MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT by BD

A comparison between the modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit and existing BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit is provided in the table below:

COMPONENT /CHARACTERISTIC	CSE(EXISTING DESIGN)	CSE(MODIFIED DESIGN)
Cannula	Stainless Steel	Stainless Steel
Needle Hub	Polypropylene	Polypropylene
Stylet	Polypropylene	Polypropylene
Color Additive	Pink/Gray	Pink/Gray
Gasket	None	Isobutyl Rubber
Needle Shield	Polyethylene	Polyethylene
LockingMechanism	Slide/Grip Lock	Pinch Lock
SterilizationProcess	ETO	ETO

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, the BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance. Therefore, much of the requested information regarding acceptance criteria and performance studies is not available in this type of regulatory submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify quantitative acceptance criteria for device performance in terms of metrics like sensitivity, specificity, accuracy, or other measurable outcomes typically associated with AI/software performance. The comparison table focuses on physical characteristics and materials.

Component / Characteristic	CSE (Existing Design)	CSE (Modified Design)	Acceptance Criteria (Implied)	Reported Performance
Cannula	Stainless Steel	Stainless Steel	Same material	Same material
Needle Hub	Polypropylene	Polypropylene	Same material	Same material
Stylet	Polypropylene	Polypropylene	Same material	Same material
Color Additive	Pink/Gray	Pink/Gray	Same color scheme	Same color scheme
Gasket	None	Isobutyl Rubber	Appropriate for intended use	Isobutyl Rubber (New)
Needle Shield	Polyethylene	Polyethylene	Same material	Same material
Locking Mechanism	Slide/Grip Lock	Pinch Lock	Secure locking, ease of use	Pinch Lock (New)
Sterilization Process	ETO	ETO	Same process	Same process

The "acceptance criteria" here are implied by the claim of substantial equivalence: the modified design should perform equivalently or better than the predicate device for its intended use, focusing on safety and effectiveness. The "Pinch Lock" and "Isobutyl Rubber" are changes compared to the predicate, implying these new features meet the same safety and effectiveness standards, likely through design verification and validation testing (though not detailed here).

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. This is a submission for a physical medical device, not an AI/software device that typically uses test sets of data. The "test" likely refers to engineering verification and validation testing of the physical device components, not a data-driven model.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Not applicable. Ground truth, in the context of expert review, is typically established for diagnostic or screening tests. This document describes a surgical needle set, where effectiveness is measured through its physical function and safety, not by expert interpretation of data.

4. Adjudication Method for the Test Set:

Not applicable, for the reasons mentioned above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar interpretation tasks where human readers' performance is being evaluated, often with and without AI assistance. This document pertains to a physical medical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used:

Not applicable in the typical sense of AI/software performance. For a physical device like this, "ground true" would relate to whether the device functions as intended (e.g., the locking mechanism securely locks, the needle delivers the anesthetic appropriately, materials are biocompatible, sterility is maintained). This would be validated through engineering tests, biocompatibility studies, and sterility assurance, rather than expert consensus on data.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the reasons mentioned above.

Summary of the Study/Evidence Provided in the Document:

The provided document (K0125884) is a 510(k) Premarket Notification to the FDA. The "study" described herein is a comparison and equivalence determination between a modified device (BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit) and an existing predicate device (BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit K945497).

The document argues for substantial equivalence based on:

Same intended use: Both devices are used for combined spinal/epidural (CSE) anesthesia procedure.
Similar confirmation of needle placement.
Same range of needle gauge sizes.
Similar insertion technique.
Same materials: For most components (cannula, needle hub, stylet, needle shield).
Same sterilization process: ETO.

The key modifications are the addition of an Isobutyl Rubber Gasket and a change in the Locking Mechanism from Slide/Grip Lock to Pinch Lock. The submission implies that these changes do not alter the fundamental safety or effectiveness of the device for its intended use, and therefore the modified device is substantially equivalent to the legally marketed predicate. This is a regulatory pathway to demonstrate that a new device is as safe and effective as an already approved device, without requiring extensive new clinical trials specific to the modified device, provided the changes are minor and do not raise new questions of safety or effectiveness.

Summary

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KO125884

1 Becton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 www.bd.com

SEP = 6 2001

Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of a stylized sun-like symbol on the left and the letters "BD" in bold, sans-serif font on the right. The sun-like symbol features a central circle with radiating lines, resembling a person with outstretched arms.

Indispensable to human health

Summary of Safety and Effectiveness for the BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit

1 BD Contact person:
Pasquale Amato Regulatory Compliance Coordinator BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847- 4513 (201) 847- 4855 Fax
Device Name: BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit 2
Predicate Device(s): 3
- 3.1 BD Durasafe™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit K945497.
Intended Uses: The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used 4 to perform the combined spinal/epidural (CSE) anesthesia procedure.
Device Description and Comparison: ട്

COMPONENT /CHARACTERISTIC	CSE(EXISTING DESIGN)	CSE(MODIFIED DESIGN)
Cannula	Stainless Steel	Stainless Steel
Needle Hub	Polypropylene	Polypropylene
Stylet	Polypropylene	Polypropylene

Summary of Safety and Effectiveness

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COMPONENT /CHARACTERISTIC	CSE(EXISTING DESIGN)	CSE(MODIFIED DESIGN)
Color Additive	Pink/Gray	Pink/Gray
Gasket	None	Isobutyl Rubber
Needle Shield	Polyethylene	Polyethylene
LockingMechanism	Slide/Grip Lock	Pinch Lock
SterilizationProcess	ETO	ETO

Equivalence determination: 6
The modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is substantially The modified DD Durasale - Place are the existing unmodified predicate equivalent in product lances! Epidural Lock CSE Needle Set/Kit exhibits the following similarities as detailed below:
Same intended use .
Similar confirmation of needle placement .
Same range of needle gauge sizes .
Similar insertion technique .
Same materials .
Same sterilization process .

In summary the modified BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit in Juminary the mountssion is, in our opinion, substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized representation of a human figure. The emblem is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP = 6 2001

Mr. Pasquale Amato BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417

Re: K012584

BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit Regulation Number: 868.5140/868.5150 Regulation Name: Anesthetic Conduction Kit/Anesthesia Conduction Needle Regulatory Class: II (two) Product Code: 73 CAZ/BSP Dated: August 9, 2001 Received: August 10, 2001

Dear Mr. Amato:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market the device, subject to the general controls provisions of Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Pasquale Amato

In addition, we have determined that your device kit contains Povidine Iodine Solution and Xylocaine (Lidocaine) 1 percent which are subject to regulation as drugs.

Our substantially equivalent determination does not apply to the drug component[s] of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug component[s]. For information on applicable Agency requirements for marketing this [these] drug[s], we suggest you contact:

Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0101

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely yours,

Qallertell

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment 2

Indications for Use Statement

510(k) Number: not known at this time

Device Name: BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit

Indications for Use: The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is used to perform the combined spinal/epidural (CSE) anesthesia procedure.

Oalle Hill
Division of Cardiovascular & Respiratory Devices
510(k) Number RO12584

prescription use ✓

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).