The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. This is accomplished by providing the patient a source of oxygen from the Bi-Flow D/R through a device such as a facemask or endotracheal tube. Between the oxygen source and the patient interface is the Bi-Flow valve, which allows for the release of oxygen from its source when triggered by the operator thus providing emergency respiratory support. For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator. This is accomplished by the patient triggering the valve with his her negative inspiratory force and the source gas being delivered to the patient through a face mask.

Additionally, there is a non-rebreathing valve (reusable version or single patient use version) attached to the Bi-Flow D/R which directs the patient's exhalation back to atmosphere. The combination of the Bi-Flow D/R and the non-rebreathing valve as a single device is commonly referred to as a Demand Valve.

The power for the device is provided by the compressed oxygen source. There is no additional source of power for this device.

The Bi-Flow D/R will be sold by Spiracle Technology only by or on the order of a physician and is intended to be used exclusively by trained health care professionals. The Bi-Flow D/R will be sold as a component of a respiratory support system to be configured by the health care provider. As such, it will be compatible with all commonly available oxygen source and face mask connections.

Device Description

The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. The small portable device is primarily constructed of aluminum components and utilizes a plastic and silicone rubber inhalation valve. The device is gas powered and has no electronic components or software. The device is pilot actuated.

AI/ML Overview

The provided text is a 510(k) summary for the Spiracle Technology Bi-Flow D/R, a medical device (Demand Valve) intended to provide manual mechanical ventilation. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than a detailed performance study with acceptance criteria and statistical analysis typical of AI/software devices.

Therefore, many of the requested categories for AI/software device evaluation cannot be fully addressed from this document.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format with specific performance metrics and target values (e.g., accuracy > 95%, sensitivity > 90%). Instead, it refers to general functional and environmental testing.

Acceptance Criteria (Implied)	Reported Device Performance
Meets performance objectives	"demonstrated that the device meets its performance objectives"
Complies with applicable standards and FDA guidelines	"complies with applicable standards and FDA guidelines"
Withstands various environmental conditions (impact/drop, vomitus, immersion, storage temperature, operating temperature)	"testing of the device has been performed under various environmental conditions, including impact/drop testing, vomitus testing, immersion testing, storage temperature testing and operating temperature testing."
Provides manual mechanical ventilation and acts as an Inhalator (functional)	"The Bi-Flow D/R is designed to provide manual mechanical ventilation..." and "For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator."

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

The document does not specify a "test set" in the context of data used for an algorithm. It discusses "functional and environmental testing" on the physical device. Therefore, no information is provided regarding data provenance (country of origin, retrospective/prospective).

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

Not applicable. This device is a mechanical ventilator, not an AI/software diagnostic tool that requires expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of adjudication, as this is a hardware device assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical hardware device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be engineering specifications and functional requirements (e.g., proper oxygen flow, valve actuation, pressure limits, environmental resilience). The document indicates performance was assessed against "performance objectives" and "applicable standards and FDA guidelines."

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is a mechanical device, not an AI algorithm.

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

Not applicable. No training set is used.

Summary

{0}------------------------------------------------

K982225

OCT 78 1998

Spiracle Technology Bi-Flow D/R 510(k) SUMMARY

Submitter's Name. Address. Telephone Number. Contact Person and Date Prepared

Submitter

Guv Gansel Spiracle Technology 16520 Harbor Blvd., #D Fountain Vallev. CA 92708-1360 Telephone: (714) 418-1091 Facsimile: (714) 418-1095

Contact Person

Guv Gansel Spiracle Technology 16520 Harbor Blvd., #D Fountain Vallev. CA 92708-1360 Telephone: (714) 418-1091 Facsimile: (714) 418-1095

Name of Device

Trade Name: Bi-Flow Demand/Resuscitator (Bi-Flow D/R) Common Name: Demand Valve Classification Name: Powered Emergency Ventilator Device Classification: 21 CFR § 868.5925

Predicate Devices

Allied Healthcare Products (Life Support Products) Models:

063 Demand Valve 063R Demand Valve

Intended Use

The Bi-Flow D/R is designed to provide manual mechanical ventilation triggered by the operator to a nonbreathing patient. This is accomplished by providing the patient a source of oxygen from the Bi-Flow D/R through a device such as a facemask or endotracheal tube. Between the oxygen source and the patient interface is the Bi-Flow valve, which allows for the release of oxygen from its source when triggered by the operator. For the spontaneous breathing patient, the Bi-Flow D/R may be used as an Inhalator. This is accomplished by the patient triggering the valve with his/her negative inspiratory force and the source gas being delivered to the patient through a face mask.

Technological Characteristics and Substantial Equivalence

The Bi-Flow D/R is substantially equivalent to other demand valves including the Allied Healthcare Products (Life Support Products) CPR/Demand Valve Model 063 and CPR/Demand Valve Model 063R. These predicate devices, like the Bi-Flow D/R are pneumatically powered devices used to provide emergency respiratory support. These predicate device was sold prior to 1976.

{1}------------------------------------------------

Performance Data

Extensive functional testing of the Bi-Flow D/R has been performed. In addition, testing of the device has been performed under various environmental conditions, including impact/drop testing, vornitus testing, immersion testing, storage temperature testing and operating temperature testing. The functional and environmental testing performed on the device demonstrated that the device meets its performance objectives and complies with applicable standards and FDA guidelines.

Bi-Flow510(k).doc

16520 Harbor Blvd., #D

Fountain Valley, CA 92708-1360 .

. 714.418.1091 Fax. 714.418.1095

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 28 1998

Mr. Guy Gansel Spiracle Technology 16520 Harbor Boulevard, #D Fountain Valley, CA 92708-1360

K982225 Re: Bi-Flow Demand/Resuscitator Model 504 Regulatory Class: II (two) Product Code: 73 BTL September 30, 1998 Dated: Received: October 1, 1998

Dear Mr. Gansel:

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 leqally 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 Regulations, 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 regulation 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. Guy Gansel

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,

Thomas J. Callahan

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

Enclosure

{4}------------------------------------------------

Spiracle Technology Bi-Flow D/R Indication For Use Statement

510(k) Reference Number:

K982225

Statement of Indications for Use:

The power for the device is provided by the compressed oxygen source. There is no additional source of power for this device.

Prescription Use

(Division Sign Off)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number _

Bi-Flows10(k).dac

16520 Harbor Blvd., #D

Fountain Valley, CA 92708-1360

714.418.1091

ﻪ

Regulation Number and Section

§ 868.5925 Powered emergency ventilator.

(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).