(68 days)
No
The device description focuses on mechanical components and features, with no mention of AI or ML.
No.
The device is a connector for catheters used in regional anesthesia rather than directly administering therapy or treating a condition itself.
No
The device description explicitly states that the EpiFuse™ Catheter Connector is a component for administering regional or local anesthesia, not for diagnosing a condition.
No
The device description clearly details a physical connector made of materials like an elastomeric tube and a living hinge, designed to physically connect and retain a catheter. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "administer patient regional or local anesthesia." This is a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is a catheter connector used to connect a catheter for delivering anesthesia. It is a physical component used in a medical procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The device is clearly intended for use in a clinical procedure for administering medication, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SIMS Regional Anesthesia Tray is intended to be used to administer patient regional or local anesthesia.
Product codes
CAZ
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 offers one hand activation for a simplified ease of use and includes a secure locking mechanism to reduce the risk catheter disconnection.
The SIMS Regional Anesthesia Tray is comprised of various procedural components including needles, syringes, fenestrated drape, Touhy epidural needles and EpiFuse™ Catheter connector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K0926657
510(k) Summary (Per 21 CFR 807.92)
-
- 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
- SPONSOR
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
1
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
2
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.
3
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™)