(77 days)
No
The device description lists standard components for epidural and combined spinal/epidural kits, and there is no mention of AI, ML, or image processing.
Yes
The device is used for the delivery of epidural and combined spinal/epidural anesthesia, which is a medical treatment.
No
The device is designed for the delivery of epidural and combined spinal/epidural anesthesia, which is a therapeutic or pain management procedure, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (needles, catheter, syringe, adapter) and does not mention any software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Delivery of Epidural anesthesia... and delivery of combined spinal/epidural anesthesia". This describes a procedure performed directly on a patient for therapeutic purposes (anesthesia).
- Device Description: The components listed (needles, catheter, syringe, adapter) are all instruments used for delivering substances into the body or accessing anatomical spaces.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on sample analysis
- Reagents or other components typically associated with in vitro testing
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used for a medical procedure, not for analyzing samples.
N/A
Intended Use / Indications for Use
Delivery of Epidural anesthesia for the epidural kits and delivery of combined spinal/epidural anesthesia for the combined kits.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K920076, K932614, K894725, K932400, K932569, K933711, K925014, K941493
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510(k) Notification - Alexander Medical Epidural Kit and Combined Spinal/Epidural Kit
Submitter
Ken Palmer, Ph.D., Senior technical Adviser MTC, BRI International 15825 Shady Grove Road Rockville, Maryland 20850 Phone 301-548-0500 Fax 301-548-9556
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.
1
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 variaus ... combinations with other epidural and combined spinal/epidiral kits legally.conthe 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.
2
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 epidiral 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.
3
| 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
- Epidural
Needle - 17 gauge 3
hole epidural
catheter - no adaptor
- 26 gauge
pencil point
needle - epidural
filter - Loss of
resistance
syringe - Drugs and
other
components
Epidural
- Epidural
needle - Epidural
Catheter - 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 |
Table of Technological Characteristics
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.
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