iPEP System and vPEP

K160636 · D R Burton Healthcare, LLC · BWF · Aug 3, 2016 · Anesthesiology

Device Facts

• Record ID: K160636
• Device Name: iPEP System and vPEP
• Applicant: D R Burton Healthcare, LLC
• Product Code: BWF · Anesthesiology
• Decision Date: Aug 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Device Story

iPEP System and vPEP are respiratory therapy devices. iPEP combines a volumetric incentive spirometer (up to 4000 cc) and an oscillatory PEP module; vPEP is a standalone PEP device. PEP module uses a flap valve/rocker mechanism to generate oscillations during exhalation; incentive spirometer uses a piston/ball to measure inspired volume during inhalation. Used in hospital, clinical, and home settings. Operated by patients under prescription. iPEP allows both therapies in one unit; PEP cartridge is removable for independent use (Pocket PEP). Healthcare providers use output to monitor patient inspiratory effort and airway clearance. Benefits include improved secretion clearance and prevention/reversal of atelectasis.

Clinical Evidence

No clinical testing performed. Evidence consists of comparative bench testing (PEP frequency, amplitude, pressure, and volumetric accuracy) and usability studies with 30 participants (15 lay users, 15 healthcare providers).

Technological Characteristics

Mechanical respiratory devices. PEP mechanism: flap valve/rocker. Incentive spirometer: piston/ball. Materials: externally communicating, tissue/mucosa contact, limited duration (<24 hours). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed. No energy source; manual operation. Single-patient, multi-use.

Indications for Use

Indicated for patients requiring inspiratory exercise and PEP therapy who are capable of generating an exhalation flow of 10 lpm for 3-4 seconds.

Regulatory Classification

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.

Predicate Devices

• Roadrunner PEP Device (K991561)
• Acapella (K002768)
• Cliniflo Incentive Spirometer (K003146)

Reference Devices

• Trudell Aerabika Oscillating Positive Expiratory Pressure (K123400)

Submission Summary (Full Text)

{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 [phone] or [phone] 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 [phone] or [phone] 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug 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. "

FORM FDA 3881 (8/14

Page 1 of 1

Publishing Services [phone]

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

{3}------------------------------------------------

510(k) Summary Page 1 of 7 3-Aug-16

| Company | D R Burton Healthcare LLC<br>3936 South Fields Street<br>Farmville, NC 27828<br>Tel - 847-641-0500 |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Dennis Cook<br>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.)<br>K002768 – Acapella (DHD Healthcare Corp.)<br>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 (<24 hours). The testing performed was cytotoxicity, sensitization, and irritation.

#### Clinical Testing Summary -

There was no clinical testing performed.

#### Discussion of Differences

The differences between the proposed devices and predicates are:

- Combining 2 technologies into 1 package ●
- o We have placed the PEP module inside the incentive spirometer housing, yet each device serves as a standalone. The incentive spirometer is performed upon user inhalation and PEP is performed upon user exhalation. Instead of performing these therapies in 2 separate and independent devices we have combined them into a convenient configuration
- . iPEP System can be separated into 2 separate devices
- The ability to remove the PEP module and use it as an independent PEP device, O referred to as PocketPEP, is unique. However, the performance of the PEP device is similar to the predicate.

These differences to do raise new risk or safety concerns and thus we can conclude the proposed iPEP System and vPEP devices are substantially equivalent to predicates.

{7}------------------------------------------------

# 510(k) Summary

# Table 1 – Comparison of Proposed Device vs. Predicates

| Attribute | Predicate | Proposed |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| | DHD Acapella | iPEP System and vPEP |
| | K991561 / K002768 | |
| Indications for Use | indicated for use as a Positive Expiratory Pressure (PEP) Device | The D R Burton iPEP Therapy System is intended for use as a |
| | • improves clearance of secretions<br>• may reduce the need for postural drainage<br>• facilitates opening of airways in patients with Cystic<br>Fibrosis, COPD, asthma, and lung diseases with<br>secretory problems<br>• may be used to prevent or reverse atelectasis | 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. |
| Environments of use | Home care settings and hospitals | iPEP System for hospital and clinical settings |
| | | vPEP for hospital and home care setting. |
| Prescriptive | Yes | Yes |
| Patient population | Patients requiring PEP therapy | Patients requiring inspiratory exercise and capable of generating an |
| | | exhalation flow of 10 lpm for 3-4 seconds. |
| Single patient, multi-use | Yes | Yes |
| Patient interface | Mouthpiece | Mouthpiece |
| Basic components | Rocker which generates oscillation during exhalation | Flap valve which generates oscillation during exhalation |
| | One-way valve | One-way valve |
| | Mouthpiece | Mouthpiece |
| Mean Frequency range (Hz) | 7.0 @ 5 lpm | 8.0 @ 5 lpm |
| Criteria within 15% | 13.7 @ 25 lpm | 13.0 @ 25 lpm |
| Mean Amplitude / Pressure | 5.9 @ 5 lpm | 5.5 @ 5 lpm |
| (cmH2O) | 23.2 @ 25 lpm | 22.7 @ 25 lpm |
| Criteria within 15% | | |
| Mean Pressure (cmH2O)at | Min - 0 @ 5 lpm | Min - 0 @ 5 lpm |
| Min and Max settings | Min - 2.9 @ 25 lpm | Min - 2.5 @ 25 lpm |
| Criteria within 15% | Max - 5.9 @ 5 lpm | Max – 5.5 @ 5 lpm |
| | Max - 26.1 @ 25 lpm | Max - 25.1 @ 25 lpm |
| Has means to adjust | Yes, variable exhalation opening | Yes, variable exhalation opening |
| amplitude / pressure | | |
| Attribute | Predicate<br>DHD Acapella<br>K991561 / K002768 | Proposed<br>iPEP System and vPEP |
| Cleaning method | Rinse, soap and water | Rinse, soap and water |
| Performance testing | | Age<br>Cleaning / simulated life<br>Drop test<br>Frequency (Hz)<br>Amplitude (cmH2O)<br>Pressure at min / max settings (cmH2O) |
| Type of Patient contact with<br>materials | Externally communicating / Tissue<br>Surface contact / mucosa<br>Limited duration (< 24 hours) | Externally communicating / Tissue<br>Surface contact / mucosa<br>Limited duration (< 24 hours) |

{8}------------------------------------------------

# 510(k) Summary

## Table 2 - Comparison for Incentive Spirometer

| Attribute | DHD Cliniflo /Coach<br>K003146 | Proposed<br>iPEP with Incentive Spirometer |
|---------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended as an inspiratory deep breathing positive exerciser | The D R Burton iPEP Therapy System is intended for use as a<br>Positive Expiratory Pressure (PEP) by patients capable of<br>generating an exhalation flow of 10 lpm for 3-4 seconds and an<br>Incentive Spirometer as an inspiratory, deep breathing positive<br>exerciser. |
| Environments of use | Home care settings and hospitals | iPEP System for hospital and clinical settings |
| Prescriptive | Yes | Yes |
| Patient population | Patients requiring inspiratory exercise | Patients requiring inspiratory exercise |
| Single patient, multi-use | Yes | Yes |
| Patient interface | Mouthpiece with flex-tubing | Mouthpiece with flex-tubing |
| Basic components | Housing<br>1 ball / piston<br>Tubing<br>Mouthpiece | Housing<br>1 ball / piston<br>Tubing<br>Mouthpiece |

{9}------------------------------------------------

#### 510(k) Summary Page 7 of 7 3-Aug-16

| Attribute | DHD Cliniflo /Coach<br>K003146 | Proposed<br>iPEP with Incentive Spirometer |
|-------------------------------------------|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Volume range | 2500 and 5000 cc | 4000 cc |
| Performance testing | Volume accuracy<br>2500 cc (14 – 21%)<br>5000 cc (16 – 21%) | Volume accuracy<br>4000 cc (1.6 to 2.2%)<br>Age Testing<br>Pre and post- exposure<br>Drop test<br>Cleaning |
| Type of Patient contact<br>with materials | Externally communicating / Tissue<br>Surface contact / mucosa<br>Limited duration (< 24 hours) | Externally communicating / Tissue<br>Surface contact / mucosa<br>Limited duration (< 24 hours) |

#### Substantial Equivalence Conclusion

As detailed, the indications for use, patient population, environment of use, technology or principle of operation, and performance are substantially equivalent to the predicates.

The identified differences between the proposed D R Burton iPEP system or vPEP and the predicates – K991561 / K002768 – DHD Acapella for PEP and K003146 - DHD Clinifio as an Incentive Spirometer based upon the comparative performance testing allows us there are no new safety or effectiveness concerns that raise new risks and thus the can be determined to be substantially equivalent.