BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE

• K Number: K991300
• Device Name: BOEING, POSITIVE AIRWAY PRESSURE (PAP) THERAPY DEVICE
• Manufacturer: DHD HEALTHCARE CORP.
• Date Cleared: 1999-07-12 ( 87 days)
• Product Code: BWF
• Regulation Number: 868.5690

Intended Use

Boeing is indicated for the treatment and prevention of atelectasis. Boeing 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.

Device Description

The DHD Boeing is a single-patient-use Respiratory Therapy device. The standard system consists of a flow amplification body, compressed oxygen/air tubing, pressure port cap, and mouthpiece. The mouthpiece can be replaced with a mask.

Predicate Devices

K962749, K944900

Reference Devices

K962749,K944900

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical respiratory therapy device with no mention of AI or ML capabilities. The performance studies focus on pressure and oxygen delivery, not algorithmic performance.

Therapeutic

Yes
The device is indicated for the treatment and prevention of atelectasis, which is a therapeutic purpose.

Diagnostic

No
The device is used for treatment and prevention of atelectasis, which indicates a therapeutic purpose rather than diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components like a flow amplification body, tubing, pressure port cap, and mouthpiece, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for the treatment and prevention of atelectasis by facilitating the opening of airways. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
• Device Description: The device is a respiratory therapy device that works by flow amplification and potentially providing supplemental oxygen. It interacts directly with the patient's airways.
• Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

Therefore, the Boeing device described is a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

"Boeing is indicated for the treatment and prevention of atelectasis. Boeing 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."

Product codes

BWF

Device Description

"The DHD Boeing is a single-patient-use Respiratory Therapy device. The standard system consists of a flow amplification body, compressed oxygen/air tubing, pressure port cap, and mouthpiece. The mouthpiece can be replaced with a mask."

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

"Federal (USA) Law restricts this device to sale by or on the order of a physician."
"Boeing is intended for use in a hospital."

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)

"The non-clinical bench testing performed compares the DHD Boeing against the predicate device and against its own performance specifications. These areas which define the performance of the device include: airway pressure (expiratory and inspiratory) and supplemental oxygen delivery. In each test Boeing performed substantially equivalent to the predicate device and met its specifications."

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K962749, K944900

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

JUL 12 1999

BOEING 510(k) SUBMITTAL

SECTION 16

510(k) Summary

• 1. Submitter: DHD Healthcare Corporation 125 Rasbach Street Canastota, NY 13032
     Phone: [phone] Fax:

Lawrence Weinstein, Technology Manager Contact:

• 2. Device Name

a. Trade name:	Boeing (final name tbd)
b. Common name:	Positive Airway Pressure (PAP) Device
c. Classification name:	Incentive Spirometer - 868.5690

• K962749, K944900 TheraPEP®, 3. Predicate Device: DHD Healthcare Corporation 125 Rasbach Street Canastota, NY 13032

4. Device Description

The DHD Boeing is a single-patient-use Respiratory Therapy device. The standard system consists of a flow amplification body, compressed oxygen/air tubing, pressure port cap, and mouthpiece. The mouthpiece can be replaced with a mask.

• 5. Intended Use
     Positive Airway Pressure (PAP) Therapy for the treatment and prevention of atelectasis.
• 6. Technological Characteristics Compared to Predicate
     The DHD Boeing utilizes standard institutional provided compressed air or oxygen in conjunction with patient breathing to provide positive airway pressure. TheraPEP utilizes a restrictive orifice in conjunction with patient breathing to provide positive airway pressure. Both Boeing and the predicate device allow adjustment to achieve the desired patient airway pressure for the same range of breathing rates.
• 7. Summary of Studies
     The non-clinical bench testing performed compares the DHD Boeing against the predicate device and against its own performance specifications. These areas which define the performance of the device include: airway pressure (expiratory and inspiratory) and supplemental oxygen delivery. In each test Boeing performed substantially equivalent to the predicate device and met its specifications.

BOEING

K991300

04/99

1

BOEING 510(k) SUBMITTAL

SECTION 16

510(k) Summary

• 8. Conclusions Drawn from the Studies For the common indications for use, Boeing performs substantially equivalent to the predicate device. In the opinion of DHD Healthcare Corporation, it is substantially equivalent to the predicate device and does not adversely affect safety and effectiveness compared to the predicate device.
     TheraPEP is a registered trademark of DHD Healthcare Corporation.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 12 1999

Mr. Larry Weinstein DHD Healthcare Corporation One Madison Street Wampsville, NY 13163

K991300 Re: Boeing, Positive Airway Pressure (PAP) Therapy Device Requlatory Class: II (two) Product Code: 73 BWF Dated: April 9, 1999 Received: April 16, 1999

Dear Mr. Weinstein:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

3

Page 2 - Mr. Larry Weinstein

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation · Center for Devices and Radiological Health

Enclosure

4

Intended Use Statement

510(k) Number (if known):_

Device Name: Boeing

Indications For Use:

1. Purpose/Claims:

Boeing is indicated for the treatment and prevention of atelectasis. Boeing 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.

2. Target Patient Population:

Patients requiring therapy for treatment and prevention of atelectasis who are capable of following directions for Positive Airway Pressure (PAP) therapy.

3. Intended Environment For Use:

• Labeling reflects the statement: "Federal (USA) Law restricts this device to sale by 3.1. or on the order of a physician."
• Boeing is intended for use in a hospital. 3.2.

4. Legally Marketed Predicate Device:

• Name: TheraPEP DHD Healthcare Corporation Manufacturer: 125 Rasbach Street Canastota, NY 13032 Tel: [phone] FAX: [phone]
  510(k) No. K962749 & K944900

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

"Chal. C.A. for JXH"

Division of Cardiovascular, Respiratory, and Neurological Devices 991300 510(k) Number