EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT

K964783 · Alexander Medical, Inc. · CAZ · Feb 12, 1997 · Anesthesiology

Device Facts

• Record ID: K964783
• Device Name: EPIDURAL MINI KIT, ELDOR COMBINED SPINAL/EPIDURAL KIT
• Applicant: Alexander Medical, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Feb 12, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.

Device Story

Kits contain needles, catheters, and accessories for regional anesthesia. Epidural kit includes Eldor needle, catheter, Touhy-Borst adapter, loss of resistance syringe, and filter. Combined kit adds pencil point spinal needle. Procedure involves locating epidural space with epidural needle; for combined kits, spinal needle is passed through epidural needle lumen to access subarachnoid space for spinal block; spinal needle removed; epidural catheter threaded through epidural needle into epidural space for post-op analgesia (up to 72 hours). Used in clinical settings by anesthesia providers. Benefits include combined intraoperative spinal anesthesia and post-operative epidural analgesia.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to legally marketed predicate devices.

Technological Characteristics

Components: Stainless steel needles (Eldor needle with external conduit, pencil point spinal needle), polyamide nylon catheter, Touhy-Borst adapter, loss of resistance syringe, epidural filter. Procedure: Two-needle technique for combined spinal/epidural; single-needle for epidural. Connectivity: None. Energy source: None (manual). Sterilization: Not specified, but components are legally marketed.

Indications for Use

Indicated for patients requiring epidural and/or spinal anesthesia for surgical procedures or post-operative analgesia.

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

• B. Braun’s Espocan Combined Spinal Needle Set and Tray (K932400, K932569)
• Neurodelivery’s Combined E-Sp (K933711)
• Preferred Medical’s Epi-Spinal Tray and Miniset (K925014)
• Kendall Safetrak Combined Ep/Sp (K941493)
• Mediziv Regional Anesthesia Tray (K932614)
• Becton Dickinson’s “Durasafe” combined Spinal/Epidural Anesthesia Kit (K920076)
• Mediziv Epidural Set and Tray (K894725)

Submission Summary (Full Text)

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FEB 12 1997

510(k) Notification - Alexander Medical
Epidural Kit and Combined Spinal/Epidural Kit
K964783

Submitter Ken Palmer, Ph.D., Senior technical Adviser
MTC, BRI International
15825 Shady Grove Road
Rockville, Maryland 20850
Phone [phone]
Fax [phone]

On behalf of:
Alexander Medical
9055 N.W. 13th Court
Coral Springs, FL 33071

Date summary was prepared 11/25/1996

Name(s) of the device: Epidural and Combined Spinal/Epidural Kits

Identification of predicate device(s):

Combined spinal/epidural kits have been introduced to the U.S. market in the 1990's, and many have received FDA approval. These include B. Braun’s Espocan Combined Spinal Needle Set and Tray (K932400, K932569), Neurodelivery’s Combined E-Sp (K933711), Preferred Medical’s Epi-Spinal Tray and Miniset (K925014), Kendall Safetrak Combined Ep/Sp (K941493), Mediziv Regional Anesthesia Tray (K932614), and Becton Dickinson’s “Durasafe” combined Spinal/Epidural Anesthesia Kit (K920076). The components vary from kit to kit, but the catheter is the same as Becton Dickinson’s Durasafe.

Epidural kits have been marketed since before the medical device amendments, and many have received FDA clearance. These include epidural kits by Spinal Specialties, Kendall, Becton Dickinson, Preferred Medical, and many others. The components included in Alexander Medical’s epidural kits are essentially the same. There are no new indications for use or claims made for the kits or the components contained in the kits.

Alexander Medical - Epidural and Spinal/Epidural Kit 510(k)

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510(k) Notification - Alexander Medical
Epidural Kit and Combined Spinal/Epidural Kit

## Description of the device:

The Epidural kit includes an epidural needle (Eldor combined spinal/epidural), epidural catheter, Touhy-Borst Adapter, Loss of resistance syringe, and Epidural. The epidural/spinal combined kit includes the same components and adds a pencil point spinal needle.

## Intended Use

Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.

## Comparison of device characteristics to predicate

Epidural and combined spinal/epidural kits are not new to the U.S. market. All the components used in Alexander Medical's kits are legally marketed components and most are included in various combinations with other epidural and combined spinal/epidural kits legally on the market.

Epidural kits have been marketed since before the medical device amendments, and many have received FDA clearance. These include epidural kits by Spinal Specialties, Kendall, Becton Dickinson, Preferred Medical, and many others. The components included in Alexander Medical's epidural kits are essentially the same. There are no new indications for use or claims made for the kits or the components contained in the kits.

Combined spinal/epidural kits have been introduced to the U.S. market in the 1990's, and many have received FDA approval. These include B. Braun's Espocan Combined Spinal Needle Set and Tray (K932400, K932569), Neurodelivery's Combined E-Sp (K933711), Preferred Medical's Epi-Spinal Tray and Miniset (K925014), Kendall Safetrak Combined Ep/Sp (K941493), Mediziv Regional Anesthesia Tray (K932614), and Becton Dickinson's "Durasafe" combined Spinal/Epidural Anesthesia Kit (K920076). The components vary from kit to kit, but the catheter is the same as Becton Dickinson's Durasafe.

Alexander Medical - Epidural and Spinal/Epidural Kit 510(k)

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510(k) Notification - Alexander Medical
Epidural Kit and Combined Spinal/Epidural Kit

The technological characteristics of the combined spinal/epidural kit as compared to the predicate devices are essentially the same. The Eldor needle is already cleared through the FDA, and is essentially similar to Neurodelivery’s E-Sp (K933711), except the tubular needle guide is shorter than the Neurodelivery device. B. Braun’s Espocan in K932400 is also similar, except the tubular guide is within the epidural needle and a back hole is added for passage of the needle. The extra lumen is small enough to not allow an epidural catheter to pass through while allowing passage of a 26 gauge needle. The feature of the Eldor and Neurodelivery needles is that the tubular needle guide is on the outside of the epidural needle, and there is no back hole in the epidural needle as with B. Braun’s Escopan. Drawings and more detailed information are available in K935255, the 510(k) for the Eldor needle. This 510(k) is for kits utilizing the Eldor needle.

The Kendall Safetrak Combined Ep/Sp K941493, The Mediziv Regional Anesthesia Tray K932614, and the Becton Dickinson Durasafe K920076 kits also contain components needed for both epidural and spinal anesthesia procedures. These combined epidural/spinal kits involve a two needle technique allowing a spinal anesthetic to be given for intraoperative anesthesia while an epidural catheter is placed for post-op analgesia for up to 72 hours. The product consists of a longer spinal needle which can be passed through a traditional epidural needle. To perform this procedure, the epidural space is located with a Touhy epidural needle. The 26 gauge pencil point needle is passed through the lumen of the epidural needle out the tip and advanced through the dura matter to access the subarachnoid space. The 26 gauge spinal needle passes through the 17 gauge epidural needle because of the difference in size between the outside diameter of the spinal needle and the inside diameter of the epidural needle. A spinal block is administered through the spinal needle, which is then removed, leaving the epidural needle in place. The epidural catheter is threaded through the epidural needle into the epidural space to the desired depth and the epidural needle is removed. The Becton Dickinson and Kendall devices include a 17 gauge epidural needle and a 24 gauge spinal needle. These predicates include a 20 gauge catheter that is inserted into the patient through the epidural needle for epidural anesthesia.

Alexander Medical - Epidural and Spinal/Epidural Kit 510(k)

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510(k) Notification - Alexander Medical

Epidural Kit and Combined Spinal/Epidural Kit

Table of Technological Characteristics

| Device Name | DEVICE
Alexander Medical Epidural and Combined Spinal/Epidural Kits | PREDICATE
Becton Dickinson Durasafe | PREDICATE
Mediziv Epidural Set and Tray and the Regional Anesthesia Tray | |
| --- | --- | --- | --- | --- |
| 510(k) numbers | NEW- This submission | K920076 | K932614 Regional (Combined)
K894725 Epidural Tray | |
| Indications for use | Epidural and/or Spinal Anesthesia | Same | Same | |
| Warnings / Precautions | 1) Withdrawing epidural catheter through needle
2) limit to 72 hours of use
3) warning about interthecal medications | Same | Same | |
| Components | 1) Eldor needle with conduit outside epidural needle K935255
2) 20 gauge 3 hole epidural catheter - K840202
3) Touhy Borst Adaptor - Preamendment
4) 27 gauge pencil point Spinal Needle - K944905 (not in Epidural Kit)
5) Epidural Filter - Preamendment
6) Loss of resistance syringe - Preamendment
NO DRUGS, NO GLOVES
Epidural Kit includes all item except #4 | 1) Epidural needle with back eye hole
2) 20 gauge 3 hole epidural catheter
3) Touhy Borst Adaptor
4) 25 gauge pencil point needle
NO DRUGS, NO GLOVES | Combined
1) Epidural Needle
2) 17 gauge 3 hole epidural catheter
3) no adaptor
4) 26 gauge pencil point needle
5) epidural filter
6) Loss of resistance syringe
7) Drugs and other components | Epidural
1) Epidural needle
2) Epidural Catheter
3) Epidural Filter
4) Loss of resistance syringe |
| Materials | Needles - Stainless Steel
Catheter - Polyamide Nylon | Same | Same | |
| Certifications | See section 12 for Kit Certification and truth and accuracy statement | NA | NA | |
| Biocompatibility | All components are legally marketed and are made with biocompatible materials | All components are legally marketed materials | All components are legally marketed materials | |

Conclusion: All components are legally marketed, and other devices with the same or similar components and same intended use are legally on the market. The kits are substantially equivalent.

Alexander Medical - Epidural and Spinal/Epidural Kit 510(k)