(185 days)
None
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The device description focuses on monitoring cycling conditions, which is a standard function for ventilators.
No
The VAR-Monitor is described as a device that "monitors cycling conditions during operation" of another device (the VAR) that delivers ventilatory support. It does not itself deliver therapy.
No
The device monitors cycling conditions during operation of another device (VAR), which is a ventilatory support system. It is not described as identifying or classifying diseases or conditions.
No
The device description explicitly states it is a "battery (9 VDC) operated device that is mounted onto the VAR," indicating it is a hardware component, 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 ventilatory support." This describes a device used on a patient to provide a medical intervention (ventilation), not a device used to examine specimens from a patient to diagnose or monitor a condition.
- Device Description: The device "monitors cycling conditions during operation" of a ventilator. This is a monitoring function related to the operation of a life support device, not a diagnostic test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for direct patient care and monitoring of a life support system, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
Product codes
73 BTL
Device Description
The VAR-Monitor is a battery (9 VDC) operated device that is mounted onto the VAR to monitor cycling conditions during operation.
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
Not Found
Intended User / Care Setting
properly trained personnel
Description of the training set, sample size, data source, and annotation protocol
None
Description of the test set, sample size, data source, and annotation protocol
None
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The VAR with VAR-Monitor 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1
510(k) Summary
| K07326 | |||
|---|---|---|---|
| 1. Submitter | |||
| Information | VORTRAN Medical Technology 1, Inc. | ||
| 21 Golden Land Court, Sacramento, CA 95834 | MAY 23 2008 | ||
| 2. Contact | |||
| Information | James Lee, Senior Vice President | ||
| TEL: (800) 434-4034 FAX: (916) 648-9751 | |||
| 3. Trade Name | VAR with VAR-Monitor™ | ||
| 4. Common Name | Ventilator, Emergency, Powered (Resuscitator) | ||
| 5. Device Class | Class II | ||
| 6. Product Code | 73 BTL | ||
| 7. Product | |||
| Classification | Per CFR section 868.5925 | ||
| 8. Classification | |||
| Panel | Anesthesiology | ||
| 9. Predicate | |||
| Device | RespirTech PRO | ||
| RespirTech PRO O₂C | |||
| VAR-Plus Model PCM | 510(k) No.: K973975 | ||
| 510(k) No.: K001430 | |||
| 510(k) No.: K041473 | |||
| 10. Device | |||
| Description | The VAR-Monitor is a battery (9 VDC) operated device that is | ||
| mounted onto the VAR to monitor cycling conditions during | |||
| operation. | |||
| 11. Intended Use | The device is to be used by properly trained personnel to | ||
| deliver emergency, short term, constant flow - pressure cycled | |||
| ventilatory support. | |||
| 12. Substantial | |||
| Equivalency | |||
| Evaluation | The VAR with VAR-Monitor meets and exceeds "Standard | ||
| Specification for Minimum Performance and Safety | |||
| Requirements for Resuscitators Intended for Use with | |||
| Humans," ASTM Designation: F 920-93 (Reapproved 1999). | |||
| 13. Operational | |||
| Characteristics | VAR-Monitor detects a non-cycling condition of the VAR | ||
| modulator Indicating that no pressure changes have occurred. | |||
| When the VAR-Monitor is powered on and ready, the device | |||
| will check for the "pressure signal." If the pressure stays | |||
| unchanged for more than the preset time of eight (8) seconds, | |||
| both visual and audible alarms will be activated. |
1
510(k) Summary
- The VAR with VAR-Monitor provides short term, pressure 14.Clinical cycled, constant flow ventilatory support using either pressure Application control or pressure support. The device is not an ICU stand alone ventilator. Set up and use of the VAR with VAR-Monitor 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 for the VAR. Power on the VAR-Monitor to monitor the VAR cycling and detect any VAR non-cycling condition. This non-cycling condition will trigger the alarm (audible and visual) to notify attending personnel of an abnormal condition. Possible changing conditions could include but are not limited to: (i) increases or decreases in supply gas flow or no gas flow because tank is empty or has been turned off; (ii) patlent disconnect or airway leak; or (iil) a change in patient All these conditions may cause the VAR to stop condition. cycling or stay in a spontaneous "pressure assisted" mode, waiting for the patient to trigger the next breath.
-
- Clinical Tests None
- 16.Adverse S & E None Information
- The VAR with VAR-Monitor passed all required tests and 17. Conclusion demonstrated that it meets all predetermined acceptance criteria for applicable standards. In conclusion, the modified VAR with VAR-Monitor is substantially equivalent (SE) to legally marketed predicate devices.
[Signature]
James Lee
[Typed Name]
November 16, 2007
[Dated]
Senior Vice President
[Title]
VAR-P 510k Summary
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 depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
Mr. James Lee Senior Vice President VORTRAN Medical Technology 1, Incorporated 21 Golden Land Court Sacramento, California 95834
Re: K073261 Trade/Device Name: VAR with VAR-Monitor Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: April 23, 2008 Received: April 28, 2008
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Svetta y Michael ms
Chiu Lin, Ph.D. 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
510(k) Number (if known): K073261
Device Name: VAR with VAR-Monitor
Indications For Use:
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
Prescription Use 2 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
i Vhm
Page 1 of 1
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 1607326