(65 days)
Not Found
No
The description focuses on the physical characteristics and basic electrical stimulation function of the needle, with no mention of AI or ML algorithms for image processing, data analysis, or decision support.
No.
This device is designed for peripheral nerve stimulation and localization, not for treating a disease or condition.
No
The device is intended for locating and stimulating nerves for nerve block anesthesia, not for diagnosing a condition or disease. It aids in a procedure rather than providing diagnostic information.
No
The device description clearly outlines a physical needle with specific material properties, dimensions, and features (FEP coating, stainless steel, marker bands, echogenic dimpling, insulated wire). Performance studies listed are related to the physical characteristics of the needle (leakage, tensile strength, etc.), not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "locating and stimulating peripheral nerves and nerve plexuses for nerve block anesthesia techniques." This is a direct intervention on the patient's body for a therapeutic purpose (anesthesia).
- Device Description: The device is a needle designed for physical insertion into the body.
- Lack of In Vitro Activity: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis on specimens.
The device is a medical device used in vivo (within the living body) for a procedural purpose.
N/A
Intended Use / 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.
Product codes
BSP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound guidance
Anatomical Site
peripheral nerves and nerve plexuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Special 510(k): Device Modification Focus™ Echogenic Nerve Stimulating Needle Cook Incorporated 18 June 2010
510(k) SUMMARY
t
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:
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
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
5
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