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.

AI/ML Overview

This document describes a 510(k) submission for the BD DURASAFE™ CSE TRAY WITH STELLA-CATH™, which is a modified version of an existing device. The core of the submission is to demonstrate the substantial equivalence of the new device to the predicate device (BD Durasafe™ Combined Spinal Epidural Anesthesia Needle Set/Kit).

This is a medical device submission and does not describe an AI/ML algorithm or a study involving human readers or experts to establish ground truth in the context of an AI/ML system. Therefore, many of the requested fields cannot be directly answered.

The "acceptance criteria" here refer to performance specifications for the new device that demonstrate it is as safe and effective as the predicate device. The "study" refers to mechanical testing that verified these specifications.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion (Specification Requirement)	Reported Device Performance
BD Stella-Cath™ Catheter Performance	Meets all specification requirements; not inferior to current product.
All Components Conformance	Conform to physical, mechanical, and biological specifications.
ISO 594 (Conical Fittings)	Conforms to standard.
ISO 7864 (Sterile Disposable Needles)	Conforms to standard.
ISO 7886-1 (Sterile Disposable Syringes)	Conforms to standard.
ISO 10993-1 (Biological Evaluation of Medical Devices)	Conforms to standard.
Cannula Strength	Same as predicate device (Federal Stiffness Test).
Needle Bond Strength	Same as predicate device (8 lb. minimum).
Biocompatibility	Same as predicate device (ISO standards met).
Materials	Same as predicate device (Approved materials).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated. The document mentions "mechanical testing results," implying tests were conducted, but the number of units tested is not provided.
Data Provenance: Not specified, but likely refers to internal testing conducted by Becton Dickinson and Company.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involves mechanical and physical testing of a medical device, not an AI/ML system or a clinical study requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. The device performance is assessed against predefined engineering specifications and ISO standards, not through human adjudication of diagnostic interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study is for a medical device's physical and mechanical properties, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as no algorithm is being evaluated. The "standalone" performance refers to the device's inherent mechanical and biological characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" here is defined by industry standards (ISO), pre-defined engineering specifications, and the established performance characteristics of the predicate device. For example, "Needle Bond Strength - 8 lb. minimum" is a ground truth specification.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm being developed or trained.

9. How the ground truth for the training set was established

This is not applicable as there is no AI/ML algorithm being developed or trained.

Summary

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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.

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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: Toprovide a device toaccomplish the CombinedSpinal (CSE) EpiduralTechnique
2.Gauge Sizes:Spinal NeedleEpidural Needle	same as the predicate device	25/27G17/18G
3.Tip Configuration:Spinal NeedleEpidural Needle	same as the predicate device	Whitacre or Quincke PointTuohy-Shliff Point
4.Acessories (in the kitmodels)	same as the predicate device	Catheter, Tuohy BorstAdapter, Filter, LOR Syringe
5.Colors:Spinal HubsSpinal HandlesEpidural HubsEpidural Handle/Stylet	same as the predicate device	Reed Blue (25G)Reed Blue (25G)NoneReed 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 packaginglabels. No change in Directionfor Use.	Provide Labels and Directionfor Use where appropriate.

Regulation Number and Section

§ 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).