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K Number
K123211
Device Name
A5 ANESTHESIA DELIVERY SYSTEM
Manufacturer
DATASCOPE CORP., PATIENT MONITORING DIVISION
Date Cleared
2013-02-14

(125 days)

Product Code
BSZ,CBQ,CBR,CBS,CCK,CCL,NHO,NHP,NHQ
Regulation Number
868.5160
Type
Abbreviated
Panel
AN
Reference & Predicate Devices
K102471,K092449
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A5 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in adult and pediatric populations.

Device Description

The A5 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

AI/ML Overview

The provided text describes the A5 Anesthesia Delivery System and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria or a study detailing device performance against such criteria in the manner requested.

The document indicates:

  • Summary of Performance Testing: "The A5 has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards." It then lists numerous IEC, ISO, CGA, and ASTM standards.
  • User Evaluation: "The A5 has been evaluated by end-users and found to meets performed within its intended use and met their specific needs."

However, it does not provide:

  • A table of specific acceptance criteria (e.g., accuracy +/- X%, sensitivity, specificity) with reported device performance metrics against those criteria.
  • Details on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for establishing ground truth.
  • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • Sample size or specific ground truth establishment methods for a training set.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, because this information is not present in the provided text. The document focuses on regulatory compliance through adherence to standards and user evaluations rather than detailed performance metrics.

§ 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).