(28 days)
Not Found
No
The summary describes a physical medical device (urinary catheter) with a hydrophilic coating and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
A urinary catheter is used for drainage, not for treating a disease or condition.
No
Explanation: The device description states its purpose is for "drainage of the bladder" and "intermittent catheterization of the urethra," indicating a therapeutic or facilitative role rather than a diagnostic one.
No
The device description clearly states it is a physical catheter with a hydrophilic coating, indicating it is a hardware device.
Based on the provided information, the LoFric® Plus Single Use Urinary Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intermittent catheterization of the urethra," which is a procedure performed directly on the patient's body to drain the bladder.
- Device Description: The device is a physical catheter designed to be inserted into the urethra. It facilitates drainage of urine from the bladder.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not perform any analysis or testing of a specimen.
Therefore, the LoFric® Plus Single Use Urinary Catheter is a medical device used for a therapeutic/diagnostic procedure performed in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LoFric® Plus Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
Product codes (comma separated list FDA assigned to the subject device)
72 GBM
Device Description
The LoFric® Plus Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating. The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes.
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)
Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements.
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.
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
K01237
Page 1 of 2
AUG 2 3 2001
510K Summary of Safety and Effectiveness
Astra Tech AB Lofric Plus Catheter
-
- Sponsor Name Astra Tech, INC. 430 Bedford St. Lexington, MA 02173
-
- Device Name
| Proprietary Name: | Astra Tech AB LoFric® Plus Single Use
Urinary Catheter |
|----------------------|--------------------------------------------------------------------------|
| Common/Usual Name: | Urethral Catheters |
| Classification Name: | Urethral Catheters and Accessories
72 GBM, Class II - Urology Devices |
-
- Identification of Legally Marketed Device
The modified The LoFric® Plus Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750).
- Identification of Legally Marketed Device
4. Device Description
The LoFric® Plus Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating.
The surface is hydrophilic and when the catheter is immersed in water or physiological saline solution for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of lengths andsizes.
5. Intended Use
The LoFric® Plus Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
1
K012374
Page 2 of 2
Comparison of Technological Characteristics 6
The modified The LoFric® Plus Single Use Urinary Catheter is substantially equivalent in intended use and design to the currently marketed The LoFric® Plus Single Use Urinary Catheter (K896750).
The only difference between the LoFric® Plus Single Use Urinary Catheter and The only difference both on the addition of a 15 cm size length to the the product line. These differences do not raise new questions of safety and effectiveness. Laboratory data demonstrates this.
6. Performance Testing
Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements.
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
AUG 2 3 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Astra Tech AB % Mr. Bruce R. Manning New England Biomedical Research, Inc. 96 West Main Street NORTHBOROUGH MA 01532
Re: K012374
Astra Tech AB LoFric® Plus Single Use Urinary Catheter (Urological Catheters and Accessories) Dated: July 25, 2001 Received: July 26, 2001 Regulatory Class: II 21 CFR 876.5130/Procode: 78 GBM
Dear Mr. Manning:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have and assisses We have reviewed your Secuent 116(k) houtsation of mises to the enclosure) to begally marketed predicate contracts on the device is substantaly equiralin (or the marceles). 16, the enactment date of the Medical Device Amendments, or to devices marked in interstate continete provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act therefore, market the device, subject on the gallering pro notice, and manufacturing procice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Prematet Approval), it may be subjections If your device is classince (Secadore) into clubs to copied on to topodate over found in the Code of Feaced Regulations, to such additional controls. Existure high regulation assumes compliance with the Current Good Manufacturing
Title 21, Parts 800 to 895. A substantialion assumes of Alabora I I III 21, Patts 800 to 692. A Subsantany Quirtual Collection (QS) for Medical Device: Cencral regulation (2) CFR Pat Practice requirements, is set four in the Quality Of Sock to Aministration (FDA) will verify such assumptions. Failure 820) and that, through periodic QS hispections, the regulatory action. In addition, FDA may publish further announcements to comply with the Unit Tegulation nay result in regalatory this response to your premarket notification sumission in the lucture comerning your device in all I cocral Regised. " Tease notes with a ct for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of the read the substantial equivalence of your device to a legally market predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vite If you done specific arriver to your derite of Campliance at (301) 594-4639. Additionally, for questions on the promotion and diagnosite of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, advising of your derres, promotet notification" (21CFR 807.97). Other general information on your responsibilities under Nisulanding of Icelerice to premation "QS to the manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmadsmamain.html".
Sincerely yours,
Nancy C. Brogdon
Nancy C. B Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Astra Tech AB LoFric® Plus Single Use Urinary Catheter Device Name:
Indications For Use:
The LoFric® Plus Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use Prescription Use (Per 21 CFR 801.109) (Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012374