B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY

K954953 · Bd Becton Dickinson Vacutainer Systems Preanalytic · CAZ · May 20, 1996 · Anesthesiology

Device Facts

• Record ID: K954953
• Device Name: B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY
• Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
• Product Code: CAZ · Anesthesiology
• Decision Date: May 20, 1996
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Regional Anesthesia: To provide a device to accomplish the Combined Spinal (CSE) Epidural Technique

Device Story

The BD Stella-Cath™ CSE Kit/Tray is a procedural kit used by clinicians to perform combined spinal-epidural anesthesia. The device consists of a spinal needle, an epidural needle, and accessories including a filter, LOR syringe, and the Stella-Cath™ epidural catheter. The primary modification from the predicate is the inclusion of the Stella-Cath™ catheter, which features a star-shaped internal profile designed to improve flow characteristics. The kit is used in clinical settings to facilitate the administration of regional anesthesia. The clinician uses the needles and catheter to access the epidural and subarachnoid spaces; the star-shaped catheter profile is intended to maintain patency and facilitate drug delivery. The device functions identically to the predicate, providing the same clinical utility for regional anesthesia procedures.

Clinical Evidence

Bench testing only. Mechanical testing demonstrated that the Stella-Cath™ catheter meets all specification requirements. Components conform to ISO 594 (conical fittings), ISO 7864 (needles), ISO 7886-1 (syringes), and ISO 10993-1 (biocompatibility).

Technological Characteristics

Kit includes spinal/epidural needles and nylon epidural catheter with star-shaped internal profile. Conforms to ISO 594 (6% Luer taper), ISO 7864, ISO 7886-1, and ISO 10993-1. Needle bond strength minimum 8 lb. Cannula strength meets Federal Stiffness Test.

Indications for Use

Indicated for patients requiring regional anesthesia via the Combined Spinal Epidural (CSE) technique.

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

• BD Durasafe™ Combined Spinal Epidural Anesthesia Needle Set/Kit (K932249)

Submission Summary (Full Text)

{0}

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 [phone]
Fax [phone]
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)

4.0 PRODUCT DESCRIPTION / FUNCTION
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 internal profile.
4.2 Function - The subject device will function the same as predicate devices.

5.0 COMPARISON OF MODIFIED AND PREDICATE DEVICES EQUIVALENCE
5.1 Descriptive Comparison To a Legally Marketed Device
The predicate, legally marketed device is the BD Durasafe™ 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}

SUMMARY OF SAFETY AND EFFECTIVENESS
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. Accessories (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. |