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 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.

AI/ML Overview

The provided document is a 510(k) Summary for the D R Burton iPEP System and vPEP, which are devices intended for Positive Expiratory Pressure (PEP) therapy and as Incentive Spirometers. The study described is a non-clinical bench testing and usability study, focused on demonstrating substantial equivalence to predicate devices. There is no clinical study described.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two comparison tables (Table 1 for PEP function, Table 2 for Incentive Spirometer function) comparing the proposed device against its predicates. The acceptance criteria for the proposed device are implicitly set by its performance falling within a certain range (e.g., 15%) of the predicate devices' performance.

Attribute	Acceptance Criteria (Implicit from Predicate Performance)	Reported Device Performance (Proposed iPEP System and vPEP)
PEP Function (Table 1)
Mean Frequency (Hz) @ 5 lpm	7.0 Hz (Predicate: DHD Acapella)	8.0 Hz
Mean Frequency (Hz) @ 25 lpm	13.7 Hz (Predicate: DHD Acapella)	13.0 Hz
Mean Amplitude / Pressure (cmH2O) @ 5 lpm	5.9 cmH2O (Predicate: DHD Acapella)	5.5 cmH2O
Mean Amplitude / Pressure (cmH2O) @ 25 lpm	23.2 cmH2O (Predicate: DHD Acapella)	22.7 cmH2O
Min Pressure (cmH2O) @ 5 lpm	0 cmH2O (Predicate: DHD Acapella)	0 cmH2O
Min Pressure (cmH2O) @ 25 lpm	2.9 cmH2O (Predicate: DHD Acapella)	2.5 cmH2O
Max Pressure (cmH2O) @ 5 lpm	5.9 cmH2O (Predicate: DHD Acapella)	5.5 cmH2O
Max Pressure (cmH2O) @ 25 lpm	26.1 cmH2O (Predicate: DHD Acapella)	25.1 cmH2O
Incentive Spirometer Function (Table 2)
Volume range	2500 cc and 5000 cc (Predicate: DHD Cliniflo / Coach)	4000 cc
Volume accuracy @ 2500 cc	14 – 21% (Predicate: DHD Cliniflo / Coach)	Not directly comparable at 2500cc.
Volume accuracy @ 5000 cc	16 – 21% (Predicate: DHD Cliniflo / Coach)	Not directly comparable at 5000cc.
Volume accuracy @ 4000 cc	Implies similar accuracy to predicate models at comparable volumes. (Predicate values are 14-21% at similar volumes.)	1.6 to 2.2% (Significantly better than reported predicate range, but applied to a different volume. The summary states "The results demonstrated equivalent performance," implying this accuracy is considered acceptable and substantially equivalent to the predicate's performance range.)

Note on "Criteria within 15%": This phrase appears in Table 1 for Frequency and Amplitude/Pressure, suggesting that the proposed device's performance metrics were expected to be within 15% of the predicate device's values. The reported values for the iPEP and vPEP appear to meet this implicit criterion.

Additional Bench Testing:

Aging, Simulated Life (cleaning), Drop Testing, Cleaning: Performed with pre- and post-exposure evaluation.
Biocompatibility Materials: Cytotoxicity, sensitization, and irritation testing for materials with limited duration (<24 hours) patient contact.
Usability Studies: Confirmed appropriate design and instructions for use for intended user groups.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Description: The "test set" for the non-clinical, comparative bench testing is not explicitly defined in terms of a specific number of units or data points beyond the flow rates (5 lpm and 25 lpm) at which measurements were taken. However, for "Usability Studies," there were at least 15 users per identified group (lay users and Healthcare Providers).
Data Provenance: The data is generated from bench testing and usability studies conducted by D R Burton Healthcare LLC. This is prospective data from internal testing. There is no mention of country of origin for the data beyond the company's location in Farmville, North Carolina, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is largely not applicable as the described studies are non-clinical bench tests and usability tests.

For the bench testing, the "ground truth" is established by direct measurement against engineering specifications and comparison to the performance of predicate devices per existing literature or internal testing of those devices. No independent clinical experts are mentioned for establishing ground truth in this context.
For the usability studies, the "ground truth" (i.e., whether the device is usable and instructions are clear) is assessed by the performance and feedback of the users themselves. The document states "2 user groups, lay users and Healthcare Providers," but does not specify their individual qualifications beyond being "Healthcare Providers."

4. Adjudication Method for the Test Set

Not applicable as there is no mention of a formal adjudication process for establishing a "ground truth" from expert opinions for the non-clinical bench testing or usability studies. The bench tests rely on objective measurements, and usability studies on user feedback and performance.

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

Not applicable. This device is a medical instrument (incentive spirometer, PEP device), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have an "algorithm" in the sense of AI or image analysis. Its performance is mechanical and measured directly in the bench tests described. The device's function is standalone in its mechanical operation, but it requires human interaction for its intended therapeutic purpose (patient breathing into it).

7. The Type of Ground Truth Used

For PEP and Incentive Spirometer performance (frequency, amplitude, pressure, volume accuracy): The ground truth is based on direct physical measurements using calibrated equipment, compared to the established performance characteristics and specifications of the predicate devices.
For Biocompatibility: Ground truth is established by standardized laboratory testing against accepted biological safety norms (cytotoxicity, sensitization, irritation).
For Usability: Ground truth is established by observations of user interactions and user feedback against predefined usability metrics and risk analysis requirements.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical product. There is no mention or implication of a machine learning or AI model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K160636

Device Name

iPEP System and vPEP

Indications for Use (Describe)

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

Company	D R Burton Healthcare LLC3936 South Fields StreetFarmville, NC 27828Tel - 847-641-0500
Official Contact:	Dennis CookPresident & 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.

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.

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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.

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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.

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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.

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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• may reduce the need for postural drainage• facilitates opening of airways in patients with CysticFibrosis, COPD, asthma, and lung diseases withsecretory problems• 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	PredicateDHD AcapellaK991561 / K002768	ProposediPEP System and vPEP
Cleaning method	Rinse, soap and water	Rinse, soap and water
Performance testing		AgeCleaning / simulated lifeDrop testFrequency (Hz)Amplitude (cmH2O)Pressure at min / max settings (cmH2O)
Type of Patient contact withmaterials	Externally communicating / TissueSurface contact / mucosaLimited duration (< 24 hours)	Externally communicating / TissueSurface contact / mucosaLimited duration (< 24 hours)

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510(k) Summary

Table 2 - Comparison for Incentive Spirometer

Attribute	DHD Cliniflo /CoachK003146	ProposediPEP 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 aPositive Expiratory Pressure (PEP) by patients capable ofgenerating an exhalation flow of 10 lpm for 3-4 seconds and anIncentive Spirometer as an inspiratory, deep breathing positiveexerciser.
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	Housing1 ball / pistonTubingMouthpiece	Housing1 ball / pistonTubingMouthpiece

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

Attribute	DHD Cliniflo /CoachK003146	ProposediPEP with Incentive Spirometer
Volume range	2500 and 5000 cc	4000 cc
Performance testing	Volume accuracy2500 cc (14 – 21%)5000 cc (16 – 21%)	Volume accuracy4000 cc (1.6 to 2.2%)Age TestingPre and post- exposureDrop testCleaning
Type of Patient contactwith materials	Externally communicating / TissueSurface contact / mucosaLimited duration (< 24 hours)	Externally communicating / TissueSurface contact / mucosaLimited 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.

Regulation Number and Section

§ 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).