The Tec 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed for use only with General Electric's Selectatec Series Manifolds.

Device Description

The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers are designed for the metered delivery of specific inhalation anesthetic agents for use in continuous flow techniques of inhalation anesthesia. The vaporizers are available in Sevoflurane and Isoflurane variants. Each vaporizer is agent specific and is clearly labeled with the name of the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures. The vaporizer is designed to be used on Selectatec series mounted manifolds.
The output concentration of the Tec 820/850 vaporizer is regulated by the "variable flow-split" method, where a total flow of fresh gas from upstream enters the vaporizer where it is split into two streams. One stream flows into the fresh gas bypass circuit and the other stream flows through the vaporizing chamber where it is saturated with the vapor of the liquid anesthetic agent.
Both gas paths have methods to regulate the flow to achieve desired total output agent concentration. Before exiting the vaporizer through the gas outlet, the split gas streams are joined. The combined total flow then flows out from the vaporizer via the Selectatec circuitry to the anesthesia gas delivery system.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Tec 820 and Tec 850 anesthetic vaporizers, demonstrating their substantial equivalence to a predicate device (Tec 7). This submission is for medical hardware, not a software-based AI/ML device. Therefore, the questions related to AI/ML device performance (like MRMC studies, standalone AI performance, number of experts, and training/test set details) are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the non-clinical study that proves it meets those criteria.

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

The document refers to "Design Inputs" as the acceptance criteria and "Result" as the reported device performance.

Verification category	Design Inputs being verified	Reported Device Performance (Result)
Biocompatibility	Extractables	PASS
	Leachables	PASS
	Particulate Matter (PM)	PASS
Concentration accuracy	Accuracy of the concentration of agent delivered	PASS
	Dial graduations are accurate	PASS
	Flow Range and Flow Resistance	PASS
Requirements with drug	Liquid volume	PASS
	Vaporizer filling time	PASS
	Vaporizer draining time from the maximum liquid level mark	PASS
Temperature and Humidity	Operating temperature and humidity	PASS
	Storage temperature and humidity	PASS
MRI Compatibility	Performance after exposure to a magnetic field of at least 400 gauss	PASS
	MR safety evaluation	PASS
	MR compatibility evaluation	PASS
Physical Specifications and Configurations	Physical specifications, including weight, height, width, depth	PASS
	Compatibility with the Selectatec backbar	PASS
	Compatibility of appropriate filling ports with the associated fillers	PASS
	Interlock mechanism	PASS

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

The document describes "non-clinical tests" and "functional testing" to verify and validate the performance of the vaporizer. It does not specify a "sample size for the test set" in terms of number of devices tested, but rather indicates that "The Tec 820 and Tec 850 have been fully verified and validated". There's no mention of country of origin for data as this relates to manufactured product testing, not patient data. The testing is retrospective in the sense that it's performed on manufactured devices after design, to prove the design meets specifications.

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

Not applicable. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" here is the design specifications and functional requirements of the vaporizer, established through engineering design and regulatory standards.

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

Not applicable. This is not an AI/ML device requiring human adjudication of performance outcomes. The outcomes are objective measurements against engineering specifications ("PASS" or "FAIL").

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 (anesthetic vaporizer), not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This is a hardware device. Its performance is inherent to the device itself.

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

The "ground truth" for this device's performance validation is its design inputs and specifications, as established by the manufacturer, and meeting relevant recognized standards for medical devices of this type. The objective tests performed (e.g., concentration accuracy, flow range, temperature compensation) measured the actual device performance against these pre-defined engineering targets.

8. The sample size for the training set:

Not applicable. This is a hardware device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a hardware device.

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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration."

January 4, 2018

Datex-Ohmeda, Inc. Trishia Mercier Regulatory Affairs Leader 3030 Ohmeda Drive, PO Box 7550 Madison, Wisconsin 53707-7550

Re: K172702

Trade/Device Name: Tec 820, Tec 850 Regulation Number: 21 CFR 868.5880 Regulation Name: Anesthetic Vaporizer Regulatory Class: Class II Product Code: CAD Dated: December 6, 2017 Received: December 7, 2017

Dear Trishia Mercier:

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.

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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)

K172702

Device Name Tec 820

Tec 850

Indications for Use (Describe)

The Tec 820 and Tec 850 vaporizers are designed for use in continuous of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporations in inlet flow and fluctuating pressures. The vaporizer is designed for use only with General Electric's Selectatec Series Manifolds.

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

☑ 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 807.92 the following summary of information is provided:

Date:	September 6, 2017
Submitter:	GE HealthcareDatex-Ohmeda, Inc.3030 Ohmeda DrivePO Box 7550Madison, WI 53707-7550
Primary ContactPerson:	Trishia MercierSenior Regulatory Affairs LeaderDatex-Ohmeda, Inc., a General Electric companyTelephone: +1 (608) 695-8319Fax: +1 (608) 646-6488Email: Trishia.Mercier@ge.com
Secondary ContactPerson:	Monica MorrisonSenior Regulatory Affairs DirectorDatex-Ohmeda, Inc., a General Electric companyTelephone: +1 (608) 515-3077Fax: +1 (608) 646-7464Email: Monica.Morrison@ge.com
Device Trade Name:	Tec 820, Tec 850
Common/Usual Name:	Vaporizer, Anesthesia
Classification Names:	21CFR868.5880
Product Code:	CAD
Predicate Device(s):	Tec 7 (K031027 and K012924)
Device Description:	The Datex-Ohmeda Tec™ 820 and Tec 850 vaporizers aredesigned for the metered delivery of specific inhalationanesthetic agents for use in continuous flow techniques ofinhalation anesthesia. The vaporizers are available inSevoflurane and Isoflurane variants. Each vaporizer is agentspecific and is clearly labeled with the name of the anestheticagent for which it is designed. The vaporizer is temperature, flowand pressure compensated so that its output remains relativelyconstant despite cooling due to evaporation, variations in inletflow and fluctuating pressures. The vaporizer is designed to beused on Selectatec series mounted manifolds.The output concentration of the Tec 820/850 vaporizer isregulated by the "variable flow-split" method, where a total flowof fresh gas from upstream enters the vaporizer where it is split
	into two streams. One stream flows into the fresh gas bypasscircuit and the other stream flows through the vaporizingchamber where it is saturated with the vapor of the liquidanesthetic agent.Both gas paths have methods to regulate the flow to achievedesired total output agent concentration. Before exiting thevaporizer through the gas outlet, the split gas streams are joined.The combined total flow then flows out from the vaporizer viathe Selectatec circuitry to the anesthesia gas delivery system.
Indications for Use:	The Tec 820 and Tec 850 vaporizers are designed for use incontinuous flow techniques of inhalation anesthesia. They areavailable in isoflurane and sevoflurane. Each vaporizer is agentspecific and is clearly labeled with the anesthetic agent for whichit is designed. The vaporizer is temperature, flow and pressurecompensated so that its output remains relatively constant despitecooling due to evaporation, variations in inlet flow andfluctuating pressures. The vaporizer is designed for use only withGeneral Electric's Selectatec Series Manifolds.
Technology:	The Tec 820 and Tec 850 vaporizers are designed for use incontinuous flow techniques of inhalation anesthesia. Anestheticagent (sevoflurane or isoflurane) is poured into the vaporizerthrough the filler port, which is specific to the anesthetic agentbeing used. The agent flows into the sump, which serves as areservoir for agent until its use. To use the vaporizer, theclinician turns the control dial on the top of the vaporizer to thedesired concentration setting, indicated by markings on the dial.The vaporizer is temperature, flow and pressure compensated sothat its output remains relatively constant despite cooling due toevaporation, variations in inlet flow and fluctuating pressures.
	The Tec 820 and Tec 850 vaporizers are based on the Tec 7vaporizers, utilizing the same technology and primary design.Changes include the introduction of Closed-Fill filling systems,changes in materials within the vaporizer, changes toperformance specifications within standard limits and cosmeticchanges which do not affect the technology or intended use ofthe vaporizer.
	The Tec 820 and Tec 850 vaporizers employ the samefundamental scientific technology as its predicate device, the Tec7. There is no change to the vaporizer technology as a result ofthis 510(k).

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Determination of Substantial Equivalence:

The following has been considered in evaluating the substantial equivalence of the Tec 820 and Tec 850 vaporizers to the predicate device:

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Summary of Changes to the Indications for Use:

The indications for use for the Tec 820 and Tec 850 are substantially equivalent to the predicate Tec 7 vaporizer. Some of the wording of the Tec 820 and Tec 850 indications for use has been simplified in the description of the function of the vaporizer. The Tec 820 and Tec 850 are available for use with only two anesthetic agents, Sevoflurane and Isoflurane, which is a narrower list than the variants available for the Tec 7 (available for use with Sevoflurane, Isoflurane, Enflurane and Halothane). GE has proposed revising the statement indicating that the vaporizer should be used only on Selectatec series mounted manifolds. This is not a change from the Tec 7, but includes slightly stronger wording indicating the limitations of the compatible anesthesia machines.

These differences are minor in nature, and are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and do not affect the safety and effectiveness of the device when used as labeled.

	Predicate Device	Proposed Device
	Tec 7	Tec 820, Tec 850
Indicationsfor Use	The Datex-Ohmeda Tec 7 vaporizer isdesigned for the metered delivery ofspecific inhalation anesthetic agentsfor use in continuous flow techniquesof inhalation anesthesia. It is availablein Halothane, Isoflurane, Sevoflurane,and Enflurane variants. Each vaporizeris agent specific and is clearly labeledwith the name of the anesthetic agentthat it is designed for. The vaporizer istemperature, flow, and pressurecompensated so that its output remainsrelatively constant despite cooling dueto evaporation, variations in inlet flowand fluctuating pressures. Thevaporizer is designed to be used onSelectatec series mounted manifolds.	The Tec 820 and Tec 850 vaporizersare designed for use in continuousflow techniques of inhalationanesthesia. They are available inisoflurane and sevoflurane. Eachvaporizer is agent specific and isclearly labeled with the anestheticagent for which it is designed. Thevaporizer is temperature, flow andpressure compensated so that its outputremains relatively constant despitecooling due to evaporation, variationsin inlet flow and fluctuating pressures.The vaporizer is designed for use onlywith General Electric's SelectatecSeries Manifolds.

Summary of the Technological Characteristics:

	Predicate DeviceTec 7	Proposed DeviceTec 820, Tec 850	Discussion ofDifferences
Technology	Pneumatic vaporizerdesigned for use incontinuous flow techniquesof inhalation anesthesia.Anesthetic agent	Pneumatic vaporizerdesigned for use incontinuous flow techniquesof inhalation anesthesia.Anesthetic agent	Identical

	(sevoflurane or isoflurane)is poured into the vaporizerthrough the filler port,which is specific to theanesthetic agent beingused. The agent flows intothe sump, which serves as areservoir for agent until itsuse. The outputconcentration of the Tec 7vaporizers is regulated bythe 'variable flow-split'Method. The vaporizer istemperature, flow andpressure compensated sothat its output remainsrelatively constant despitecooling due to evaporation,variations in inlet flow andfluctuating pressures.	(sevoflurane or isoflurane)is poured into the vaporizerthrough the filler port,which is specific to theanesthetic agent beingused. The agent flows intothe sump, which serves as areservoir for agent until itsuse. The outputconcentration of the Tec800 series vaporizers isregulated by the 'variableflow-split' Method. Thevaporizer is temperature,flow and pressurecompensated so that itsoutput remains relativelyconstant despite coolingdue to evaporation,variations in inlet flow andfluctuating pressures.
Principle ofOperation	A total flow of fresh gasfrom upstream flowmetersenters the vaporizer fromthe flowmeter where it isimmediately split into twostreams. One stream flowsinto the fresh gas bypasscircuit and the other streamflows through thevaporizing chamber whereit is enriched with thevapor of the liquidanesthetic agent.	A total flow of fresh gasfrom upstream flowmetersenters the vaporizer fromthe flowmeter where it isimmediately split into twostreams. One stream flowsinto the fresh gas bypasscircuit and the other streamflows through thevaporizing chamber whereit is enriched with thevapor of the liquidanesthetic agent.	Identical.
FillingSystemsAvailable	Easy Fil™ ISOEasy Fil SEVQuick Fil	Easy Fil ISOEasy Fil SEVQuick FilSafe-T-Seal™Piramal Fill	Substantiallyequivalent. There isno change to theEasy Fil ISO, EasyFil SEV, or QuickFil filling systems.Two closed fillfilling systems arebeing introduced,the Safe-T-Seal andPiramal Fill.Verification hasdemonstrated thatthese filling systems
		are substantiallyequivalent to thefilling systemsavailable with thepredicate device.

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Summary of Non-Clinical Tests:

The Tec 820 and Tec 850 vaporizers underwent functional testing to assure that the performance of the vaporizer is not adversely affected by the changes described in this 510(k). The Tec 820 and Tec 850 have been fully verified and validated to demonstrate that the vaporizers meet their design inputs and design specifications. The following is a summary of the testing performed to demonstrate substantial equivalence:

Verification category	Design Inputs being verified	Result	Reference
Biocompatibility	Extractables	PASS	Section 15.3
	Leachables	PASS	Section 15.4
	Particulate Matter (PM)	PASS	Section 15.5
Concentrationaccuracy	Accuracy of the concentration of agentdelivered	PASS	Section 18.3.1
	Dial graduations are accurate	PASS	PASS
	Flow Range and Flow Resistance	PASS	PASS
Requirements withdrug	Liquid volume	PASS	Section 18.3.2
	Vaporizer filling time	PASS	PASS
	Vaporizer draining time from themaximum liquid level mark	PASS	PASS
Temperature andHumidity	Operating temperature and humidity	PASS	Section 18.3.3
	Storage temperature and humidity	PASS	PASS
MRI Compatibility	Performance after exposure to amagnetic field of at least 400 gauss	PASS	Section 18.3.4
	MR safety evaluation	PASS	PASS
	MR compatibility evaluation	PASS	PASS
	Physical specifications, includingweight, height, width, depth	PASS	Section 18.3.5

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PhysicalSpecifications andConfigurations	Compatibility with the Selectatecbackbar	PASS	Section 18.3.6
	Compatibility of appropriate filling portswith the associated fillers	PASS
	Interlock mechanism	PASS

In addition, formative and summative usability testing was performed to validate that the vaporizers meet their intended use. No issues were raised and no residual risks remain. The intended users, uses and use environments of the Tec 820 and Tec 850 vaporizers have been validated.

This testing was successfully completed and demonstrates that all design outputs meet the intended design inputs and intended uses, and all product specifications continue to be met and the Tec 820 and Tec 850 vaporizers perform in a manner which is substantially equivalent to the predicate Tec 7 vaporizer.

Summary of Clinical Testing for the Device:

The Tec 820 and Tec 850 incorporates modifications to the predicate Tec 7. The changes to the vaporizer described in this 510(k) did not require clinical studies to support substantial equivalence. The changes made were completely evaluated by non-clinical tests to verify and validate the performance of the vaporizer.

Conclusion:

The summary above demonstrates that there are no different questions of safety or effectiveness for the Tec 820 and Tec 850 vaporizers. GE Healthcare considers the Tec 820 and Tec 850 vaporizers to substantially equivalent to the predicate device(s), the Tec 7.

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).