(162 days)
Not Found
Not Found
No
The summary describes a simple urinary drainage catheter with no mention of AI, ML, image processing, or any computational analysis of data.
Yes
The device is described as "intended for drainage of urine," which directly addresses a medical condition or function, categorizing it as therapeutic.
No
This device is a urinary drainage catheter, which is used for treatment (draining urine) rather than diagnosis.
No
The device is described as a "flexible tube intended for drainage of urine," which is a physical hardware component, not software.
Based on the provided information, the Footprint Urinary Drainage Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health. They are used for diagnosis, monitoring, or screening.
- The Footprint Urinary Drainage Catheter is a device that is inserted into the body to drain urine. Its function is mechanical and therapeutic, not diagnostic.
The description clearly states its purpose is for "drainage of urine from small pediatric or Neonatal patients," which is a direct intervention on the patient, not an analysis of a specimen.
N/A
Intended Use / Indications for Use
The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
small pediatric or Neonatal 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): 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.
Not Found
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
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows a stylized emblem or logo. It features a series of three parallel, curved lines that resemble the wings of a bird in flight. The lines are thick and bold, creating a sense of movement and dynamism. The emblem is positioned in the upper portion of the image, with a faint, partial word or phrase visible below it, oriented vertically.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2 2009
Mr. Clyde N. Baker Regulatory Manager Footprint Medical, Inc. 1203 Camden Street SAN ANTONIO TX 78215
Re: K090576
Trade/Device Name: Footprint Urinary Drainage Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 24, 2009 Received: July 29, 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.
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
1
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jandra M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
090576
510(K) NUMBER (if known):
FOOTPRINT URINARY DRAINAGE CATHETER DEVICE NAME:
INDICATIONS FOR USE:
The Footprint Urinary Drainage Catheter is a flexible tube intended for drainage of urine from small pediatric or Neonatal patients. This is a prescription device intended for use for less than 30 days. It is not implanted and is not a life supporting device.
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION
| PRESCRIPTION USE
| (per 21 CFR 801.109) | XX |
|---|---|
| ------------------------------------------ | ---- |
I A M In Norg (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
OR
Over The Counter Use
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