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: 20, 21, 22 and 23.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cook Incorporated Focus™ Echogenic Nerve Stimulating Needle:

Based on the provided text, the submission is a "Special 510(k): Device Modification," indicating that the device is an updated version of an already cleared predicate device (22 and 23 Gauge Focus Echogenic Nerve Stimulating Needle, 510(k) number K093209). The modification involves introducing new gauge sizes (20 and 21 Gauge) for the existing needle design. Therefore, the focus of the testing is to demonstrate that these new gauge sizes perform comparably to the predicate devices and maintain safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test. Instead, it relies on demonstrating that the device reliably performs based on these tests. For a device modification, the implicit acceptance criterion is often that the results for the modified device are comparable to, or within acceptable limits of, the predicate device's performance for these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Leakage: No leakage beyond acceptable limits.	"The following tests were conducted to demonstrate reliable design and performance of the Focus Needle: - Leakage..."
Tensile Strength: Sufficient to prevent breakage during use.	"Tensile strength..."
Cannula Break Strength: Sufficient to prevent breakage during use.	"Cannula break strength..."
Penetration Force: Appropriate for intended use.	"Penetration force..."
Sterilization Testing: Device is sterile and maintains sterility.	"Sterilization testing..."
Biocompatibility Testing: Device is biocompatible.	"Biocompatibility testing."
Overall: Safe and effective for intended use.	"The results of these tests provide reasonable assurance that the device is safe and effective for its intended use."

Note: The provided text confirms that these tests were conducted and their results "provide reasonable assurance that the device is safe and effective," implying that the devices met the internal acceptance parameters for these tests, even if the specific numerical criteria are not detailed in this summary.

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

The document does not specify the sample sizes used for any of the tests (Leakage, Tensile strength, Cannula break strength, Penetration force, Sterilization testing, Biocompatibility testing).

The data provenance is also not explicitly stated. However, as this is a 510(k) submission from Cook Incorporated, it is highly likely that the testing was conducted prospectively by or for Cook Incorporated, likely in laboratories within the United States (where Cook is based), to support the substantial equivalence claim for the modified device.

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

The device being described is a physical medical device (needle) that undergoes engineering and biological performance testing, not an AI/software device that requires expert adjudication for diagnostic ground truth. Therefore, these types of experts and their qualifications would not be applicable to the studies described. The "ground truth" for these tests would be established through established engineering standards, laboratory protocols, and validated test methods.

4. Adjudication Method for the Test Set

Similar to point 3, an "adjudication method" like 2+1 or 3+1 is not applicable for the type of engineering and biological performance testing conducted on this physical medical device. The results are typically quantitative measurements against predefined specifications or qualitative observations (e.g., presence/absence of leakage, successful sterilization) based on established testing methodologies.

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

This is not applicable as the device is a physical echogenic nerve stimulating needle, not an AI-assisted diagnostic tool or a software device. Therefore, no MRMC study or AI assistance evaluation would have been conducted or is mentioned.

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

This is not applicable as the device is a physical echogenic nerve stimulating needle, not an AI algorithm.

7. The Type of Ground Truth Used

For the tests conducted:

Leakage, Tensile Strength, Cannula Break Strength, Penetration Force: The ground truth would be established by engineering specifications, industry standards, and validated test methods, which dictate acceptable ranges and limits for these physical properties. For example, a tensile strength test would result in a specified force value, which is then compared against a minimum requirement.
Sterilization Testing: The ground truth is confirmed through validated sterilization protocols (e.g., achieving a sterility assurance level – SAL) and methods like bacteriostasis/fungistasis tests for sterility, and endotoxin limits for pyrogenicity.
Biocompatibility Testing: The ground truth is established by ISO 10993 standards and related biological evaluation tests, which determine if a material is biologically benign and does not cause adverse reactions.

8. The Sample Size for the Training Set

This is not applicable as the device described is a physical medical device, not a machine learning model that requires a training set. The "training" for such a device comes from engineering design principles, material science, and manufacturing processes.

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

This is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Special 510(k): Device Modification Focus™ Echogenic Nerve Stimulating Needle Cook Incorporated 18 June 2010

510(k) SUMMARY

K101728

AUG 2 5 2010

Submitted By: Sean R. Werner, PhD. Regulatory Science Associate Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 (812) 339-2235 x 2685 14 May, 2010

Trade Name: Cook Incorporated Focus™ Echogenic Nerve Stimulating Needle

Proposed Classification Name: Needle, Conduction, Anesthetic (W/Wo introducer)

Indications for Use: 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.

Predicate Devices: 22 and 23 Gauge Cook Incorporated Focus Echogenic Nerve Stimulating Needle, 510(k) number K093209.

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: 20, 21, 22 and 23.

Substantial Equivalence:

The 20 and 21 Gauge Focus Echogenic Nerve Stimulating Needles are substantially equivalent to the predict 22 and 23 Gauge needles.

{1}------------------------------------------------

Special 510(k): Device Modification Focus™ Echogenic Nerve Stimulating Needle Cook Incorporated 18 June 2010

Test Data:

The following tests were conducted to demonstrate reliable design and performance of the Focus Needle:

Leakage, ●
Tensile strength, .
Cannula break strength, .
Penetration force, .
Sterilization testing, ●
Biocompatibility testing. .

The results of these tests provide reasonable assurance that the device is safe and effective for its intended use.

COMPANY CONFIDENTIAL

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized symbol with three curved lines, representing the human form. The symbol is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter. The text is in a sans-serif font and is oriented to follow the curve of the circle.

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

Mr. Sean Werner Regulatory Science Associate Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402

AUG 2 5 2010

Re: K101728

Trade/Device Name: Focus " Echogenic Nerve Stimulating Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: July 23, 2010 Received: July 26, 2010

Dear Mr. 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.

{3}------------------------------------------------

Page 2- Mr. 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 (OS) 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 vours.

Nh 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

{4}------------------------------------------------

Special 510(k): Device Modification Focus™ Echogenic Nerve Stimulating Needle Cook Incorporated 18 June 2010

K101728

Indications for Use

510(k) Number (if known):

Device Name:

Focus™ Echogenic Nerve Stimulating Needle

Indications for Use:

Prescription Use _ XX (Per 21 CFR 801.109)

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Y Schutte

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K/01728

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).