The Focus™ Echogenic Nerve Stimulating Needle is intended for locating and stimulating peripheral nerves and nerve plexuses for nerve block anesthesia techniques using a Peripheral Nerve Stimulator and/or ultrasound guidance.

Device Description

The Focus Needle is a sterile, single use FEP-coated stainless steel needle with a B Bevel tip. The needle contains black marker bands every 10 mm to aid in placement and echogenic dimpling on the distal 10 mm to enhance visibility under ultrasound guidance. An insulated wire is attached to the stainless steel cannula and can be connected to a peripheral nerve stimulator unit. The device will be available in the following gauge sizes: 22 and 23.

AI/ML Overview

The provided document describes a medical device, the Cook Incorporated Focus™ Echogenic Nerve Stimulating Needle, and its 510(k) clearance process. However, it does not contain information regarding acceptance criteria, specific device performance metrics, or a formal study comparing the device to acceptance criteria in the format usually associated with a clinical or performance study.

Instead, the document focuses on:

Substantial Equivalence: Comparing the Focus Needle to predicate devices based on technological characteristics and intended use.
Verification Testing: A list of engineering and quality control tests performed to demonstrate reliable design and performance.
Animal Model Evaluation: A general statement about verifying electrical current application to stimulate a nerve in an animal model.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document, nor can I answer many of the specific questions about sample sizes, ground truth establishment, or multi-reader studies, as these types of detailed studies are not described.

Here's an analysis of what can be extracted or inferred from the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed reported performance metrics (e.g., in terms of sensitivity, specificity, accuracy, or performance against a defined threshold). It lists verification tests that were performed to demonstrate reliable design and performance, implying that the device met the internal specifications for these tests, but the specific criteria and results are not reported.

Acceptance Criteria (Inferred from Verification Tests)	Reported Device Performance
Mechanical/Physical Integrity:
Air leakage under vacuum	Met (Implied)
Fluid leakage under pressure	Met (Implied)
Force to remove protector	Met (Implied)
Needle to hub bond strength	Met (Implied)
Wire to electrical connector bond	Met (Implied)
Wire tensile strength	Met (Implied)
Wire to hub tensile strength	Met (Implied)
Cannula break strength	Met (Implied)
Penetration force	Met (Implied)
Biocompatibility:
Biocompatibility testing	Met (Implied)
Sterilization:
Sterilization testing	Met (Implied)
Functional Performance (Nerve Stimulation/Visibility):
Electrical current application can stimulate a nerve	Verified in an animal model
Enhanced visibility by ultrasound (due to dimpling)	Implied by design

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

Test Set Sample Size: Not specified. The document mentions "an evaluation in an animal model" but does not give a sample size for this animal study or any other performance test. The other tests listed are more akin to engineering verification or quality control tests, for which "test sets" in the context of clinical performance are not typically defined.
Data Provenance: The animal study would be prospective (conducted specifically for this submission). Country of origin is not specified, but the applicant (Cook Incorporated) is based in the USA.

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

Not applicable/Not specified. The document does not describe a study involving expert readers or ground truth established by experts for performance evaluation. The animal model likely used physiological responses or direct observation of nerve stimulation to verify function, not expert consensus on image interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable/Not specified. This is relevant for studies involving human interpretation or subjective assessments, which are not described here.

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:

No. This device is a modified needle, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed/described.

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

No. This device is a physical medical instrument (a needle), not an algorithm or software. "Standalone" performance as typically understood for AI/software devices is not applicable. The device's "standalone" performance relates to its mechanical integrity, biocompatibility, sterilization, and its ability to conduct electricity and be visible under ultrasound, which were verified by the listed tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the animal model, the ground truth for nerve stimulation would likely have been direct physiological response (e.g., muscle contraction, evoked potentials) or direct visualization of nerve activation, performed by veterinary or surgical specialists. For the engineering tests, "ground truth" is typically defined by engineering specifications and objective measurements (e.g., measured force, visual inspection for leakage).

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of the "Study" described:

The document describes verification testing and an animal model evaluation rather than a formal clinical study with acceptance criteria and statistical analysis of performance against a ground truth dataset. The focus of the submission is on demonstrating substantial equivalence to predicate devices by showing that the new device shares similar technological characteristics and performs its intended functions reliably, based on engineering tests and a general functional evaluation in an animal model. These tests confirm the physical properties, safety (biocompatibility, sterilization), and basic functional aspects (nerve stimulation).

Summary

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Cook Incorporated FocusTM Echogenic Nerve Stimulating Needle Traditional 510(k) 09 October 2009

K093209
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page 1 of 3

5. 510(k) Summary

FEB 2 6 2010

Cook Incorporated Focus™ Echogenic Nerve Stimulating Needle 510(k) Summary 21 CFR 807.92

1. Submitter Information:

Applicant:

Cook Incorporated

Address:

Phone Number: Fax Number:

Contact: Contact Address:

750 Daniels Way P.O. Box 489 Bloomington, IN 47402

(800) 468-1379 (812) 332-0281

Sean Werner, PhD Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402

Contact Phone Number: Contact Fax Number:

812-339-2235 x2685 812-332-0281

2. Device Information:

Trade name: Common name: Classification:

Regulation:

Product Code:

Focus™ Echogenic Nerve Stimulating Needle Needle, Conduction, Anesthetic (W/Wo introducer) Class II

21 CFR § 868.5150 Anesthesia Conduction Needle

BSP

Company Confidential

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3. Predicate Devices:

Cook Incorporated's Focus Echogenic Nerve Stimulating Needle (hereafter referred to as the Focus Needle) is substantially equivalent to the EchoStim Facet Tip Needle manufactured by Hakko Medical Co., Ltd. of Japan and distributed in the U.S. by Havel's Inc. under 510(k) clearance K063380. The Focus Echogenic Nerve Stimulating Needle is also substantially equivalent to the Temena Hybrid Nerve Location Needle manufactured by TE ME NA under 510(k) clearance K080603.

4. Device Description:

5. Intended Use:

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6. Technological Characteristics:

The Focus Needle consists of a stainless steel cannula coated with a fluorinated ethylene propylene polymer to provide resistance to loss of electrical current along the shaft of the needle, a plastic hub with an attachment point for a connection tube, and an insulated wire attached to the cannula to allow connection to a nerve stimulator unit. Additionally, the distal 10 mm of the needle are dimpled using a pattern designed to enhance visibility by ultrasound. The technological characteristics of the Focus Needle and the two predicate devices, the EchoStim Facet Tip Needle and the Temena Hybrid Nerve Location Needle are substantially equivalent in that all devices are coated with an electrically resistant polymer to allow for electric nerve stimulation, and all devices can be visualized with ultrasound technology. No new technological aspects are being introduced with the proposed device.

To demonstrate reliable design and performance of the Focus Needle, the following verification testing was performed:

. Air leakage under vacuum,
. Fluid leakage under pressure,
Force to remove protector. .
. Needle to hub bond strength,
Wire to electrical connector bond, .
. Wire tensile strength.
. Wire to hub tensile strength,
Cannula break strength, .
. Penetration force,
Sterilization testing, .
Biocompatibility testing. .

Additionally, an evaluation in an animal model was carried out to verify that electrical current applied through the Focus Needle by a Peripheral Nerve Stimulator unit can stimulate a nerve.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Dr. Sean Werner Regulatory Science Associate Cook, Incorporated 750 Daniels Way PO Box 489 Bloomington, Indiana 47402

FEB 2 6 2010

Re: K093209

Trade/Device Name: Focus™ Echogenic Nerve Stimulating Needle Regulation Number: 21CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: February 19, 2010 Received: February 22, 2010

Dear Dr. Werner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 Dr. Werner

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Rh. for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cook Incorporated FocusTM Echogenic Nerve Stimulating Needle Traditional 510(k) 09 October 2009

4. Indications for Use Statement

510(k) Number (if known): K093209

Device Name: Focus™ Echogenic Nerve Stimulating Needle

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schulten

sion Slan-Off Division of Anesthestology. General Hospital Infection Control. Dental Devices

810(k) Number: K093209

Company Confidential

Regulation Number and Section

§ 868.5150 Anesthesia conduction needle.

(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).