(276 days)
Not Found
No
The summary describes a simple pressure monitoring device and does not mention any AI or ML terms, image processing, or data analysis beyond basic monitoring.
No.
The device's stated intended use is to "monitor the delivery of emergency, short term, ventilatory support," which indicates a monitoring function rather than a direct therapeutic intervention.
No
The device monitors the delivery of ventilatory support and cycling conditions of resuscitators, which is a monitoring function rather than a diagnostic one.
No
The device description explicitly states it is a "battery (9 VDC) operated, portable, self-contained device" and is connected via "connection tubing," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- VORTRAN Airway Pressure Monitor (VAPM) Function: The VAPM monitors the delivery of ventilatory support by measuring airway pressure. It is connected to the patient's airway via tubing.
- Lack of Sample Analysis: The description does not mention the VAPM analyzing any biological samples from the patient. Its function is to monitor a physiological parameter (airway pressure) during ventilation.
Therefore, the VAPM falls under the category of a medical device used for monitoring a physiological function, not for performing in vitro diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).
Product codes (comma separated list FDA assigned to the subject device)
CAP
Device Description
The VAPM is a battery (9 VDC) operated, portable, self-contained device that is connected to the patient via the connection tubing for monitoring cycling conditions of resuscitators such as the VORTRAN® Automatic Resuscitator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).
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)
Clinical Tests: None
The VAPM passed all required tests and demonstrated that it meets all predetermined acceptance criteria for applicable standards.
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.
VAR® with VAR-Monitor™ 510(k) No.: K073261, VAR with Manometer 510(k) No.: K001430, VAR-Plus with Manometer 510(k) No.: K041473
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
§ 868.2600 Airway pressure monitor.
(a)
Identification. An airway pressure monitor is a device used to measure the pressure in a patient's upper airway. The device may include a pressure gauge and an alarm.(b)
Classification. Class II (performance standards).
0
VORTRAN Medical Technology 1, Inc.
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510(k) Summary - VORTRAN APM™ K103639
| 1. | Submitter
Information | VORTRAN Medical Technology 1, Inc.
21 Goldenland Court, Suite 100, Sacramento, CA 95834 |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact
Information | James Lee, Executive Vice President & COO
TEL: (800) 434-4034
FAX: (916) 648-9751 |
| 3. | Trade Name | VAPM™ (VORTRAN Airway Pressure Monitor) Kit |
| 4. | Device
Classification
Name | Monitor, Airway Pressure
(Includes Gauge And/or Alarm) |
| 5. | Device Class | Class II |
| 6. | Regulation
Number | 868.2600 |
| 7. | Classification
Product Code | CAP |
| 8. | Classification
Advisory
Committee | Anesthesiology |
| 9. | Review
Advisory
Committee | Anesthesiology |
| 10. | Predicate
Device | VAR® with VAR-Monitor™ 510(k) No.: K073261
VAR with Manometer 510(k) No.: K001430
VAR-Plus with Manometer 510(k) No.: K041473 |
| 11. | Device
Description | The VAPM is a battery (9 VDC) operated, portable, self-
contained device that is connected to the patient via the
connection tubing for monitoring cycling conditions of
resuscitators such as the VORTRAN® Automatic Resuscitator. |
| 12. | Intended Use | The VORTRAN Airway Pressure Monitor (VAPM) is to be used
by properly trained personnel to monitor the delivery of
emergency, short term, ventilatory support to adult (using VAPM-
3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric
Model). |
| 13. | Substantial
Equivalency
Evaluation | The VAPM is substantially equivalent (SE) to legally marketed
predicates like the VAR with VAR-Monitor (K073261) and other
commercially available pressure manometer / alarm devices. |
| 14. | Clinical
Application | The VAPM is connected to the VAR and patient via a ¼"
diameter tubing through an HME/bacteria filter. There will be no
flow of gas between the VAPM and VAR/patient circuit. |
| 15. Compliance
with
Performance
Standards | The VAPM complies with the following INTERNATIONAL
ELECTROTECHNICAL COMMISSION performance standards
for medical electrical equipment, such as [i] IEC/UL-60601-1:
General Requirements for Safety and; [ii] IEC 60601-1-8: --
Collateral Standard: General requirements, tests and guidance
for alarm systems in medical electrical equipment and medical
electrical systems; [iii] IEC 60601-1-2: Collateral standard:
Electromagnetic compatibility - Requirements and tests. | |
| 16. Functional
Characteristics | [a] MONITORS: The VAPM is designed to monitor the operation
of the VAR device when it is connected to a patient. The VAPM
will display airway pressure like a pressure manometer and the
LCD shows PIP (Peak Inspiratory Pressure) and PEEP (Positive
End Expiratory Pressure) in cm-H2O. Other respiratory functions
such as Respiratory Rate (breaths per minute), inspiratory and
expiratory time (seconds) and I:E Ratio are also displayed on the
LCD using the same airway pressure signals.
[b] ALARMS: An alarm function is also built into the VAPM to
facilitate monitoring of the patient's respiratory function and to
alert clinicians of any abnormalities. When the VAR stops
cycling for a predetermined time, the VAPM will activate the
NON-CYCLING ALARM. In addition, when the respiratory rate
or airway pressure exceeds the preset limit, the HIGH RATE and
/ or HIGH PIP alarms will be activated. The VAPM has a flashing
red LED and makes an audible sound when the alarm conditions
display on the LCD. | |
| 17. Clinical Tests | None | |
| 18.
Adverse
S & E Info | None | |
| 19. Conclusion | The VAPM passed all required tests and demonstrated that it
meets all predetermined acceptance criteria for applicable
standards. | |
1
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্ত
510(k) Summary - VORTRAN APM™ K103639
James Lee
[Signature]
James Lee
[Typed Name]
July 25, 2011
[Dated]
Executive VP & COO
[Title]
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird-like shape, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James Lee Executive Vice President & COO Vorton Medical Technology 1, Incorporated 21 Golden Land Court Sacramento, California 95834
SEP 1 5 2011
Re: K103639
Trade/Device Name: VORTRAN® Airway Pressure Monitor Regulation Number: 21 CFR 868.2600 Regulation Name: Airway Pressure Monitor Regulatory Class: 11 Product Code: CAP Dated: September 14, 2011 Received: September 14, 2011
Dear Mr. 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.
3
Page 2 - Mr. Lee
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
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 Radiological Health
Enclosure
4
Indications for Use
July 25, 2011
K103639 510(k) Number (if known):
VORTRAN® Airway Pressure Monitor Device Name:
Indications for Use:
:
The VORTRAN Airway Pressure Monitor (VAPM) is to be used by properly trained personnel to monitor the delivery of emergency, short term, ventilatory support to adult (using VAPM-3900 Adult Model) and/or pediatric (using VAPM-3800 Pediatric Model).
X AND/OR Prescription Use : (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 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)
L. Shutter
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K103639