(149 days)
No
The summary describes a mechanical respiratory therapy device (PEP and incentive spirometer) and does not mention any computational or data-driven features indicative of AI/ML.
Yes
The device is intended for use as Positive Expiratory Pressure (PEP) and as an Incentive Spirometer, both of which are therapeutic interventions for respiratory conditions.
No
The device is intended for therapeutic use (Positive Expiratory Pressure and Incentive Spirometry) for patients to perform breathing exercises, not to diagnose a condition.
No
The device description clearly outlines physical components like a volumetric incentive spirometer, an oscillatory PEP module (cartridge), mouthpiece, carrying case, and dust cover, indicating it is a hardware device with potentially integrated software for measurement or feedback, but not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for Positive Expiratory Pressure (PEP) and Incentive Spirometry. These are therapeutic and exercise-based functions related to respiratory mechanics.
- Device Description: The description details physical components like a volumetric incentive spirometer and an oscillatory PEP module. These are mechanical devices used for breathing exercises and airway clearance.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. The device interacts directly with the patient's respiratory system.
In summary, the D R Burton iPEP Therapy System and vPEP are respiratory therapy devices, not IVDs.
N/A
Intended Use / Indications for Use
The D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.
Intended for single-patient, multi-use.
iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting
Product codes
BWF
Device Description
D R Burton Healthcare as indicated above proposes to offer 2 devices which we will refer to as the:
- iPEP (integrated Incentive spirometer with PEP) system and
- vPEP which is a standalone PEP therapy device
iPEP system
- Volumetric Incentive Spirometer up to 4000 cc
- Oscillatory PEP module (cartridge)
The design of the iPEP system permits the PEP cartridge to be removed and used as an independent PEP device, which we refer to as the Pocket PEP.
In order to use the Pocket PEP the iPEP system includes a separate mouthpiece, carrying / storage case and dust cover which are needed when one wants to use the PEP cartridge independent of the iPEP systems (Pocket PEP).
When the PEP cartridge is removed from the iPEP system, one can insert a cover where the PEP cartridge has been removed to allow the incentive spirometer to be used one its own.
vPEP
- The vPEP is the standalone device that is pre-assembled and is not intended to be used in the iPEP System. The vPEP incorporates the identical internal components of the PEP cartridge of the iPEP system.
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
Not Found
Intended User / Care Setting
iPEP System for hospital and clinical settings
vPEP for hospital, clinical, and home care 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
Comparative Bench Testing
We performed comparative testing of the PEP functions including frequency and amplitude (pressure) as well as volume accuracy / repeatability for the incentive spirometer portion as well. Each technology was compared to the applicable predicates. The results demonstrated equivalent performance. These results demonstrated that the proposed device is equivalent to the predicates - K991561 / K002768 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer.
Testing that was performed included:
- Aging, Simulated Life (cleaning), Drop Testing, Cleaning
- Pre- and post- exposure
- PEP amplitude (resistance) and frequency
- Testing was performed at minimum and maximum expected flow rates of 5 lpm and 25 lpm
- Mean Frequency (Hz)
- Mean Amplitude (cmH2O)
- Pressure at Minimum and Maximum levels (cmH2O)
- Comparative PEP performance
- Volumetric Accuracy - repeatability
- Comparative Volumetric accuracy
Usability Studies
Usability testing was performed with 2 users groups, lay users and Healthcare Providers, with at least 15 users per identified group. Testing included the appropriate tasks based upon the risk analysis. Testing found that the design of the device and instructions for use were appropriate for the intended user groups.
Biocompatibility Materials
We tested the materials in direct and indirect patient contact based upon the duration of contact, for a cumulative exposure (
§ 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 3, 2016
D R Burton Healthcare LLC C/O Paul Dryden Consultant 3936 S Fields St Farmville, North Carolina 27828
Re: K160636
Trade/Device Name: iPEP System and vPEP Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: July 2, 2016 Received: July 6, 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 the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Tina Kiang, PhD Acting 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) K160636
Device Name
iPEP System and vPEP
Indications for Use (Describe)
The D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.
Intended for single-patient, multi-use.
iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care 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 Page 1 of 7 3-Aug-16
| Company | D R Burton Healthcare LLC
3936 South Fields Street
Farmville, NC 27828
Tel - 847-641-0500 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Dennis Cook
President & CEO |
| Proprietary or Trade Name: | iPEP System and vPEP |
| Common/Usual Name: | Spirometer, therapeutic (incentive) |
| Product Code: | BWF, Class II |
| Classification / CFR: | 21CFR 868.5690 |
| Device: | iPEP System and vPEP |
| Predicate Devices: | K991561 - Roadrunner PEP Device (DHD Healthcare Corp.)
K002768 – Acapella (DHD Healthcare Corp.)
K003146 - Cliniflo Incentive Spirometer (DHD Healthcare Corp.) |
Device Description:
D R Burton Healthcare as indicated above proposes to offer 2 devices which we will refer to as the:
- iPEP (integrated Incentive spirometer with PEP) system and ●
- . vPEP which is a standalone PEP therapy device
iPEP system
- Volumetric Incentive Spirometer up to 4000 cc
- Oscillatory PEP module (cartridge) ●
The design of the iPEP system permits the PEP cartridge to be removed and used as an independent PEP device, which we refer to as the Pocket PEP.
In order to use the Pocket PEP the iPEP system includes a separate mouthpiece, carrying / storage case and dust cover which are needed when one wants to use the PEP cartridge independent of the iPEP systems (Pocket PEP).
When the PEP cartridge is removed from the iPEP system, one can insert a cover where the PEP cartridge has been removed to allow the incentive spirometer to be used one its own.
vPEP
- The vPEP is the standalone device that is pre-assembled and is not intended to be used in the iPEP ● System. The vPEP incorporates the identical internal components of the PEP cartridge of the iPEP system.
Indications for Use:
The D R Burton iPEP Therapy System is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.
4
510(k) Summary Page 2 of 7 3-Aug-16
Intended for single-patient, multi-use.
iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting
Patient Population:
Patients requiring inspiratory exercise and capable of generating an exhalation flow of 10 lpm for 3-4 seconds.
Environment of Use:
iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting
Substantial Equivalence Discussion
Table 1 and Table 2 compare the key features of the proposed D R Burton iPEP with incentive spirometer and vPEP with the identified predicates. The comparison demonstrates that the devices can be found to be substantially equivalent to the identified predicates. We based this conclusion upon the following:
Indications for Use -
The indications for use are similar for the proposed device when compared to the predicates - K991561 / K002768 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer. Discussion - We note that the indications for use wording have changed with time. Recent PEP devices have added language related to patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds. This specific wording of the indications for use statement can be found in K123400 - Trudell Aerabika Oscillating Positive Expiratory Pressure. We do not believe that the additional language changes the intent of the indications for use but provides clarity for the user and patient population.
Patient Population -
The patient population is defined as patients requiring inspiratory exercise and / or PEP therapy is equivalent to the predicates - K991561 / K002678 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer .
Discussion - The patient populations are equivalent to the predicates - K991561 / K002678 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer. We note that the indications for use wording have changed with time. Recent PEP devices have added language related to patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds. This specific wording of the indications for use statement can be found in K123400 - Trudell Aerabika Oscillating Positive Expiratory Pressure. We do not believe that the additional language changes the intent of the indications for use but provides clarity for the user and patient population.
Environment of Use -
The environments of use are similar to predicates - K991561 / K002768 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer.
Discussion - We have defined the environment of use for the iPEP System to be hospital and clinical settings and the VPEP, standalone PEP device to be hospital, clinical and home care setting. These environments of use are similar to the predicates - K991561 / K002768 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer.
5
510(k) Summary Page 3 of 7 3-Aug-16
Principle of Operation and Technology -
The design, components, and principle of operation of the PEP mechanism, a rocker method, that generates oscillations during exhalation and the incentive spirometer in which a float rises during inhalation have been shown to be equivalent to the predicates – K991561 / K002768 – DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer.
Discussion - The Incentive Spirometer design is a 1 ball / piston volume based system for incentive spirometer that upon the patient inhaling raises the ball to indicate the volume of inspired air and the method of a rocker means that generates oscillations during exhalation for PEP are equivalent to the predicates - K991561 / K002768 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer.
The proposed iPEP system is different from the predicates in that is allows both therapies to be housed in the same unit so the user can receive both therapies during one treatment period. This difference is a matter of convenience for the user; the performance and function of the individual technologies are substantially equivalent to the predicates. Any differences do not raise any new safety or effectiveness concerns.
Non-Clinical Testing Summary -
Comparative Bench Testing
We performed comparative testing of the PEP functions including frequency and amplitude (pressure) as well as volume accuracy / repeatability for the incentive spirometer portion as well. Each technology was compared to the applicable predicates. The results demonstrated equivalent performance. These results demonstrated that the proposed device is equivalent to the predicates - K991561 / K002768 - DHD Acapella for PEP and K003146 - DHD Cliniflo as an Incentive Spirometer.
Testing that was performed included:
- Aging, Simulated Life (cleaning), Drop Testing, Cleaning ●
- o Pre- and post- exposure
- . PEP amplitude (resistance) and frequency
- Testing was performed at minimum and maximum expected flow rates of 5 lpm and 25 lpm O
- Mean Frequency (Hz) o
- Mean Amplitude (cmH2O) o
- Pressure at Minimum and Maximum levels (cmH2O) O
- . Comparative PEP performance
- . Volumetric Accuracy - repeatability
- Comparative Volumetric accuracy
Usability Studies
Usability testing was performed with 2 users groups, lay users and Healthcare Providers, with at least 15 users per identified group. Testing included the appropriate tasks based upon the risk analysis. Testing found that the design of the device and instructions for use were appropriate for the intended user groups.
6
510(k) Summary Page 4 of 7 3-Aug-16
Biocompatibility Materials -
We tested the materials in direct and indirect patient contact based upon the duration of contact, for a cumulative exposure (