V60 Anesthetic Vaporizer
Device Facts
| Record ID | K150167 |
|---|---|
| Device Name | V60 Anesthetic Vaporizer |
| Applicant | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. |
| Product Code | CAD · Anesthesiology |
| Decision Date | Jun 30, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5880 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system. The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.
Device Story
V60 Anesthetic Vaporizer is an unheated, calibrated device for evaporating liquid anesthetic agents; used in clinical settings by healthcare professionals. Fresh gas enters the device and splits into two pathways: carrier gas (through pressure compensation and liquid vaporizing systems) and diluted gas (through bypass and temperature compensation systems). These pathways recombine to output a controlled concentration of anesthetic gas to an anesthesia delivery system. The device features a manual concentration control dial and is compatible with Selectatec-style manifolds. It provides a mechanism for filling liquid agents via Pour Fill, Key Filler, or Quik-Fil systems. By delivering precise anesthetic concentrations, the device enables clinicians to maintain patient anesthesia during surgical procedures.
Clinical Evidence
No clinical data. Substantial equivalence is supported by non-clinical bench testing, including functional and system-level performance evaluations (filling rate, leakage, output concentration accuracy, flow rates, tilt tolerance, temperature/pressure/humidity effects, and resistance). Biocompatibility was verified per ISO 10993 standards, including cytotoxicity and irritation testing, supplemented by particulate matter and VOC testing.
Technological Characteristics
Unheated, agent-specific vaporizer. Materials meet ISO 10993 biocompatibility requirements. Features Selectatec-compatible plug-in connectors. Operates via split-flow principle with temperature and pressure compensation. Dimensions/volume: 360ml (dry wick). Environmental range: 10-40°C, 15-95% humidity, 70-106 kPa. Mechanical dial for concentration control. No software or electronic sensing components described; purely mechanical/pneumatic operation.
Indications for Use
Indicated for use in clinical environments for the evaporation of liquid anesthetic agents (Isoflurane or Sevoflurane) and delivery of controlled concentrations to an anesthetic delivery system.
Regulatory Classification
Identification
An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.
Predicate Devices
- DRAGER-VAPOR 2000 (K971923)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2015
Shenzhen Mindray Bio-medical Electronics Co., Ltd Tang Hao Product Approval Engineer Mindray Building, Keji 12th Rd. South Hi-tech Industrial Park Nanshan Shenzhen Guangdong China 518057
Re: K150167
Trade/Device Name: V60 Anesthetic Vaporizer Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: Class II Product Code: CAD Dated: May 22, 2015 Received: June 1, 2015
#### Dear Mr. Tang:
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.
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Page 2 - Tang Hao
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 (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 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K150167
Device Name V60 Anesthetic Vaporizer
Indications for Use (Describe)
V60 Anesthetic Vaporizer is an unheated, callbrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system.
The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|---------------------------------------------|
| X Prescription Use (Part 21 CFR 801 Subnart D) | Over-The-Counter Use (21 CER 801 Subnart C) |
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# 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the V60 Anesthetic Vaporizer is provided below.
### 1. Statement
This is a Traditional 510(k) report for V60 Anesthetic Vaporizer, this is a new device for this submission.
### 2. Applicant Device Information
| Device Proprietary Name: | V60 Anesthetic Vaporizer |
|----------------------------|-----------------------------------|
| Device Common Name: | Vaporizer, Anesthesia, non-heated |
| Classification Panel: | Anesthesiology |
| Classification Regulation: | Class II |
| Product Code: | CAD |
| Regulation Number: | 868.5880 |
## Indications for Use:
V60 Anesthetic Vaporizer is an unheated, calibrated anesthetic vaporizer used for evaporating liquid anesthetic agents and delivering mixed gas of controlled concentration to an anesthetic delivery system.
The V60 Anesthetic Vaporizer is available in models specific for use with Isoflurane and models available specific for use with Sevoflurane.
#### Submitter Information 3.
### Manufacturer Name :
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen 518057, P.R. China
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## Mindray
### Contact Person of the Submission:
Ms. Yanhong Bai Manager Regulatory Affairs Technical Regulation Department Shenzhen Mindray Bio-Medical Electronics Co., Ltd Mindray Building, Keji 12th Road South, Hi-tech Industrial Park Nanshan, Shenzhen, 518057 P.R. China TEL: (86) - 755-8188 5635 FAX: (86) - 755-2658 2680 EMAIL: baiyanhong@mindray.com
#### Legally Marketed Predicate Devices 4.
Device Name: DRAGER-VAPOR 2000
K971923 K-number:
Product Code: CAD
- Intended Use: The Vapor 2000 is intended for vaporization and delivery of a controlled amount of liquid anesthetic agent. The Vapor 2000 is designed and labeled accordingly for use with Enflurane, Isoflurane, Halothane, and Sevoflurane.
Manufacturer: DRAGER MEDICAL, INC.
#### ട്. De vice de scription:
### Summary of Technological Characteristics :
The below figure illustrates the main internal functions of the Mindray V60 anesthetic vaporizer. Fresh gas enters the vaporizer and is then divided into two pathways. One pathway of fresh gas is called carrier gas which goes through the pressure compensation system and liquid vaporizing system. The other pathway of fresh gas is called diluted gas which goes through the bypass system and temperature compensation system. The two gas pathways of diluted gas and carrier gas then mix to form mixed anesthetic gas with a certain concentration before the outlet of the vaporizer.
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Image /page/5/Figure/3 description: The image shows a schematic diagram of a liquid vaporizing system. The diagram includes several components such as a fresh gas inlet, a bypass way, a temperature compensation system, and a concentration control system. Other components include a safety valve, a liquid vaporizing system, a filling system, and a pressure compensation system. The diagram illustrates the flow of gas and liquid through the system.
#### Technological Comparison between predicate and proposed devices: ●
The subject Mindray V60 Anesthetic Vaporizer are substantially equivalent to predicate Drager vapor 2000 (K971923)vaporizers respecting indications for use, basic operation and performance specifications when used in non-MRI operating room
The subject Mindray V60 Anesthetic Vaporizer and predicate Drager vapor 2000 share the same intended use
To achieve intended use a vaporizer must
- Provide a filling system for the operator to fill anesthetic agent 1)
- 2) Be able to be installed correctly on an anesthetic delivery system
- Provide a mechanism to evaporate liquid anesthetic agents and deliver mixed gas 3) of controlled concentration to an anesthetic delivery system
- 4) Provide a mechanism for the user to adjust output concentration of agent
As a result, to achieve the same intended use the subject Mindray V60 Anesthetic Vaporizer and predicate Drager vapor 2000 is substantially equivalent with respect to the above 4 items, that is
- Provide equivalent filling systems 1)
- Share the same installation method and connector 2)
- 3) Share similar basic principle to output controlled concentration
- 4) Provide equivalent mechanism to adjust output concentration
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The following table illustrates the comparison of above mentioned key performance items between V60 vaporizer and predicate Drager vapor 2000 vaporizer (K971923)
| Technical<br>Characteristics | Proposed Device<br>Mindray V60 Anesthetic Vaporizer | Predicate Device<br>Drager Vapor 2000 Vaporizer (K971923) | Conclusion | |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------|
| Filling system | Pour Fill | Vapor of filling spout | | |
| | Key Filler | Keyed filling | Identical | |
| | Quik-Fil | Quik Fil | | |
| Volume | 360 ml (dry wick)<br>300 ml (moist wick)<br>260 ml (between the minimum and maximum<br>marks) | 360 ml (dry wick)<br>300 ml (moist wick)<br>260 ml (between the minimum and maximum<br>marks) | Identical | |
| Connection to<br>anesthesia gas<br>machine | Selectatec-compatible plug-in connectors | Selectatec-compatible plug-in connectors | Identical | |
| Output<br>concentration<br>accuracy | Operating<br>environment | 15 to 35°C or<br>0.2 to 10 L/min | 10 to 15°C or<br>35 to 40°C or<br>10 to 15 L/min | Similar |
| | Operating<br>environment | 15 to 35°C or<br>0.25 to 10 L/min | 10 to 15°C or<br>35 to 40°C or<br>10 to 15 L/min | |
| | Set<br>concentration<br><=6% | ±0.20 vol.%<br>or ±20% rel.,<br>whichever is<br>greater | +0.30/-0.20<br>vol.% or +25/-<br>20% rel.,<br>whichever is<br>greater | |
| | Set<br>concentration<br>> 6% | ±0.25 vol.%<br>or ±20% rel.,<br>whichever is<br>greater | +0.35/-0.25<br>vol.% or +30/-<br>20% rel.,<br>whichever is<br>greater | |
| Technical<br>Characteristics | Proposed Device<br>Mindray V60 Anesthetic Vaporizer | Predicate Device<br>Drager Vapor 2000 Vaporizer (K971923) | Conclusion | |
| Flow range | 0.2 to 15L/min<br>0.2 to 10L/min for concentrations >5Vol.% | 0.25 to 15L/min<br>0.25 to 10L/min for concentrations >5Vol.% | Similar | |
| Maximum angle of<br>tilt<br>(fixed on machine) | 30° | 30° | Identical | |
| Environmental<br>conditions | Temperature 10 to 40°C<br>Humidity15 to 95%, non-condensing<br>Atmospheric pressure 70 to 106 kPa | Temperature 10 to 40°C<br>Humidity 0 to 95%, non-condensing<br>Atmospheric pressure 70 to 110 kPa | Similar | |
| Difference between<br>pressure range and<br>ambient pressure<br>on the vaporizer<br>outlet | -10kPa~20kPa | -10kPa~20kPa | Identical | |
| Resistance | 70cmH2O@10L/min | 70cmH2O@10L/min | Identical | |
| Dial/calibration<br>markings | Isoflurane Vaporizer<br>0、0.2、0.4、0.6、0.8、1.0、1.5、2.0、2.5、3.0、3.5、4.0、5.0、6.0 | Isoflurane Vaporizer<br>0、0.2、0.4、0.6、0.8、1.0、1.5、2.0、2.5、3.0、3.5、4.0、5.0、6.0 | Identical | |
| | Sevoflurane Vaporizer<br>0、0.2、0.4、0.6、0.8、1.0、1.5、2.02.5、3.0、3.5、4.0、5.0、6.0、7.0、8.0 | Sevoflurane Vaporizer<br>0、0.2、0.4、0.6、0.8、1.0、1.5、2.02.5、3.0、3.5、4.0、5.0、6.0、7.0、8.0 | | |
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Based on the above information it is concluded that the V60 Anesthetic Vaporizer is substantially equivalent to the above named predicate devices.
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#### 6. Substantial Equivalence Considerations
The V60 Anesthetic Vaporizer has been tested and found to be in compliance with FDA recognized performance standards.
The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological evaluation of medical devices". The compatibility of the gas contacting component materials in the finished product meets the requirement of Biocompatibility.
The applicant device is compliance with the standard of ANSI/AAMI ES60601-1:2005, and the product is safe during the use. It can be used in the clinical environment. It is substantially equivalent to other anesthetic vaporizer product.
A risk analysis has been developed to identify potential hazards and documents the mitigation of the hazards.
The V60 Anesthetic Vaporizer has been evaluated and found to meet its intended use and meet the user's specific needs.
The V60 Anesthetic Vaporizer has been tested and found to be in compliance with the following performance standards:
- ISO 14971:2007, Medical devices - application of risk management to medical devices.
- ANSI/AAMI ES 60601-1:2005/(R)2012 and A1:2012,, C1:2009/(R)2012 and A 2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1:
General Requirements for Basic Safety and Essential Performance (IEC60601-1:2005,mod).
- IEC 62366:2014, Medical devices - application of usability engineering to medical devices.
- ISO 10993-1:2009, Biological evaluation of medical devices -- part 1: evaluation and testing within a risk management process.
- ISO 10993-5: 2009, Biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity.
- ISO 10993-10: 2010, Biological evaluation of medical devices - part 10: tests for irritation and skin sensitization.
- ISO 15223-1:2012, Medical devices - symbols to be used with medical device labels, labelling, and information to be supplied - part 1: general requirements.
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- IEC 60601-2-13:2009, Medical electrical equipment part 2-13: particular ● requirements for the safety and essential performance of anaesthetic systems.
- ISO 5360:2012. Anaesthetic vaporizers - agent specific filling systems.
- ISO 8835-4:2004, Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices.
- IEC 60601-1-6:2010, medical electrical equipment -- part 1-6: general requirements for basic safety and essential performance -- collateral standard: usability.
However, the V60 Anesthetic Vaporizer often has gas path materials which cannot be tested by the above listed tests. We performed a number of non-clinical tests to demonstrate the biocompatibility of the V60 Anesthetic Vaporizer.
These tests included:
- Particulates Matter testing (PM2 5/PM10)
- · Volatile Organic Compounds testing (VOCs)
We performed as intended in each test. These tests results indicated that the V60 Anesthetic Vaporizer complies with its predetermined specifications and FDA recognized consensus standards. These tests were equivalent to the testing required of the predicate devices.
### 7. Performance Data
- To establish the substantial equivalence of the V60 Anesthetic Vaporizer, Mindray conducted functional and system level testing on the subject devices. The testing provided an evaluation of the performance of each of the models of the subject device. The functional and system level testing showed that the devices continue to meet specifications and the performance of the device is equivalent to the predicate.
- The following table is a summary of performance testing that has been conducted on the subject V60. Testing was designed in accordance with industry-recognized methods. All performance of the V60 vaporizer was verified through the successful completion of all tests.
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| Tests | Description | Test report Index |
|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Filling Rate | Record the time needed to fill certain<br>volume of agent and then calculate the<br>filling rate | Appendix H4 (minima<br>and maxima as per<br>clauses 8 of ISO 5360) |
| Filling Leakage | Weigh the vaporizer and agent bottle<br>before and after filling to calculate the<br>filling leakage | Appendix H4 (minima<br>and maxima as per<br>clauses 9 of ISO 5360) |
| Volume | Measure the volume needed to fill the<br>vaporizer | Appendix H10, Chapter<br>4.16 |
| Output<br>Concentration<br>Accuracy | Verify that the output concentration of<br>V60 vaporizers can meet the product<br>specifications when the vaporizer<br>working at specified conditions | Appendix H10,<br>Chapters 4.12, 4.14 |
| Flow Rates | Verify that the output concentration of<br>V60 vaporizers can meet the product<br>specifications with specified flow rate | Appendix H10, Chapter<br>4.14 |
| Maximum<br>Angles of Tilt | Verify that the output concentration of<br>V60 vaporizers can meet the product<br>specifications with specified maximum<br>tilt angle | Appendix H10, Chapter<br>4.17; Appendix G1 |
| Temperature<br>Range | Verify that the output concentration of<br>V60 vaporizers can meet the product<br>specifications with specified temperature | Appendix H10, Chapter<br>4.12; Appendix G3 |
| Humidity,<br>Maximum<br>Atmospheric<br>Pressure | Verify that the output concentration of<br>V60 vaporizers can meet the product<br>specifications with specified humidity<br>and atmospheric pressure | Appendix G3 |
| Difference<br>Between Pressure<br>Range &<br>Atmospheric<br>Pressure at Outlet | Verify that the output concentration of<br>V60 vaporizers can meet the product<br>specifications with specified back<br>pressure at outlet | Appendix H10, Chapter<br>4.13 |
| Resistance | Measure the pressure rise at inlet of the<br>V60 vaporizers when the vaporizer is<br>routed with 10L/min gas flow | Appendix H10, Chapter<br>4.18 |
| Dial Mark<br>Calibration | Inspect Dial Mark Calibration on control<br>dial of the V60 vaporizers | Appendix H10, Chapter<br>4.7 |
| Compatibility<br>testing | Verify that the V60 vaporizers are<br>compatible with anesthesia machine with<br>Selectatec manifold including<br>installation, leakage and interlock<br>function | Appendix H10, Chapter<br>4.6, 4.9, 4.19 |
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#### Substantial Equivalence Conclusion 8.
The applicant device has demonstrated through performance testing, same classification information, same performance, same indications and intended use, same design principle and feature, similar product design and specifications, and non-clinical testing that the proposed devices and predicate have been found to be substantially equivalent.
