(205 days)
The Spacelabs Medical 90519 Anesthesia Delivery System provides intermittent or continuous gas inhalation for adults and children (neonatal and pediatric). It allows the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anesthetic agents: Halothane, Isoflurane, Enflurane, or Sevoflurane, It provides safe and accurate gas flows to maintain patient respiration during anesthesia, and incorporates a ventilator, an oxygen monitor, and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anesthesia machine. It is recommended for use only by trained physicians, in the operating room or similar surgical environments.
The Spacelabs Medical 90519 Anesthesia Delivery System is designed to deliver anesthetic gases in a controlled hospital environment. The System incorporates a valveless patient circuitry design which offers very low resistance during spontaneous breathing since it allows for the ebb and flow of natural breathing gases. Oxygen, nitrous oxygen, and air are supplied to the gas distribution system for mixing with the selected anesthetic agent and delivery to the patient through the ventilation system. Another circuit separately provides for the cycling of patient expiration gases. The operator may select from two operating modes options: in manual mode the patient can be ventilated manually via a hand bag or the patient can breathe spontaneously; alternately, the controls can be set so that the patient is continually ventilated by the device. The control settings provide ease of use for both pediatric and adult patient populations in that the System may be set by the anesthesiologist for the appropriate tidal volume range based on patient needs. The System uses standard, commercially-available anesthesia system accessories appropriate to meet the needs of the clinician and patient. The delivery of gases is time cycled, volume controlled, pressure limited, and monitored for alarm states and error messages. Additional user-selectable convenience features include a hold switch to permit the temporary cessation of mechanical (continual) ventilation to facilitate the taking of imagery (e.g. x-rays) and a "sigh" switch to provide extra volume above the set tidal volume at a defined interval to allow for the more complete expiration of carbon dioxide.
The provided text describes the Spacelabs Medical 90519 Anesthesia Delivery System and its 510(k) submission. However, it does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics in the format requested. The document focuses on establishing substantial equivalence to a predicate device (the Falcon Anaesthesia System) and mentions general safety and performance testing.
Therefore, many of the requested details cannot be extracted directly from the given text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document states: "The Spacelabs Medical 90519 Anesthesia Delivery System has been subject to extensive safety and performance testing, to ensure that the device meets all its functional requirements and performance of specifications."
However, it does not provide a table specifying exact acceptance criteria (e.g., specific thresholds for flow rates, pressure limits, or accuracy of gas mixing) nor does it report the quantitative results or performance metrics from these tests. It only mentions that the device is designed to meet general safety requirements and industry standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for any test set or provide details on data provenance (country, retrospective/prospective).
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)
This information is not provided in the document. The testing described is for an anesthesia delivery system, which typically involves engineering and safety evaluations against specifications and standards, rather than expert-derived ground truth as might be seen for diagnostic imaging devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This document describes a medical device for anesthesia delivery, not an AI-assisted diagnostic tool. Therefore, an MRMC study or AI-related comparative effectiveness is not relevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an anesthesia delivery system, not an algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document describes "safety and performance testing" against "functional requirements and performance of specifications" and "applicable industry and safety standards." The ground truth for such device testing would typically be the pre-defined engineering specifications and regulatory standards themselves, verified through direct measurement and testing, rather than expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive AI.
8. The sample size for the training set
This document describes a physical medical device, not a machine learning model. Therefore, the concept of a "training set" with a specified sample size is not applicable.
9. How the ground truth for the training set was established
As in point 8, this is not applicable to the described physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo for Spacelabs medical. The logo is in black and white, with the word "Spacelabs" in a bold, sans-serif font. The word "medical" is below "Spacelabs" in a smaller font. A curved line is above the word "Spacelabs". The date "NOV 20 1998" is in the upper left corner of the image.
15220 N.E. 40th Stree PO Box 97013 Redmond, Washington 98073-9713 425-882-3700
1981530 510(k) SUMMARY
Spacelabs Medical 90519 Anesthesia Delivery System
| 1. | Submitter's Name/ Contact Person: Company | Russ Garrison Director of Regulatory Affairs Spacelabs Medical Inc. 15220 N.E. 40th Street Redmond, WA 98073 |
|---|---|---|
| Telephone Facsimile | (425) 882-3913 (425) 867-3550 | |
| 2. | Name of Device | Spacelabs Medical 90519 Anesthesia Delivery System |
| Classification | Gas-Machine, Anesthesia 73BSZ; 868.5160 Class II | |
| 3. | Predicate Device | We consider the Spacelabs Medical 90519 Anesthesia Delivery System to be substantially equivalent to currently-marketed devices with the identical intended uses. Specifically, the Spacelabs Medical 90519 Anesthesia Delivery System is substantially equivalent to the Falcon marketed by Medical and Industrial Equipment Limited (MIE) (510[k] reference K971030) for the administration of general anesthetics, continually or intermittently, and to maintain a patient's ventilation. |
| 4. | Device Description | The Spacelabs Medical 90519 Anesthesia Delivery System is designed to deliver anesthetic gases in a controlled hospital environment. |
The System incorporates a valveless patient circuitry design which offers very low resistance during spontaneous breathing since it allows for the ebb and flow of natural breathing Oxygen, nitrous oxygen, and air are supplied to the gas distribution system for mixing with the selected anesthetic agent and delivery to the patient through the ventilation system. Another circuit separately provides for the cycling of patient expiration gases.
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gases.
The operator may select from two operating modes options: in manual mode the patient can be ventilated manually via a hand bag or the patient can breathe spontaneously; alternately, the controls can be set so that the patient is continually ventilated by the device.
The control settings provide ease of use for both pediatric and adult patient populations in that the System may be set by the anesthesiologist for the appropriate tidal volume range based on patient needs. . The System uses standard, commercially-available anesthesia system accessories appropriate to meet the needs of the clinician and patient.
The delivery of gases is time cycled, volume controlled, pressure limited, and monitored for alarm states and error messages. Additional user-selectable convenience features include a hold switch to permit the temporary cessation of mechanical (continual) ventilation to facilitate the taking of imagery (e.g. x-rays) and a "sigh" switch to provide extra volume above the set tidal volume at a defined interval to allow for the more complete expiration of carbon dioxide.
- The Spacelabs Medical 90519 Anesthesia Delivery 5. Intended Use System provides intermittent or continuous gas inhalation for adults and children (neonatal and pediatric). It allows the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anesthetic agents: Halothane, Isoflurane, Enflurane, or Sevoflurane. It provides safe and accurate gas flows to maintain patient respiration during anesthesia, and incorporates a ventilator, an oxygen monitor, and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anesthesia machine. It is recommended for use only by trained physicians, in the operating room or similar surgical environments.
- The intended use, design, materials, accessories, energy 6. Comparison of Technological source, and principles of operation are similar to the Characteristics Falcon Anaesthesia System. Both systems utilize a "bag in bottle" technology to provide fresh and anesthetic gases and to control the ventilation cycle. Both systems offer the convenience for use in both pediatric and adult patients by user adjustment of the tidal volume range
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control to the appropriate mode setting. Both units are time cycled, volume controlled, and pressure limited at user-selectable settings, generating alarms and error messages as appropriate.
The Spacelabs Medical 90519 Anesthesia Delivery System differs from the Falcon in offering a valveless patient circuitry to provide a low resistance pathway for the delivery of fresh gas to the patient. The 90519 System additionally features the capabilities for user selection of a "sigh" capability for more complete expiration of CO2 gas, a "hold" feature to temporarily maintain a breath to reduce patient motion during a photographic (e.g. x-ray) session, and the automated calculation and display of monitored parameters such as resistance and minute volume for user convenience.
- The Spacelabs Medical 90519 Anesthesia Delivery Standards 7. System is designed to meet the general safety requirements for medical equipment, including the requirements of UL2601-1, C222.2 No. 601-1, IEC 601-1 and IEC-1-2. The 90519 also meets the requirements of industry standards for anesthesia delivery systems, including ASTM, EN, and ISO Standards. The device will be CE marked as a Class IIB device to the Medical Devices Directive.
- The Spacelabs Medical 90519 Anesthesia Delivery 8. Testing System has been subject to extensive safety and performance testing, to ensure that the device meets all its functional requirements and performance of specifications. Safety and standards testing has been, or will be, performed by third party agencies to ensure the System complies to applicable industry and safety standards.
In conclusion, the Spacelabs Medical 90519 Anesthesia Delivery System is as safe and effective as its predicate device and raises no new issues.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1998
Ms. Nancy Gertlar Spacelabs Medical, Inc. 15220 N.E. 40th Street P.O. Box 97013 Redmond, WA 98073-9713
Re: K981530 Spacelabs Medical 90519 Anesthesia Delivery System Requlatory Class: II (two) Product Code: 73 BSZ Dated: August 27, 1998 Received: August 28, 1998
Dear Ms. Gertlar:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Nancy Gertlar
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
sincerely yours,
Thomas J. Callahan
Thomas J. Čallahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Page 1 of 1
K981530 510(k) Number (if known): Not Known (New Submission)
Device Name: Spacelabs Medical 90519 Anesthesia Delivery System
Indications for Use:
The Spacelabs Medical 90519 Anesthesia Delivery System provides intermittent or continuous gas inhalation for adults and children (neonatal and pediatric). It allows the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anesthetic agents: Halothane, Isoflurane, Enflurane, or Sevoflurane, It provides safe and accurate gas flows to maintain patient respiration during anesthesia, and incorporates a ventilator, an oxygen monitor, and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anesthesia machine. It is recommended for use only by trained physicians, in the operating room or similar surgical environments.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| Prescription Use(Per 21 CFR 801.109)(Optional Format 1-2-96) | ✓ |
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OR
| Over-The-Counter Use | |
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Division Sign-Off) (Division Sign Off, On-)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number _
§ 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).