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.

AI/ML Overview

The DHD Boeing device (Positive Airway Pressure (PAP) Device) was determined to be substantially equivalent to the predicate device, TheraPEP, based on non-clinical bench testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Performance Specification)	Reported Device Performance
Airway Pressure (Expiratory)	Met specifications
Airway Pressure (Inspiratory)	Met specifications
Supplemental Oxygen Delivery	Met specifications
Substantial Equivalence to Predicate Device	Achieved

2. Sample Size and Data Provenance for Test Set:

The submission does not specify the exact sample sizes used for each bench test. However, it states that the non-clinical bench testing compared the DHD Boeing against the predicate device and against its own performance specifications.
Data Provenance: The tests were non-clinical bench tests performed by the manufacturer, DHD Healthcare Corporation. No information is provided regarding data provenance in terms of country of origin or whether it was retrospective or prospective, as it pertains to bench testing.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable for this submission. The "ground truth" in this context refers to established performance specifications and the performance of the predicate device, which are determined through engineering principles and existing regulatory decisions rather than expert consensus on individual cases.

4. Adjudication Method for Test Set:

Not applicable as this was non-clinical bench testing comparing against specifications and a predicate device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices involving human interpretation of results, which is not applicable to a Positive Airway Pressure (PAP) device.

6. Standalone Performance Study (Algorithm Only):

Yes, a form of standalone performance study was done through the "non-clinical bench testing" which compared the DHD Boeing against its "own performance specifications." This indicates the device's technical performance was evaluated independently of human-in-the-loop operation, reflecting its inherent functionality.

7. Type of Ground Truth Used:

The ground truth used was based on:
- Performance Specifications: The device met its own predefined performance specifications for airway pressure (expiratory and inspiratory) and supplemental oxygen delivery.
- Predicate Device Performance: The Boeing's performance was compared to and found substantially equivalent to the legally marketed predicate device, TheraPEP, regarding these performance characteristics.

8. Sample Size for Training Set:

This information is not applicable. This device is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and development would involve engineering prototypes and iterative testing, but not a "training set" as understood in machine learning.

9. How Ground Truth for Training Set was Established:

Not applicable, as there is no "training set" for this type of medical device. The "ground truth" for its design and testing would be derived from engineering standards, material properties, physiological requirements for PAP therapy, and the performance characteristics of existing predicate devices.

Summary

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JUL 12 1999

BOEING 510(k) SUBMITTAL

SECTION 16

510(k) Summary

1. Submitter: DHD Healthcare Corporation 125 Rasbach Street Canastota, NY 13032
  Phone: 315-697-2221 315-697-5191 Fax:

Lawrence Weinstein, Technology Manager Contact:

1. 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

1. Intended Use
  Positive Airway Pressure (PAP) Therapy for the treatment and prevention of atelectasis.
1. 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.
1. 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

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BOEING 510(k) SUBMITTAL

SECTION 16

510(k) Summary

1. 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.

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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.

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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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

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Intended Use Statement

510(k) Number (if known):_

Device Name: Boeing

Indications For Use:

1. Purpose/Claims:

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: 315-697-2221 FAX: 315-697-5191
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)

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

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).