(486 days)
Not Found
No
The device description and testing focus on mechanical and performance characteristics of a vibratory PEP device. There is no mention of AI, ML, or any computational analysis of data to inform device function or output.
Yes
The device is described as a "therapeutic spirometer" and is intended to "aid in the mobilization and expectoration of secretions" and "open airways," which are direct therapeutic actions.
No
The device is described as a therapeutic device for positive expiratory pressure (PEP) intended to mobilize secretions, open airways, and deliver medication, primarily aiding in treatment and management of respiratory conditions rather than diagnosis.
No
The device description explicitly states it is a "hand-held vibratory positive expiratory pressure (PEP) device" and describes physical components and testing related to hardware performance, materials, and reprocessing.
Based on the provided information, this 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Smiths Medical acapella® Choice Blue Vibratory PEP Device is a therapeutic device used to help patients mobilize and expectorate secretions from their lungs. It works by providing positive expiratory pressure and vibrations.
- Intended Use: The intended use is for therapy and drug delivery, not for analyzing biological samples to provide diagnostic information.
- Lack of Diagnostic Testing: The description focuses on the mechanical function of the device, its ability to deliver medication, and its performance in bench testing and drug delivery verification. There is no mention of analyzing patient samples or providing diagnostic results.
Therefore, the device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.
Product codes
BWF
Device Description
The subject and predicate acapella® devices are within Smiths Medical's product family for a therapeutic spirometer hand-held vibratory positive expiratory pressure (PEP) device provided to the end-user as a non-sterile, single patient use. The subject device helps aid in the mobilization and expectoration of secretions that accumulate in the lungs of adult and pediatric users who may have Cystic Fibrosis, COPD, asthma, including lung diseases with secretory problems, and patients with atelectasis.
The subject device provides PEP therapy to a patient by producing airflow vibrations that can be delivered in any position to effectively mobilize secretions, open airways and deliver medication (nebulization). These devices have been found to give independence to patients with chronic respiratory diseases, as the therapy can be done at the patient's convenience without the need for clinical assistance.
Principle of Operation: The acapella® Choice Blue Vibratory PEP Device using a non-return valve that upon patient exhalation will create positive end expiratory pressure and oscillations. The device is adjustable to different frequencies. Rotation of the knob between the limits of the cam surfaces allows the physician or clinician to set a desired frequency and pressure for an individual patient or user, and the desired frequency and pressure can be replicated by referring to the indictor on the knob.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs, airways
Indicated Patient Age Range
adults and children (5 years and up)
Intended User / Care Setting
Hospital, clinics, physician offices, home setting
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 of the components comprising each configuration of the subject acapella® Choice Blue Vibratory PEP Device were assessed and tested appropriately to design controls; i.e. design verification, design validations. Testing listed below passed and were verified against their requirements and acceptance criteria:
- Temperature exposure and accelerated aging
- Performance testing (bench) - drop, online therapeutic output, orientation, breakaway pressure, inhalation mode resistance and stutter tests.
- Nebulizer specification verification
- Reprocessing (cleaning and disinfection) verification
- Packaging (transport and distribution) per ASTM D4169
- Biocompatibility per ISO 10993-1
- Biocompatibility per ISO 18562 for gas pathway safety
Additional drug delivery verification testing was conducted for the nebulizer performance with three (3) different aerosol medications (i.e., albuterol sulfate, cromolyn sodium, ipratropium bromide). Specifications were established via a performance test using an eight-stage cascade impactor at a flow rate of 28 L/min equipped with USP induction port throat. Three (3) device samples were tested per each drug. Aerosol was sampled directly from the outlet. The acceptance criteria of the test were that the aerosol performance of any medication, nebulizer, and flow rate would not be statistically different at a confidence level of 95% between the acapella® Choice Blue Vibratory PEP Device and acapella® DH as compared to the nebulizer by itself.
Drug delivery performance of acapella® Choice Blue Vibratory PEP Device combined with a standard nebulizer configuration was compared to same nebulizer configuration without the acapella® Choice Blue Vibratory PEP Device. The delivery of aerosolized drugs with acapella® Choice Blue Vibratory PEP Device when connected to a small volume nebulizer was found to be clinically comparable to the performance of the nebulizer alone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 24, 2019
Smiths Medical % Dawn Norman Executive Vice President MRC-X, LLC 6075 Poplar Avenue, Suite 500 Memphis. Tennessee 38119
Re: K181660
Trade/Device Name: acapella Choice Blue Vibratory PEP Device Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: September 20, 2019 Received: September 23, 2019
Dear Ms. Norman:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 mediation-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,
for
Michael Ryan Division 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
2
Indications for Use
510(k) Number (if known) K181660
Device Name
acapella® Choice Blue Vibratory PEP Device
Indications for Use (Describe)
The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K181660 acapella® Choice Blue
| Date of Preparation: | October 23, 2019 |
|---|---|
| Submitter: | Smiths Medical |
| 6000 Nathan Lane North | |
| Minneapolis, MN 55442 | |
| USA | |
| Establishment Registration Number: | 3012307300 |
| Company Contact (Primary): | Dawn N. Norman |
| MRC X | |
| 6075 Poplar Avenue, Suite 500 | |
| Memphis, TN 38119 | |
| 01-618-604-3064 | |
| Trade Name(s): | Incentive Spirometer |
| Device Name(s): | acapella® Choice Blue Vibratory PEP Device |
| Device Classification: | Class II |
| Regulation Number | |
| and Product Codes: | 21 CFR § 868.5690 / BWF |
| Spirometer, Therapeutic (Incentive) |
Primary Predicate Device
| Primary Predicate Device Name /
Original 510(k) Owner | Product Code /
Regulation | FDA 510k Number /
Clearance Date |
|----------------------------------------------------------|------------------------------|-------------------------------------|
| acapella® DH
Original 510(k) owner: DHD Healthcare | BWF
21 CFR 868.5690 | K002768
September 6, 2000 |
General Device Description
The subject and predicate acapella® devices are within Smiths Medical's product family for a therapeutic spirometer hand-held vibratory positive expiratory pressure (PEP) device provided to the end-user as a non-sterile, single patient use. The subject device helps aid in the mobilization and expectoration of secretions that accumulate in the lungs of adult and pediatric users who may have Cystic Fibrosis, COPD, asthma, including lung diseases with secretory problems, and patients with atelectasis.
The subject device provides PEP therapy to a patient by producing airflow vibrations that can be delivered in any position to effectively mobilize secretions, open airways and deliver medication (nebulization). These devices have been found to give independence to patients with chronic respiratory diseases, as the therapy can be done at the patient's convenience without the need for clinical assistance.
Principle of Operation
The acapella® Choice Blue Vibratory PEP Device using a non-return valve that upon patient exhalation will create positive end expiratory pressure and oscillations. The device is adjustable to different frequencies. Rotation of the knob between the limits of the cam surfaces allows the
4
510(k) SUMMARY
bringing technology to life
K181660 acapella® Choice Blue
physician or clinician to set a desired frequency and pressure for an individual patient or user, and the desired frequency and pressure can be replicated by referring to the indictor on the knob.
Indications for Use
The Smiths Medical acapella® Choice Blue Vibratory PEP Device is intended for use as a Positive Expiratory Pressure (PEP) device for adults and children (5 years and up). It may also be used simultaneously with nebulized aerosol drug delivery.
Contraindications
Although no absolute contraindications to the use of PEP Therapy have been reported, the following should be carefully evaluated before a decision is made to initiate therapy:
- · Inability to tolerate increased work of breathing
- · Hemodynamic instability
- · Intracranial pressure (ICP) > 20 mm Hq
- · Acute sinusitis
- · Recent facial, oral or skull surgery or trauma
- · Epistaxis
- · Esophageal surgery
- Active hemoptysis
- · Untreated pneumothorax
- Nausea
- · Known or suspected tympanic membrane rupture or another middle ear pathology
Substantial Equivalence
The following table presents the comparison of the acapella devices with a discussion of the differences to follow.
| Table 1 Predicate Comparison | ||
|---|---|---|
| Features | Proposed Device acapella® | |
| Choice Blue Vibratory PEP Device | Predicate Device acapella® DH | |
| Indications for use | The Smiths Medical acapella® Choice Blue | |
| Vibratory PEP Device is intended for use as | ||
| a Positive Expiratory Pressure (PEP) | ||
| device for adults and children (5 years and | ||
| up). It may also be used simultaneously | ||
| with nebulized aerosol drug delivery. | Intended for use as a Positive Expiratory | |
| Pressure (PEP) device. It may also be used | ||
| simultaneously with nebulized aerosol drug | ||
| delivery. | ||
| Environment of | ||
| Use | Hospital, clinics, physician offices, home | |
| setting | Hospital, clinics, physician offices, home | |
| setting | ||
| Patient Population | Adults and children (5 years and up) under | |
| the supervision of an adult | Adults and children (4 years and up) under the | |
| supervision of an adult | ||
| Principle of | ||
| Operation (PEP) | Therapeutic spirometer device that works | |
| by assisting the patient to produce | ||
| oscillatory vibrations in the airways | Therapeutic spirometer device that works by | |
| assisting the patient to produce oscillatory | ||
| vibrations in the airways | ||
| Mode of Vibration | Magnetic Rocker assembly | Magnetic Rocker assembly |
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bringing technology to life
K181660 acapella® Choice Blue
| Table 1 Predicate Comparison | ||
|---|---|---|
| Features | Proposed Device acapella® | |
| Choice Blue Vibratory PEP Device | Predicate Device acapella® DH | |
| Resistance Dial | Dial for Selection Range: 1 to 5 | Dial for Selection Range: 1 to 5 |
| Minimum | ||
| expiratory flow | ||
| required | 15 L/M | 15 L/M |
| Material / Color / | ||
| Body Design | Polycarbonate / Blue / Able to be opened | |
| for cleaning | Styrene-butadiene / Green / Closed body | |
| Use with a | ||
| nebulizer | Ability to connect to nebulized aerosol drug | |
| delivery system | Ability to connect to nebulized aerosol drug | |
| delivery system | ||
| Specified | ||
| Nebulizer | Salter Labs 8900 Series | |
| Carefusion Airlife Misty Max 10 | ||
| Westmed UniHEART | Small Volume Nebulizers | |
| Duration of Use | Single patient, multi-use | |
| Up to 6 months use | Single patient, multi-use | |
| Up to 6 months use | ||
| Cleaning method | Soap / water & disinfecting with Boiling | |
| water | Soap / water & disinfecting with Alcohol, or | |
| Hydrogen Peroxide or Glutaraldehyde | ||
| Accessories | None | Face masks or TheraPrep Pressure Indicator |
| Components | Mouthpiece, cover and rocker assembly | Mouthpiece and body only; body does not come |
| apart | ||
| Biocompatibility | ||
| ISO 10993-1 | Biocompatible based on ISO 10993 | |
| • External Communicating (Indirect gas | ||
| pathway) | ||
| • Tissue / Bone / Dentin | ||
| communicating | ||
| • Duration of Use - prolonged duration | ||
| based on cumulative exposure (> 24 | ||
| hours to 30 days) | ||
| And | ||
| • Surface Contact | ||
| • Mucosal membrane | ||
| • Duration of Use - prolonged duration | ||
| based on cumulative exposure (> 24 | ||
| hours to 30 days) | Biocompatible based on ISO 10993 | |
| Shelf-life | 2 years | 2 years |
Summary of Technological Characteristics
The technology for delivery PEP therapy is unchanged between the subject and the predicate devices. The subject device shares the same technological characteristics as the 510(k) cleared for the predicate device, acapella® DH (K002768); these characteristics include:
- . Provide controllable and variable resistance to the expiratory phase of breathing and therefore creates increased trans-pulmonary pressure within the lung.
- Create vibrations that mimic the oscillatory frequency of cilia. This aids in loosening . secretions from the walls of the airways by altering the viscoelastic properties of secretions.
- Contain a flow tube to create a channel for air to pass through and for the vibrations travel back to the user.
6
s medical bringing technology to life
K181660 acapella® Choice Blue
- Have an adjustable resistance dial raises and lowers the magnet based on the users' . exhalation capacity.
- . Contain a mouthpiece that connects the users' mouth to the device.
- . Provide the ability to connect a nebulizer in-line that allows the user to inhale the aerosolized drug and then exhale through the PEP device.
The differences between the subject and predicate device are minimal and include differences in the materials of the outer and internal components. The subject device is now able to be opened for cleaning by the user throughout the lifetime of the device, whereas the predicate is a closed system. Smiths Medical has determined these two (2) modifications do not affect the device's intended use, indication for use or alter the device's fundamental scientific technology of Positive Expiratory Pressure therapy.
Summary of Non-Clinical Testing
Non-clinical testing of the components comprising each configuration of the subject acapella® Choice Blue Vibratory PEP Device were assessed and tested appropriately to design controls; i.e. design verification, design validations. Testing listed below passed and were verified against their requirements and acceptance criteria:
- Temperature exposure and accelerated aging
- . Performance testing (bench) - drop, online therapeutic output, orientation, breakaway pressure, inhalation mode resistance and stutter tests.
- Nebulizer specification verification ●
- Reprocessing (cleaning and disinfection) verification ●
- Packaging (transport and distribution) per ASTM D4169 .
- . Biocompatibility per ISO 10993-1
- Biocompatibility per ISO 18562 for gas pathway safety .
Additional drug delivery verification testing was conducted for the nebulizer performance with three (3) different aerosol medications (i.e., albuterol sulfate, cromolyn sodium, ipratropium bromide). Specifications were established via a performance test using an eight-stage cascade impactor at a flow rate of 28 L/min equipped with USP induction port throat. Three (3) device samples were tested per each drug. Aerosol was sampled directly from the outlet. The acceptance criteria of the test were that the aerosol performance of any medication, nebulizer, and flow rate would not be statistically different at a confidence level of 95% between the acapella® Choice Blue Vibratory PEP Device and acapella® DH as compared to the nebulizer by itself.
Drug delivery performance of acapella® Choice Blue Vibratory PEP Device combined with a standard nebulizer configuration was compared to same nebulizer configuration without the acapella® Choice Blue Vibratory PEP Device. The delivery of aerosolized drugs with acapella® Choice Blue Vibratory PEP Device when connected to a small volume nebulizer was found to be clinically comparable to the performance of the nebulizer alone.
Summary of Differences and Discussion of Substantial Equivalence
The Smiths Medical acapella® Choice Blue Vibratory PEP Device is substantially equivalent to the predicate device, acapella® DH, K002786, based on device characteristic comparisons. These characteristics include the similar intended use, same clinical application, same general design, same useful life, same packaging and same principle of operation and similar performance.
7
510(k) SUMMARY
bringing technology to life
K181660 acapella® Choice Blue
The indications for use are similar for patient population, environment and indication. Contraindications are identical to the predicate. The principal of operation is identical to the predicate. The technological characteristic differences are minimal and have been demonstrated to be substantially equivalent through comparative testing to the predicate and do not increase patient risk. Cleaning and disinfection methods are different, and the differences validated. Performance characteristics of the subject and predicate devices, both with and without a nebulizer, have been evaluated and both meet the acceptance criteria and are therefore substantially equivalent.
Substantial Equivalence Conclusion
Smiths Medical concludes the differences between the subject and predicate device do not impact the indications for use, intended use, mechanical and/or fundamental scientific technology of the device, do not raise new or different questions of safety risks imposed on the patient or device use and that the subject device is as safe and effective as the predicate device; therefore, the subject device, acapella® Choice Blue Vibratory PEP Device, is considered substantially equivalent to the predicate.