(30 days)
Not Found
No
The summary describes a mechanical device for securing catheters and does not mention any AI or ML components or functions.
No
Explanation: The device is used for securing catheters and does not treat or diagnose a disease or condition.
No
The device is described as securing percutaneous indwelling catheters and preventing migration or pull-out, which are functions related to securement and access, not diagnosis. Its purpose is to physically anchor a catheter.
No
The device description clearly states it is a "single use, sterile device" consisting of a "subcutaneous anchor," indicating it is a physical 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 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 physical device used to hold a catheter in place, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description reinforces this, describing a "single use, sterile device for securing indwelling catheters" with a "subcutaneous anchor." This is a mechanical device, not a reagent, instrument, or system intended for in vitro examination of specimens.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical securement.
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 is a single use, sterile device for securing indwelling catheters. The device is a standalone 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)
Performance tests included dimensional verification; securement reliability. The company performed testing to demonstrate that the device meets all product specifications and is able to secure catheters to insertion sites. The device uses the same material as its predicate device and meets similar specification as its predicate devices. Test results demonstrate that the device functions as intended.
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
SecurAcath Special 510(k) Notification
510(k) Page 24
APR 2 7 2012
SECTION 8. 510(K) SUMMARY
8.1 ADMINISTRATIVE INFORMATION
8.1.1 Name and address
Sponsor:
181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: (763) 225-6699 Fax: (763) 225-6694
Contact Person Sew-Wah Tay, PhD Regulatory Consultant 18555 37th Ave N, Plymouth, MN 55446
Tel: 612-801-6782 Fax: 763-208-4465 Email: swtav@libramed.com
March 27, 2012 Date Prepared:
8.1.2 Device Name
| Trade Name | SecurAcath |
|---|---|
| Common Name | Catheter securement device |
| Classification Name | Implanted subcutaneous securement |
| catheter | |
| Classification | 21 CFR 880.5970/880.5210 |
| Class II |
8.1.3 Applicant
Applicant"s Name:
Interrad Medical Inc. 181 Cheshire Lane, Suite 100 Plymouth, MN 55441 Tel: (763) 225-6699 Fax: (763) 225-6694
T
1
8.2 PREDICATE DEVICE
Interrad Medical Inc. SecurAcath Device, K092306
8.3 Intended/indication 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.
8.4 TECHNOLOGICAL CHARACTERISTICS
The SecurAcath is a single use, sterile device for securing indwelling catheters. The device is a standalone 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.
8.5 SUBSTANTIAL EQUIVALENCE
The SecurAcath device covered by this submission is substantially equivalent to the original Interrad Medical SecurAcath device K092306.
The SecurAcath™ has the same indication for use, same principles of operation, and similar technological characteristics as the previously cleared predicate device. The minor differences between this device and its predicate devices do not raise new questions of safety or efficacy.
8.6 PERFORMANCE DATA
Performance tests included dimensional verification; securement reliability. The company performed testing to demonstrate that the device meets all product specifications and is able to secure catheters to insertion sites. The device uses the same material as its predicate device and meets similar specification as its predicate devices. Test results demonstrate that the device functions as intended.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Interrad Medical. Incorporated C/O Dr. Sew-Wah Tay Regulatory Consultant Libra Medical, Incorporated 8401 73rd Avenue North Suite 63 Minneapolis, Minnesota 55428
APR 2 7 2012
Re: `K120935
Trade/Device Name: SecurAcath Divice Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term Intravascular Catheter. Regulatory Class: II Product Code: OKC, KMK Dated: March 27, 2012 Received: March 28, 2012
Dear Dr. Wah Tay:
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- Dr. Wah Tay
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 /ucm 115809.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,
Anthony D. Watson, B.S., M.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
March 27, 2012
SECTION 7. INDICATION FOR USE STATEMENT
510(k) Number (if known):
Device Name: SecurAcath Device
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.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rhi C. Ch
(Division Sign-Off) (Division Sign-Um)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, Devices Division of Anosthoontal Devices
510(k) Number: _