SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM

K962880 · Sherwood Medical Co. · CAZ · Dec 9, 1996 · Anesthesiology

Device Facts

• Record ID: K962880
• Device Name: SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM
• Applicant: Sherwood Medical Co.
• Product Code: CAZ · Anesthesiology
• Decision Date: Dec 9, 1996
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The combo tray is intended for Surgical or OB regional anesthesia blocks.

Device Story

Sterile, single-use procedure tray containing components for combined spinal/epidural (CSE) anesthesia; includes Tuohy epidural needle and Whitacre spinal needle. Clinician places epidural needle into epidural space; inserts spinal needle through epidural needle into spinal cavity; administers spinal anesthetic for rapid onset; removes spinal needle; inserts epidural catheter through epidural needle for long-term anesthetic delivery. Used in surgical or obstetric settings by clinicians. Benefits include combined rapid and sustained pain relief.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through comparison of components and intended use to legally marketed predicate devices.

Technological Characteristics

Sterile, single-use procedure tray. Components include Tuohy epidural needles and Whitacre spinal needles. No electronic, software, or energy-based components. Manual operation.

Indications for Use

Indicated for patients requiring regional anesthesia for surgical or obstetric procedures, specifically those benefiting from the rapid onset of spinal anesthesia combined with the long-term pain relief of epidural anesthesia.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Sensi-Touch Epidural Anesthesia Delivery System (K950929)
• Durasafe Combined Spinal Epidural Sets (K932249)
• Espocan Combined Spinal/Epidural Sets (K932400)

Reference Devices

• Sensi-Touch Spinal Trays (preamendment)

Submission Summary (Full Text)

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510(k) Summary of Safety & Efficacy: Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System

Submitted by: Sherwood Medical Co., 1915 Olive St., St. Louis, MO 63103, [phone]
Contact: Dennis Pozzo, Regulatory Affairs Manager
Date Prepared: June 4, 1996

DEC 9 1996
K962880

The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System will include all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package. This procedure tray will be available in several configurations of tray components. This device is a Class II device per 21 CFR 868.5140, Procode: 73CAZ.

The combo tray is intended for Surgical or OB regional anesthesia blocks. The rational for combining the epidural and spinal needles into one kit is as follows; an epidural block takes approximately 25 minutes for onset of the anesthetic, whereas, a spinal block takes approximately 5 min. for onset of anesthetic. Therefore, the patient benefits from both quick pain relief associated with a spinal and long-term pain relief associated with an epidural.

The procedure is as follows, the clinician will first place the epidural needle in the patient's epidural space. The spinal needle is then inserted through the epidural needle into the spinal cavity. The anesthetic is then administered through the spinal needle for quick pain relief. The spinal needle is then removed and an epidural catheter is inserted through the epidural needle into the epidural space. The catheter provides a conduit for the administration and re-administration of anesthetic into the epidural space to provide long term pain relief.

The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System is substantially equivalent to Sherwood Medical's currently marketed Sensi-Touch Epidural Anesthesia Delivery System (preamendment & #K950929) and Sensi-Touch Spinal Trays (preamendment) in that they both contain the components commonly required to place an anesthesia needle for regional anesthesia. Furthermore, the proposed tray will contain both a Tuohy Epidural Needle and a Whitacre Spinal Needle (currently marketed needles).

The major difference is that the currently marketed spinal and epidural trays are separate in that a tray either contain a spinal or epidural needle, not both.

The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System is substantially equivalent to the Durasafe Combined Spinal Epidural Sets (cleared via the 510(k) process, #K932249) in that they both have the same intended use and basic components.

The Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System is substantially equivalent to the Espocan Combined Spinal/Epidural Sets (cleared via the 510(k) process, #K932400) in that they both have the same intended use and basic components.