(203 days)
Not Found
No
The description details a manually operated mechanical ventilation device with no mention of AI or ML components.
Yes
The device is described as a manually operated ventilation device for emergency ventilation that provides gas flow to the patient and actively removes gas from the lungs, indicating a direct therapeutic function.
No
The device description clearly states its purpose is for "emergency ventilation" and "manual, intermittent ventilation with oxygen," not for diagnosing conditions.
No
The device description explicitly states it is a "manually operated ventilation device" consisting of a "handheld unit" with a "polymer manifold" and connections for oxygen supply and a transtracheal catheter. This clearly describes a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Ventrain's Function: Ventrain is a device used for direct intervention in the body (ventilation via a transtracheal catheter) to support a physiological function (breathing). It does not analyze samples taken from the body.
The description clearly states its purpose is for emergency ventilation and actively managing gas flow within the lungs. This is a therapeutic and life-support function, not an in vitro diagnostic one.
N/A
Intended Use / Indications for 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 accomplished by manual, intermittent ventilation with oxygen through the catheter for subsequent lung inflation and deflation.
Product codes (comma separated list FDA assigned to the subject device)
BTL
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lungs (implied by "lung inflation and deflation")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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
The results of all verification and validation testing demonstrate that all system and design requirements for the Ventrain device have been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAR 2 6 2014
Traditional 510(k) Dolphys Medical - Ventrain
Page 8 of 36 December 2013
5. 510(K) SUMMARY
Acc. to 807.92
| Applicant's Name and Address: | Dolphys Medical B.V.
De Lismortel 31
Eindhoven 5612AR
The Netherlands |
|---------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Fabienne Peters
Head QAC/RA
+31 40 7516020
Phone:
+31 40 7516022 (direct) |
| Applicants US Contact Person: | Not yet appointed |
| Date submission was prepared: | 23 Dec 2013 |
| Device Name: Trade
name: Common
Name: Classification
Name: | Ventrain
Ventilator
21 CFR 868.5925, Powered emergency ventilator:
Product code BTL, ventilator, emergency, powered
(resuscitator) |
| Class: | 2 |
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
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
1
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
2
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.
3
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
4
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
5
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 for | |
| Use | For emergency ventilation via a small lumen transtracheal catheter, in |
| case conventional ventilation by mask and I or a large-bore | |
| endotracheal tube cannot be performed. Ventilation is accomplished | |
| A | |
| by manual, intermittent ventilation with oxygen through the catheter | |
| for 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)
Anya C. Harry -S 4: 2012-04-2 2014.03.26 . . . : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : ,用用 일 합뉴질의 11월 11 ... 14:18:35 -04'00'