For emergency ventilation via a small lumen transtracheal catheter, in case conventional ventilation by mask and/or a large-bore endotracheal tube cannot be performed. Ventilation is accomplished by manual, intermittent ventilation with oxygen through the catheter for subsequent lung inflation and deflation.

Device Description

Ventrain is a manually operated ventilation device that provides adequate ventilation through a narrow-bore transtracheal catheter, even in case of a completely obstructed upper airway. Ventrain is specifically designed for 'cannot intubate, cannot ventilate' emergencies where conventional ventilation by mask and/or large-bore endotracheal tube cannot be performed.

Ventrain consists of a handheld unit for manual control of gas flow to the patient. One side of the handheld is connected with an oxygen supply, such as an oxygen cylinder. The other side of the handheld is connected to a transtracheal catheter inserted in the patient.

The handheld contains a polymer manifold for channeling the gas flow through the device. The user controls ventilation by opening or closing holes in the manifold with the thumb and index finger.

Ventrain is capable of actively removing gas from the lungs in the expiration phase by suction (Expiratory Ventilation Assistance). Therefore, Ventrain can also be used for patients with a complete upper airway obstruction

AI/ML Overview

The provided text is related to a 510(k) submission for the "Ventrain" device, a manually operated ventilation device. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study for meeting specific acceptance criteria in the manner requested (e.g., performance metrics with numerical targets).

Therefore, I cannot extract the information required to populate all sections of your request, such as a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert qualifications, or details on ground truth establishment, as these are typically found in performance testing reports or clinical study summaries, which are explicitly stated as "not required" for this submission (according to "Summary of Clinical testing" section).

Here's what can be extracted based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document in the format of specific numerical acceptance criteria. The document states:
"Ventrain passed a series of tests that demonstrate that the device is capable of performing to its stated Intended Use in its intended environments."
And, "The results of all verification and validation testing demonstrate that all system and design requirements for the Ventrain device have been met."
It also mentions performance specifications were compared to the predicate device, noting "maximum minute volumes are lower with Ventrain than with the predicate device. Literature showed that this smaller range of minute volumes possible with Ventrain is still sufficient for its intended use."

Without specific metrics and their target values, a table cannot be constructed.

2. Sample size used for the test set and the data provenance

Sample size for test set: Not specified. The document mentions "a series of tests" and "verification and validation testing" but does not give sample sizes for these tests, nor does it refer to a distinct "test set" in the context of image-based or diagnostic AI.
Data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not specified. The testing described is primarily engineering and performance testing on the device itself, not data analysis from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As no clinical or data-based "test set" requiring expert ground truth is described, this information is not provided.

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

Not applicable. This information is not provided.

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, an MRMC comparative effectiveness study was not done. The document explicitly states under "Summary of Clinical testing": "Clinical testing was not required to demonstrate substantial equivalence." This type of study would fall under clinical testing.

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

Not explicitly applicable. The device is a manually operated mechanical ventilator. The concept of "standalone algorithm performance" as typically applied to AI or diagnostic software does not directly translate here. The device's performance is inherently tied to its mechanical function and user operation.

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

Not applicable. No ground truth in the context of diagnostic or interpretive outcomes is described, as no clinical study or data analysis is presented. The "ground truth" for the device's performance would be engineering specifications and standards (e.g., ISO10651-5), as stated in the document: "Qualification included performance testing as per 1S010651-5 standard, hazard analysis conform the ISO14971standard and system level verification and validation tests."

8. The sample size for the training set

Not applicable/Not specified. The device is a mechanical ventilator; there is no "training set" in the context of machine learning or AI models.

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

Not applicable. As there is no training set for an AI model, this information is irrelevant.

Summary of Study (Based on Provided Text):

The acceptance criteria for the Dolphys Medical - Ventrain device were primarily based on its ability to demonstrate substantial equivalence to a legally marketed predicate device (ManuJet III, K112783) and compliance with relevant engineering standards.

The study that proves the device meets "acceptance criteria" (understood as demonstrating safety and effectiveness for 510(k) clearance) was a series of engineering and performance tests, not clinical trials or AI performance evaluations. Key aspects of this "study" or submission included:

Comparison to Predicate Device: The Ventrain was compared to the ManuJet III on aspects such as intended use, patient population, operating principle, energy source, gas supply, patient connections, performance specifications (frequency, minute volumes, I:E ratio), and ambient conditions.
Performance Testing: "Ventrain passed a series of tests that demonstrate that the device is capable of performing to its stated Intended Use in its intended environments." This included qualification as per the ISO10651-5 standard (likely related to lung ventilators), ISO14971 standard for hazard analysis (risk management for medical devices), and "system level verification and validation tests."
Biocompatibility: All gas-conducting parts were found to be biocompatible in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing.

The unique aspect of Ventrain providing (assisted) expiration was noted, and the manufacturer concluded it "did not introduce new risks." While maximum minute volumes were lower than the predicate, literature supported their sufficiency for the intended use.

Crucially, the submission explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." This means no human-subjects clinical studies were conducted for this 510(k) clearance.

Summary

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MAR 2 6 2014

Traditional 510(k) Dolphys Medical - Ventrain

Page 8 of 36 December 2013

K132759

5. 510(K) SUMMARY

Acc. to 807.92

Applicant's Name and Address:	Dolphys Medical B.V.De Lismortel 31Eindhoven 5612ARThe Netherlands
Contact Person:	Ms. Fabienne PetersHead QAC/RA+31 40 7516020Phone:+31 40 7516022 (direct)
Applicants US Contact Person:	Not yet appointed
Date submission was prepared:	23 Dec 2013
Device Name: Tradename: CommonName: ClassificationName:	VentrainVentilator21 CFR 868.5925, Powered emergency ventilator:Product code BTL, ventilator, emergency, powered(resuscitator)
Class:	2

Device Description:

The handheld contains a polymer manifold for channeling the gas flow through the device. The user controls ventilation by opening or closing holes in the manifold with the thumb and index finger.

Intended use:

For emergency ventilation via a small lumen transtracheal catheter, in case conventional ventilation by mask and/or a large-bore endotracheal tube cannot be performed. Ventilation is

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accomplished by manual, intermittent ventilation with oxygen through the catheter for subsequent lung inflation and deflation.

Legally marketed devices to which substantial equivalence is claimed:

Device Name

ManuJet III

510(k) Number K112783

Substantial Equivalence:

Ventrain and the predicate device were compared on the following aspects:

. Intended Use
. Intended patient population
Intended use environments .
. Operating principle, energy source
� Gas supply
Patient connections .
Performance specifications such as frequency, minute volumes, I:E ratio .
. Ambient conditions

With respect to the operating principle, the difference between both devices is that Ventrain provides (assisted) expiration through the device whereas the predicate device has no such functionality and therefore requires a partially open airway for expiration. As a result, a fully blocked airway is no contra indication for Ventrain and Ventrain can be used with a broader patient population compared to the predicate device. Further analysis showed that the expiration functionality did not introduce new risks

With respect to performance specifications, maximum minute volumes are lower with Ventrain than with the predicate device. Literature showed that this smaller range of minute volumes possible with Ventrain is still sufficient for its intended use.

On all other aspects, there were either no differences found were deemed not clinically significant.

From the comparison with the predicate device and the discussion of specific differences, it was concluded that:

Ventrain has the same intended use as the predicate device .
Differences between both devices do not raise new questions of safety and effectiveness .
. Ventrain is at least as safe and effective as the predicate device

Summary of Performance Testing:

Ventrain passed a series of tests that demonstrate that the device is capable of performing to its stated Intended Use in its intended environments.

Qualification included performance testing as per 1S010651-5 standard, hazard analysis conform the ISO14971standard and system level verification and validation tests.

All gas conducting parts were found to be biocompatible in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices - Part 1: Evaluation and testing

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Traditional 510(k) Dolphys Medical - Ventrain

The results of all verification and validation testing demonstrate that all system and design requirements for the Ventrain device have been met.

Summary of Clinical testing

Clinical testing was not required to demonstrate substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.

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

March 26, 2014

Dolphys Medical B.V. Ms. Fabienne Peters De Lismortel 31 Building Caralyst Eindhoven, Netherlands 5612 AR

Re: K132759

Trade/Device Name: Ventrain Regulation Number: 21 CFR 868.5925 Regulation Name: Powered emergency ventilator Regulatory Class: Class II, Product Code: BTL Dated: December 23, 2013 Received: December 26, 2013

Dear Ms. Peters:

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.

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

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Page 2 - Ms. Fabienne Peters

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mary S. Runner -S

Erin I. Keith, M.S. Acting Director Division of Anesthesiolgoy, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Dolphys Medical - Ventrain

Page 7 of 36 Dacamber 2013

4. INDICATIONS FOR USE STATEMENT

510(k)Number	K132759
Device Name	Ventrain
Indications forUse	For emergency ventilation via a small lumen transtracheal catheter, incase conventional ventilation by mask and I or a large-boreendotracheal tube cannot be performed. Ventilation is accomplishedAby manual, intermittent ventilation with oxygen through the catheterfor subsequent lung inflation and deflation.

Indications for Use

Prescription Use × · (Part 21 CFR 801 subpari D)

AND/OR

Over-The-Counter Use (Pari 21 CFR 801 subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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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).