(138 days)
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No
The description focuses on the physical components and procedural steps of a regional anesthesia delivery system, with no mention of AI or ML capabilities.
No.
The device is a delivery system for anesthetics, which are therapeutic, but the device itself does not directly provide therapy; it facilitates the administration of medication.
No
The device is described as a delivery system for anesthesia, intended for performing spinal and epidural procedures to deliver anesthetic. It does not perform any diagnostic function.
No
The device description explicitly states it includes "all components commonly required to perform both a spinal and epidural procedure in a sterile, single use procedure-ready package," indicating it is a physical kit containing hardware components like needles and catheters, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "Surgical or OB regional anesthesia blocks." This describes a procedure performed directly on a patient for therapeutic purposes (pain relief), not for examining specimens from the body to diagnose or monitor a condition.
- Device Description: The description details a system for delivering anesthetic agents into the epidural and spinal spaces of a patient. This is a direct intervention on the patient's body.
- Regulatory Classification: The device is classified as a Class II device per 21 CFR 868.5140, which is for "Anesthesia conduction kit." This classification falls under the Anesthesiology medical specialty and is not related to in vitro diagnostics.
- Lack of IVD Characteristics: The description does not mention any components or processes related to testing or analyzing biological specimens (blood, urine, tissue, etc.) outside of the body.
In summary, the Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System is a medical device used for performing a surgical procedure (anesthesia delivery), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The combo tray is intended for Surgical or OB regional anesthesia blocks.
Product codes
73CAZ
Device Description
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.
Mentions image processing
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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
clinician
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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.5140 Anesthesia conduction kit.
(a)
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.(b)
Classification. Class II (performance standards).
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510(k) Summary of Safety & Efficacy: Sensi-Touch™ Combo Spinal/Epidural Regional Anesthesia Delivery System
DEC 9 1996 Sherwood Medical Co., 1915 Olive St., Submitted by: St. Louis, MO 63103, (314) 621-7788 St. Louis, MO 63103, (314) 621-7788
Dennis Pozzo, Regulatory Affairs Manager Contact : Date Prepared: June 4, 1996
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 Therefore, the patient benefits from both quick pain anesthetic. 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 Reqional 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 .