OutputPEP pressures,vibration frequenciesand amplitudesproduced at eachspeed are equivalent. |
| SoftwareControl | Yes | Yes | No | Same as predicate |
| MeanFrequency | 6 Hz to 65Hz | 30 Hz-52Hz | 7Hz- 22Hz | Mean frequenciesgenerated by subjectdevice are within therange generated bypredicate and referencedevice. |
| PressureAmplitude | 9-23 cmH2O | 2-32 cmH2O | 1-21 cmH2O | Pressure amplitudegenerated by subjectdevice is within therange generated bypredicate and referencedevice. |
| MeanPressure | 7-10 cmH2O | 1-11 cmH2O | 1-25 cmH2O | Mean pressuregenerated by subjectdevice is within therange generated bypredicate. |
| PressureLimitation | Based on hardwareblower limitations | Limited by patient'srespiratory effort | Limited by patient'srespiratory effort | Output pressure ofblower limited duringsingle and multiplefaults to <20cmH2O |
| Power Supply | AC Mains connected DCpower supply,110~240V 50/60Hz | Charger: AC mainsconnected DC powersupply, 110~240 V /50/60HzHand Unit: 3 cell NiMHrechargeable battery(nominal 3.6V). | None (mechanicaldevice) | Wall power to BaseUnit - same aspredicate; however,Hand Unit is connectedand powered by BaseUnit, instead ofrechargeable batteries |
| Sterility | Used non-sterile | Used non-sterile | Used non-sterile | Same as predicate |
| Characteristic | Pulsehaler™ | Aerosure (K140772)Predicate Device | Aerobika (K123400)Reference Device | Comparison |
| Standards withwhich theDeviceComplies | ISO 10993; IEC 60601-1-2; IEC 60601-1, IEC60601-1-6, IEC 60601-1-11, ISO18562 | ISO 10993; IEC 60601-1-2; IEC 60601-1 | ISO 10993 | Additional applicablestandards 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.
§ 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).