SEDASYS® Computer-Assisted Personalized Sedation System - P080009
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval.
Product Name: SEDASYS ® Computer-Assisted Personalized Sedation System
PMA Applicant: Ethicon Endo-Surgery, Inc.
Address: 4545 Creek Road, Mail Location #110, Cincinnati, Ohio 45242
Approval Date: May 3, 2013
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf8/p080009a.pdf
What is it? The SEDASYS System is a computer-assisted personalized sedation device that delivers the drug propofol for minimal-to-moderate sedation. The device provides comprehensive patient monitoring and limits the depth of sedation by adjusting drug delivery accordingly.
How does it work? The SEDASYS System is a computer-assisted device that administers the prescription drug propofol into the blood stream via intravenous IV infusion. The device can detect signs associated with oversedation and can automatically modify or stop infusion.
The four piece system includes:
- Bedside Monitoring Unit (BMU) designed to stay with the patient from before the procedure, through the procedure and post-procedure recovery.
- Procedure Room Unit (PRU) designed to stay in the procedure room and provides additional patient monitoring. It also contains the propofol infusion pump controller.
- Display monitors and connectors.
- Disposable devices for single patient use.
When is it used? The SEDASYS System is used to deliver the drug propofol to patients 18 years and older who require sedation while undergoing colonoscopy and esophagogastroduodenoscopy (EGD) procedures. The device is restricted for use by health care professionals that have the types of training defined in the labeling, and to settings where an anesthesia professional is immediately available for assistance or consultation.
What will it accomplish? The SEDASYS System is a first-of-a-kind device that will allow non-anesthesia professionals to administer propofol during colonoscopy and EGD procedures provided they have training that meets the requirements and in settings having immediate availability of an anesthesia professional as defined in the labeling.
The pivotal study for the SEDASYS System demonstrated that healthy patients who were sedated using the device had lower occurrences of low blood oxygen levels (hypoxemia) compared to similarly healthy patients who were sedated with midazolam or similar medication during elective colonoscopy and upper endoscopy procedures.
In the pivotal study, the SEDASYS System was associated with in deeper-than-intended sedation in approximately 2.5% of patients using the device.
A simulation-based moderate sedation training program developed by the International Society for Anesthetic Pharmacology is expected to aid in preventing and mitigating these occurrences by expert instruction in the pharmacology of propofol and airway management. Post-approval studies will be conducted to evaluate the need for immediate availability of a trained anesthesia professional for safe use of the SEDASYS System in clinical practice..
When should it not be used? The SEDASYS System should not be used:
- In patients with known hypersensitivity to 1% propofol injectable emulsion or its components
- Patients with allergies to eggs, egg products, soybeans, or soy products
- Patients with a known hypersensitivity to fentanyl
- Pregnant or lactating women
- Delivery of any drug other than 1% propofol injectable emulsion
- Patients with a full stomach
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.