(168 days)
No
The device description and performance studies focus on mechanical and pneumatic operation, with no mention of AI or ML.
Yes.
It is a ventilator that provides ventilatory support to patients, which is a therapeutic function.
No
The device description states its function is to deliver ventilatory support, which is a treatment, not to diagnose a condition.
No
The device description clearly outlines physical components like a pulmonary modulator, patient connector tee, moving diaphragm, and springs, indicating it is a hardware device with mechanical functions, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver emergency, short term, constant flow, pressure cycled ventilator support". This describes a device used on a patient to provide respiratory assistance, not a device used to test samples from a patient to diagnose a condition.
- Device Description: The description details the mechanical function of a ventilator, including gas flow, pressure cycling, and patient connection. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances within these samples for diagnostic purposes.
In summary, the VORTRAN® GO2VENT™ is a medical device used for respiratory support, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.
Product codes (comma separated list FDA assigned to the subject device)
BTL
Device Description
The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient).
The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
InputImaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients weighing 10kg and above.
Intended User / Care Setting
properly trained personnel
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)
-
Non-Clinical Performance Testing/Performance Data/Compliance with Performance Standards
The VORTRAN® GO2VENT™, just as the VAR-Plus, meets the "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans" ASTM Designation: F 920 -93. A separate non-clinical test showed that all requirements were also met for ISO 10651-5, "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators". The determination for substantial equivalence was based on a comparison of performance data between the new device and predicate device (FDA 510(k) No. K041473). The predicate device performance tests were documented. To demonstrate substantial equivalence, the new device was also tested using "ASTM F920-93 (Reapproved 1999)". In addition, the features that are considered technological differences were tested. The function of the new FiO2 entrainment feature (at 50% and 100% FiO2 settings) and device shelf-life were tested with the results documented. The new Beryllium-Copper springs were tested for performance and fatigue. -
Clinical Studies None
-
Key Results:
The VORTRAN® GO2VENT™ is substantially equivalent to a predicate device: The VAR-Plus. The results from the nonclinical tests show that the device achieves predefined acceptance criteria for all assessments that were previously performed on the predicate device. VORTRAN® GO2VENT™, just as the VAR-Plus, meets the "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans" ASTM Designation: F 920 - 93. All requirements were also met for ISO 10651-5, "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gaspowered emergency resuscitators". The VORTRAN® GO2VENT™ has been shown to be substantially equivalent to the predicate device.
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.
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2017
Vortran Medical Technology 1, Inc. James Lee Executive Vice President & COO 21 Goldenland Court, #100 Sacramento, California 95834
Re: K162968
Trade/Device Name: VORTRAN® GO2VENT™ Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: Class II Product Code: BTL Dated: March 2, 2017 Received: March 10, 2017
Dear James Lee:
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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162968
Device Name
VORTRAN® GO2VENT™
Indications for Use (Describe)
This Device is to be used by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled ventilator support on patients weighing 10kg and above.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary / K162968 - VORTRAN® GO2VENT™
I. SUBMITTER
VORTRAN® Medical Technology 1, Inc. 21 Goldenland Court, Suite 100 Sacramento, CA 95834 USA
Phone: (800) 434-4034 Fax: (916) 648-9751
Contact Person: James Lee Date Prepared: March 31, 2017
II. DEVICE
Name of Device: VORTRAN® GO2VENT™ Common or Usual Name: Ventilator, Emergency, Powered (Resuscitator) Classification Name: Powered Emergency Ventilator Regulation Number: 21 CFR 868.5925 Regulatory Class: II Product Code: BTL Classification Advisory Committee: Anesthesiology Review Advisory Committee: Anesthesiology
III. PREDICATE DEVICE
| K041473 | VORTRAN® Automatic Resuscitator (VAR-Plus)
(Primary Predicate Device) |
|---------|----------------------------------------------------------------------------|
| K153733 | VORTRAN® Manometer
(Reference Device – For Material Compatibility Only) |
IV. DEVICE DESCRIPTION
The VORTRAN® GO2VENT™ provides short term, constant flow, pressure cycled ventilatory support in either pressure control or pressure support modes on patients weighing 10kg and above. In the pressure support mode, the rate dial of the VORTRAN® GO2VENT™ is set so that the baseline pressure is above the set PEEP allowing the patient to initiate inhalation by drawing the baseline pressure down to the set PEEP. The device includes the pulmonary modulator (an exhalation valve that opens at PIP and closes at PEEP) and a patient connector tee to supply gas flow, entrain additional air, and provides a redundant pop-off valve for patient care. The working mechanism of the VORTRAN® GO2VENTTM consists of a moving diaphragm which adds or subtracts spring force when it is moved from a horizontal to a vertical position, the addition or subtraction of spring force will affect the PIP setting by 1~3 cm-H2O. The VORTRAN® GO2VENT™ will function in any position as long as the final adjustments are made in a secured position (strapped or taped to the patient).
4
510(k) Summary / K162968 - VORTRAN® GO2VENTTM
The VORTRAN® GO2VENT™ is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VORTRAN® GO2VENT™ is simple. Set desired flow and adjust pressure dial to obtain desired I-time and/or tidal volume (see tidal volume chart in instructions), and adjust rate dial to obtain desired rate and I to E ratio.
| Device Model Number: | 6123-10 |
|---|---|
| Device Accessories: | Elbow Flex Hose, Oxygen Tubing, Pressure Manometer |
| Interaction with Patient: | The Elbow Flex Hose has indirect contact with patient |
INDICATIONS FOR USE V.
This device is intended to be use by properly trained personnel to deliver emergency, short term, constant flow, pressure cycled, ventilatory support on patients weighing 10kg and above.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A. Technical Modifications:
MR conditional - The new model of the VORTRAN® Automatic Resuscitator has been modified with new springs made of Beryllium-Copper instead of the Stainless-Steel. This change was verified (in the Shellock MR Testing on Vortran Products Report) to make the device MR Conditional. The report concluded that the VORTRAN® GO2VENT™ can be used in an MRI environment with a static magnetic field of 3-Tesla or less, and a spatial gradient magnetic field of 10,000-gauss/cm or less. Shellock performs their tests based on ASTM F2052 - Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment. We have verified that the performance of the beryllium-copper springs is substantially equivalent to the stainless-steel springs.
New Entrainment Connectors for the 50% and 100% FiO2 Delivery - The new device connectors include a combination knob that can be rotated from the 100% FiO2 (a fully closed position of entrainment ports) to the 50% FiO2 (a position of having entrainment ports open) versus the two connectors of the predicate device that the 100% FiO2 connector should be completely removed to access the 50% FiO2 connector. The modification facilitates the FiO2 change from 50% to 100% FiO2 and vice versa. All testing data have shown and verified that the change in the knobs has not degraded the performance and the device delivers the required specifications.
5
510(k) Summary / K162968 – VORTRAN® GO2VENT™
The tables below show the technological differences and similarities of our VORTRAN® GO2VENT™ compared to the predicate device (VAR-Plus).
Operational Characteristics:
| NEW DEVICE | PREDICATE DEVICE | |
|---|---|---|
| Device Name | VORTRAN® GO2VENT™ | VORTRAN® Automatic Resuscitator (VAR-Plus) |
| 510(k) Number | N/A | K041473 |
| Maximum Inspiratory Flow | 40 L/min | |
| Same as predicate device | 40 L/min | |
| Ventilatory Frequency | Auto-adjusting to lung capacity [c] | |
| Same as predicate device | Auto-adjusting to lung capacity [c] | |
| Peak Pressure Range | 10 - 45 cm-H2O [d] | |
| Same as predicate device | 10-45 cm-H2O [d] | |
| PEEP | 2 - 9 cm-H2O [d] | |
| Same as predicate device | 2 - 9 cm-H2O [d] | |
| Required Source Pressure | 50 psig | |
| Same as predicate device | 50 psig | |
| Dead Space | 4 ± 3 mL | |
| Same as predicate device | 4 ± 3 mL | |
| Inspiratory Resistance | 3 ± 1 cm-H2O / L / sec | |
| Same as predicate device | 3 ± 1 cm-H2O / L / sec | |
| Expiratory Resistance | 3 ± 1 cm-H2O / L / sec | |
| Same as predicate device | 3 ± 1 cm-H2O / L / sec | |
| High Pressure Pop-off | Yes, 60 cm H2O | |
| Same as predicate device | Yes, 60 cm H2O | |
| Visual or Audible Indication | ||
| of High Pressure | Yes | |
| Same as predicate device | Yes | |
| Same as predicate device |
6
510(k) Summary / K162968 – VORTRAN® GO2VENT™
Functional Characteristics:
| NEW DEVICE | PREDICATE DEVICE | |||
|---|---|---|---|---|
| Device Name | VORTRAN® GO2VENT™ | VORTRAN® Automatic Resuscitator (VAR-Plus) | ||
| 510(k) Number | N/A | K041473 | ||
| FiO2 Devliery | 50% FiO2 by entraining room air | FiO2 of >85% when supplied with 100% O2 | 50% FiO2 by entraining room air | FiO2 of >85% when supplied with 100% O2 |
| Supply 100% O2 | ||||
| [A] | Image: B | |||
| Supply 100% O2 | ||||
| [B] | Supply 100% O2 | |||
| [C] | Supply 100% O2 | |||
| [D] | ||||
| Method of | ||||
| Changing | ||||
| Delivery of | ||||
| FiO2 when | ||||
| supplied with | ||||
| 100% O2 | [A] Delivers FiO2 at | |||
| 50% by entraining | ||||
| room air when | ||||
| setting the selector | ||||
| dial to the 50% | ||||
| mark on the new | ||||
| patient tee | [B] Delivers FiO2 of |
85% by NOT
entraining room air
when setting the
selector dial to the
100% mark on the
new patient tee | [C] Delivers FiO2 at
50% by entraining
room air when the
100% adaptor is
removed, exposing
the 50%
entrainment nozzle
on the patient tee | [D] Delivers FiO2 of
85% by NOT
entraining room air
when the 100%
adaptor is
connected to the
patient tee |
| Oxygen
Concentration | Delivers FiO2 >85% or 50% by entraining room air
Same as predicate device | | Delivers FiO2 >85% or 50% by entraining room air
[e] | |
Image /page/6/Figure/5 description: This image shows a comparison between a new device and a predicate device. The new device is labeled as "VORTRAN® GO2VENT™" with a 510(k) number of N/A. The predicate device is labeled as "VORTRAN® Automatic Resuscitator (VAR-Plus)" with a 510(k) number of K041473. The image shows the devices in two different scenarios: 50% FiO2 by entraining room air and FiO2 of >85% when supplied with 100% O2.
7
510(k) Summary / K162968 – VORTRAN® GO₂VENT™
Material of Construction:
| NEW DEVICE | PREDICATE DEVICE | ||
|---|---|---|---|
| Device Name | VORTRAN® GO2VENT™ | VORTRAN® Automatic Resuscitator | |
| (VAR-Plus) | VORTRAN® Manometer | ||
| 510(k) Number | N/A | K041473 | K153733 |
| Date SE Decision | NA | July 15, 2004 | September 16, 2016 |
| Housing | K-Resin®, Polycarb | ||
| Same as predicate device | K-Resin® | Polycarb | |
| Internal Springs | Beryllium-Copper [f] | ||
| Same as predicate device | 302 Stainless Steel | Beryllium-Copper [f] | |
| Pressure and Rate | |||
| Dials | HDPE | ||
| Same as predicate device | DOW® HDPE 12450 color blue | Acetal | |
| One-Way Valve | |||
| Body | HDPE | ||
| Same as predicate device | DOW® HDPE 12450 | N/A | |
| Flapper Valve | Silicone | ||
| Same as predicate device | Silicon Polymer | N/A | |
| Diaphragm | Silicone | ||
| Same as predicate device | Silicone | SILICONE/ | |
| Natural | |||
| Disk Center | Nylon | ||
| Same as predicate device | Nylon | N/A |
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing ●
| Device Nature of Body Contact Category: | Duration of Contact for the Device: | |||
|---|---|---|---|---|
| External Communicating | Up to 30 days | |||
| Part | ||||
| No. | Part Description | Patient Contact Status | ||
| Substantial Equivalence | ||||
| Device (510K #) | Material/Color | |||
| 1. | 6007 | 100% - 50% VAR Nozzle | Indirect patient contact | |
| K153733 | Polycarbonate/White | |||
| 2. | 6008 | FiO2 Controller Knob | Indirect patient contact | |
| K041473 | HDPE/Green | |||
| 3. | 6009 | Entrainment Barrel | Indirect patient contact | |
| K153733 | Polycarbonate/White | |||
| 4. | 2015 | One-Way Valve Body | Indirect patient contact | |
| K041473 | HDPE/Natural | |||
| 5. | 2016 | One-Way Valve Flapper | Indirect patient contact | |
| K153733 | Silicone/Red | |||
| 6. | 6005 | Pop-Off Valve Cap | No patient contact | Polycarbonate/Blue |
| 7. | 6010 | Pop-Off Valve Spring | No patient contact | Beryllium Copper |
| 8. | 2012 | Pop-Off Valve Piston | Indirect patient contact | |
| K041473 | HDPE/Red | |||
| 9. | 6006 | Patient Tee | Indirect patient contact | |
| K041473 | K-Resin®/Clear/Blue | |||
| 10. | 2291 | Manometer Assembly | Indirect patient contact | |
| K153733 | N/A | |||
| 11. | 6003 | Modulator Bottom, Single | ||
| Port | Indirect patient contact | |||
| K153733 | Polycarbonate/Clear/ | |||
| Blue | ||||
| 14. | 2182B | Diaphragm | No patient contact | Silicone/Natural |
| 2181B | Hard Center | Indirect patient contact | ||
| K041473 | Nylon/Natural |
8
510(k) Summary / K162968 - VORTRAN® GO2VENT™
Biocompatibility Testing (Continued) ●
| Device Nature of Body Contact Category:
External Communicating | | | Duration of Contact for the Device:
Up to 30 days | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|----------------------|-------------------------------------------------------------------|------------------------------|
| | Part No. | Part Description | Patient Contact Status
Substantial Equivalence Device (510K #) | Material/Color |
| 15. | 6004 | Pressure Dial Spring | No patient contact | Beryllium Copper |
| 17. | 6002 | Modulator Top | No patient contact | Polycarbonate/Clear/
Blue |
| 18. | 6017 | Rate Dial | No patient contact | HDPE/Blue |
| 19. | 6016 | Pressure Dial | No patient contact | HDPE/Blue |
| Discussion:
- Rationale for Not Needing Biocompatibility Testing: Considering the material
used in the components of the new device (VORTRAN® GO2VENT™) and the fact
that the same material used as those in the predicated devices manufactured by
VORTRAN Medical and produced with the same manufacturing process, the
material of the new device is compatible and requires no additional biocompatibility | | | | |
Animal Study ●
None
- Non-Clinical Performance Testing/Performance Data/Compliance with Performance Standards
The VORTRAN® GO2VENT™, just as the VAR-Plus, meets the "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans" ASTM Designation: F 920 -93. A separate non-clinical test showed that all requirements were also met for ISO 10651-5, "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators". The determination for substantial equivalence was based on a comparison of performance data between the new device and predicate device (FDA 510(k) No. K041473). The predicate device performance tests were documented. To demonstrate substantial equivalence, the new device was also tested using "ASTM F920-93 (Reapproved 1999)". In addition, the features that are considered technological differences were tested. The function of the new FiO2 entrainment feature (at 50% and 100% FiO2 settings) and device shelf-life were tested with the results documented. The new Beryllium-Copper springs were tested for performance and fatigue.
9
510(k) Summary / K162968 - VORTRAN® GO2VENT™
- . Clinical Studies None
VII. CONCLUSIONS
- The VORTRAN® GO2VENT™ is substantially equivalent to a predicate ● device: The VAR-Plus. The results from the nonclinical tests show that the device achieves predefined acceptance criteria for all assessments that were previously performed on the predicate device. VORTRAN® GO2VENT™, just as the VAR-Plus, meets the "Standard Specification for Minimum Performance and Safety Requirements for Resuscitators Intended for Use with Humans" ASTM Designation: F 920 - 93. All requirements were also met for ISO 10651-5, "Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gaspowered emergency resuscitators". The VORTRAN® GO2VENT™ has been shown to be substantially equivalent to the predicate device.