(148 days)
Not Found
No
The summary describes a physical medical device (urinary catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No.
The device is described as an intermittent urinary catheter, which drains the bladder but does not provide therapy or treatment for a disease or condition.
No
The device is described as an "intermittent pathway for drainage of the bladder," indicating a functional role, not an analytical or diagnostic one. Its purpose is to facilitate urine removal, not to identify, monitor, or analyze a medical condition.
No
The device description clearly states it is a physical, single-use disposable urinary catheter, which is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The LoFrio® Single Use Urinary Catheter is a device that is inserted into the body to drain urine. It is a physical device used for a therapeutic or diagnostic procedure performed on the body, not a test performed on a sample from the body.
- Lack of IVD Characteristics: The provided information does not mention any testing of samples, analysis of biological markers, or any other activities typically associated with IVDs.
Therefore, based on the intended use and device description, the LoFrio® Single Use Urinary Catheter is a medical device used for intermittent urinary catheterization, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.
Product codes
EZD
Device Description
The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
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 testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
LoFric® Single Use Urinary Catheter
K113424
510(k) Summary
APR 1 7 2012
Astra Tech AB
LoFric® Single Use Urinary Catheter
April 17, 2012
Head of Regulatory Affairs
ADMINISTRATIVE INFORMATION
Manufacturer Name: Astra Tech AB Aminogatan 1, P.O. Box 14 Mölndal, Sweden SE-431 21 Telephone: +46 31 776 30 00 Fax: +46 31 776 30 10 Official Contact: Christina Lewing
Representative/Consultant:
Floyd G. Larson Kevin A. Thomas, Ph.D. Allison C. Komiyama, Ph.D. PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 Email: flarson@paxmed.com kthomas@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name: | LoFric® Single Use Urinary Catheter |
|---|---|
| Classification Name: | Urological catheter and accessories |
| Classification Regulations: | 21 CFR Part 876.5130, Class II |
| Product Code: | EZD |
| Classification Panel: | Gastroenterology and Urology Devices Panel |
| Reviewing Branch: | Urology and Lithotripsy Devices Branch |
INTENDED USE
LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.
1
510(k) Summary
DEVICE DESCRIPTION
The LoFrice Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. This device is a single-use disposable unit and is packaged in a thermoformed tray with a heat sealed paper lid. The catheter is available in a variety of lengths and configurations to accommodate individual anatomy of both male and female users. Both Nelaton (straight tip) and Tiemann (curved tip) designs are available.
EQUIVALENCE TO MARKETED DEVICE
Astra Tech AB submits information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the LoFric® Single Use Urinary Catheter is substantially equivalent in indications and design principles to the following legally marketed predicate device, which has been determined by FDA to be substantially equivalent to a legally marketed predicate device:
Astra Tech LoFric® Single Use Urinary Catheter - K896750
The subject device and the predicate device both have the same intended use, which is for intermittent urinary catheterization. Both are single-use plastic catheters coated with polyvinyl pyrrolidone. Both are made using the same basic manufacturing technology, and both have the same performance characteristics. Performance testing and biocompatibility testing were submitted to address efficacy and safety of the device and to show substantial equivalence to the predicate device.
Overall, LoFric® Single Use Urinary Catheter has the following similarities to the predicate devices:
- has the same intended use, .
- . uses the same operating principle,
- incorporates the same basic design. .
- incorporates the same or very similar materials, and .
- . has similar packaging and is sterilized using the same materials and processes
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. The text is in all capital letters and is in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Astra Tech AB % Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 SAN DIEGO CA 92130
APR 17 2012
Re: K113424
Trade/Device Name: LoFric® Single Use Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: March 30, 2012 Received: April 2, 2012
Dear Mr. Larson:
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.
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
3
Page 2-
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 yours,
Benjamin R. Fisher, Ph.D.
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
LoFric® Single Use Urinary Catheter
K113424
Indications for Use
510(k) Number:
113424
Device Name:
LoFric® Single Use Urinary Catheter
Indications for Use:
LoFrio® Single Use Urinary Catheter is intended for intermittent urinary catheterization.
Prescription Use X ______________________________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D).
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Page 1 of __ |
|---|---|
| -------------------------------------------------------- | -------------- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Gastrointestinal, and | |
| Urological Devices | |
| 510(k) Number | K113424 |