MPS ACACIA NERVE BLOCK NEEDLE by MPS ACACIA

The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter.
The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or anti-inflammatory medication for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter.
Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective nerve blocks, Intra-articular injections (i.e. Facet blocks), Interlaminar and Transforaminal approaches.

Device Description

The MPS Acacia Nerve Block Needle consists of a stainless steel cannula with various tip types (Blunt, Housted, Touhy, Crawford, Quincke, Chiba, Sprotte, Freeman) and a molded plastic hub. A stylet is also provided consisting of a stainless steel shaft and a molded plastic hub.

The MPS Acacia Nerve Block Stimulating Needle version is electrically conductive at the distal end of the device.

The Nerve Block Needle will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and gauges.

The Nerve Block Needle may be packaged individually or as part of a kit consisting of a catheter, various syringe sizes, introducer, extension set, gauze sponge, sponge applicator, drape, absorbent towel, hospital wrap, sterile gloves, and other commonly used FDA approved accessories dependent on the application as determined by the clinician.

AI/ML Overview

The provided text is a 510(k) summary for the MPS Acacia Nerve Block Needle. It is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. This type of submission, particularly for devices like needles, typically focuses on demonstrating equivalent physical and technical characteristics, and intended use as already approved devices, rather than conducting new clinical studies with acceptance criteria and performance metrics as might be seen for more complex or novel devices.

Therefore, many of the requested categories (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of 510(k) submission. The core of this document is a comparison to predicate devices, which implies that the acceptance criteria for "safety and effectiveness" are implicitly met by demonstrating similarity to already approved devices.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied by 510(k) process for predicate devices)	Reported Device Performance (from 510(k) Summary)
Safe for intended use	"The comparison between the predicate devices and the proposed device demonstrates that the MPS Acacia Nerve Block Needle is safe and effective..."
Effective for intended use	"...and is substantially equivalent to the products currently being legally marketed by Epimed International, and Pajunk Medical Technology."
Similar physical characteristics to predicate devices	"The MPS Acacia Nerve Block Needle has similar physical and technical characteristics to the predicate devices."
Similar technological characteristics to predicate devices	"The MPS Acacia Nerve Block Needle has similar physical and technical characteristics to the predicate devices."
Similar intended use to predicate devices	"The submission is based upon similar physical characteristics and intended use to the predicate devices."
Sterile, single use, non-pyrogenic, disposable	Device "will be provided as a sterile, single use, non-pyrogenic, disposable device."
Electrically conductive (for stimulating version)	The stimulating version "is electrically conductive at the distal end of the device."

2. Sample size used for the test set and the data provenance:

Not applicable / Not provided. This 510(k) relies on demonstrating substantial equivalence to predicate devices based on physical and technical characteristics and intended use, not on a new test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate devices.

4. Adjudication method for the test set:

Not applicable / Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical medical instrument (needle), not an AI or software-as-a-medical-device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

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

7. The type of ground truth used:

Predicate device equivalence. The "ground truth" in this context is the regulatory acceptance of the predicate devices based on their established safety and effectiveness through their own approval processes. The new device demonstrates "substantial equivalence" to this established "truth."

8. The sample size for the training set:

Not applicable / Not provided. This is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable / Not provided.

Summary

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DEC 8 2005

K052946

510(k) Summary

1.	Submitter:	MPS Acacia785 Challenger StreetBrea, CA 92821Tel: 714-257-0470Fax: 714-257-0513
2.	Contact:	Fergie F. Ferguson, RA/QA ManagerMPS Acacia
3.	Date prepared:	October 18, 2005
4.	Device trade name:	Nerve Block Needle
	Common name:	Nerve Block Needle
5.	Predicate device:510(k) number:Marketed by:	Blunt Nerve Block NeedleK041843Epimed International141 Sal Landrio DriveJohnstown, NY 12095
	Predicate device:510(k) number:Marketed by:	Pajunk Anesthesia Conduction NeedleK040965Pajunk Medical TechnologyKarl-Hall-Str. 178187 GeisingenGermany
	Predicate device:510(k) number:Marketed by:	Plexolong SetK013041Pajunk Medical TechnologyKarl-Hall-Str. 178187 GeisingenGermany

ნ. Description:

The MPS Acacia Nerve Block Stimulating Needle version is electrically conductive at the distal end of the device.

The Nerve Block Needle will be provided as a sterile, single use, non-pyrogenic, disposable device and will be available in a variety of lengths and gauges.

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510(k) Summary

1. Intended Use:
  The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents to provide regional anesthesia or the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter.

The MPS Acacia Nerve Block Stimulating Needle version is also intended to ald in locating specific peripheral nerves or nerve plexuses for the precise delivery of local anesthetic agents or anti-inflammatory medication for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter.

Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective nerve blocks, Intra-articular injections (i.e. Facet blocks), Interlaminar and Transforaminal approaches.

Technological comparison to predicate device: 8.
The MPS Acacia Nerve Block Needle has similar physical and technical characteristics to the predicate devices.
1. Non-clinical test summary:
  The submission is based upon similar physical characteristics and intended use to the predicate devices.
1. Conclusion:
  The comparison between the predicate devices and the proposed device demonstrates that the MPS Acacia Nerve Block Needle is safe and effective and is substantially equivalent to the products currently being legally marketed by Epimed International, and Pajunk Medical Technology.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three overlapping shapes that resemble an abstract symbol.

2005 DEC 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fergie F. Ferguson Regulatory Affairs/Quality Assurance Manager MPS Acacia 785 Challenger Street Brea, California 92821

Re: K052946

K032940
Trade/Device Name: MedFlo Pain Kit, MedFlo Nerve Block, MedFlo Ll and MedFlo LI-KVO Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: October 18, 2005 Received: October 20, 2005

Dear Mr. Ferguson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revious your becater over 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 Interstate conmisive prior to frid] 20, 20, 20, 20, 2017 accordance with the provisions of Amendinents, or to devroes that has in (Act) that do not require approval of a premarket the rederar I vou, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fist - 100 , listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into either class II (Special Controls) or class III If your device to subject to such additional controls. Existing major regulations affecting (1 MA), it may of subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in the announcements concerning your device in the Federal Register.

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Page 2 - Mr. Ferguson

Please be advised that FDA's issuance of a substantial equivalence determination does not i least be advised that I Dr o testained on that your device complies with other requirements Incall that I DTT may made a autes and regulations administered by other Federal agencies. of the Act of ally I ederal barates as requirements, including, but not limited to: registration 1 ou must comply with an are rebeling (21 CFR Part 801); good manufacturing practice allu listing (21 CF RT rur 007), abstitisg (QS) regulation (21 CFR Part 820); and if requirents as sections in the quality ajon control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow your to one finding of substantial equivalence of your device to a premarket notification. The PDF 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), If you desire specific at not Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You entition, "Phoonalianing al information on your responsibilities under the Act from the may oveall other generalacturers, 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/cdrh/industry/support/index.html.

Sincerely yours,

Clars

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

Applicant: MPS Acacia

510(k) NUMBER (IF KNOWN): __

DEVICE NAME: MedFlo, MedFlo Pain Kit, MedFlo Nerve Block, MedFlo LI and MedFlo LI-KVO INDICATIONS FOR USE:

1. The MPS Acacia Nerve Block Needle is intended for the administration of local anesthetic agents The MI O Acadia Nerve Brook News in the administration of anti-inflammatory medication to relieve chronic pain conditions, or to facilitate placement of a catheter.
1. The MPS Acacia Nerve Block Stimulating Needle version is also intended to aid in locating The Mir O Acadia Nerves or nerve plexuses for the precise delivery of local anesthetic agents on specific portphord her voo or for the relief of chronic pain conditions or to provide regional anesthesia, or to facilitate placement of a catheter.
1. Routes of administration may include Peripheral nerve blocks, Sympathetic blocks, Selective routes on administration may include (i.e. Facet blocks), Interlaminar and Transforaminal approaches.

Prescription Use XX (Part 21 CFR 801 Subpart D) Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

Arie Sulam

Dept. Of Anesthesiology, General Hospital,

trol, Dental Devices

K052946

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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).