V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.

V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.

V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.

Device Description

V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.

AI/ML Overview

The provided text is a 510(k) Summary for the Mindray V80 Anesthetic Vaporizer. It focuses on demonstrating substantial equivalence to a predicate device (D-Vapor Anesthetic Vaporizer) by comparing technical characteristics and performance data, mainly through bench testing and compliance with various standards.

Crucially, this document does not describe a study that uses a test set, ground truth established by experts, or measures human reader performance with or without AI assistance. The device in question is an anesthetic vaporizer, which is a piece of hardware, not an AI/software device that interprets medical images or diagnoses conditions. Therefore, many of the requested elements of your query (e.g., sample size for test set, number of experts, MRMC study, standalone performance for an algorithm, training set details) are not applicable to this type of medical device submission.

However, I can extract the relevant information from the document regarding its acceptance criteria and the type of studies conducted to prove it meets those criteria, specifically concerning its performance and other safety/effectiveness aspects.

Here's a breakdown of the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document presents a comparison table between the subject device (V80 Anesthetic Vaporizer) and the primary predicate device (D-Vapor Anesthetic Vaporizer), essentially demonstrating that the acceptance criteria for the subject device are met by matching or exceeding the performance and specifications of the predicate.

Technical Characteristics (Acceptance Criteria Based on Predicate)	Subject device V80 Anesthetic Vaporizer (Reported Performance)	Primary predicate D-Vapor Anesthetic Vaporizer (Benchmark/Acceptance Target)
Performance
Concentration setting range	2vol.% to 18 vol.%	2vol.% to 18 vol.%
Calibrated setting concentration	±0.5vol.% or ±15%rel, the larger value applies in each case	±0.5vol.% or ±15%rel, the larger value applies in each case
Other setting concentration (0.2-2 L/min)	±0.9Vol.% or ±30% rel, which is greater	±0.9Vol.% or ±30% rel, which is greater
Other setting concentration (2-8 L/min)	±0.9Vol.% or ±20% rel, which is greater	±0.9Vol.% or ±20% rel, which is greater
Other setting concentration (8-15 L/min)	±0.9Vol.% or ±30% rel, which is greater	±0.9Vol.% or ±30% rel, which is greater
Flow range	0.2 to 15L/min	0.2 to 15L/min
Maximum tilt angle during working	10°	10°
Warm-up time at 22 °C	within 6 min	within 6 min
User Interface Indicators
Display Panel Indicators	Operational, No Output, Delivery Low, Fill Up, Battery	Operational, No Output, Delivery Low, Fill Up, Battery
Glass tube liquid level indicator	A sight glass on the front to visually indicate the level of agent	A sight glass on the front to visually indicate the level of agent
Audio Paused	120s	120s
Connection to anesthesia delivery system	Selectatec®-compatible plug-in connectors	Selectatec®-compatible plug-in connectors
Filling system	Saf-T-Fill™	Saf-T-Fill™
Filling volume	Total: 320 mL	Total: 300 mL
Anesthetic agent loss (24 hours in storage, 22°C)	≤0.5mL	≤0.5mL
Anesthetic agent loss (24 hours in work, 22°C)	≤2.5mL	≤2.5mL
Filling time for 240 mL Desflurane (22°C, not warmed up)	< 1 minute	< 1 minute
Filling time for 240 mL Desflurane (22°C, warmed up)	< 2 minutes	< 2 minutes
Internal Battery
Battery type	Li-ion (sealed) battery	Nickel/metal hydride (NiMH)
Bridging time when mains power supply absent (6 Vol.%, 4 L/min, fully charged)	6 minutes	maximum of 5 minutes

Note: The differences in battery type and bridging time are addressed by stating, "The differences in technological characteristics do not raise new questions of safety and effectiveness," implying these differences meet safety and effectiveness criteria.

2. Sample sizes used for the test set and the data provenance

Sample Size for Test Set: Not applicable as this is a hardware device where performance is evaluated through bench testing and compliance with standards rather than a test set of data samples. The functional and system level testing was conducted on the "subject device" (V80 Anesthetic Vaporizer). The exact number of units or test cycles for the bench testing is not specified in the summary, but it implies a sufficient number to validate performance.
Data Provenance: The testing was conducted by "Mindray" (Shenzhen Mindray Bio-Medical Electronics Co., LTD. which is based in China). The document does not specify if these were retrospective or prospective tests, but for bench testing of hardware, it would inherently be prospective (testing a new device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI/imaging devices (e.g., expert radiologist annotations) is not relevant for an anesthetic vaporizer's performance which is measured by objective physical parameters (e.g., concentration output, flow rate, warm-up time). The "ground truth" for these tests are the established specifications and consensus standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert consensus or adjudication method for medical interpretations is involved. Performance is measured against predefined engineering specifications and international standards.

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 is a hardware device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable in the context of an algorithm. However, the performance data presented is "standalone" in the sense that it measures the device's intrinsic performance characteristics (e.g., concentration delivery, flow rate) against engineering specifications, independent of human interaction other than setting up and operating the test itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance evaluation is based on:

Engineering Specifications: The design specifications the device is intended to meet.
Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (K042276 – D-Vapor Anesthetic Vaporizer).
Consensus Standards: Compliance with recognized international standards (e.g., ISO 80601-2-13, ISO 5360, IEC 60601 series, ISO 10993 series, ISO 18562 series) which define acceptable performance and safety limits for medical devices.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 31, 2024

Shenzhen Mindray Bio-Medical Electronics Co., LTD. Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South Hi-tech Industrial Park, Nanshan Shenzhen, Guangdong 518057 China

Re: K240375

Trade/Device Name: V80 Anesthetic Vaporizer (V80) Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: Class II Product Code: CAD Dated: September 30, 2024 Received: September 30, 2024

Dear Yanhong Bai:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240375

Device Name V80 Anesthetic Vaporizer

Indications for Use (Describe)

V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.

V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.

V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart 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 Mindray V80 Anesthetic Vaporizer is provided below.

1. SUBMITTER

Applicant:	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICSCO., LTD.Mindray Building, Keji 12th Road South High-tech IndustrialPark, Nanshan Shenzhen 518057, P.R. ChinaTel: +86 755 81888998Fax: +86 755 26582680
Contact:	Contact Person: Yanhong BaiTitle: Manager Regulatory AffairsPhone: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com
Date Prepared:	Oct 30, 2024
2. DEVICE
Device Trade Name:	V80 Anesthetic Vaporizer
Device Common Name:	Vaporizer, Anesthesia, Non-heated
Classification Name:	21 CFR 868.5880, Class II, Anesthetic Vaporizer
Regulatory Class:	Class II
Primary Product Code:	CAD

3. PREDICATE DEVICES

Primary predicate:

. K042276 – D-Vapor Anesthetic Vaporizer, Draeger Medical AG & Co KGaA

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4. REFERENCE DEVICES

. K000275 – DATEX-OHMEDA TEC 6 PLUS ANESTHETIC VAPORIZER, DATEXOHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA, DATEX-OHMEDA, INC.
K150167 -V60 Anesthetic Vaporizer, SHENZHEN MINDRAY BIO-MEDICAL . ELECTRONICS CO., LTD.
K202405 BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision ● N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1), SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.

5. DEVICE DESCRIPTION

V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.

6. INTENDED USE/INDICATIONS FOR USE

V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.

V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.

V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.

7. SUBSTANTIAL EQUIVALENCE

Comparison of Indications

Comparing with the primary predicate D-Vapor Anesthetic Vaporizer (K042276), the indications for use for the subject device V80 Anesthetic Vaporizer is the same.

Comparison of Technological Characteristics

The table below compares the technology characteristics and performance specifications of the subject device V80 Anesthetic Vaporizer to the predicate D-Vapor Anesthetic Vaporizer (K042276).

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Technical Characteristics	Technical Characteristics	Subject deviceV80 Anesthetic Vaporizer	Primary predicateD-Vapor Anesthetic Vaporizer
		Shenzhen Mindray Bio-MedicalElectronics Co., Ltd.(Subject device)	D-Vapor Anesthetic Vaporizer,Draeger Medical AG & Co(K042276)
Performance
Controlparameter	Concentrationsetting range	2vol.% to 18 vol.%	2vol.% to 18 vol.%
	Calibrated settingconcentration	±0.5vol.% or ±15%rel, the largervalue applies in each case	±0.5vol.% or ±15%rel, the largervalue applies in each case
	Other settingconcentration	±0.9Vol.% or ±30% rel, which isgreater (at 0.2 to 2L/min);±0.9Vol.% or ±20% rel, which isgreater (at 2 to 8L/min):±0.9Vol.% or ±30% rel, which isgreater (at 8 to 15L/min);	±0.9Vol.% or ±30% rel, which isgreater (at 0.2 to 2L/min);±0.9Vol.% or ±20% rel, which isgreater (at 2 to 8L/min);±0.9Vol.% or ±30% rel, which isgreater (at 8 to 15L/min);
Flow range		0.2 to 15L/min	0.2 to 15L/min
Maximum tilt angle during working		10°	10°
Warm-up time at 22 °C		within 6 min	within 6 min
User interface
Display Panel	Indicator	Operational	Operational
		No Output	No Output
		Delivery Low	Delivery Low
		Fill Up	Fill Up
		Battery	Battery
	Glass tube liquidlevel indicator	A sight glass on the front of thedevice to visually indicate thelevel of agent	A sight glass on the front of thedevice to visually indicate thelevel of agent
	Audio Paused	120s	120s
Connection to anesthesia delivery system
Connection to anesthesia deliverysystem		Selectatec®-compatible plug-inconnectors	Selectatec®-compatible plug-inconnectors
Filling system
Filling system		Saf-T-Fill™	Saf-T-Fill™
Filling volume		Total:320 mL	Total:300 mL
Anesthetic agent loss (24 hours instorage)		≤0.5mL(22°C)	≤0.5mL(22°C)
Anesthetic agent loss (24 hours inwork)		≤2.5mL(22°C)	≤2.5mL(22°C)
Technical Characteristics	Subject deviceV80 Anesthetic VaporizerShenzhen Mindray Bio-MedicalElectronics Co., Ltd.(Subject device)	Primary predicateD-Vapor Anesthetic Vaporizer
Filling timefor oneanestheticagent bottle ofDesflurane(240 mL)	At 22 °C and withthe Vapor not yetwarmed up	< 1 minute	< 1 minute
	At 22 °C and witha warmed-upVapor, the fillingtime is increased.	< 2 minutes	< 2 minutes
Internal Battery
	Battery	Li-ion (sealed) battery	Nickel/metal hydride (NiMH)
	Bridging time when mains powersupply absent	6 minutes (at a concentration of 6Vol.% maximum, fresh-gas flow4 L/min and fully charged battery)	maximum of 5 minutes (at aconcentration of 6 Vol.%maximum, fresh-gas flow 4L/min and fully charged battery)

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The differences in technological characteristics do not raise new questions of safety and effectiveness.

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8. PERFORMANCE DATA

To establish the substantial equivalence of the V80 Anesthetic Vaporizer, Mindray conducted functional and system level testing on the subject device. The testing provided an evaluation of the performance of the device relevant to each of the differences between the subject device and the predicate 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.

Mindray has conducted testing to ensure the subject device meets relevant consensus standards.

Biocompatibility Testing

V80 Anesthetic Vaporizer is categorized as externally communicating, indirect contact with tissue, limited contact duration (≤24 hours).

The biocompatibility tests performed on the subject device including Particulate matter test (ISO 18562-2:2017), Volatile organic compounds (VOCs) test (ISO 18562-3:2017) and Inorganic gases test

The V80 Anesthetic Vaporizer was assessed for conformity with the relevant requirements of the following standards and found to comply:

. ISO 10993-1 Fifth Edition 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare ● applications - Part 1: Evaluation and testing within a risk management process
ISO 18562-2 First edition 2017-03 Biocompatibility evaluation of breathing gas . pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
. ISO 18562-3 First edition 2017-03 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds

Software Verification and Validation Testing

Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance" Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff". Verification of the V80 Anesthetic Vaporizer was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.

The level of concern for the V80 Anesthetic Vaporizer software was determined to be Major in that the Software Device is a life-sustaining device that provides vital signs monitoring and alarms for potentially life-threatening situations for which medical intervention is necessary.

The V80 Anesthetic Vaporizer consists of the following two software subcomponents:

1. Control subsystem
1. Protection subsystem

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Electromagnetic Compatibility and Electrical Safety

The V80 Anesthetic Vaporizer was assessed for conformity with the relevant requirements of the following standards and found to comply:

IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION (edition 3.2) Medical . electrical equipment - Part 1: General requirements for basic safety and essential performance
ANSI AAMI IEC ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & ● A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical . equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability
. IEC 60601-1-8 Edition 2.2 2020-07 Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

Bench Testing

To establish the substantial equivalence of the V80 Anesthetic Vaporizer, Mindray conducted functional and system level testing on the device. The bench testing show that the subject device meets its accuracy specification and is substantially equivalent to the predicate device.

In addition, Mindray has conducted testing to ensure the subject devices meet relevant consensus standards.

. ISO 80601-2-13 First edition 2011-08-11 Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
. ISO 5360 Fourth edition 2016-02-15 Anaesthetic vaporizers - Agent specific filling systems

Shelf life

No shelf life is claimed

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9. CONCLUSION

Based on the detailed comparison of specifications for each of the characteristics to the predicate devices, the performance testing and conformance with applicable standards, the V80 Anesthetic Vaporizer can be found substantially equivalent to the predicate devices.

Regulation Number and Section

§ 868.5880 Anesthetic vaporizer.

(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).