(231 days)
K921288B
No
The device description and performance studies focus on the mechanical and material properties of a standard epidural needle, with no mention of AI or ML.
No
The device is described as an epidural needle used to administer anesthetic, which is a drug delivery device, not a therapeutic device directly providing therapy.
No
This device is used to administer anesthetic, which is a therapeutic function, not a diagnostic one. Its purpose is to deliver medication to the peridural space for pain management (anesthesia induction), not to identify or monitor medical conditions.
No
The device description clearly states it is a physical needle made of stainless steel and polycarbonate, which are hardware components.
Based on the provided information, the Kendall Blunt Tip Tuohy Epidural Needle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer anesthetic to the peridural space." This is a procedure performed in vivo (within the living body) for therapeutic purposes (anesthesia).
- Device Description: The description details a needle designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing biological samples outside of the body. This device is designed for direct use within the body.
N/A
Intended Use / Indications for Use
Like other commercially available epidural needles, the Kendall Blunt Tip Tuohy Epidural Needle is used to administer anesthetic to the peridural space.
Product codes
Not Found
Device Description
The Kendall Blunt Tip Tuohy Epidural Needle is a sterile single use device designed to be used for the induction of epidural anesthesia. The needle cannula and matched stylet are composed of stainless steel. A polycarbonate hub is insert molded onto the cannula. The hub is supplied in two configurations, a fixed wing design and a non-winged design. The cannula gauge, length and tip are equivalent to current commercially available epidural needles. A portion of the tip of a standard needle bevel is removed in a blunt grind process. The sharp cutting edges around the periphery of the needle bevel remain unchanged.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peridural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility testing was performed on the needle hub following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Functional/Mechanical testing was performed to determine needle penetration force and hub pull-off force.
Key Metrics
Not Found
Predicate Device(s)
K921288B
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
EXHIBIT #7
MAY 3 0 1996
510(k) Summary
Kendall Blunt Tip Tuohy Epidural Needle
In accordance with Section 513(1) of the SMDA and as described in 21 CFR Part 807.92 interim rule dated April 28, 1992, this summary is submitted by:
Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 Date: February 20, 1996
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- Contact Person
David A. Olson Manager Regulatory Affairs (508) 261-8530
- Contact Person
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- Name of Medical Device
| Classification Name: | Anesthesia Conduction Needle |
|---|---|
| Common or Usual Name: | Blunt Tip Epidural Needle |
| Proprietary Name: | Kendall Blunt Tip Tuohy Epidural Needle |
3. Identification of Legally Marketed Device
The Kendall Blunt Tip Tuohy Epidural Needle is substantially equivalent in composition, form, function and intended use to the commercially available Kendall 18 Gauge Calibrated Tuohy Epidural Needle (K921288B).
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- Device Description
The Kendall Blunt Tip Tuohy Epidural Needle is a sterile single use device designed to be used for the induction of epidural anesthesia. The needle cannula and matched stylet are composed of stainless steel. A polycarbonate hub is insert molded onto the cannula. The hub is supplied in two configurations, a fixed wing design and a non-winged design. The cannula gauge, length and tip are equivalent to current commercially available epidural needles. A portion of the tip of a standard needle bevel is removed in a blunt grind process. The sharp cutting edges around the periphery of the needle bevel remain unchanged.
- Device Description
1
న్. Device Intended Use
Like other commercially available epidural needles, the Kendall Blunt Tip Tuohy Epidural Needle is used to administer anesthetic to the peridural space.
6. Product Comparison
The Kendall Blunt Tip Tuohy Epidural Needle is equivalent to the referenced predicate device in that they are fabricated from identical materials, have the same function and equivalent indications for use.
7. Nonclinical Testing
Biocompatibility testing was performed on the needle hub following ISO-10993 Biological Evaluation of Medical Devices. This testing found the material contained no toxic diffusible substances.
Functional/Mechanical testing was performed to determine needle penetration force and hub pull-off force.
MB