(119 days)
Not Found
No
The description focuses on mechanical principles (pressure, oscillation) and makes no mention of AI or ML.
Yes
The device is intended to exercise patients' lungs and improve secretion clearance for individuals prescribed PEP therapy, indicating its use in treating a medical condition.
No
The primary function of the VibraPEP™ is to exercise the lungs and improve secretion clearance, which are therapeutic actions, not diagnostic.
No
The device description clearly outlines several physical components (curved tube, cap, mouthpiece, valve tube, drying tool) and describes mechanical actions (generating expiratory pressure, oscillating the tube valve). There is no mention of software as a component or the primary function of the device.
Based on the provided information, the VibraPEP™ Mucus Clearing Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "exercise patient's lungs and to improve secretion clearance." This is a therapeutic and physical therapy application, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a mechanical device that the patient exhales through to create pressure and oscillations in the airways. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts directly with the patient's respiratory system.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The VibraPEP™ does not fit this description.
N/A
Intended Use / Indications for Use
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP Device. It was designed to exercise patient's lungs and to improve secretion clearance.
Patient - Patients who have been prescribed PEP therapy
Environment - Hospital, clinics, physician offices, home setting
Product codes (comma separated list FDA assigned to the subject device)
BWF
Device Description
The VibraPEP™ is a Positive End Expiratory (PEP) device in which the user exhales through the device and the device generates expiratory pressure (resistance) and the Tube Valve oscillates creates a range of frequencies within the air column to the patient which help to promote secretion clearance. The VibraPEP™ has been designed to be very similar to the predicate RC-Cornet device (K983308). The basic design, form, function and performance have been compared to the predicate and have been demonstrated to be functionally equivalent and with the same intended use as the predicate.
The device is comprised of several components:
- Curved tube
- Cap for end of Tube
- Mouthpiece with selector
- Valve tube
- Drying tool
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs
Indicated Patient Age Range
Not Found
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)
Comparative Bench Testing
We performed a number of performance tests which included:
- Comparative Performance at 10, 20, and 40 lpm
- Average Pressure
- Average Pressure Amplitude
- Frequency
- Average Flow Rate
- Cleaning validation
- Age testing
- Mechanical / Drop test
The comparative bench testing demonstrated that the VibraPEP™ is equivalent to the predicate K983308 - RC-Cornet. See Table 1 above.
The comparative testing demonstrates that the proposed device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2016
Medica Holdings, LLC c/o Paul Dryden Regulatory Consultant for Medica Holdings, LLC 5200 Meadows Road. Suite 150 Lake Oswego, Oregon 97035
Re: K153441
Trade/Device Name: VibraPEPTM Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: February 22, 2016 Received: February 23, 2016
Dear Paul Dryden:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith -S
Erin I. Keith M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K153441
Device Name
VibraPEP™
Indications for Use (Describe)
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure, PEP Device. It was designed to exercise patient's lungs and to improve secretion clearance.
Patient - Patients who have been prescribed PEP therapy
Environment - Hospital, clinics, physician offices, home setting
Type of Use (Select one or both, as applicable)
XX Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| | 510(k) Summary
March 15, 2016
Page 1 of 5 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------|
| Date Prepared | March 15, 2016 |
| Official Contact: | George Reed
Medica Holdings, LLC
5200 Meadows Road, Suite 150
Lake Oswego, OR 97035
Tel – 503-227-1900 |
| Proprietary or Trade Name: | VibraPEP™ |
| Common/Usual Name: | Spirometer, Therapeutic (Incentive) |
| Classification Name: | BWF - 21CFR868.5690, Class II |
| Predicate Device: | Pari – RC-Cornet – K983308 |
Device Description:
The VibraPEP™ is a Positive End Expiratory (PEP) device in which the user exhales through the device and the device generates expiratory pressure (resistance) and the Tube Valve oscillates creates a range of frequencies within the air column to the patient which help to promote secretion clearance. The VibraPEP™ has been designed to be very similar to the predicate RC-Cornet device (K983308). The basic design, form, function and performance have been compared to the predicate and have been demonstrated to be functionally equivalent and with the same intended use as the predicate.
The device is comprised of several components:
- Curved tube
- Cap for end of Tube ●
- Mouthpiece with selector ●
- Valve tube
- Drying tool ●
Principle of Operation
The VibraPEP™ is a curved tube in which a long valve is inserted. As the patient blows through the VibraPEP, the hose pressure increases and buckles at the bending of the tube. When the peak pressure is reached, the hose end opens and is catapulted against the wall releasing its pressure. This process is repeated, providing an oscillation effect during the entire exhalation phase. By rotating the therapy selector, pressure and flow can be adjusted to increase or decrease the pressure and frequency of PEP therapy.
Indications for Use:
The VibraPEP™ Mucus Clearing Device is a Positive Expiratory Pressure. PEP Device. It was designed to exercise patient's lungs and to improve secretion clearance.
Patient - Patients who have been prescribed PEP therapy
Environment - Hospital, clinics, physician offices, home setting
4
510(k) Summary
March 15, 2016 Page 2 of 5
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 (IPC) > 20 mm Hg ●
- 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 other middle ear pathology .
Substantial Equivalence
| Features | Predicate - RC-Cornet
K983308 | Proposed
VibraPEP™ |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The PARI RC Cornet Mucus Clearing Device
is a Positive Expiratory Pressure PEP Device
and it was designed to exercise patient's lungs
and to improve secretion clearance. The device
was designed to work with PARI LC
Nebulizers. | The VibraPEP™ Mucus Clearing Device
is a Positive Expiratory Pressure, PEP
Device. It was designed to exercise
patient's lungs and to improve secretion
clearance. |
| Environment of Use | Hospital, clinics, physician offices, home
setting | Hospital, clinics, physician offices, home
setting |
| Patient Population | General population | Patients who have been prescribed PEP
therapy |
| Contraindications | • Hemodynamic instability
• Intracranial pressure (IPC) > 20 mm Hg
• 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 other middle ear pathology | • Hemodynamic instability
• Intracranial pressure (IPC) > 20 mm Hg
• 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 other middle ear pathology |
| Principle of Operation | Tube valve that upon patient exhalation will
create PEP and oscillation
Adjustable to create different frequencies | Tube valve that upon patient exhalation
will create PEP and oscillation
Adjustable to create different frequencies |
5
510(k) Summary
March 15, 2016
| Page 3 of 5 | ||||||
|---|---|---|---|---|---|---|
| Features | Predicate - RC-Cornet | |||||
| K983308 | Proposed | |||||
| VibraPEP™ | ||||||
| Use with a nebulizer | Pari LC nebulizer | No recommendation | ||||
| Single patient, | ||||||
| multi-use | Yes | Yes | ||||
| Cleaning method | Soap / water and Boiling water | Soap / water and Boiling water | ||||
| Components that may | ||||||
| be used | Not specified | |||||
| Tee adapter to be inserted between | ||||||
| nebulizer and mouthpiece | ||||||
| Pari LC nebulizers | No user supplied components | |||||
| Components | Curved tube | |||||
| Mouthpiece / selector | ||||||
| Tube Valve | ||||||
| Cap | ||||||
| Drying device | Curved tube | |||||
| Mouthpiece / selector | ||||||
| Tube Valve | ||||||
| Cap | ||||||
| Drying device | ||||||
| Performance – Non-clinical | ||||||
| Materials | ||||||
| per ISO 10993 | Surface Contact | |||||
| Mucosal membrane | ||||||
| Duration of Use – permanent (> 30 days) | Surface Contact | |||||
| Mucosal membrane | ||||||
| Duration of Use – permanent (> 30 days) | ||||||
| Identical materials - K983308 | ||||||
| Flow rate | Flow rate | |||||
| 10 lpm | 20 lpm | 40 lpm | 10 lpm | 20 lpm | 40 lpm | |
| Ave. Pressure | ||||||
| (cmH2O) | ||||||
| across full range | 11 – 14 | 17 – 21 | 23 – 44 | 10 – 13 | 18 – 21 | 27 – 41 |
| Ave. Pressure | ||||||
| Amplitude (cmH2O) | ||||||
| across full range | 6 – 19 | 21 – 27 | 46 – 80 | 7 – 17 | 22 – 28 | 51 – 76 |
| Ave. Flow Rate (lpm) | ||||||
| across full range | 6 – 16 | 12 – 18 | 15 – 21 | 8 – 16 | 12 – 17 | 19 – 22 |
Note: The pressure, frequency and flow testing was performed on the bench at a constant flow rate for comparative purposes.
Discussion of Substantial Equivalence
The VibraPEP™ oscillator PEP device is viewed as substantially equivalent to the predicate device because:
Indications for Use -
The proposed indications for use are to exercise patient's lungs and to improve secretion clearance. Discussion - The indications for use are similar for the proposed device and the predicate - K983308 - RC-Cornet. The use with a nebulizer is not included.
Patient Population -
The patient population has been clarified to be for patients who have been prescribed PEP therapy.
Discussion - The patient population is intended to be identical to the predicate device, however the predicate did not specify a patient population other than to imply general patient population. The proposed language is viewed as substantially equivalent with added clarification vs. the predicate - K983308 - RC-Cornet.
6
Environment of Use -
The proposed environments of use are Hospital, clinics, physician offices, home setting. Discussion - The environment of use is identical for the proposed device and the predicate -K983308 - RC-Cornet.
Technology -
The design as a curved tube with mouthpiece/selector, tube valve and cap is the identical principle of operation.
Discussion - The technology for generating oscillation and expiratory pressure is identical to the predicate - K983308 - RC-Cornet.
Non-clinical Testing
Materials -
The materials in patient contact and the gas pathway are identical to the predicate - RC-Cornet, K983308. We have evaluated the materials and their type of relations to the patient and determined that they are characterized as:
- Surface Contact .
- . Mucosal membrane
- Duration of Use permanent (> 30 days) .
Discussion - We have been supplied identification of the materials used by the predicate. We have selected the identical materials and certify that the manufacturing processes are identical for the proposed device and the predicate K983308 - RC-Cornet. We provided Material Certifications with the predicate which has the identical indications for use, patient population, environment of use, type of patient contact.
Comparative Bench Testing
We performed a number of performance tests which included:
- . Comparative Performance at 10, 20, and 40 lpm
- o Average Pressure
- Average Pressure Amplitude o
- Frequency O
- Average Flow Rate o
- . Cleaning validation
- . Age testing
- Mechanical / Drop test ●
The comparative bench testing demonstrated that the VibraPEP™ is equivalent to the predicate K983308 - RC-Cornet. See Table 1 above.
The comparative testing demonstrates that the proposed device is substantially equivalent to the predicate device.
Discussion of Differences and Substantial Equivalence Conclusion
As detailed above, the indications for use, patient population, environment of use, technology or principle of operation, and performance have been demonstrated to be substantially equivalent to the predicate.
7
510(k) Summary
March 15, 2016
Page 5 of 5
There are no differences between the proposed VibraPEP™ and the predicate – K983308 – RC-Cornet and based upon the comparative performance testing we can conclude that there are no new safety or effectiveness concerns and thus can determine then to be substantially equivalent.