(43 days)
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
The VORTRAN Automatic Resuscitator (Model VAR-Plus) provides constant flow pressure cycled ventilatory support. The primary working mechanism of the VAR-PLUS is the Modulator which is an exhalation valve that opens at a set PIP (Peak Inspiratory Pressure) pressure and closes at a lower PEEP (Positive End Expiratory Pressure) pressure. During inhalation, exhalation will not start until the peak pressure is reached. During exhalation, inhalation will not begin until the pressure drops to PEEP. The rest of the VAR-PLUS consists of the Patient Connector Tee used to supply a flow of gas, entrain additional air, and provide a redundant pop-off valve
The provided document is a 510(k) summary for the VORTRAN Automatic Resuscitator (VAR-Plus), a Class II medical device. It details the device's characteristics, intended use, and substantial equivalence to predicate devices, but it does not contain information about clinical studies measuring specific performance metrics against acceptance criteria.
The document explicitly states "Clinical Tests: None" and "Adverse S & E: None." Instead, the submission relies on in vitro testing and comparison to existing standards and predicate devices to demonstrate substantial equivalence.
Therefore, many of the requested items cannot be extracted directly from this document.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with corresponding device performance metrics. It refers to two standards/guidances that define performance and safety requirements:
- "FDA Draft Emergency Resuscitator Equivalency Guidance" 14 April 1993 868.5925 Powered Emergency Ventilator (Resuscitator) BTL
- "Standard Specification for Minimum Performance and Safety requirements for Resuscitators Intended for Use with Humans", ASTM Designation: F 920 - 93 (Reapproved 1999) An American National Standard.
However, the specific acceptance criteria from these documents and the VAR-Plus's reported performance against them are not detailed in this 510(k) summary. It only states that the device "meets" these standards. The device's operational characteristics are described qualitatively:
| Operational Characteristic | Reported Device Performance (Qualitative) |
|---|---|
| Gas Flow Input | Up to 40 L/min |
| Automatic Delivery (50 PSIG source) | 40 L/min (667 mL/second) |
| Peak Pressure (PIP) | Adjustable from 10 to 45 cm H2O |
| PEEP | Typically 1/5th of PIP |
| Inspiratory Time | Adjustable over a wide range |
| Rate | Adjustable over a wide range |
| Air Entrainment Valve | Allows patient to entrain additional air and respond to demand (pressure support) |
| Redundant Pop-off Valve | Relieves pressure at 60 cm H2O |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical tests were performed. The "in vitro testing" mentioned is not detailed in terms of sample size or methodology.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical tests requiring expert-established ground truth were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical tests requiring adjudication were performed.
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
Not applicable. This device is a mechanical resuscitator, not an AI or diagnostic imaging device that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone mechanical resuscitator. However, "standalone performance" in the context of typical AI/diagnostic device evaluation refers to the algorithm's performance without human intervention, which is not relevant here. The device's performance, as a mechanical product, was evaluated through in vitro testing against standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable for clinical studies. The "ground truth" for the in vitro testing would be the specifications and requirements outlined in the referenced FDA Guidance and ASTM Standard. Compliance was likely verified through physical measurements and observations during bench testing.
8. The sample size for the training set
Not applicable, as this is a mechanical device, not an AI/machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as this is a mechanical device, not an AI/machine learning algorithm.
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VORTRAN Medical Technology 1, Inc.
JUL 1 5 2004
May 27, 2004
510(k) Summary
- KO41473 1. Submitter VORTRAN Medical Technology, Inc. 1804 Tribute Road, Suite F, Sacramento, CA 95815 Information
- James Lee, Senior Vice President 2. Contact Information TEL: (800) 434-4034 FAX: (916) 648-9751
- VORTRAN Automatic Resuscitator (VAR-Plus™) 3. Trade Name
- Ventilator, Emergency, Powered (Resuscitator) 4. Common Name
-
- Device Class Class II
-
- Product code 73 BTL
panel
-
- Product per CFR section 868.5925 classification
-
- Classification Anesthesiology
- 10.Device The VORTRAN Automatic Resuscitator (Model VAR-Plus) Description provides constant flow pressure cycled ventilatory support. The primary working mechanism of the VAR-PLUS is the Modulator which is an exhalation valve that opens at a set PIP (Peak Inspiratory Pressure) pressure and closes at a lower PEEP (Positive End Expiratory Pressure) pressure. During inhalation, exhalation will not start until the peak pressure is reached. During exhalation, inhalation will not begin until the pressure drops to PEEP. The rest of the VAR-PLUS consists of the Patient Connector Tee used to supply a flow of gas, entrain additional air, and provide a redundant pop-off valve
- 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 In Vitro Testing per [1] "FDA Draft Emergency Resuscitator Equivalency Guidance" 14 April 1993 868.5925 Powered Emergency Evaluation Ventilator (Resuscitator) BTL and [2] "Standard Specification for Minimum Performance and Safety requirements for Resuscitators Intended for Use with Humans", ASTM Designation: F 920 - 93 (Reapproved 1999) An American National Standard.
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| 510(k) Summary | |
|---|---|
| 13.OperationalCharacteristics | The VAR-PLUS runs on a continuous flow of gas of up to 40 L/min. When connected to a 50 PSIG high flow source, the VAR-PLUS will automatically deliver 40 L/min (667 mL/second). Peak pressure may be adjusted from between 10 and 45 cm H2O and PEEP is typically 1/5th of PIP. Inspiratory time and rate are adjustable over a wide range. The VAR-PLUS is equipped with an air entrainment valve which allows the patient to entrain additional air and respond to the demands of the patient (pressure support). The VAR-PLUS is also equipped with a redundant pop-off valve that relieves pressure at 60 cm H2O. |
| 14.ClinicalApplication | The VAR-PLUS provides short term, pressure cycled, constant flow ventilatory support using either pressure control or pressure support. In the pressure support mode, the rate dial of the VAR-PLUS 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 VAR-PLUS is not an ICU stand alone ventilator with multiple monitoring features. Set up and use of the VAR-PLUS 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. |
| 15.Clinical Tests | None |
| 16.Adverse S & E | None |
Information
17.Conclusion
The VAR-PLUS is substantially equivalent to a predicate device: the RespirTech PRO and Oxylator EM-100. The VAR-PLUS meets the FDA Draft "Emergency Resuscitator Guidance" and the "Standard Specification for Minimum Performance and Safety ,Requirements for Resuscitators Intended for Use with Humans" ASTM Designation: F 920 - 93 and has been shown to be/safe and effective.
[Signature]
Gordon A. Wong, M.D.
[Typed Name]
May 27, 2004
[Dated]
President
[Title]
VAR-P 510k Summary
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with a flowing, wave-like design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 5 2004
Mr. James Lee Senior Vice President VORTRAN Medical Technology 1, Incorporated 1804 Tribute Road, Suite F Sacramento, California 95815
Re: K041473
Trade/Device Name: VORTRAN Automatic Resuscitator (VAR-Plus) Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL Dated: May 27, 2004 Received: June 2, 2004
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.
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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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours,
Syra Comar
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
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510(k) Number (if known):
Device Name: VORTRAN Automatic Resuscitator (VAR-Plus)
Indication for Use:
The device is to be used by properly trained personnel to deliver emergency, short term, constant flow - pressure cycled ventilatory support.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
· · Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use : | ✓ |
|---|---|
| (Per 21 CFR 810.109) | |
| OR Over-The-Counter Use |
(Optional Format 1-2-96)
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510(k) Number K041473
VAR-P INDICATION OF USE
§ 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).