(41 days)
Not Found
No
The description focuses on a mechanical securement device and does not mention any AI/ML components or functions.
No.
The device is intended to secure catheters, not to treat a disease or condition.
No
The provided text explicitly states that the SecurAcath device is intended to "secure catheters by means of a subcutaneous anchor" and describes it as a "standalone subcutaneous anchoring securement system." There is no mention of it being used to diagnose conditions or processes.
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." This indicates it is a physical medical device, not software-only.
Based on the provided information, the SecurAcath device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is to secure catheters in vivo (within the body) by means of a subcutaneous anchor. This is a physical securement function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical device that anchors a catheter subcutaneously and clamps the catheter shaft. This is a mechanical function, not a diagnostic process.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SecurAcath device does not perform any of these functions. It is a medical device used for the physical securement of catheters.
N/A
Intended Use / Indications for Use
The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.
Product codes (comma separated list FDA assigned to the subject device)
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.
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 tests include dimensional verification, functional tests and marking durability. The company performed testing to demonstrate that the device meets product specifications and is not negatively impacted by the material change or marking process change. The device uses a modified Polypropylene material formulation to optimize the device markings using a laser instead of pad printing the device markings. All other materials are the same as its predicate device. The device continues to meet 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
Device Marking Durability
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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
Interrad Medical Inc % Denise Lenz Regulatory Consultant Libra Medical, Inc 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K210629
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: February 19, 2021 Received: March 2, 2021
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 Mav 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
James M. Simpson Jr -S7
for Paval Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210629
Device Name SecurAcath
Indications for Use (Describe)
The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY 8
8.1 ADMINISTRATIVE INFORMATION
February 19, 2021 Date of Summary Preparation:
Contact Information 8.1.1
Submitter/Manufacturer Interrad, Inc 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: 763-225-6699 Fax: 763-225-6695
Primary Submission Contact
Primary Contact
Denise Lenz
Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Cell: 612-965-3445 Email: dlenz@libramed.com
Secondary Submission Contact
Secondary Contact
Sew-Wah Tay Regulatory Consultant, Libra Medical, Inc. 8401 73rd Ave North, Suite 63 Brooklyn Park, MN 55428 Cell: 612-801-6782 Email: swtay@libramed.com
8.1.2 Device Information
| Trade Name | SecurAcath |
|---|---|
| Common Name | Subcutaneous securement device or Subcutaneous |
| Engineered Stabilization Device | |
| Classification Name | Implanted Subcutaneous Securement Catheter |
| Classification Regulation | 21 CFR 880.5970/880.5210/878.4200 |
| Class | Class II |
| Panel | General Hospital |
| Product Code | OKC / KMK |
8.2 PREDICATE DEVICE
The modified device is substantially equivalent to the Interrad Medical SecurAcath (K180994).
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8.3 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.
8.4 INTENDED USE
The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.
INDICATIONS FOR USE 8.5
The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
- a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
- b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage
TECHNOLOGICAL CHARACTERISTICS 8.6
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 SecurAcath has the same technological characteristics as the predicate device beside the predicate device is pad printed and does not contain the laser marking additive in the polypropylene portion to optimize the laser marking of the device (K180994).
| Table 8-1: Comparison of Device Characteristics to Marketed Predicate Device | ||
|---|---|---|
| Items | Predicate SecurAcath (K180994) | SecurAcath (Current Device) |
| Product Name | Interrad Medical SecurAcath | Same-No change |
| Intended Use | The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor. | Same - No change |
| Indication for Use | The SecurAcath Device is indicated for catheter securement to the access site by means of | |
| subcutaneous anchors in: | ||
| a) Short or long-term securement of percutaneous indwelling catheters for intravenous use | ||
| b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage | Same - No change | |
| Regulation | ||
| Number and | ||
| Product Code | 21 CFR 880.5970 | |
| 21 CFR 880.5210 | ||
| 21 CFR 878.4200 | ||
| OKC/KMK | Same - No change | |
| Classification | Class II | Same - No change |
| Regulatory | ||
| Classification | ||
| Name | Device, Vascular and Non-Vascular Catheter | |
| Securement | Same - No change | |
| Technological | ||
| Characteristics | Single use, sterile device for securing | |
| indwelling catheters. The device is a stand- | ||
| alone accessory to percutaneous indwelling | ||
| catheters and consists of a subcutaneous | ||
| nitinol anchor that is deployed in the | ||
| subcutaneous space at the catheter access site | ||
| to reduce catheter migration and pull-out. | Same - No change | |
| Technology- | ||
| Materials | PP Mevopur/Compound 100% SG702 | |
| Poppy V2 (first shot material) TPE Mevopur/Counpound 100% | ||
| G2706SLRBL V2 (second shot material) Nitinol (anchor) Marabu TPR 980 (Black ink) | PP Mevopur-Orange/Compound 100% | |
| SG702 (first shot material) with laser | ||
| marking additive. Material passed ISO | ||
| 10993, design verification and shelf life | ||
| testing and does not impact safety and | ||
| effectiveness. TPE Mevopur/Compound 100% | ||
| G2706SLRBL V2 (second shot material)- | ||
| Same, no change. Nitinol with/without premium surface | ||
| finish (anchor). Material passed ISO | ||
| 10993 and design verification testing and | ||
| the change does not impact safety and | ||
| effectiveness. | ||
| Dressing | ||
| Compatibility | Compatible with standard adhesive dressing | |
| including Biopatch and Tegaderm. | Same - No change | |
| Cleaning solution | ||
| compatibility | Compatible with standard skin cleaning | |
| solution including Chlorhexidine, alcohol, | ||
| and iodine solution. | Same - No change | |
| Principles of | ||
| Operation | Catheter shaft held between the Base and Cap | |
| of the SecurAcath with nitinol anchors | ||
| extending into the subcutaneous space from | ||
| the base. | Same - No change | |
| Use duration | For the life of the catheter secured unless | |
| anchors get accidently pulled out. | Same - No change | |
| MRI | ||
| Compatibility | MR Conditional | Same - No change |
| Device | ||
| Configuration | Single use, sterile device | Same - No change |
| Packaging | ||
| Configuration | 1) Device on a backercard and an Extension | |
| Tube Tag inside a Tyvek pouch. Ten | ||
| devices in Tyvek Pouch and ten Patient | ||
| Guide Cards inside the 10-up shelf box. | 1) Device in a Tyvek pouch. 10 devices in | |
| Tyvek Pouch inside the 10-up shelf box. | ||
| Patient Guide Cards available upon | ||
| request. New packaging configuration | ||
| 2) Tyvek pouch contains anti-block additive | ||
| (CAS number 7631-86-9) in the nylon. | passed ISTA 2A, ASTM D4169, sterile | |
| barrier performance testing and ISO | ||
| 10993-7 testing and the new packaging | ||
| configuration does not impact safety and | ||
| effectiveness. | ||
| 2) Tyvek pouch contains anti-block | ||
| additive (CAS number 1344-01-0) in the | ||
| nylon. Tyvek pouch supplier data for | ||
| sterilization validation and shelf life | ||
| were evaluated and pouch sealing | ||
| process validation testing passed. The | ||
| anti-block additive in the nylon layer | ||
| does not impact safety and effectiveness. | ||
| Labeling | ||
| Configuration | 1) Extension Tube Tag included in Tyvek | |
| pouch. |
- Label content on device applied as an
ink. - Labeling on Pouch and Shelf Box. | 1) Extension Tube Tag available upon
request. New packaging configuration
passed ISTA 2A, ASTM D4169, sterile
barrier performance testing and ISO
10993-7 testing. The new packaging
configuration does not impact safety and
effectiveness. - Label content on device applied as a
laser marking. Laser marking passed
testing per IEC 60601-1 for durability of
markings and the laser marking does not
impact safety and effectiveness. - Labeling on Pouch and Shelf Box-Same,
no change. |
| Shelf Life | Shelf life of 2 years. | Shelf life of 4 years. Shelf life product was
2X sterilized, passed design verification
testing including pouch seal peel and bubble
leak tests. The extension of the shelf life does
not impact safety and effectiveness. |
| Size | 3F, 4F, 5F, 6F, 7F, 8F, 10F, 12F | Same - No change |
| Biocompatibility | Meets ISO 10993-1 | Same - No change |
| Sterilization
method and
sterility | EtO and SAL of 10-6 | Same - No change |
8.7 DEVICE COMPARISON
Table 8-1; Comparison of Dovice Charactoristics to Marketed Prodicate Device
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PERFORMANCE DATA 8.8
Performance tests include dimensional verification, functional tests and marking durability. The company performed testing to demonstrate that the device meets product specifications and is not negatively impacted by the material change or marking process change. The device uses a modified Polypropylene material formulation to optimize the device markings using a laser instead of pad printing the device markings. All other materials are the same as its predicate device. The device continues to meet the same specifications as its predicate devices. Test results demonstrate that the device functions as intended. The following tests were performed:
Dimensional
7
Joint Tensile Strength Base & Cover Interaction Hinge performance Device Marking Durability
SUBSTANTIAL EQUIVALENCE 8.9
The SecurAcath device covered by this submission is substantially equivalent to the predicate Interrad Medical SecurAcath device K180994.
The Polypropylene material formulation change and change from pad printing to laser marking to the SecurAcath device results in the same indication for use, same principles of operation, same technological characteristics, incorporates the same design, and are packaged and sterilized using the same materials and processes as the previously cleared predicate device. The changes do not raise new questions of safety or efficacy.
8.10 CONCLUSION
Based on the test data, the same intended use, and same indications for use, the modified SecurAcath device is found to be substantially equivalent to its predicate.