The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.

Device Description

The EnduraVent-5 Ventilator is a self-contained, portable ventilator, consisting totally of non-magnetic components which include: (10 a gas inlet connector, (2) a gas inlet filter, (3) two timing valves, (4) a pilot actuator valve, (5) a flow metering valve, and, (6) a pressure-relief valve. During the inspiratory time phase of the system, a small portion of the gas flowing through the system is diverted to the exhalation valve diaphragm, inflating the diaphragm in sequence with the inspiratory time, thereby allowing the main gas flow from the Device to flow to the patient. During the expiratory phase, all ventilator gas flow ceases, the exhalation valve opens and the patients's exhaled gases flow to atmosphere.

AI/ML Overview

The provided 510(k) summary for the EnduraVent-5 Ventilator describes its substantial equivalence to a predicate device, the Magellan Ventilator. It does not detail a study involving specific acceptance criteria or performance metrics for the EnduraVent-5 beyond confirming it operates as designed and functions as intended, with a focus on manufacturing process verification.

Here's an analysis based on the provided text, addressing your questions where possible:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in a table format. It broadly states:

Acceptance Criteria (Implied)	Reported Device Performance
Device operates as designed.	"In all instances, the EnduraVent-5 Ventilator functioned as intended."
Delivery of gas volumes.	"delivery of the gas volumes... was verified."
Delivery of frequencies.	"delivery of the... frequencies... was verified."
Function of safety devices.	"delivery of the... safety devices was verified."
Manufacturing process consistent with predicate.	"Bench testing... was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing" but does not specify the sample size for the tests conducted.
The data provenance is not explicitly stated, but the testing was conducted by Providence Global Medical, Inc. in the context of a US 510(k) submission. It appears to be prospective testing for the EnduraVent-5 against the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. This type of information is typically relevant for AI/software-based devices assessing medical images or complex data, where human expert review establishes ground truth. For a mechanical ventilator, the "ground truth" is typically defined by engineering specifications and physical measurements, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. Adjudication methods are typically used when multiple human readers interpret data, and their disagreements need resolution to establish ground truth. This is not described for the ventilator's performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document describes a comparison between the EnduraVent-5 Ventilator and its predicate, the Magellan Ventilator, based on "exactly duplicated technological characteristics and components, and exactly the same principles of operations." It is a substantial equivalence claim for a physical medical device, not an AI or software-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant or discussed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The EnduraVent-5 is a physical ventilator; the concept of a "standalone algorithm" is not relevant here. The performance testing was of the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing of the EnduraVent-5 Ventilator appears to have been established by:

Engineering specifications and design intent: "confirms that the device operates as designed."
Comparison to the predicate device: "Bench testing with the Endura-Vent-5 and the predicate Magellan Ventilator was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories." This implies the predicate's known and accepted performance served as a benchmark.
Physical measurements: Verification of "delivery of the gas volumes, frequencies, and safety devices."

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set is relevant for this device.

In summary: The 510(k) submission for the EnduraVent-5 Ventilator relies on demonstrating substantial equivalence to a legally marketed predicate device (Magellan Ventilator). The "study" described is primarily bench testing to confirm that the new device replicates the predicate's design and performs as intended, using the same testing protocols. The focus is on verifying manufacturing consistency and functional operation rather than specific quantitative performance metrics against a defined "ground truth" that would be typical for a diagnostic or AI-driven device.

Summary

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

ho92263

JAN 2 1 2010

510(k) SUMMARY Providence Global Medical, Inc's EnduraVent-5 Ventilator

Submitters Name, Address, Telephone Number, Contact Person and Date Prepared

Submitters Name: Helen Redd, President Providence Global Medical, Inc. 4659 South 2300 East, # 203 Salt Lake City, UT 84117 Telephone: 800 292 8765 Contact Person: Helen Redd, President Date Prepared: July 15, 2009

Name of Device and Name/Address of Sponsor

EnduraVent-5 Ventilator Providence Global Medical, Inc. 4659 South 2300 East, # 203 Salt Lake City, UT 84117

Common or Usual Name

Ventilator, Continuous, Facility Use

Classification Name

Continuous Ventilator (21 C.F.R. § 868.5895)

Product Code

CBK

Predicate Device

Magellan Ventilator (K002951)

Indications for Use

The EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only.

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

Technological Characteristics

心

子

Performance Data Verification of Device and Identical Predicate Device

Performance testing was conducted that confirms that the device operates as designed. In all instances, the EnduraVent-5 Ventilator functioned as intended and delivery of the gas volumes, frequencies, and safety devices was verified. Bench testing with the Endura-Vent-5 and the predicate Magellan Ventilator was made to verify the production process of the EnduraVent-5 using the exactly the same protocols used by both factories

Substantial Equivalence

The EnduraVent-5 Ventilator is as safe and effective as the predicate Magellan Ventilator. The EnduraVent-5 Ventilator has the same intended uses, exactly duplicated technological characteristics and components, and exactly the same principles of operations as its predicate device. Any minor labeling differences between the EnduraVent-5 Ventilator and its predicate device raise no new issues of safety or effectiveness. Thus, the EnduraVent-5 Ventilator is substantially equivalent.

The same person that developed the predicate (K002951) Magellan Ventilator, has now replicated the predicate device with the Endura Vent-5 Ventilator. The predicate device has been . in continuous production since 2000 with zero reported problems to either the FDA or the Manufacturer during that time.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Helen Redd President Providence Global Medical, Incorporated 4659 South 2300 East, 203 Salt Lake City, Utah 84117

JAN 21 2010

Re: K092263

Trade/Device Name: EnduraVent-5 Ventilator Regulation Number: 21CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: January 14, 2010 Received: January 14, 2010

Dear Ms. Redd ..

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. 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.

{3}------------------------------------------------

Page 2- Ms. Redd

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

for

Radiological Health

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Enclosure

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

Indications for Use Statement

510(k) Number (if known) K092263

Device Name: EnduraVent-5 Ventilator

Indications for Use:

EnduraVent-5 Ventilator is indicated to provide mechanical ventilation for adults and pediatric patients (pediatrics greater than 9 kg body weight) during in-hospital transport only .

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-the -counter Use (21 C.F.R. Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation

L. Schulten

(Division Sign-Off) Division of Anesthesiology. General Hoapital Infection Control, Dental Devices

510(k) Number: K092263

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).