(30 days)
None
No
The device description and performance studies focus on the physical properties and functionality of a urinary catheter, with no mention of AI or ML technologies.
No
The device is a urinary catheter intended for drainage, not for treating a disease or condition.
No
The device is described as a urinary catheter intended for intermittent catheterization and drainage of the bladder, not for diagnosing medical conditions. Its primary function is therapeutic or facilitative, allowing for urine drainage.
No
The device description clearly outlines physical components like a catheter, collection bag, and water sachet, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "intermittent catheterization of the urethra," which is a procedure performed on the human body to drain the bladder.
- Device Description: The device is a catheter designed to be inserted into the urethra.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of a specimen. It is a medical device used for a physical procedure.
Therefore, the LoFric® Hydro-Kit II Single Use Urinary Catheter is a medical device, not an IVD.
N/A
Intended Use / Indications for Use
The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
Product codes
72 GBM, 78 GBM
Device Description
The LoFric® Hydro-Kit II 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. The catheter is packed within a bag for urine collection. The urine collection bag is used as a wetting container prior to catheterization. Inside the closed urinary bag, a water sachet is placed. By holding the product upright and exerting a light pressure on the folded water sachet, the water will activate the hydrophilic catheter surface.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, 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 (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)
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.
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K043241
Page 1 of 2
Astra Tech, Inc
DEC 2 3 2004
510K Summary of Safety and Effectiveness
Astra Tech AB Lofric Hydro-Kit II Single Use Urinary Catheter
- Sponsor Name 1. Astra Tech, Inc.
- Device Name 2.
| Proprietary Name: | Astra Tech AB LoFric® Hydro-Kit II 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 3.
The modified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use to the LoFric® Single Use Urinary Catheter (K896750).
4. Device Description
The LoFric® Hydro-Kit II 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.
The catheter is packed within a bag for urine collection. The urine collection bag is used as a wetting container prior to catheterization. Inside the closed urinary bag, a water sachet is placed. By holding the product upright and exerting a light pressure on the folded water sachet, the water will activate the hydrophilic catheter surface.
1
K043241
Page 2 of 2
-
ട. Intended Use
The LoFric® Hydro-Kit II Single Use Urinary Catheter is intended for intermittent catheterization of the urethra. -
Comparison of Technological Characteristics රි
The modified The LoFric® Hydro-Kit II Single Use Urinary Catheter is substantially equivalent in intended use and design to the currently marketed The LoFric® Single Use Urinary Catheter (K896750).
The difference between the LoFrio® Hydro-Kit II Single Use Urinary Catheter and the predicate is the packaging concept and addition of accessories as urine collection bag and water sachet. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this.
-
- Performance Testing
Laboratory testing and biocompatibility testing was conducted to determine device functionality and conformance to design input requirements.
- Performance Testing
2
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2004
Mr. Niklas Lidskog President Astra Tech, Inc. 890 Winter Street, Suite 310 WALTHAM MA 02451
Re: K043241
Ro452 Fi
Trade/Device Name: Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 GBM Dated: November 22, 2004 Received: December 1, 2004
Dear Mr. Lidskog:
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); 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'll collection of substantial equivalence of your device to a legally premarked notheadon: "The PDF mastification 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), please if you desire specific active as one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allo, production other general information on your responsibilities under the Act from the 801:27). " Ou may octurers, International and Consumer Assistance at its toll-free number (800) DIVISION of Unian Hallacturess http://www.fda.gov/cdrl/dsma/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K043241 510(k) Number (if known):
Astra Tech AB LoFric® Hydro-Kit II Single Use Urinary Catheter Device Name:
Indications For Use:
The LoFric® Hydro-Kit II 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)
1 Prescription Use __
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
David A. Hegmann
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _