LAURIMED SPINAL INJECTION SYSTEM

K080140 · Laurimed, LLC · BSP · May 9, 2008 · Anesthesiology

Device Facts

• Record ID: K080140
• Device Name: LAURIMED SPINAL INJECTION SYSTEM
• Applicant: Laurimed, LLC
• Product Code: BSP · Anesthesiology
• Decision Date: May 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laurimed Spinal Injection System is intended for use in procedures where injection is required. The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.

Device Story

The Laurimed Spinal Injection System is a sterile, single-use, disposable device consisting of a needle and a flexible catheter with an atraumatic distal tip. It is used by clinicians to deliver local anesthetic agents into the epidural space of the spine to provide regional anesthesia. The device functions as a conduit for fluid administration. It is intended for use in clinical settings where spinal injection procedures are performed.

Clinical Evidence

Bench testing only. Non-clinical performance testing was conducted to validate device performance and ensure it meets design specifications.

Technological Characteristics

Sterile, single-patient use, disposable device. Comprises a needle and a flexible catheter with an atraumatic distal tip. Designed for the infusion of local anesthetics into the epidural space.

Indications for Use

Indicated for patients requiring spinal epidural injections for the administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.

Regulatory Classification

Identification

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

Predicate Devices

• Epimed International, Inc. Blunt Nerve Block Needle (K041843)
• B. Braun Medical's Introcan Safety IV Catheter (K020785)
• Pajunk Medical Technology GmbH Anesthesia Conduction Needles (K040965)
• Smiths Medical ASD Portex Epidural Catheter (K062005)

Submission Summary (Full Text)

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K080140

510(k) Notification Spinal Injection System

# 510(k) Summary

MAY - 9 2008

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Name, Address, Phone and Fax Number of Applicant A.

Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: [phone] Fax: [phone]

## в. Contact Person

Nancy Lincé Clinical and Regulatory Affairs Consultant [phone]

## C. Date Prepared

January 21, 2008

#### D. Device Name

Spinal Injection System Trade Name: Common Name: Needle, Conduction, Anesthetic (w/wo Introducer) Anesthesia Conduction Needle (21 CFR §868.5150, Classification Name: Product Code BSP)

## E. Predicate Devices

The Laurimed Spinal Injection System is substantially equivalent to the Epimed International, Inc. Blunt Nerve Block Needle (K041843); B. Braun Medical's Introcan Safety IV Catheter (K020785); Pajunk Medical Technology GmbH Anesthesia Conduction Needles (K040965); and the Smiths Medical ASD Portex Epidural Catheter (K062005).

## ப Device Description

The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine.

The Spinal Injection System is supplied as a sterile, single patient use, disposable device.

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#### G. Intended Use

The Laurimed Spinal Injection System is intended for use in procedures where injection is required.

The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.

#### H. Technological Comparison

The technological characteristics and principals of operation of the Spinal Injection System are substantially equivalent to the noted predicate devices.

#### l. Summary of Non-Clinical Performance Data

Results of the non-clinical performance testing demonstrated that the Spinal Injection System is safe and effective for its intended use.

#### J. Summary of Data

The Spinal Injection System has been carefully compared to legally marketed devices with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Spinal Injection System functions as intended and meets design specifications. The comparison and non-clinical performance results demonstrate that the device is substantially equivalent to the predicate devices and is safe and effective for its intended use.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 9 2008

Ms. Nancy Lincé Clinical and Regulatory Affairs Consultant Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, California 94063

Re: K080140

Trade/Device Name: Spinal Injection System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: April 4, 2008 Received: April 7, 2008

Dear Ms. Lincé:

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 - Ms. Lincé

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,

Chris Litte, 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 Statement

510(k) Number (if known): K080140

Device Name: Spinal Injection System

Indications for Use:

Spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.

Prescription Use X (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: K080140