K Number

Device Name

D R Burton OxyPAP

Manufacturer

D R Burton Healthcare, LLC

Date Cleared

2020-02-19

(208 days)

Product Code

BWF

Regulation Number

868.5690

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K991300

Reference Devices

K173819, K040991

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical respiratory therapy device and does not mention any AI or ML components or capabilities.

Therapeutic

Yes
The device is indicated for the "treatment and prevention of atelectasis," which is a medical condition. This indicates a therapeutic purpose.

Diagnostic

The device is indicated for the treatment and prevention of atelectasis and provides positive airway pressure; it is a therapy device, not a diagnostic one.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "handheld respiratory therapy device" and mentions "Bench Testing" including "Drop testing" and "Effects of aging," which are indicative of hardware components and physical testing, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the D R Burton® OxyPAP™ device is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the treatment and prevention of atelectasis and providing supplemental oxygen. This is a therapeutic intervention directly applied to the patient's airway.
Device Description: It's described as a handheld respiratory therapy device that creates positive airway pressure. This is a physical therapy device.
Anatomical Site: The anatomical site is the airway, which is part of the patient's body.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.

The OxyPAP™ device is clearly a therapeutic medical device used to treat a condition in the patient's respiratory system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

BWF

Device Description

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

5 years and above

Intended User / Care Setting

hospital and clinical 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)

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

Key results: 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.

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.

K991300

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.

K173819, K040991

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

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).

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

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

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)

510(k) Summary

Date Prepared	19-Feb-20
D R Burton Healthcare, LLC
3936 S Fields St
Farmville, NC 27828
Tel - 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 Spirometer
21 CFR 868.5690
Class II
Predicate Device:	K991300 – DHD Healthcare Corp. – Boeing, Positive Airway
Pressure (PAP) Therapy Device
Reference Devices:	K173819 – Trudell VersaPAPTM Device
K040991 – 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.

Table 1 – Comparison to Predicate and Reference Devices
	Proposed
OxyPAP	Predicate
DHD EzPAP	Reference
Trudell VersaPAP	Reference
Ambu Pressure Manometer
510(k)
CFR		K991300	K173918	K040991
Classification		868.5690
BWF		868.2600
CAP
Classification name		Incentive Spirometer		Monitor, airway pressure (includes gauge and/or alarm
Indications for Use	D R Burton OxyPAP is
indicated for the treatment
and prevention of atelectasis.
It also has the ability to
provide supplemental oxygen
when used with compressed
oxygen. 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 OxyPAPTM
should not be more than 24
hours total combined time.
The environment of use is for
hospital and clinical setting.	Boeing is indicated for the
treatment and prevention of
atelectasis. Boing facilitates
opening of airways in patients
requiring prevention or
treatment of atelectasis.
Boeing also has the ability to
provide supplemental oxygen
when used with compressed
oxygen.	VersaPAPTM is indicated
for the treatment and
prevention of atelectasis.
VersaPAPTM also has the
ability to provide
supplemental oxygen
when used with
compressed oxygen.	To provide visual indication of a
patient's airway pressure during
ventilation. It may be attached to the
manometer port or proximal port on
ventilation devices such as resuscitation
bags, hyperinflation bags, CPAP mask,
or CPAP circuits.
Patient Population	Patients (ages 5 years and
above) who are capable of
following directions for
positive airway pressure
(PAP) therapy.	Patients requiring therapy for
treatment and prevention of
atelectasis who are capable of
following directions for PAP
therapy	Patients (ages 5 years and
above) who are capable of
following directions for
positive airway pressure
(PAP) therapy.	No population
Environments	Hospital and clinical settings	Hospital and clinical settings	Hospital and clinical
settings	Hospital and clinical settings
	Proposed
OxyPAP	Predicate
DHD EzPAP	Reference
Trudell VersaPAP	Reference
Ambu Pressure Manometer
Operating principles	• Venturi principle created by
compressed gas source
• Supplemental oxygen port
• Measures airway pressure
with manometer
• Adjustable pressure	• Venturi principle created by
compressed gas source
• Supplemental oxygen port	• Venturi principle created
by compressed gas
source
• Supplemental oxygen
port
• Measures airway
pressure with
manometer
• Adjustable pressure	• Measures airway pressure with
manometer
Single patient,
multi-use	Yes. Typical use is