LAURIMED SPINAL INJECTION SYSTEM

K091818 · Laurimed, LLC · BSP · Sep 23, 2009 · Anesthesiology

Device Facts

• Record ID: K091818
• Device Name: LAURIMED SPINAL INJECTION SYSTEM
• Applicant: Laurimed, LLC
• Product Code: BSP · Anesthesiology
• Decision Date: Sep 23, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Indicated for use in injections into the epidural space. Not for use with other catheters or needles.

Device Story

Trucath Spinal Injection System is a sterile, single-use, disposable device designed for epidural space injections. It integrates a flexible catheter with an atraumatic distal tip into a conduction needle. Used by clinicians in a clinical setting to facilitate spinal anesthesia or medication delivery. The device functions as a conduit for injections; it does not involve electronic processing, software, or automated decision-making. The atraumatic tip design aims to minimize tissue trauma during insertion. The system is intended for use as a standalone unit and is not compatible with other catheters or needles.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Sterile, single-patient use, disposable conduction needle system. Includes a flexible catheter with an atraumatic distal tip. No electronic components, software, or energy sources. Mechanical device for manual injection.

Indications for Use

Indicated for use in injections into the epidural space. Not for use with other catheters or needles.

Regulatory Classification

Identification

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

Predicate Devices

• Laurimed Spinal Injection System (K083909)

Submission Summary (Full Text)

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# SEP % 8 2009

Special 510(k) Spinal Injection System

# 510(k) Summary

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]

### B. Contact Person

Sevrina Ciucci Regulatory Affairs Consultant [phone]

### C. Date Prepared

September 22, 2009

#### D. Device Name

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

#### ட். Predicate Devices

The Trucath Spinal Injection System is substantially equivalent to the Laurimed Spinal Injection System (K083909).

#### F. Device Description

The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine.

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

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## Intended Use

Indicated for use in injections into the epidural space. Not for use with other catheters or needles.

#### Technological Comparison G.

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

#### H.. Summary of Non-Clinical Data

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

#### l. Summary of Data

The Trucath Spinal Injection System has been carefully compared to a legally marketed device 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 Trucath Spinal Injection System functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device and is safe and effective for its intended use.

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

Ms. Sevrina Ciucci Regulatory Affairs Consultant Laurimed L.L.C. 500 Arguello Street, Suite 100 Redwood City, California 94063

SEP 2 3 2009

K091818 Re:

> Trade/Device Name: Trucath Spinal Injection System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: August 24, 2009 Received: August 25, 2009

Dear Ms. Ciucci:

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 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. Ciucci

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use Statement

K 1691818 510(k) Number (if known):

Trucath Spinal Injection System Device Name:

Indications for Use:

The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.

Prescription Use ×

OR (per 21 CFR 801.109) Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultze

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

510(k) Number:

KO 9.1818