(151 days)
Not Found
None
No
The summary describes a physical medical device (umbilical catheter) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
The device is used for diagnostic and administrative purposes (sampling blood, monitoring blood pressure, administering fluids) rather than for treating a disease or condition.
No
Explanation: The device is intended for sampling blood, monitoring blood pressure, or administering fluids, which are procedures for patient management and treatment rather than for diagnosis.
No
The device description clearly states it is a "SILICONE UMBILICAL CATHETER, DUAL LUMEN," which is a physical medical 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 sampling blood, monitoring blood pressure, or administering fluids intravenously. These are procedures performed directly on the patient's body, not on samples of bodily fluids or tissues in vitro (outside the body).
- Device Description: The device is a silicone umbilical catheter, which is a physical device inserted into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or any other activity typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on direct patient intervention.
N/A
Intended Use / Indications for Use
THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.
Product codes
FOS
Device Description
Not Found
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
NEONATAL AND PEDIATRIC PATIENTS
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Mr. Clyde N. Baker Regulatory Manager Footprint Medical, Incorporated 1203 Camden Street San Antonio, Texas 78215
SEP % 5 2009
Re: K091213
Trade/Device Name: Silicone Umbilical Catheter, Dual Lumen Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code; FOS Dated: September 14, 2009 Received: September 18, 2009
Dear Mr. Baker:
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.
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.
1
Page 2- Mr. Baker
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.
Anting D. a. Wintin for
Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
510(K) NUMBER (if known): K-091213
DEVICE NAME: FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER, DUAL LUMEN.
INDICATIONS FOR USE:
THIS PRODUCT IS INTENDED FOR USE IN NEONATAL AND PEDIATRIC PATIENTS TO SAMPLE BLOOD, MONITOR BLOOD PRESSURE OR ADMINISTER FLUIDS INTRAVENOUSLY.
concurrence of cdrh, office of device evaluation
Chandler Ross
(Division Sign-Off) C Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: Ko91213
| PRESCRIPTION USE | XX |
|---|---|
| (per 21 CFR 801.109) |
OR
Over The Counter Use
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