ECHOBRIGHT

K093662 · Life-Tech, Inc. · CAZ · Jun 24, 2010 · Anesthesiology

Device Facts

• Record ID: K093662
• Device Name: ECHOBRIGHT
• Applicant: Life-Tech, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Jun 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Echobright Kit is for regional anestheria and analgesia via blockade of peripheral nerves.

Device Story

Echobright Kit is a medical device used for regional anesthesia and analgesia. It facilitates peripheral nerve blockade. The device is intended for use by healthcare professionals in clinical settings. It functions as a kit to assist in the administration of anesthetic agents to specific nerve sites, aiding in pain management and surgical anesthesia. The kit components are used by clinicians to perform nerve blocks, which can improve patient outcomes by providing targeted pain relief.

Clinical Evidence

No clinical data provided; bench testing only.

Indications for Use

Indicated for regional anesthesia and analgesia via peripheral nerve blockade in patients requiring such procedures.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## JUN 2 4 2010

Mr. Jeff Kasoff Director of Regulatory Affairs Life Tech, Incorporated 13235 North Promenade Boulevard Stafford, Texas 77477

Re: K093662

Trade/Device Name: Echobright Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: June 11, 2010 Received: June 22, 2010

Dear Mr. Kasoff:

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. Kasoff

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Susan Ruane

T 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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K093662

## Indications for Use

510(k) Number (if known): 10 93662 Device Name: Echo bright Kit Indications For Use: The intended use of the Echobright Kit is for regional anestheria and analgesia via blockade of peripheral nerves.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schutter

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

510(k) Number: k093662 Page 1 of 2