The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of anesthetic vapor. The D-Vapor is intended for use with Desflurane. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Device Description

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of an anesthesia delivery system with a controlled amount of Desflurane anesthetic vapor in concentrations of 2 to 18 vol.%.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "D-Vapor," an anesthetic vaporizer. This type of regulatory submission in 2004 did not typically include detailed performance studies with acceptance criteria in the format requested, as it relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting de novo clinical trial data.

Therefore, many of the requested data points (like sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable (N/A) or not provided in this type of document for this class of device at this time.

Here's an attempt to answer the questions based only on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner. Instead, it describes features and functionalities that demonstrate substantial equivalence to predicate devices (Tec 6 Plus and Vapor 2000). The "performance" is implied by matching or having similar characteristics to these existing devices.

Feature/Characteristic	D-Vapor Performance (as reported)	Acceptance Criteria (Implied by Predicate Devices)
Agent Delivered	Desflurane anesthetic via electronic vaporizer	Delivers Desflurane
Concentration Adjustment	2-18 Vol.%	Covers a range (e.g., Tec 6 Plus: 1-18 Vol.%)
Display Panel	Visual indication of: Operational, No Output, Low Agent Level, Warm Up, Battery Status	Similar visual indications as Tec 6 Plus
Alarms	Audible alarms, ability to silence alarms	Similar audible alarms and silencing as Tec 6 Plus
Sight Glass	Visual indication of agent level for filling and monitoring	Similar sight glass as Vapor 2000
Quick Connect Systems	Compatible with Vapor 2000 or Tec 6 plug-in systems for Selectatec®	Compatibility with existing quick connect systems
Permanent Installation	Block connector with o-rings and screws (like Tec 6 Plus) or conical fittings (like Vapor 2000)	Options for permanent installation
Keyed Filling System	Saf-T-Fill™ system for Desflurane bottles only	Keyed system to ensure correct agent (like Tec 6 Plus)
Transport Mode	Allows removal from delivery system with agent in vaporizer	Similar transport mode as Vapor 2000
MRI Contraindication	Contraindicated for use in MRI environment	Similar contraindication as Tec 6 Plus

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

Sample Size: Not specified. The submission focuses on device description and comparison to predicates, not a clinical test set.
Data Provenance: Not applicable for a traditional "test set" in this context. The data provided describes the device's features and its relation to predicate devices.

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

Number of Experts: Not specified. The submission does not describe a process of establishing ground truth with experts for a test set.
Qualifications of Experts: Not specified.

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

Adjudication Method: Not applicable. No test set requiring expert adjudication is described.

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

MRMC Study: No. This device is an anesthetic vaporizer, not an AI-powered diagnostic device, so an MRMC study with human readers assisting AI is not relevant or described.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable in the context of an algorithm. The device's performance is described in terms of its mechanical and electronic functions. The device is a standalone functional unit within an anesthesia delivery system.

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

Type of Ground Truth: Not applicable in the sense of a diagnostic or predictive algorithm. The "truth" for this device lies in its ability to accurately deliver a controlled concentration of Desflurane, as verified through engineering tests and comparison to established predicate devices. The document implies that the predicate devices' long-standing safe and effective use serves as a form of "ground truth" for the overall device category's functionality.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/ML device requiring a training set.

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

Ground Truth for Training Set: Not applicable.

Summary

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K642276

SEP 2 3 2004

A Dräger and Siemens Company

Summary of Safety and Effectiveness Data Relating to Substantial Equivalence

D-Vapor Proprietary Name:

Common Name: Anesthesia Vaporizer

Classification Name: Anesthetic Vaporizer

73 CAD Product Codes:

Device Class: Class II

Draeger Medical AG & Co KGaA Manufacturer: 53/55 Moislinger Allee Luebeck, Germany

Establishment Registration Number: 9611500

Devices to which substantial equivalence is claimed: K971923 Vapor 2000 Tec 6 Plus K000275

Device Description:

Indications for Use:

Intended Use:

The D-Vapor is intended to be used with Desflurane anesthetic agent, and inserted in the fresh-gas line of an anesthesia delivery system. It is not intended for use with Enflurane, Halothane, Isoflurane, or Sevoflurane, or in a breathing system.

Draeger Medical, Inc.
3135 Quarry Road
Telford, PA 18969
Tel: 215-721-5400, ext. 2363
Toll-free: 800-4DRAGER (437-2437)
Fax: 215-721-5412
E-mail: wwwinfo@draegermed.com

http://www.draeger-medical.com

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Substantial Equivalence:

Like the Tec 6 Plus, the D-Vapor is an electronic vaporizer which delivers desflurane anesthetic agent. The D-Vapor can be adjusted from 2- 18 Vol.%, while the Tec 6 Plus adjustment is 1-18 Vol.%. Both the D-Vapor and the Tec 6 Plus have front display panels which provide the user with a visual indication of the status of the vaporizer for the following

categories: Operational, No Output, Low Agent Level, Warm Up, and Battery Status. Both systems also provide audible alarms, and the ability to silence alarms. Like the Vapor 2000, the D-Vapor provides a sight glass on the front of the device to visually indicate the level of agent in the vaporizer both for filling the vaporizer and monitoring remaining agent within the vaporizer.

The D-Vapor can be used with quick connect systems identical to the Vapor 2000 plug in adapter system, or identical to the Tec 6 plug in system for Selectatec® plug in connectors. It can be permanently installed using a block connector with o-rings and screws like the Tec 6 Plus, or used with conical fittings like the Vapor 2000.

The D-Vapor and the Tec 6 Plus have keyed filling systems to only allow the use of Desflurane bottles with the Saf-T-Fill™ system when adding Desflurane agent to the vaporizers.

The D-Vapor and the Vapor 2000 have a transport mode allowing the vaporizer to be removed from the delivery system and moved with agent in the vaporizer.

Both the D-Vapor and the Tec 6 Plus are contraindicated for use in an MRI environment.

Draeger Medical, Inc.
3135 Quarry Road
Telford, PA 18969
Tel: 215-721-5400, ext. 2363
Toll-free: 800-4DRAGER (437-2437)
Fax: 215-721-5412
E-mail: wwwinfo@draegermed.com

http://www.draeger-medical.com

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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 an abstract symbol that resembles an eagle or a bird in flight, with three stylized wing-like shapes above a wavy line.

SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Gale E. Winarsky Regulatory Affairs Project Manager Dräegar Medical, Incorporated 3135 Quarry Road Telford, Pennsylvania 18969

Re: K042276

Trade/Device Name: D-Vapor Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: II Product Code: CAD Dated: August 20, 2004 Received: August 23, 2004

Dear Ms. Winarsky:

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 - Ms. Winarsky

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,

Susan Ropp

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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Indications for Use

510(k) Number (if known): _ ko42276

Device Name: ___D-Vapor

Indications for Use:

The D-Vapor is an electronic calibrated vaporizer designed to enrich the fresh gas flow of The D- Vapor is an electronic a controlled amount of anesthetic vapor. The D-Vapor an anosthoon a with Desflurane. It is not intended for use with Enflurane, Halothane, Is intended for abo will and or for use in a breathing circuit. Federal law restricts this device to sale by or on the order of a physician.

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CQRH, Office of Device Evaluation (ODE)

Susan Dunno

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

1042220 510(k) Number ..

Page 1 of 1

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).