(203 days)
Not Found
No
The 510(k) summary explicitly states that the only change is the replacement of an epidural catheter with a new catheter of a different material and shape. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on mechanical testing of the catheter.
Yes
The device is intended for regional anesthesia, which is a therapeutic intervention, and it facilitates a medical procedure (Combined Spinal Epidural Technique) to achieve pain relief or numbness.
No
The device is described as an epidural catheter for administering regional anesthesia, specifically for the Combined Spinal Epidural Technique. Its purpose is to accomplish a medical procedure, not to diagnose a condition. The described change is merely a replacement of one catheter with another, and the performance studies focus on mechanical testing of the catheter.
No
The device description explicitly states the change is replacing a physical component (epidural catheter) with a new physical component (Stella-Cath™ Epidural Catheter). The performance studies also focus on mechanical testing of this physical component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Regional Anesthesia: To provide a device to accomplish the Combined Spinal (CSE) Epidural Technique." This describes a medical procedure performed on a patient, not a test performed on a sample of biological material in vitro (outside the body).
- Device Description: The device is an epidural catheter and a kit for a specific anesthesia technique. This is a medical device used for a procedure, not for diagnostic testing.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The focus is on the physical device and its use in a medical procedure.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Regional Anesthesia: To provide a device to accomplish the Combined Spinal (CSE) Epidural Technique
Product codes
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Device Description
The only change described in this 510(k) is replacing the epidural catheter with the Stella-Cath™ Epidural Catheter, a nylon epidural catheter with star shape interna profile. The subject device will function the same as predicate devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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
The mechanical testing results show that the BD Stella-Cath™ catheter meets all the specification requirements, and is not any inferior than the current product in any aspects. All components in the kit conform to the physical mechanical and biological specifications found in the product standards referenced below.
Key Metrics
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Predicate Device(s)
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).
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SUMMARY OF SAFETY AND EFFECTIVENESS
Becton Dickinson and Company
BD DURASAFE™ CSE TRAY WITH STELLA-CATH™
- 1.0 BD CONTACT PERSON Gregory Morgan, Manager Regulatory Affairs Phone (201)847-4344 Fax (201) 847-4868 Becton Dickinson and Company 1 Becton Drive, Building 2, MC226 Franklin Lakes, New Jersey 07417-1884
K954953
MAY 20 1996
2.0 DEVICE NAME
BD Stella-Cath™ Combined Spinal/Epidural (CSE) Kit/Tray
3.0 PREDICATE DEVICE
BD Durasafe™ Combined Spinal Epidural Anesthesia Needle Set/Kit (K932249)
PRODUCT DESCRIPTION / FUNCTION 4.0
- 4.1 Description - The only change described in this 510(k) is replacing the epidural catheter with the Stella-Cath™ Epidural Catheter, a nylon epidural catheter with star shape interna profile.
- 4.2 Function - The subject device will function the same as predicate devices.
COMPARISON OF MODIFIED AND PREDICATE DEVICES EQUIVALENCE રે .0
ર : 1 Descriptive Comparison To a Legally Marketed Device
The predicate, legally marketed device is the BD Durasafet™ Combined Spinal/Epidural Anesthesia Needle Set/Kit (FDA 510(k) # K932249).
The subject device, BD Stella-Cath™ Combined Spinal/Epidural Kit/Tray is identical to the predicate device in all respects with the exception of the internal profile of the epidural catheter.
1
Becton Dickinson and Company BD DURASAFE™ CSE TRAY WITH STELLA-CATH™
5.2 Performance Data Supporting Substantial Equivalence
The mechanical testing results show that the BD Stella-Cath™ catheter meets all the specification requirements, and is not any inferior than the current product in any aspects. All components in the kit conform to the physical mechanical and biological specifications found in the product standards referenced below.
| ISO 594 | Conical Fittings with a 6% (LUER) Taper |
|---|---|
| ISO 7864 | Sterile Disposable Needles |
| ISO 7886-1 | Sterile Disposable Syringes |
| ISO 10993-1 | Biological Evaluation of Medical Devices Part I: Guidance on Selection of Tests |
5.3 Reference Table A For Comparison Table
This summary of Safety and Effectiveness data is being submitted in compliance with the Safe Medical Device Act.
TABLE A
See next page
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TABLE A
Side-by-Side Comparison Table
| ELEMENT OF COMPARISON | B-D DURASAFE™
COMBINED SPINAL EPIDURAL (CSE)
KIT/TRAY WITH STELLA-CATH™
(SUBJECT DEVICE) | B-D DURASAFE™
COMBINED SPINAL EPIDURAL
(CSE) NEEDLE SET/KIT
(PREDICATE DEVICE) |
|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| 1.
Intended Uses | same as the predicate device | Regional Anesthesia: To
provide a device to
accomplish the Combined
Spinal (CSE) Epidural
Technique |
| 2.
Gauge Sizes:
Spinal Needle
Epidural Needle | same as the predicate device | 25/27G
17/18G |
| 3.
Tip Configuration:
Spinal Needle
Epidural Needle | same as the predicate device | Whitacre or Quincke Point
Tuohy-Shliff Point |
| 4.
Acessories (in the kit
models) | same as the predicate device | Catheter, Tuohy Borst
Adapter, Filter, LOR Syringe |
| 5.
Colors:
Spinal Hubs
Spinal Handles
Epidural Hubs
Epidural Handle/Stylet | same as the predicate device | Reed Blue (25G)
Reed Blue (25G)
None
Reed Gray (17G); Pink (17G) |
| 6.
Cannula Strength | same as the predicate device | Federal Stiffness Test |
| 7.
Needle Bond Strength | same as the predicate device | 8 lb. minimum |
| 8.
Biocompatibility | same as the predicate device | ISO |
| 9.
Materials | same as the predicate device | Approved |
| 10. Labeling | added tradename to packaging
labels. No change in Direction
for Use. | Provide Labels and Direction
for Use where appropriate. |