(95 days)
Not Found
No
The summary describes a mechanical securement device and does not mention any AI or ML components or functionalities.
No.
The device is used to secure percutaneous indwelling catheters, not to treat a disease or condition itself.
No
The device is described as a securement system for indwelling catheters, used to anchor catheters to an access site. Its function is to secure medical devices, not to diagnose conditions or diseases.
No
The device description explicitly states it is a "standalone subcutaneous anchoring securement system" and describes physical components like a "blunt nitinol anchor," "Base Assembly," and "Cover," indicating it is a hardware device.
Based on the provided information, this 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 details a "subcutaneous anchoring securement system" with a "blunt nitinol anchor deployed into the subcutaneous space." This further confirms its use within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to secure devices within the body.
N/A
Intended Use / Indications for Use
The SecurAcath 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
OKC, KMK
Device Description
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
The intended use of the SecurAcath device is to secure catheters by means of a subcutaneous anchor.
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)
Performance testing, includes dimensional verification, functional tests and securement reliability. Testing was performed to demonstrate that the device meets product specifications and is able to secure catheters to access sites. The device uses the same material as its predicate device and meets the same specifications as its predicate devices. Test results demonstrate that the device functions as intended. The following tests were performed:
- Dimensional
- Joint Tensile Strength
- Base & Cover Interaction
- Hinge performance
- Catheter Securement Performance
- Catheter Interaction
In all instances, the subject device functioned as intended and demonstrated equivalent performance to the predicate device.
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
§ 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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 26, 2018
Interrad Medical Inc % Denise Lenz Regulatory Consultant Libra Medical, Inc 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K180769
Trade/Device Name: SecurAcath Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: OKC, KMK Dated: May 21, 2018 Received: May 29, 2018
Dear Denise Lenz:
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.
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
1
801); medical device 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180769
Device Name SecurAcath
Indications for Use (Describe)
The SecurAcath 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K180769 510(K) SUMMARY
| Manufacturer's Name: | Interrad, Inc
181 Cheshire Lane, Suite 100
Plymouth, MN 55441 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Corresponding Official: | Denise Lenz
Regulatory Consultant, Libra Medical, Inc.
8401 73rd Ave North, Suite 63
Brooklyn Park, MN 55428 |
| Telephone Number: | 612-965-3445 |
| Email: | dlenz@libramed.com |
| Preparation Date: | June 25, 2018 |
| Device Trade Name: | SecurAcath |
| Device Common or Usual Name: | Implanted subcutaneous securement catheter |
| Regulation Name: | Percutaneous, implanted, long-term intravascular catheter. |
| Regulation Number: | 21 CFR 880.5970 |
| Product Code: | OKC, KMK |
| Device Class: | Class II |
| Classification Panel: | General Hospital |
| Primary Predicate Device: | K120935; SecurAcath |
Purpose of 510(k)
The purpose of this 510(k) is to add the 10F and 12F sized SecurAcath devices to the SecurAcath family to secure 10F and 12F catheters and to update the product specification testing requirements for device fatigue and reliability testing.
Indications for Use
The SecurAcath 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.
4
Device Description
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
The intended use of the SecurAcath device is to secure catheters by means of a subcutaneous anchor.
Technological Characteristics Comparison
The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters. The securement to the catheter access site is achieved by means of a blunt nitinol Anchor deployed into the subcutaneous space at the catheter access site. The securement of the catheved by the clamping of the catheter shaft between the Base Assembly and Cover of the device. This reduces catheter migration and accidental pull-out while not significantly affecting fluid flow.
The changes between the subject device and predicate device is the addition of the 10F and 12F sized SecurAcath devices to the SecurAcath family to secure 10F and 12F catheters. Design changes for the 10F and 12F includes the removal of alignment fingers and the shaft lock shape change to oval.
| Characteristic | Predicate Device:
SecurAcath (K120935) | Subject Device:
SecurAcath (K180769) | Comparison |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The SecurAcath 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. | The SecurAcath 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. | Same |
| Regulation
Number | 21 CFR 880.5970 | 21 CFR 880.5970 | Same |
| Product Code | OKC, KMK | OKC, KMK | Same |
| Device
Configuration | Single use, sterile device | Single use, sterile device | Same |
| Catheter
compatibility | 3F, 4F, 5F, 6F, 7F, 8F | 3F, 4F, 5F, 6F, 7F,
8F, 10F, 12F | Different |
| Biocompatibility | Materials testing in
accordance with ISO
10993-1 | Identical materials used in
new device configurations | Same |
| Sterility | EtO and SAL of 10-6
In accordance with ISO
11135 | EtO and SAL of 10-6
In accordance with ISO
11135 | Same |
5
Substantial Equivalence Discussion
The indications for use and intended use of the predicate 510(k) K120935, are equivalent to the subject 510(k) device.
The differences between the subject device and predicate device are the following:
- The additional sizes of 10F and 12F compatibility to the device ●
- Update the product specification testing requirements to the device fatigue and reliability . testing.
The additional sizes (10F, 12F) for SecurAcath have the same principles of operation, same technological characteristics, incorporate the same basic design, incorporate the same materials, have the same shelf life, and are packaged and sterilized using the same materials and processes as the previously cleared predicate device. The changes have been verified/validated through performance testing and risk management activities.
Based on the aforementioned modifications to the subject device, the subject device does not raise different types of safety and effectiveness questions when compared to the predicate device.
Performance Testing Summary
Based on a risk analysis of the changes, the following testing was conducted to demonstrate substantial equivalence to the predicate device:
Performance testing, includes dimensional verification, functional tests and securement reliability. Testing was performed to demonstrate that the device meets product specifications and is able to secure catheters to access sites. The device uses the same material as its predicate device and meets the same specifications as its predicate devices. Test results demonstrate that the device functions as intended. The following tests were performed:
- . Dimensional
- Joint Tensile Strength ●
- . Base & Cover Interaction
- Hinge performance ●
- . Catheter Securement Performance
- Catheter Interaction ●
A risk analysis was completed in accordance with ISO 14971:2012, Medical Devices -Applications of Risk Management to Medical Devices.
In all instances. the subject device functioned as intended and demonstrated equivalent performance to the predicate device.
CONCLUSION
The modifications to the device do not raise different questions of safety and effectiveness and are supported by risk management activities. The SecurAcath is substantially equivalent to the Interrad Medical SecurAcath device, cleared under K120935.