PERIPHERAL NERVE BLOCK SUPPORT TRAY

K073187 · Life-Tech, Inc. · CAZ · Apr 22, 2008 · Anesthesiology

Device Facts

• Record ID: K073187
• Device Name: PERIPHERAL NERVE BLOCK SUPPORT TRAY
• Applicant: Life-Tech, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Apr 22, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Peripheral Nerve Block Support Tray is used for administration of regional or local anesthesia to a patient

Device Story

Peripheral Nerve Block Support Tray; sterile kit containing components for regional or local anesthesia administration. Used in clinical settings by healthcare professionals. Facilitates anesthesia delivery; supports procedural workflow. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Support tray for anesthesia administration. Class II device (21 CFR 868.5140, Product Code CAZ). Mechanical kit components; no electronic, software, or energy-based features.

Indications for Use

Indicated for patients requiring regional or local anesthesia administration.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2008

Mr. Jeff Kasoff, RAC Director of Regulatory Affairs Life-Tech, Incorporated 4235 Greenbriar Drive Stafford, Texas 77477-3995

Re: K073187

Trade/Device Name: Peripheral Nerve Block Support Tray Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: April 10, 2008 Received: April 11, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours.

Shih-Lin Lu, Ph.D.

Chiu Lin, Ph.D. 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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## Indications for Use

510(k) Number (if known): K073) 8 Tray Device Name: Periphera) Nerve Block Support Indications For Use: ations For Use:
Peripheral Nerve Block Support Tray is used for administration The egional or local anestheria to a patient

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)

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

510(k) Number: K073187

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