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

K012584 · Bd · CAZ · Sep 6, 2001 · Anesthesiology

Device Facts

• Record ID: K012584
• Device Name: MODIFICATION TO: BD DURASAFE PLUS EPIDURAL LOCK CSE NEEDLE SET/KIT
• Applicant: Bd
• Product Code: CAZ · Anesthesiology
• Decision Date: Sep 6, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The BD Durasafe™ Plus! Epidural Lock CSE Needle Set/Kit is a medical device used by clinicians to perform combined spinal/epidural (CSE) anesthesia. The device consists of a needle set/kit designed to facilitate the CSE procedure, which involves the administration of anesthesia into both the epidural and spinal spaces. The primary modification from the predicate device is the inclusion of an isobutyl rubber gasket and a pinch lock mechanism, replacing the previous slide/grip lock. The device is used in a clinical setting by healthcare professionals to assist in needle placement during anesthesia administration. The output is the successful positioning of the needle for the delivery of anesthetic agents, which aids in pain management for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Stainless steel (cannula), polypropylene (hub, stylet), isobutyl rubber (gasket), polyethylene (needle shield). Sterilization: ETO. Mechanism: Pinch lock system for needle security. Form factor: Needle set/kit.

Indications for Use

Indicated for patients undergoing combined spinal/epidural (CSE) anesthesia procedures.

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™ Variable Extension Combined Spinal Epidural (CSE) Needle Set/Kit (K945497)

Submission Summary (Full Text)

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KO125884

1 Becton Drive Franklin Lakes, New Jersey 07417 tel: [phone] 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 [phone] (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

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 /<br>CHARACTERISTIC | CSE<br>(EXISTING DESIGN) | CSE<br>(MODIFIED DESIGN) |
|-------------------------------|--------------------------|--------------------------|
| Cannula | Stainless Steel | Stainless Steel |
| Needle Hub | Polypropylene | Polypropylene |
| Stylet | Polypropylene | Polypropylene |

Summary of Safety and Effectiveness

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| COMPONENT /<br>CHARACTERISTIC | CSE<br>(EXISTING DESIGN) | CSE<br>(MODIFIED DESIGN) |
|-------------------------------|--------------------------|--------------------------|
| Color Additive | Pink/Gray | Pink/Gray |
| Gasket | None | Isobutyl Rubber |
| Needle Shield | Polyethylene | Polyethylene |
| Locking<br>Mechanism | Slide/Grip Lock | Pinch Lock |
| Sterilization<br>Process | 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 [phone]

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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 ✓