(119 days)
Not Found
No
The description focuses on mechanical and physical compensation mechanisms (temperature, flow, pressure) and a "variable flow-split" method for regulating anesthetic agent delivery. There is no mention of AI or ML algorithms for decision-making, control, or analysis.
No.
This device is designed for the metered delivery of inhalation anesthetic agents during anesthesia, which is a supportive function to a medical procedure rather than a direct therapeutic intervention for a disease or condition.
No
Explanation: The device is a vaporizer designed for the metered delivery of inhalation anesthetic agents during anesthesia, which is a therapeutic function, not a diagnostic one. It delivers agents for treatment rather than identifying or monitoring a medical condition.
No
The device description clearly details a physical vaporizer with mechanical components for regulating gas flow and anesthetic agent delivery. It also mentions physical specifications, compatibility with hardware manifolds, and testing related to physical properties and environmental factors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "continuous flow techniques of inhalation anesthesia." This describes a medical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details how the device delivers anesthetic agents to a patient's respiratory system. It does not mention analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment based on sample analysis
The device is clearly an anesthesia vaporizer, which is a medical device used in the delivery of anesthetic gases to a patient during surgery or other medical procedures.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
CAD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key results from non-clinical tests showed PASS for the following categories: Biocompatibility (Extractables, Leachables, Particulate Matter), Concentration accuracy (Accuracy of the concentration of agent delivered, Dial graduations are accurate, Flow Range and Flow Resistance), Requirements with drug (Liquid volume, Vaporizer filling time, Vaporizer draining time from the maximum liquid level mark), Temperature and Humidity (Operating temperature and humidity, Storage temperature and humidity), MRI Compatibility (Performance after exposure to a magnetic field of at least 400 gauss, MR safety evaluation, MR compatibility evaluation, Physical specifications, including weight, height, width, depth), Physical Specifications and Configurations (Compatibility with the Selectatec backbar, Compatibility of appropriate filling ports with the associated fillers, Interlock mechanism).
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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);
1
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
2
Indications for Use
510(k) Number (if known)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 6, 2017 |
|---|---|
| Submitter: | GE Healthcare |
| Datex-Ohmeda, Inc. | |
| 3030 Ohmeda Drive | |
| PO Box 7550 | |
| Madison, WI 53707-7550 | |
| Primary Contact | |
| Person: | Trishia Mercier |
| Senior Regulatory Affairs Leader | |
| Datex-Ohmeda, Inc., a General Electric company | |
| Telephone: +1 (608) 695-8319 | |
| Fax: +1 (608) 646-6488 | |
| Email: Trishia.Mercier@ge.com | |
| Secondary Contact | |
| Person: | Monica Morrison |
| Senior Regulatory Affairs Director | |
| Datex-Ohmeda, Inc., a General Electric company | |
| Telephone: +1 (608) 515-3077 | |
| Fax: +1 (608) 646-7464 | |
| Email: 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 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. | |
| Indications for Use: | 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. | |
| Technology: | The Tec 820 and Tec 850 vaporizers are designed for use in |
| continuous flow techniques of inhalation anesthesia. Anesthetic | |
| agent (sevoflurane or isoflurane) is poured into the vaporizer | |
| through the filler port, which is specific to the anesthetic agent | |
| being used. The agent flows into the sump, which serves as a | |
| reservoir for agent until its use. To use the vaporizer, the | |
| clinician turns the control dial on the top of the vaporizer to the | |
| desired concentration setting, indicated by markings on the dial. | |
| 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 Tec 820 and Tec 850 vaporizers are based on the Tec 7 | |
| vaporizers, utilizing the same technology and primary design. | |
| Changes include the introduction of Closed-Fill filling systems, | |
| changes in materials within the vaporizer, changes to | |
| performance specifications within standard limits and cosmetic | |
| changes which do not affect the technology or intended use of | |
| the vaporizer. | |
| The Tec 820 and Tec 850 vaporizers employ the same | |
| fundamental scientific technology as its predicate device, the Tec |
- There is no change to the vaporizer technology as a result of
this 510(k). |
4
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:
5
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 | |
| Indications | ||
| for Use | The Datex-Ohmeda Tec 7 vaporizer is | |
| designed for the metered delivery of | ||
| specific inhalation anesthetic agents | ||
| for use in continuous flow techniques | ||
| of inhalation anesthesia. It is available | ||
| in Halothane, Isoflurane, Sevoflurane, | ||
| and Enflurane variants. Each vaporizer | ||
| is agent specific and is clearly labeled | ||
| with the name of the anesthetic agent | ||
| that it is designed for. 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 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. |
Summary of the Technological Characteristics:
| | Predicate Device
Tec 7 | Proposed Device
Tec 820, Tec 850 | Discussion of
Differences |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | Pneumatic vaporizer
designed for use in
continuous flow techniques
of inhalation anesthesia.
Anesthetic agent | Pneumatic vaporizer
designed for use in
continuous flow techniques
of inhalation anesthesia.
Anesthetic agent | Identical |
| | | | |
| | (sevoflurane or isoflurane)
is poured into the vaporizer
through the filler port,
which is specific to the
anesthetic agent being
used. The agent flows into
the sump, which serves as a
reservoir for agent until its
use. The output
concentration of the Tec 7
vaporizers is regulated by
the 'variable flow-split'
Method. 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. | (sevoflurane or isoflurane)
is poured into the vaporizer
through the filler port,
which is specific to the
anesthetic agent being
used. The agent flows into
the sump, which serves as a
reservoir for agent until its
use. The output
concentration of the Tec
800 series vaporizers is
regulated by the 'variable
flow-split' Method. 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. | |
| Principle of
Operation | A total flow of fresh gas
from upstream flowmeters
enters the vaporizer from
the flowmeter where it is
immediately 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 enriched with the
vapor of the liquid
anesthetic agent. | A total flow of fresh gas
from upstream flowmeters
enters the vaporizer from
the flowmeter where it is
immediately 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 enriched with the
vapor of the liquid
anesthetic agent. | Identical. |
| Filling
Systems
Available | Easy Fil™ ISO
Easy Fil SEV
Quick Fil | Easy Fil ISO
Easy Fil SEV
Quick Fil
Safe-T-Seal™
Piramal Fill | Substantially
equivalent. There is
no change to the
Easy Fil ISO, Easy
Fil SEV, or Quick
Fil filling systems.
Two closed fill
filling systems are
being introduced,
the Safe-T-Seal and
Piramal Fill.
Verification has
demonstrated that
these filling systems |
| | | are substantially
equivalent to the
filling systems
available with the
predicate device. | |
6
7
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 | |
| Concentration | |||
| accuracy | Accuracy of the concentration of agent | ||
| delivered | PASS | Section 18.3.1 | |
| Dial graduations are accurate | PASS | PASS | |
| Flow Range and Flow Resistance | PASS | PASS | |
| Requirements with | |||
| drug | Liquid volume | PASS | Section 18.3.2 |
| Vaporizer filling time | PASS | PASS | |
| Vaporizer draining time from the | |||
| maximum liquid level mark | PASS | PASS | |
| Temperature and | |||
| Humidity | Operating temperature and humidity | PASS | Section 18.3.3 |
| Storage temperature and humidity | PASS | PASS | |
| MRI Compatibility | Performance after exposure to a | ||
| magnetic field of at least 400 gauss | PASS | Section 18.3.4 | |
| MR safety evaluation | PASS | PASS | |
| MR compatibility evaluation | PASS | PASS | |
| Physical specifications, including | |||
| weight, height, width, depth | PASS | Section 18.3.5 |
8
| Physical
Specifications and
Configurations | Compatibility with the Selectatec
backbar | PASS | Section 18.3.6 |
|--------------------------------------------------|---------------------------------------------------------------------------|------|----------------|
| | Compatibility of appropriate filling ports
with 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.