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

AI/ML Overview

This is a 510(k) premarket notification for a medical device modification, specifically for the EpiFuse™ Catheter Connector within the SIMS Regional Anesthesia Trays. The provided document is a summary and an FDA clearance letter, not a detailed study report. Therefore, much of the requested information regarding a comprehensive clinical study or specific acceptance criteria with detailed performance metrics is not present. This type of submission often relies on a comparison to predicate devices and verification/validation testing rather than extensive clinical trials with human subjects.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of specific, numeric acceptance criteria. Instead, it broadly states that "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."

This suggests that the acceptance criteria would have been defined internally by the manufacturer and likely cover aspects such as:

Catheter Compatibility: Successful connection, retention, and release of 19G, 20G, and 21G epidural catheters.
Leakage Prevention: Effective sealing to prevent leakage.
Ease of Use: One-hand activation.
Secure Locking Mechanism: Reduction of disconnection risk.
Biocompatibility: Likely assessed based on material specifications, not explicitly detailed here.
Sterility: Assessed as part of the overall tray.
Dimensional Accuracy: Fit within the tray and with catheters.
Material Strength/Durability: E.g., ability to withstand repeated use/sterilization if applicable (though this is a disposable connector).

Reported Device Performance:

Compatibility: "suitable for use with 19G, 20G, and 21G epidural catheters."
Safety and Effectiveness: "safe and effective for its intended use."
Key Features and Benefits (implying performance):
- Yellow connector body for easy identification as Epidural.
- One-hand activation.
- Secure locking mechanism to reduce risk of catheter disconnection.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided text. The phrase "Verification/validation testing" is broad and does not detail specific sample sizes for tests such as pull strength, leak tests, or functional evaluations.
Data Provenance: Not specified. It's internal manufacturer testing, so it would be laboratory-based and likely conducted at the manufacturer's facility in Keene, NH, USA. It is not a clinical study with patient data, so "retrospective or prospective" is not applicable in the human-subject sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Given that this is a 510(k) for a device component, the "ground truth" would likely be established through engineering specifications, material standards, and performance testing against industry standards, not by clinical expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 typically refer to the resolution of discrepancies in expert interpretations (e.g., in reading medical images or clinical outcomes). This document describes engineering verification and validation, not a multi-expert review process for clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done or reported in this document. Such studies are typically for diagnostic imaging devices or software where human readers interpret data with and without AI assistance. This device is a mechanical connector.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This is a physical medical device component, not an algorithm. Its performance inherently involves human interaction for placement and connection.

7. Type of Ground Truth Used

The "ground truth" for this device would be established through engineering specifications, functional requirements, material standards, and performance against predefined testing protocols (e.g., for catheter retention force, leak integrity, ease of activation). It is not pathology, outcomes data, or expert consensus in the clinical sense. The document states "Verification/validation testing confirm..." which implies objective, measurable criteria were used.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, no training set is involved for this type of device.

Summary

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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: +1 603-352-3812, prompt 4, x2923 Fax: +1 603-352-6412 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: +1 603 352 3812 F: +1 603 355 8157 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the perimeter. At the center of the seal is a stylized depiction of an eagle, which is a common symbol used in US government emblems.

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 (800) 638-2041 or (301) 796-7100 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™)

Regulation Number and Section

§ 868.5140 Anesthesia conduction kit.

(a)
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.(b)
Classification. Class II (performance standards).