(449 days)
No
The summary describes a mechanical securement device and does not mention any AI or ML components or functionalities.
No
The device is described as a securement system for percutaneous indwelling catheters. Its function is to secure catheters, not to treat a disease or condition itself.
No
Explanation: The device description and intended use clearly state that the SecurAcath device is a "subcutaneous anchoring securement system" used to "secure the catheter to the access site." It functions as a mechanical securement device for catheters, not for diagnosing any medical conditions.
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: The intended use is for securing percutaneous indwelling catheters for intravenous use or abscess/general drainage. This is a physical securement function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device description details a mechanical anchoring system using subcutaneous anchors and clamping. This is a physical device for securing a catheter, not a system for analyzing biological samples.
- 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 information for diagnosis, monitoring, or screening
The SecurAcath is a medical device used for securing catheters in vivo (within the body), not for performing diagnostic tests in vitro (outside the body).
N/A
Intended Use / Indications 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 or long-term securement of percutaneous indwelling catheters for abscess/general drainage
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.
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
Performance tests include dimensional verification, functional tests and securement reliability. The company performed testing 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 Base & Cover Interaction Catheter Securement Performance Catheter Interaction Human Factor Design Validation
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5210 Intravascular catheter securement device.
(a)
Identification. An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
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July 9, 2019
Interrad Medical Inc. % Denise Lenz Regulatory Consultant Libra Medical, Inc 8401 73rd Ave North, Suite 63 Brooklyn Park, Minnesota 55428
Re: K180994
Trade/Device Name: SecurAcath (5F, 6F, 7F, 8F, 10F, 12F) Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter Regulatory Class: Class II Product Code: OKC, KMK Dated: April 13, 2018 Received: April 16, 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. 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.
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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 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 mediation-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.
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180994
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 or long-term securement of percutaneous indwelling catheters for abscess/general drainage
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K180994
510(K) SUMMARY 8
8.1 ADMINISTRATIVE INFORMATION
Date of Summary Preparation: July 8, 2019
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 Device, Intravascular Catheter Securement Classification Regulation 21 CFR 880.5210 21 CFR 878.4200 Class Class II
General Hospital Panel Product Code KMK
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8.2 PREDICATE DEVICE
The SecurAcath is substantially equivalent to the following:
- · K180769 Interrad Medical SecurAcath
DEVICE DESCRIPTION 8.3
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.
8.5 INDICATIONS 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
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 (K180769)
8.7 PERFORMANCE DATA
Performance tests include dimensional verification, functional tests and securement reliability. The company performed testing 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 Base & Cover Interaction Catheter Securement Performance Catheter Interaction Human Factor Design Validation
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SUBSTANTIAL EQUIVALENCE 8.8
The SecurAcath device covered by this submission is substantially equivalent to the predicate Interrad Medical SecurAcath device K180769.
The SecurAcath has the same intended use as the predicates. The SecurAcath has the same technological characteristics and operating principles as the predicate SecurAcath.
The differences in indication for use of the SecurAcath and the predicates do not raise new questions of safety and efficacy.
The SecurAcath is determined to be substantially equivalent to the Revolution catheter securement device and the presently marketed Interrad Medical SecurAcath (K180769)
CONCLUSION 8.9
The results of these activities demonstrate that the SecurAcath is as safe, as effective, and performs as well as the predicate devices.