(86 days)
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 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, 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.
Here's an analysis of the provided text to fulfill your request.
Based on the provided documents, there is no specific study described that proves the device meets particular acceptance criteria in the format you've requested.
The documents are a 510(k) Summary of Safety and Effectiveness and an FDA clearance letter for the Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer. These types of documents assert substantial equivalence to previously cleared devices rather than providing detailed clinical or performance studies with acceptance criteria in the way you might find for novel AI/ML medical devices.
Instead, the submission relies on:
- Substantial Equivalence: The key argument is that the Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer is substantially equivalent to existing Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers.
- Compliance with Voluntary Standards: The device was designed to comply with applicable portions of EN 740, ISO 5358, and ASTM F1161.
- Engineering Tests/Validation: The document states, "The Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizers have been validated through testing that, in part, support the compliance of the current and predicate device to the above mentioned standards." However, it does not detail these tests, their acceptance criteria, or their results.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth, expert adjudication, or MRMC studies for a performance study.
Here's how I would answer your request based on the lack of this specific information in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from a detailed performance study) | Reported Device Performance (from a detailed performance study) |
|---|---|
| Not specified in the provided documents. | Not specified in the provided documents. |
| The submission asserts substantial equivalence to predicate devices and compliance with voluntary standards (EN 740, ISO 5358, ASTM F1161). It mentions "testing that... support the compliance," but detailed criteria and results are not provided. | The device is described as designed for "metered delivery of specific inhalation anesthetic agents," and is "temperature, flow and pressure compensated so that its output remains relatively constant." No quantitative performance metrics from specific tests are given. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not specified. The provided document does not describe a test set or data provenance in the context of a performance study for this device. The submission focuses on substantial equivalence and compliance with engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This pertains to clinical or diagnostic performance studies, which are not detailed in the provided documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This information is relevant for studies involving human interpretation or expert consensus on ground truth, which is not 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
- No. The device described is an anesthesia vaporizer, a hardware medical device, 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/Not specified. This is a hardware device; the concept of a standalone "algorithm only" performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not specified. For a hardware device like an anesthesia vaporizer, "ground truth" typically refers to engineering specifications, calibrated measurements, and adherence to safety and performance standards, rather than clinical outcomes or diagnostic interpretations. The document refers to compliance with voluntary standards (EN 740, ISO 5358, ASTM F1161).
8. The sample size for the training set
- Not applicable/Not specified. This concerns AI/ML devices, not a hardware device like an anesthesia vaporizer.
9. How the ground truth for the training set was established
- Not applicable/Not specified. This concerns AI/ML devices, not a hardware device like an anesthesia vaporizer.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a black circle with a white "D" inside it, along with the text "K031027" written diagonally. The text appears to be handwritten and is oriented at an angle relative to the circle. The circle is positioned in the upper-left portion of the image, while the text extends downwards and to the right.
JUN 2 6 2003
Summary of Safety and Effectiveness
April 1, 2003
| Subject: | 510(k) Summary of Safety and Effectiveness Information for theDatex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer |
|---|---|
| Proprietary: | Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer |
| Common: | Vaporizer, Anesthesia |
| Classification: | Anesthesiology, 73CAD, 21CFR868.5880, Class II |
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer is substantially equivalent to the currently marketed Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers (isoflurane, halothane, sevoflurane, enflurane), which were the subject of cleared 510(k) premarket notifications K012924, K942091 and K892057.
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, 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 Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer was designed to comply with the applicable portions of the following voluntary standards;
-
- EN 740 Anesthetic Work Stations
-
- ISO 5358 Anesthetic Gas Machines
-
- ASTM F1161 Specifications for Anesthetic Gas Machines
The Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer and the currently marketed Datex-Ohmeda Tec 7 (isoflurane, halothane, sevoflurane) and Datex-Ohmeda Tec 5 Anesthesia Vaporizers (isoflurane, halothane, sevoflurane), substantially equivalent in uses, design concepts, technologies and materials. The Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizers have been validated through testing that, in part, support the compliance of the current and predicate device to the above mentioned standards.
Contact: William E. Exner Vice President, Regulatory and Quality Affairs
Datex-Ohmeda, Inc P.O. Box 7550 Madison, WI 5370" ww.dates of mach as a Telephone 608-221-1551 Toll Free 800-345-2700 Facsimile 608-222-9147
Datav. Ohmods
{1}------------------------------------------------
| Device Name | |
|---|---|
| Device Name: Proprietary | Datex-Ohmeda Tec 7 (enflurane)Anesthesia Vaporizer |
| Device Name: Common | Anesthesia Vaporizer |
| Device Name: Classification | Vaporizer, Anesthesia, Non-heated |
| Device Classification and Panel | |
| Device Classification: | 73CAD - 21CFR868.5880 - Class II |
| Device Panel: | Anesthesiology |
| Predicate Devices | |
| Datex-Ohmeda Tec 5 Anesthesia Vaporizer(isoflurane, halothane, sevoflurane, enflurane) | 510(k)s K942091 and K892057 |
| Datex-Ohmeda Tec 7 Anesthesia Vaporizer(isoflurane, halothane, sevoflurane) | 510(k) K012924 |
| Performance Standards Information | |
| To the best knowledge of Datex-Ohmeda, performance standards have not beenpromulgated by the FDA for this device. | |
| Device Manufacturing Facility Information | |
| Datex-Ohmeda, Inc. | |
| Anesthesia, Drug Delivery and Ventilation Business Unit | |
| Ohmeda Drive | |
| P.O. Box 7550 | |
| Madison, WI 53707 | |
| USA | |
| Telephone | 608-221-1551 |
| Facsimile | 608-223-2496 |
| Establishment Registration and Owner/Operator Numbers | |
| Datex-Ohmeda Establishment Registration Number: | 2112667 |
2112667
8030853 Datex-Ohmeda Owner/Operator Number:
.
{2}------------------------------------------------
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Rockville MD 20850
Mr. William E. Exner Vice President, Regulatory and Quality Affairs Datex-Ohmeda, Incorporated P.O. Box 7550 Madison, WI 53707
Re: K031027
Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane) Regulation Number: 868.5880 Regulation Name: Vaporizer, Anesthesia, Non-heated Regulatory Class: Class II (two) Product Code: 73 CAD Dated: May 27, 2003 Received: May 28, 2003
Dear Mr. Exner:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
JUN 2 6 2002
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.
{3}------------------------------------------------
Page 2 - Mr. William E. Exner
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 (OS) 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,
Sura Runser
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
K031027 510(k) Number (if known):
Datex-Ohmeda Tec 7 (enflurane) Anesthesia Vaporizer Device Name:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
General Hospital.
510(k) Number: K031027
Prescription Use
(Per 21CFR801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(
§ 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).