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.

AI/ML Overview

The Alexander Medical Epidural Kit and Combined Spinal/Epidural Kit did not undergo a study with acceptance criteria in the traditional sense, as it was cleared through the 510(k) pathway by demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics through a clinical trial.

Instead, the "acceptance criteria" can be inferred as demonstration of equivalence in key characteristics to legally marketed predicate devices. The study proving this "acceptance" is the 510(k) Notification submission itself, which presents a detailed comparison of the new device's characteristics to those of established predicate devices.

Here's the breakdown of how the provided information addresses your request, interpreted in the context of a 510(k) submission:

1. Table of Acceptance Criteria and the Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are the characteristics of the predicate devices. The "reported device performance" is the comparison of Alexander Medical's device to these predicates.

Acceptance Criteria (Predicate Device Characteristics)	Reported Device Performance (Alexander Medical Device Characteristics)
Indications for Use: Epidural and/or Spinal Anesthesia	Same: Epidural and/or Spinal Anesthesia
Warnings/Precautions: (Same as predicates)	Same: (Same warnings/precautions listed)
Components:	Components:
- Epidural needle (with or without back eye hole)	- Eldor needle with conduit outside epidural needle (K935255)
- 20-22 gauge 3-hole epidural catheter	- 20 gauge 3-hole epidural catheter (K840202)
- Touhy-Borst Adaptor (Preamendment)	- Touhy-Borst Adaptor (Preamendment)
- 24-26 gauge pencil point Spinal Needle	- 27 ga pencil point Spinal Needle (K944905) (not in Epidural Kit)
- Epidural Filter (Preamendment)	- Epidural Filter (Preamendment)
- Loss of resistance syringe (Preamendment)	- Loss of resistance syringe (Preamendment)
- No Drugs, No Gloves (for some predicates)	- No Drugs, No Gloves
Materials: Needles-Stainless Steel, Catheter-Polyamide Nylon	Same: Needles-Stainless Steel, Catheter-Polyamide Nylon
Biocompatibility: All components legally marketed and made with biocompatible materials	Same: All components are legally marketed and are made with biocompatible materials
Technological Characteristics: Essentially the same as predicates	Essentially the same: Eldor needle cleared (K935255), similar to Neurodelivery's E-Sp (K933711) and B. Braun's Espocan (K932400) with minor design variations. Spinal needle size difference (27g vs 24-26g).

Conclusion from 510(k) Submission: "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."

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

Sample Size: Not applicable. This was not a study involving patient data or a test set of samples. The submission relies on a comparison of device specifications and components to legally marketed predicate devices.
Data Provenance: Not applicable. No clinical or performance data was generated for the Alexandar Medical device to establish its effectiveness or safety independently. The data provenance refers to the regulatory clearances of the individual components and predicate devices (e.g., K935255 for the Eldor needle, K920076 for Becton Dickinson's Durasafe). This is essentially retrospective data in the sense that it relies on previously established clearances.

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

Not applicable. There was no "ground truth" to establish for a test set in the context of a clinical study. Substantial equivalence is determined by regulatory review of similarities to predicate devices. The "experts" involved are the FDA reviewers who assess the submission based on their knowledge of medical device regulations and relevant clinical standards.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication was used. The regulatory review process for 510(k) involves an assessment by FDA personnel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses human reader performance with and without AI assistance, which is irrelevant for a device like an epidural kit cleared via substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This device is a physical medical kit, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness of the identified predicate devices and the individual legally marketed components as demonstrated through their prior FDA clearances. The Alexander Medical device is considered "substantially equivalent" if it does not raise new questions of safety or effectiveness compared to these predicates.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the machine learning sense. The "training" for the submission comes from the prior regulatory clearances of numerous similar devices and components already on the market.

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

Not applicable. As there is no training set as understood in AI/ML, there is no ground truth established for it. The "ground truth" for the overall submission's argument of substantial equivalence relies on existing regulatory approvals and industry standards for similar devices and components. These standards and approvals were established through various means, including pre-amendment status, previous 510(k) clearances, and potentially clinical data for those predicate devices or components (though not part of this specific 510(k) submission).

Summary

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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 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.

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

Description of the device:

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.

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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 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.

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Device Name	DEVICEAlexander Medical Epidural andCombined Spinal/Epidural Kits	PREDICATEBecton DickinsonDurasafe	PREDICATEMediziv Epidural Set andTray and the RegionalAnesthesia 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 throughneedle2) limit to 72 hours of use3) warning about interthecal medications	Same	Same
Components	1) Eldor needle with conduit outsideepidural needle K9352552) 20 gauge 3 hole epidural catheter -K8402023) Touhy Borst Adaptor - Preamendment4) 27 gauge pencil point Spinal Needle -K944905 (not in Epidural Kit)5) Epidural Filter - Preamendment6) Loss of resistance syringe -PreamendmentNO DRUGS, NO GLOVESEpidural Kit includes all item except #4	1) Epidural needlewith back eye hole2) 20 gauge 3 holeepidural catheter3) Touhy BorstAdaptor4) 25 gauge pencilpoint needleNO DRUGS, NOGLOVES	Combined1) EpiduralNeedle2) 17 gauge 3hole epiduralcatheter3) no adaptor4) 26 gaugepencil pointneedle5) epiduralfilter6) Loss ofresistancesyringe7) Drugs andothercomponentsEpidural1) Epiduralneedle2) EpiduralCatheter3) EpiduralFilter4)Loss ofresistancesyringe
Materials	Needles - Stainless SteelCatheter - Polyamide Nylon	Same	Same
Certifications	See section 12 for Kit Certification and truthand accuracy statement	NA	NA
Biocompatibility	All components are legally marketed and aremade with biocompatible materials	All components arelegally marketedmaterials	All components are legallymarketed 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.

道

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).