EPIFUSE CATHETER CONNECTOR, MODEL: 4909E

K092657 · Smiths Medical Asd, Inc. · CAZ · Nov 4, 2009 · Anesthesiology

Device Facts

• Record ID: K092657
• Device Name: EPIFUSE CATHETER CONNECTOR, MODEL: 4909E
• Applicant: Smiths Medical Asd, Inc.
• Product Code: CAZ · Anesthesiology
• Decision Date: Nov 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIMS Regional Anesthesia Tray is intended to be used to administer patient regional or local anesthesia.

Device Story

The EpiFuse™ Catheter Connector is a component of the SIMS Regional Anesthesia Tray used for regional/local anesthesia administration. It features a two-half design joined by a living hinge with an internal elastomeric tube. The clinician inserts an epidural catheter (19G, 20G, or 21G) into the base; folding the connector secures the catheter and creates a leak-proof seal. The yellow-colored body identifies it as an epidural component. The device allows one-handed activation and includes a locking mechanism to prevent accidental disconnection. To remove the catheter, a Luer slip device is inserted into a release aperture to separate the halves. Used in clinical settings by healthcare providers, the device simplifies catheter management and enhances securement during anesthesia delivery.

Clinical Evidence

No clinical data. Verification and validation testing were performed to confirm the safety and effectiveness of the EpiFuse™ Catheter Connector as a component of the SIMS Regional Anesthesia Tray.

Technological Characteristics

The device is an anesthesia conduction kit component. The EpiFuse™ Catheter Connector features a living hinge design, elastomeric tube for sealing/retention, and a Luer slip-activated release mechanism. It is designed for 19G, 20G, and 21G epidural catheters. The connector body is yellow for identification. No specific material standards or software algorithms are described.

Indications for Use

Indicated for the administration of regional or local anesthesia to 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.

Predicate Devices

• SIMS Regional Anesthesia Trays (K965017)

Submission Summary (Full Text)

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K0926657

## 510(k) Summary (Per 21 CFR 807.92)

- 1. SPONSOR
Smiths Medical ASD, Inc. 10 Bowman Drive Keene, NH 03431 Tel: [phone], prompt 4, x2923 Fax: [phone] Primary Contact: Cindy Engelhardt

Date Prepared: August 26 2009

#### 2. DEVICE NAME

Proprietary Name: SIMS Regional Anesthesia Trays Common/Usual Name: Anesthesia conduction kits Classification Name: Anesthesia conduction kits

### 3. PREDICATE DEVICES

SIMS Regional Anesthesia Trays (K965017)

#### 4. DEVICE DESCRIPTION

The EpiFuse™ Catheter Connector is an alternate catheter connector for inclusion in the SIMS Regional Anesthesia Tray.

The EpiFuse™ Catheter Connector consists of two halves joined by a living hinge. The main body contains an elastomeric tube. The catheter is inserted into the input hole at the base of the connector and is retained by the elastomeric tube when the two halves of the connector are folded together. The elastomeric tube also creates a seal to prevent leakage. The design of the modified EpiFuse™ Catheter Connector allows the user to close the device with one hand while holding the catheter with the other. To release the catheter, a Luer slip device is inserted into the release aperture and the two halves of the connector will separate allowing removal of the catheter.

The key features and benefits of the EpiFuse™ Catheter connector include a yellow connector body for easy identification as Epidural during clinical use. The EpiFuseTM Catheter Connector is designed for use with 19G, 20G, and 21G epidural catheters. It

# smiths medical

bringing technology to life

Smiths Medical ASD Inc. Smiths Medical North America 10 Bowman Drive Keene, NH 03431 0724, USA T: [phone] F: [phone] www.smiths-medical.com

NOV - 4 2009

ﻳﻜﺴﺎ

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offers one hand activation for a simplified ease of use and includes a secure locking mechanism to reduce the risk catheter disconnection.

### 5. INTENDED USE/INDICATIONS FOR USE

The SIMS Regional Anesthesia Tray is intended to be used to administer patient regional or local anesthesia.

### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The SIMS Regional Anesthesia Tray is comprised of various procedural components including needles, syringes, fenestrated drape, Touhy epidural needles and EpiFuse™ Catheter connector.

### 7. PERFORMANCE TESTING

Verification/validation testing confirm that the EpiFuse™ Catheter Connector is suitable for use with 19G, 20G, and 21G epidural catheters and is safe and effective for its intended use as a component of the SIMS Regional Anesthesia Tray.

Very truly yours,

SMITHS MEDICAL ASD, INC.

Canoe tt

Cynthia Engelhardt Regulatory Affairs Specialist

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Ms. Cindy Engelhardt Regulatory Affairs Specialist Smiths Medical ASD, Incorporated 10 Bowman Drive Keene, New Hampshire 03431

NOV - 4 2009

Re: K092657

Trade/Device Name: SIMS Regional Anesthesia Tray Regulation Number: 21CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: October 16, 2009 Received: October 19, 2009

Dear Ms. Engelhardt:

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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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/ucm11.5809.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 yours.

Susan Brunner

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

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: SIMS Regional Anesthesia Tray

Indications for Use:

The SIMS Regional Anesthesia Tray is used to administer patient regional or local anesthesia.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Z Schulth

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

510(k) Number: k92657

August 26, 2009 Smiths Medical Special 510(k): Device Modification - SIMS Regional Anesthesia Tray Alternate Catheter Connector (EpiFuse™)