The D R Burton® OxyPAP™ device is indicated for the treatment and prevention of atelectasis. It also has the ability to provide supplemental oxygen when used with compressed oxygen. It includes the option of a pressure manometer. The device is for patients (ages 5 years and above) who are capable of following directions for positive airway pressure (PAP) therapy.

Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.

The environment of use is for hospital and clinical setting.

Device Description

The OxyPAP device is a handheld respiratory therapy device that creates a positive airway pressure. The OxyPAP device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The OxyPAP device is a single patient use device.

AI/ML Overview

The provided text describes the D R Burton OxyPAP device, its indications for use, and a comparison to predicate and reference devices for a 510(k) submission. However, this document does not contain any information about acceptance criteria, a specific study proving the device meets these criteria, or details regarding AI/algorithm performance and ground truth establishment.

The document is a US FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated standalone study. The "Performance" and "Non-clinical Comparative Performance" sections primarily describe comparative testing to show similarity to existing devices.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will explain what information is present and what is missing.

Summary of what can be extracted from the document:

Device Name: D R Burton OxyPAP
Device Type: Incentive Spirometer, Positive Airway Pressure (PAP) Therapy Device
Indications for Use: Treatment and prevention of atelectasis; ability to provide supplemental oxygen when used with compressed oxygen. For patients (ages 5 years and above) capable of following directions for PAP therapy. Normal use not more than 24 hours total combined time. Environment of use: hospital and clinical setting.
Predicate Device: K991300 – DHD Healthcare Corp. – Boeing, Positive Airway Pressure (PAP) Therapy Device
Reference Devices: K173819 – Trudell VersaPAP™ Device; K040991 – Ambu Disposable Pressure Manometer

Missing/Not Applicable Information based on the prompt's requirements:

The document focuses on substantial equivalence for a medical device that is not an AI/ML powered device. As such, information typically associated with AI/ML device validation studies (like distinct acceptance criteria for algorithm performance, expert review for ground truth, MRMC studies, training/test set details, etc.) is not present and not applicable to this type of device submission.

Specifically, the following sections of your request cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document presents comparative performance data (e.g., Mean PEEP, Mean Peak Expiratory Pressure), but these are comparisons to predicate/reference devices, not explicit acceptance criteria for a standalone study performance. There are no clear quantitative acceptance criteria stated for the D R Burton OxyPAP itself beyond being "substantially equivalent" to the predicate.
2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device, not an algorithm being tested on a data set. The "bench testing" mentioned includes performance testing and drop testing, but no "sample size" in the context of data points.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering and clinical performance testing, not expert review of AI outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for an AI-assisted workflow, which is not the case here.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
7. The type of ground truth used: For a physical device, "ground truth" would refer to measured physical properties or clinical outcomes. The document discusses "Biocompatibility" (material certification to a legally marketed device) and "Bench Testing" (comparative performance, drop testing, effects of aging). These are the "truths" for this device.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Information that is present (though not in the requested format for AI/ML devices):

Device Performance Reported (Comparative, not against specific acceptance criteria):
- Proposed OxyPAP:
  - Mean PEEP (cmH2O) @800 ml TV: 2.81 @ 5 Lpm, 12 @ 10 Lpm, 12.75 @ 15 Lpm
  - Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 20 (400 TV) / 21 (800 TV)
  - Mean Inspiratory Pressure (cmH2O) @800 ml TV: -0.7 @ 5 Lpm, -4.7 @ 10 Lpm, -3.46 @ 15 Lpm
  - Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 3.1 @ 5 Lpm, 12.1 @ 10 Lpm, 13 @ 15 Lpm
- Predicate DHD EzPAP (for comparison):
  - Mean PEEP (cmH2O) @800 ml TV: 2 @ 5 Lpm, 8 @ 10 Lpm, 16 @ 15 Lpm
  - Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 22 (400 TV) / 26 (800 TV)
  - Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 5 @ 5 Lpm, 11 @ 10 Lpm, 20 @ 15 Lpm

The core conclusion of the document is that "Based upon the comparative performance testing we have demonstrated that the proposed device compared to the predicate and reference devices can be found to be substantially equivalent." This is the primary "acceptance criterion" for a 510(k) submission of this nature.

Summary

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February 19, 2020

D R Burton Healthcare, LLC Paul Dryden Consultant 3936 S Fields St Farmville, North Carolina 27828

Re: K192000

Trade/Device Name: D R Burton OxyPAP Regulation Number: 21 CFR 868.5690 Regulation Name: Incentive Spirometer Regulatory Class: Class II Product Code: BWF Dated: February 8, 2020 Received: February 11, 2020

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K192000

Device Name

D R Burton® OxyPAP™M

Indications for Use (Describe)

Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.

The environment of use is for hospital and clinical setting.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

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510(k) Summary

Date Prepared	19-Feb-20
D R Burton Healthcare, LLC3936 S Fields StFarmville, NC 27828Tel - 252-228-7038
Official Contact:	Dennis Cook - President
Proprietary or Trade Name:	D R Burton OxyPAP
Common/Usual Name:	Incentive Spirometer
Classification Code/Name:	BWF – Incentive Spirometer21 CFR 868.5690Class II
Predicate Device:	K991300 – DHD Healthcare Corp. – Boeing, Positive AirwayPressure (PAP) Therapy Device
Reference Devices:	K173819 – Trudell VersaPAPTM DeviceK040991 – Ambu Disposable Pressure Manometer

Device Description:

Indications for Use:

Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.

The environment of use is for hospital and clinical setting.

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Table 1 – Comparison to Predicate and Reference Devices
	ProposedOxyPAP	PredicateDHD EzPAP	ReferenceTrudell VersaPAP	ReferenceAmbu Pressure Manometer
510(k)CFR		K991300	K173918	K040991
Classification		868.5690BWF		868.2600CAP
Classification name		Incentive Spirometer		Monitor, airway pressure (includes gauge and/or alarm
Indications for Use	D R Burton OxyPAP isindicated for the treatmentand prevention of atelectasis.It also has the ability toprovide supplemental oxygenwhen used with compressedoxygen. The device is forpatients (ages 5 years andabove) who are capable offollowing directions forpositive airway pressure(PAP) therapy. Normal use ofthe D R Burton OxyPAPTMshould not be more than 24hours total combined time.The environment of use is forhospital and clinical setting.	Boeing is indicated for thetreatment and prevention ofatelectasis. Boing facilitatesopening of airways in patientsrequiring prevention ortreatment of atelectasis.Boeing also has the ability toprovide supplemental oxygenwhen used with compressedoxygen.	VersaPAPTM is indicatedfor the treatment andprevention of atelectasis.VersaPAPTM also has theability to providesupplemental oxygenwhen used withcompressed oxygen.	To provide visual indication of apatient's airway pressure duringventilation. It may be attached to themanometer port or proximal port onventilation devices such as resuscitationbags, hyperinflation bags, CPAP mask,or CPAP circuits.
Patient Population	Patients (ages 5 years andabove) who are capable offollowing directions forpositive airway pressure(PAP) therapy.	Patients requiring therapy fortreatment and prevention ofatelectasis who are capable offollowing directions for PAPtherapy	Patients (ages 5 years andabove) who are capable offollowing directions forpositive airway pressure(PAP) therapy.	No population
Environments	Hospital and clinical settings	Hospital and clinical settings	Hospital and clinicalsettings	Hospital and clinical settings
	ProposedOxyPAP	PredicateDHD EzPAP	ReferenceTrudell VersaPAP	ReferenceAmbu Pressure Manometer
Operating principles	• Venturi principle created bycompressed gas source• Supplemental oxygen port• Measures airway pressurewith manometer• Adjustable pressure	• Venturi principle created bycompressed gas source• Supplemental oxygen port	• Venturi principle createdby compressed gassource• Supplemental oxygenport• Measures airwaypressure withmanometer• Adjustable pressure	• Measures airway pressure withmanometer
Single patient,multi-use	Yes. Typical use is < 14 days, less than 24 hours cumulative use
Ability to adjust flowrate	Yes			N/A
Ability to adjustpressure duringexhalation	Yes, via a “PEEP” type valve	Yes via an adjustable openingand via flow rate	Yes adjustable	N/A
Maximumrecommended pressure	< 20 cmH2O			N/A
Pressure manometerrange	0-20 cmH2O	No manometer	0-20 cmH2O	0-20 cmH2O
PAP Flow rate	5-15 Lpm			N/A
Pressure			N/A	N/A
Mean PEEP(cmH2O)@800 ml TV	2.81 @ 5 Lpm12 @ 10 Lpm12.75 @ 15 Lpm	2 @ 5 Lpm8 @ 10 Lpm16 @ 15 Lpm	N/A	N/A
Mean Peak ExpiratoryPressure(cmH2O)@800 ml TV	15 Lpm / 15 cmH2O20 (400 TV) / 21 (800 TV)	15 Lpm / 15 cmH2O22 (400 TV) / 26 (800 TV)	N/A	N/A
	ProposedOxyPAP	PredicateDHD EZPAP	ReferenceTrudell VersaPAP	ReferenceAmbu Pressure Manometer
Mean InspiratoryPressure(cmH2O)@800 ml TV	-0.7 @ 5 Lpm-4.7 @ 10 Lpm-3.46 @ 15 Lpm	Not known	Not known
Mean ExpiratoryPressure(cm H2O)@ 800 ml TV	3.1 @ 5 Lpm12.1 @ 10 Lpm13 @ 15 Lpm	5 @ 5 Lpm11 @ 10 Lpm20 @ 15 Lpm	N/A
Shelf-life	1 year	N/A	N/A	N/A
Biocompatibility	Externally communicating, tissue and Surface Contact, mucosal contact, limited duration (<24 hours)Use of material certificationconfirmed materials andprocessing were identical to alegally marketed device.	N/A	N/A	N/A

Table 1 - Comparison to Predicate and Reference Devices

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The OxyPAP device is substantially equivalent to the predicate device because:

Indications -

The proposed indications for use for the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with compressed oxygen are similar. Discussion -

The subject device has similar indications for use as the predicate.

Patient Population -

The patient population is similar, where we have specified the age, the predicate did not.

Discussion -

The subject device has similar population as the predicate.

Environment of Use -

Hospital and healthcare setting due to the requirement for compressed air / oxygen source.

Discussion -

The subject device has similar environments of use as the predicate.

Technology -

The technology for generating PAP is similar to the predicate. The ability to adjust pressure and measure airway pressure is similar to the reference K173918 - Trudell VersaPAP.

The technology of measuring and monitoring pressure via a spring pressure manometer is similar to the references K173918 and K040991.

Discussion -

The subject device has similar technology and principle of operation, interface with the patient as the predicate.

The predicate was not cleared with the ability to attach a pressure manometer, yet the reference K173918 which has similar indications for use does have this feature.

Performance –

The differences in performance features is compared to the predicate and reference for pressure monitoring and they were not significant and can be found to be substantially equivalent.

Discussion -

The subject device has substantially equivalent performance to the predicate and applicable reference devices.

Non-clinical Comparative Performance

Biocompatibility -

The materials in patient contact are considered as having 2 types of patient contact:

External communicating, tissue contacting, limited duration and
Surface contact, mucosal contact, limited duration for the mouthpiece ●
. Use of material certification confirmed materials and processing were identical to a legally marketed device.

Bench Testing -

Performance testing included:

Comparative performance testing to the predicate across the range of performance .

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Comparative performance of the pressure manometer to the reference ●
. Drop testing
. Effects of aging

Discussion of Differences

The subject device incorporates a pressure manometer which the predicate does not. However, we provide a reference device. K173819, which has the same indications for use and incorporates a pressure manometer. We evaluated and compared the performance of the pressure manometer to another reference device, K040991, as K173819 did not include performance data and samples were not available to test.

There were no differences which would raise new or different concerns of safety and effectiveness.

Substantial Equivalence Conclusion

Based upon the comparative performance testing we have demonstrated that the proposed device compared to the predicate and reference devices can be found 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).