(663 days)
K863207, K850648A, K901117A
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No
The document describes a mechanical anesthesia delivery system and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device delivers inhalation anesthetic agents, which are drugs used to induce or maintain anesthesia, but it is not itself a therapeutic device. It is a system for delivering the therapeutic agent.
No
This device is designed to deliver inhalation anesthetic agents, fulfilling a therapeutic and supportive role during medical procedures, rather than diagnosing a condition.
No
The device description explicitly states it is a "system" consisting of hardware components like a vaporizer, mounting attachments, covers, ports, and tubes. It is a modification of an existing hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a platform for the delivery of inhalation anesthetic agents." This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description details a system for delivering anesthetic gases, including a vaporizer, mounting attachments, and gas delivery components. These are all related to administering treatment, not performing tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition
In summary, the Ohmeda Excel Draw-Over Military Vaporizer System is an anesthesia delivery system, which falls under the category of medical devices used for treatment and patient management, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Not Found
Product codes
73BSZ, 73CAD, 73BZR, 73CCN
Device Description
The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.
The Ohmeda Excel Draw-Over Military Vaporizer System is a modification of the Ohmeda Excel 210 that has been made to facilitate the Ohmeda Single-Agent Draw-Over Vaporizer and the militaries needs. The system consists of an Ohmeda Single Agent Draw Over Vaporizer and a kit that allows the vaporizer to be used with an Ohmeda Excel system. The kit consists of mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and an extended length oxygen enrichment tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K863207, K850648A, K901117A
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image shows the word "OHMEDA" in a bold, sans-serif font. The letters are large and black, and they appear to be slightly distressed or aged. The word is centered in the image, and the background is white.
THE BOC GROUP
Ohmeda Inc Ohmeda Drive PO Box 7550 Madison WI 53707-7550 608 221 1551
0
October 2, 1996
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Ohmeda Excel Draw-Over | ||
|---|---|---|---|
| Military Vaporizer System | |||
| Proprietary: | Ohmeda Excel Draw-Over Military Vaporizer System | ||
| Common: | Anesthesia Machine | ||
| Classification: | Primary: | Gas Machine for Anesthesia Class II 21CFR868.5160 - 73BSZ | |
| Secondary: | Anesthetic Vaporizer (non heated) Class II 21CFR868.5880 - 73CAD | ||
| Breathing Gas Mixer Class II 21CFR868.5330 - 73BZR | |||
| Uncompensated Thorpe Tube Flowmeter | Class II 21CFR868.2320 - 73CCN |
OCT - 8 1996
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 1992.
The Ohmeda Excel Draw-Over Military Vaporizer System is substantially equivalent to the following currently marketed Ohmeda devices:
- Ohmeda "B' Series Gas Delivery System (currently known as the Ohmeda Excel Anesthesia System) 1. which was the subject of a cleared 510(k) premarket notification on 10/30/86 with FDA log number K863207.
- Ohmeda PAC Portable Anesthesia Machine that was the subject of a cleared 510(k) premarket notification 2. on 7/1/85 with FDA log number K850648A.
- Ohmeda Universal PAC Portable Anesthesia Machine that was the subject of a cleared 510(k) premarket లు notification on 9/7/90 with FDA log number K901117A.
The Ohmeda Excel Draw-Over Military Vaporizer System is specifically designed for use with the Ohmeda Single-Agent Draw-Over Vaporizer. It consists of an Excel 210 system with an attached draw-over vaporizer. The purpose is to provide a platform for the delivery of inhalation anesthetic agents using the draw-over vaporizer and supplemental gas supply.
The Ohmeda Excel Draw-Over Military Vaporizer System is a modification of the Ohmeda Excel 210 that has been made to facilitate the Ohmeda Single-Agent Draw-Over Vaporizer and the militaries needs. The system consists of an Ohmeda Single Agent Draw Over Vaporizer and a kit that allows the vaporizer to be used with an Ohmeda Excel system. The kit consists of mounting attachments, O2 flush cover, monitoring ports, scavenging interconnection, and an extended length oxygen enrichment tube.
The Ohmeda Excel Draw-Over Military Vaporizer System was designed to comply with the applicable portions of the following voluntary standards:
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- ASTM F1161-1988 - "Standard Specification for Minimum Performance and Safety Requirements for Components and Systems of Continuous Flow Anesthesia Machines".
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- MIL-STD-14728 - "Human Engineering Design Criteria for Military Systems, Equipment and Facilities".
Standards agencies, such as U.L. and E.T.L., do not provide specific certification services for this type of device.
The Ohmeda Excel Draw-Over Military Vaporizer System and the currently marketed devices are substantially equivalent in technological characteristics, theory of operation, and use of accessories.