(84 days)
Not Found
No
The summary describes a standard intermittent urinary catheter with no mention of AI or ML capabilities. The performance studies focus on physical and biocompatibility testing, not algorithmic performance.
Yes
Explanation: The device is a urinary catheter, which is used for drainage of the bladder. This addresses a medical condition (urinary retention or need for intermittent drainage) and is intended to restore normal body function or alleviate symptoms, fitting the definition of a therapeutic device.
No
Explanation: The device is described as a single-use catheter for intermittent urinary catheterization, specifically for drainage of the bladder. Its function is to provide a pathway for drainage, which is a therapeutic or management function, not a diagnostic one. There is no mention of it being used to identify or determine a medical condition.
No
The device description clearly describes a physical catheter and associated water packet, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Intermittent urinary catheterization," which is a procedure performed directly on the patient to drain the bladder.
- Device Description: The device is a catheter designed to be inserted into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not perform any such analysis.
The device is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Intermittent urinary catheterization.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
LoFric® Sense™ is a single-use catheter designed as an intermittent pathway for drainage of the bladder. The catheters are available in one length with a Nelaton (straight) tip and a variety of diameters to accommodate individual anatomy. Each catheter is packaged with a water packet that is to be broken immediately before use in order to soak the tubing.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence included: dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623.
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.
Astra Tech, LoFric® Primo™ - K122078
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
K123751
Page 1 of 2
LoFric® Sense™
FEB 2 8 2013
510(k) Summary
Wellspect HealthCare
LoFric® Sense™
December 27, 2012
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Wellspect HealthCare
Aminogatan 1, P. O. Box 14
Mölndal, Sweden SE-431 21 | |
|---------------------------|---------------------------------------------------------------------------------|--------------------------------------------|
| | Telephone: | +46 31 376 40 00 |
| | Fax: | +46 31 376 30 10 |
| Official Contact | Herman Fahlström | |
| | Head of Quality Systems and Regulatory Affairs | |
| Representative/Consultant | Allison C. Komiyama, Ph.D. | |
| | Floyd G. Larson | |
| | PaxMed International, LLC | |
| | 12264 El Camino Real, Suite 400 | |
| | San Diego, CA 92130 | |
| | Telephone: | +1 (858) 792-1235 |
| | Fax: | +1 (858) 792-1236 |
| | Email: | akomiyama@paxmed.com
flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | LoFric® Sense™ |
|---|---|
| Classification Name | Urological catheter and accessories |
| Classification Regulations | 21 CFR Part 876.5130, Class II |
| Product Code | EZD |
| Classification Panel | |
| Reviewing Branch | Gastroenterology and Urology Devices Panel |
| Urology and Lithotripsy Devices Branch |
510(k) Summary
1
510(k) Summary
K123751
Page 2 of 2
INTENDED USE
Intermittent urinary catheterization.
DEVICE DESCRIPTION
LoFric® Sense™ is a single-use catheter designed as an intermittent pathway for drainage of the bladder. The catheters are available in one length with a Nelaton (straight) tip and a variety of diameters to accommodate individual anatomy. Each catheter is packaged with a water packet that is to be broken immediately before use in order to soak the tubing.
EQUIVALENCE TO MARKETED DEVICE
Wellspect HealthCare submits information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, LoFric® Sense " is substantially equivalent in indications and design principles to the following legally marketed predicate device:
Astra Tech, LoFric® Primo™ - K122078
The subject device and the predicate device have the same intended use for intermittent urinary catheterization. All are single-use plastic catheters coated with polyvinyl pyrrolidone. They are made using the same basic manufacturing technology, and all have similar 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. Any differences in the technological characteristics between the subject and predicate device do not raise new issues of safety or efficacy.
Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence included: dimensional analysis, biocompatibility testing and modified performance testing according to ASTM F623.
The data included in this submission demonstrate substantial equivalence to the predicate device listed above.
Overall, LoFric® Sense" has the following similarities to the predicate device:
- . 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2013
Wellspect HealthCare % Allison C. Komiyama, Ph.D. Senior Regulatory Specialist PaxMed International, LLC 12264 El Camino Real, Suite 400 SAN DIEGO CA 92130
Re: K123751
Trade/Device Name: LoFric® Sense™ Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: December 5, 2012 Received: December 6, 2012
Dear Dr. Komiyama:
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. Ilsting 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.
3
Page 2 - Allison C. Komiyama, Ph.D.
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/3/Picture/6 description: The image shows the name "Benjamin B. Fisher -S" in a stylized font. The first name, Benjamin, is written in a simple, bold font. The middle initial and last name are written in a more complex, geometric font that appears to be made up of lines and shapes. The "-S" at the end is written in the same simple, bold font as the first name.
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
Indications for Use
K123751 510(k) Number:
LoFric® Sense™ Device Name:
Indications for Use:
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 1
Benjamin 2013.02.28
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Jrological Devices 510(k) Number _ KIZ375