(345 days)
Not Found
No
The summary describes a mechanical device for securing catheters and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as an accessory for securing percutaneous indwelling catheters, not as a device used for treating a disease or condition itself.
No
The device is described as a securement device for indwelling catheters, designed to reduce catheter migration and pull-out. It does not perform any diagnostic function such as identifying, assessing, or predicting disease.
No
The device description explicitly states it is a "single use, sterile device" consisting of a "subcutaneous anchor," which are physical components, not software.
Based on the provided information, the SecurAcath Universal Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor." This describes a device used in vivo (within the body) to secure a catheter.
- Device Description: The description reinforces this by explaining it's a "subcutaneous anchor that is deployed in the subcutaneous space." This is a physical device used on the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to perform tests on biological samples to provide information about a person's health. The SecurAcath Universal Device's function is purely mechanical securement of a catheter within the body.
N/A
Intended Use / Indications for Use
The SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
Product codes (comma separated list FDA assigned to the subject device)
LJS
Device Description
The SecurAcath Universal is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.
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)
The company performed testing to demonstrate that the device meets all product specifications. In all instances, the SecurAcath Universal functioned as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”
0
JUL - 9 2010
510(k) SUMMARY
Interrad Medical, Inc. SecurAcath Universal
.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Interrad Medical 181 Cheshire Lane Suite 100 Plymouth, MN 55441
763-225-6699 Telephone:
763-225-6695 Facsimile:
Contact Person: Joseph M. Goldberger, President & CEO, Interrad Medical
Date Prepared: July 8, 2010
Name of Device and Name/Address of Sponsor
Device Name: SecurAcath Universal
Sponsor: Interrad Medical 181 Cheshire Lane Suite 100 Plymouth, MN 55441
Common or Usual Name
Catheter securement device
Classification Name
Accessory to a percutaneous, implanted, long-term intravascular catheter
Predicate Devices
Interrad SecurAcath Catheter (K082047, K083081)
Venetec Statlock (K943147, now 510(k) exempt)
Arrow Staple Anchoring Device, which is provided with the Teleflex / Arrow Central Venous Catheter Kits (believed to be class I, 510(k)-exempt)
1
Intended Use / Indications for Use
The SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
Technological Characteristics
The SecurAcath Universal is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.
Performance Data
The company performed testing to demonstrate that the device meets all product specifications. In all instances, the SecurAcath Universal functioned as intended.
Substantial Equivalence
The SecurAcath Universal is substantially equivalent to the SecurAcath, Statlock, and Arrow Stapling device. The SecurAcath Universal has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the device and its predicate devices raise no new issues of safety or effectiveness as demonstrated by performance testing conducted. Thus, the SecurAcath Universal is substantially equivalent.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
Interrad Medical, Incorporated Mr. Joseph M. Goldberger President & Chief Executive Officer 181 Cheshire Lane, Suite 100 Plymouth, Minnesota 55441
JUL - 9 2010
Re: K092306
Trade/Device Name: SecurAcath Universal Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 2, 2010 Received: June 2, 2010
Dear Mr. Goldberger:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
Page 2- Mr. Kahan
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/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/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 vours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _
Device Name:
SecurAcath Universal
Indications for Use:
The SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ofvision Sign-Off) vision of Anesthesiology, General Hospital mection Control, Dental Devices
Page of
510(k) Number: K092306