FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE

K101728 · Cook, Inc. · BSP · Aug 25, 2010 · Anesthesiology

Device Facts

• Record ID: K101728
• Device Name: FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE
• Applicant: Cook, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Aug 25, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Focus™ Echogenic Nerve Stimulating Needle is a sterile, single-use device for peripheral nerve block anesthesia. Input: electrical current from external peripheral nerve stimulator; ultrasound waves for visualization. Device consists of FEP-coated stainless steel cannula with B-bevel tip; features black marker bands (10 mm intervals) for depth placement and echogenic dimpling (distal 10 mm) for ultrasound visibility. Attached insulated wire connects to nerve stimulator. Used in clinical settings by anesthesia providers. Needle facilitates nerve localization via electrical stimulation and ultrasound-guided placement. Benefits include enhanced needle visibility and precise nerve targeting for anesthesia delivery.

Clinical Evidence

Bench testing only. Testing included leakage, tensile strength, cannula break strength, penetration force, sterilization, and biocompatibility. No clinical data provided.

Technological Characteristics

Materials: FEP-coated stainless steel. Design: B-bevel tip, 10 mm black marker bands, echogenic dimpling on distal 10 mm. Energy: Electrical stimulation via external peripheral nerve stimulator. Sizes: 20, 21, 22, 23 Gauge. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring peripheral nerve or nerve plexus localization and stimulation for nerve block anesthesia. Used with peripheral nerve stimulators and/or ultrasound guidance.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• 22 and 23 Gauge Cook Incorporated Focus Echogenic Nerve Stimulating Needle (K093209)

Submission Summary (Full Text)

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

#### 510(k) SUMMARY

t

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 [phone] 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.

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

# Test Data:

S

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

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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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.

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#### 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 [phone] or [phone] 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

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

# K101728

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#### Indications for Use

510(k) Number (if known):

#### Device Name:

Focus™ Echogenic Nerve Stimulating Needle

#### 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.

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)

OR

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