The Dräger-Vapor 2000 (Vapor 2000) is a non-heated calibrated vaporizer designed to enrich the fresh gas flow of an ancsthesia delivery system with a controlled amount of anesthetic vapor. Separate models of the single-agent vaporizer are intended for use with one of the following agents: isoflurane, halothane, cofluranc, or sevofiuranc. The vaporizer is not intended for use with desflurane, or for use within an anesthetic breathing system. Federal law restricts this device to sale by or on the order of a physician.

Device Description

The Dräger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents.

AI/ML Overview

The provided text describes the Dräger-Vapor® 2000, an anesthesia vaporizer, and its substantial equivalence to a predicate device, the Dräger-Vapor® 19.1. It details the device's features and the testing conducted to demonstrate compliance and performance, but it does not contain information typically associated with studies proving device performance against acceptance criteria for AI/ML-based medical devices.

Therefore, many of the requested fields cannot be filled as the information is not present in the provided document. The document describes a traditional medical device, not an AI/ML-based one.

Here's a breakdown of the available and unavailable information based on the prompt:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Result)
Compliance with ASTM Standard F 1161-88	Testing was done to demonstrate compliance. (Specific results not detailed, but assumed to meet the standard for substantial equivalence).
Effect of Temperature on Concentration Output	Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence).
Effect of Gas Flow on Concentration Output	Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence).
Effect of Duration of Use on Concentration Output	Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence).
Effect of Tilting on Concentration Output	Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence).
Effect of Back Pressure on Concentration Output	Testing was done to demonstrate the effect. (Specific results not detailed, but assumed to meet performance criteria for substantial equivalence).
Functionality of Transport Mode (Vapor 2000 specific)	Secures the vaporizer from spillage of liquid agent, leakage of anesthetic vapor, and closes off the vaporizing chamber isolating liquid agent or vapors from the rest of the vaporizer. (Implied to function as designed for substantial equivalence).
Reservoir Size (Vapor 2000 vs. Vapor 19.1)	The Vapor 2000 has a larger reservoir than the Vapor 19.1. (A factual difference, not a performance metric per se, but contributes to design change).
Equivalence in Intended Use and Principle of Operation	The Vapor 2000 and Vapor 19.1 have the same intended use and principle of operation. (This is a core claim for substantial equivalence, not a direct performance test result).
Design for use with specific agents (Enflurane, Isoflurane, Halothane, Sevoflurane)	The Vapor 2000 is designed and labeled accordingly for use with these agents. (Implied that testing verifies compatibility and correct vaporization for these agents).
Not intended for use with Desflurane or within an anesthetic breathing system	Explicitly stated as a design limitation/intended use. (Implied that it would not perform correctly in these scenarios, and testing confirms this or it's a design choice).

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets acceptance criteria is a series of engineering tests and demonstrations of compliance and substantial equivalence to a predicate device (Dräger-Vapor® 19.1). The document explicitly states: "Qualification of the Vapor 2000 included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effect of temperature, gas flow, duration of use, tilting, and back pressure on concentration output."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Not specified. For a physical device like this, "sample size" would refer to the number of units tested, and this detail is not provided.
Data Provenance: Not applicable in the context of clinical data provenance. The testing would have been conducted by the manufacturer, Drägerwerk AG, in Germany. It's engineering test data, not patient data.
Retrospective/Prospective: Not applicable. This refers to the type of clinical study, not engineering validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not applicable. Ground truth, in the context of AI/ML, refers to a label or outcome established by human experts or definitive tests. For a vaporizer, performance is determined by physical measurements and adherence to engineering standards, not expert interpretation of outputs.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Not applicable. This concept is relevant for reconciling discrepancies in expert opinion for ground truth, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This is a type of clinical study, specifically for diagnostic algorithms often involving human interaction, which is not relevant for this physical device.
Effect Size of Human Readers Improve with AI vs. without AI assistance: Not applicable.

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

No. This device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used:

Engineering Standards and Specifications: The "ground truth" for this device's performance is its measured output (e.g., concentration levels) against established engineering standards (like ASTM F 1161-88) and the manufacturing specifications for the device. It's objective physical measurement, not expert consensus or pathology in a clinical sense.

8. The Sample Size for the Training Set:

Not applicable. This device does not use a training set as it's not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established:

Not applicable. This device does not use a training set.

Summary

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K71923

SEP 1 6 1997

Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

Proprietary Name: Dräger-Vapor® 2000

Classification Name: Vaporizer, Anesthesia, Non-heated

Device Class: Class II

Initial Distributor: North American Dräger 3135 Quarry Road Telford, Pennsylvania 18969
Establishment Registration Number: 2517967
Manufacturer: Drägerwerk AG Lübeck, Germany
Establishment Registration Number: 2517967

Device to which substantial equivalence is claimed: Dräger-Vapor® 19.1 K940255

Device Description:

The Dräger-Vapor 2000 (Vapor 2000) is a concentration calibrated non-heated vaporizer for vaporizing liquid anesthetic agents.

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,

Substantial Equivalence:

The Vapor 2000 is substantially equivalent to the Dräger-Vapor 19.1 (Vapor 19.1). Both are concentration calibrated, non-heated vaporizers for vaporizing liquid anestheiic agents with a vaporizing chamber bypass. Both the Vapor 2000 and Vapor 19.1 are available with attached funnel or key-index filling systems. The Vapor 2000 will also be available with the Quik-Fill™ filling system.

The Vapor 2000 differs slightly from the Vapor 19.1 in that the Vapor 2000 has a transport mode which secures the vaporizer from spillage of liquid agent, leakage of anesthetic vapor, and closes off the vaporizing chamber isolating liquid agent or vapors from the rest of the vaporizer.

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The Vapor 2000 has a larger reservoir than the Vapor 19.1.

The Vapor 2000 and the Vapor 19.1 have the same intended use and principal of operation and are substantially equivalent.

Qualification of the Vapor 2000 included testing to demonstrate compliance with ASTM Standard F 1161-88, and the effect of temperature, gas flow, duration of use, tilting, and back pressure on concentration output.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 1 6 1997

Mr. James J. Brennan North American Drager 3135 Quarry Road 18869 Telford, Pennsylvania

к971923 Re: Dräger-Vapor® 2000 Regulatory Class: II (two) Product Code: 73 CAD August 5, 1997 Dated: Received: August 5, 1997

Dear Mr. Brennan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. James J. Brennan

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1

510(k) Number (if known): K971923

Device Name: Drager-Vapor& 2000

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

. Bazant

Over-The-Counter Use_

Afl. A. Ciall.

(Optional Format 1-2-96)

(Division Sign-Off) (Division Sign-Oit)
Division of Cardiovascular, Respiratory, Division of Occal Devices

510(k) Number _

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).