(300 days)
Not Found
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.
Yes.
The device is used for intermittent urinary catheterization, which is a medical procedure to drain the bladder and manage urinary retention or incontinence, thereby providing a therapeutic benefit.
No
Explanation: The device is described as a catheter for intermittent urinary catheterization, designed for drainage of the bladder. Its function is to facilitate the physical removal of urine, not to diagnose a medical condition.
No
The device description clearly outlines a physical medical device (urinary catheter) with associated hardware components (tubing, coating, packaging, etc.) and extensive bench testing related to these physical properties. There is no mention of any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For intermittent urinary catheterization." This describes a procedure performed on the body to drain the bladder, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device (a catheter) used to facilitate drainage, not a reagent, instrument, or system used to examine a specimen.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is a medical device used for a therapeutic/procedural purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
For intermittent urinary catheterization.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The proposed device: LoFric® Elle™, is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheter is prelubricated with a hydrophilic coating and immersed in water-based wetting fluid within its primary package. The primary package contains a sealed water container from which the wetting fluid migrates to the catheter tubing and activates the catheter surface. This results in minimal steps for preparation prior to use.
LoFric® Elle™, is available in one length (10cm) with a Nelaton (straight) tip and diameters of 10 Fr, 12 Fr and 14 Fr, to accommodate individual anatomy of female users.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bladder through the Urethra
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:
a) Biocompatibility testing was performed according to ISO 10993-1:2018 (Biological evaluation of medical devices, Part 1 : Evaluation and testing within a risk management process) and FDA Guidance "Use of International Standard ISO 10993-1".
b) Bench testing was performed according to ISO 20696:2018 (Sterile urethral catheters for single use) and internal test methods.
Performance testing was conducted according to applicable sections of standards in order to document the following properties of the LoFric Elle hydrophilic catheter:
Strength was verified by the test method in Annex A of ISO 20696.
Flow rate was verified by the test method in Annex E of ISO 20696.
Peak tensile force was verified by the test method in Annex H of ISO 20696.
Kink stability was verified according to ISO 20696.
Coating appearance was verified according to ISO 20696.
Diameter sizes were verified by design according to ISO 20696.
Water retention was verified by the internal method.
Coefficient of friction was verified by the internal method.
Osmolality was verified by the internal method.
Packaging sterile integrity was verified by the internal method.
Flexural Strength was verified by the internal method.
Beam Bending stiffness was verified by the internal method.
pH level was verified by the internal method.
All tests passed.
c) Sterilization validation was conducted according to AAMI/ANSI/ISO 11137-1:2015 (Sterilization of health care products = Radiation Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices) and ISO 11137-2 (Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose).
d) Requirements for materials, sterile barrier systems, and packaging systems was conducted according to ISO 11607-1:2006/(R)2010 (Packaging for terminally sterilized medical devices - Part 1).
e) Validation requirements for forming, sealing, and assembly processes was conducted according to ISO 11607-2:2006/(R)2010 (Packaging for terminally sterilized medical devices - Part 2).
f) Environmental conditioning and simulated shipping distribution were conducted according to
· ASTM D4332-14, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing and;
· ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
g) Real time and accelerated aging shelf life testing was completed according to ASTM F1980-16 (Standard guide for accelerated aging of sterile barrier systems for medical devices).
All tests met the pre-determined acceptance criteria.
No data from human clinical studies has been included to support the substantial equivalence of the LoFric Elle.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 17, 2022
Dentsply Sirona Rebecca Sporer Regulatory Affairs Specialist 221 West Philadelphia Street, Suite 60W York, PA 17401
Re: K211212
Trade/Device Name: LoFric® Elle™ Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: January 18, 2022 Received: January 19, 2022
Dear Rebecca Sporer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica K. Nguyen, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211212
Device Name LoFric® Elle™
Indications for Use (Describe) For intermittent urinary catheterization.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
Image /page/3/Picture/1 description: The image shows the Dentsply Sirona logo, which consists of a stylized leaf-like shape on the left and the text "Dentsply Sirona" on the right. The text is in a simple, sans-serif font. Below the logo is the alphanumeric code "K211212".
Page 1 of 5
510(k) SUMMARY LoFric® Elle™ K211212
- Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17404
| Contact Person: | Rebecca Sporer |
|---|---|
| Telephone Number: | 717-849-4793 |
| Fax Number: | 717-849-4343 |
| Email: | Corporate-RA@dentsplysirona.com |
| Date Prepared: | February 15, 2022 |
2. Device Name:
-
Proprietary Name: LoFric® Elle™ ●
II -
Classification Name: Urological catheter and accessories .
- Classification Number: 876.5130
-
Device Class: .
-
Product Code: EZD ●
3. Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| LoFric® Sense™ | K123751 | Wellspect HealthCare |
| (a division of Dentsply IH AB) |
4. Description of Device:
The proposed device: LoFric® Elle™, is a range of sterile, single-use, urinary catheters designed as an intermittent pathway for drainage of the bladder. The catheter is prelubricated with a hydrophilic coating and immersed in water-based wetting fluid within its primary package. The primary package contains a sealed water container from which the wetting fluid migrates to the catheter tubing and activates the catheter surface. This results in minimal steps for preparation prior to use.
LoFric® Elle™, is available in one length (10cm) with a Nelaton (straight) tip and diameters of 10 Fr, 12 Fr and 14 Fr, to accommodate individual anatomy of female users.
-
- Indications for Use:
For intermittent urinary catheterization
- Indications for Use:
4
6. Substantial Equivalence:
The subjects of this Traditional 510(k) is the introduction of the LoFric® Elle™, which is submitted due to the following principles:
- The subject and predicate device are sterile, single use, hydrophilic coated catheters intended for intermittent urinary catheterization.
- . The subject device shares the same coating and is made of the same basic tubing material as the predicate device.
The difference between LoFric® Elle™, and the predicate device is the different:
- . Wetting fluid and agent.
- Packaging configuration and visual appearance. ●
- Slightly modified chemical composition of the tubing base material.
- Different dip-coating solvent.
These modifications are made for ease of use and discretion improvements. An overview of the similarities and differences between the subject and predicate device is given in Table 1.
-
- Non-Clinical Performance Data.
Non-clinical testing data that was submitted, referenced, or relied upon to demonstrate substantial equivalence included:
- Non-Clinical Performance Data.
-
a) Biocompatibility testing was performed according to ISO 10993-1:2018 (Biological evaluation of medical devices, Part 1 : Evaluation and testing within a risk management process) and FDA Guidance "Use of International Standard ISO 10993-1".
-
b) Bench testing was performed according to ISO 20696:2018 (Sterile urethral catheters for single use) and internal test methods.
Performance testing was conducted according to applicable sections of standards in order to document the following properties of the LoFric Elle hydrophilic catheter:
- Strength was verified by the test method in Annex A of ISO 20696.
- Flow rate was verified by the test method in Annex E of ISO 20696.
- Peak tensile force was verified by the test method in Annex H of ISO 20696.
- Kink stability was verified according to ISO 20696.
- Coating appearance was verified according to ISO 20696.
- Diameter sizes were verified by design according to ISO 20696.
- Water retention was verified by the internal method.
- Coefficient of friction was verified by the internal method.
- Osmolality was verified by the internal method.
- Packaging sterile integrity was verified by the internal method.
- Flexural Strength was verified by the internal method.
- Beam Bending stiffness was verified by the internal method.
- pH level was verified by the internal method.
5
All tests passed.
- c) Sterilization validation was conducted according to AAMI/ANSI/ISO 11137-1:2015 (Sterilization of health care products = Radiation Part 1: Requirements for development, validation, and routine control of sterilization process for medical devices) and ISO 11137-2 (Sterilization of health care products - Radiation Part 2: Establishing the sterilization dose).
- d) Requirements for materials, sterile barrier systems, and packaging systems was conducted according to ISO 11607-1:2006/(R)2010 (Packaging for terminally sterilized medical devices - Part 1).
- e) Validation requirements for forming, sealing, and assembly processes was conducted according to ISO 11607-2:2006/(R)2010 (Packaging for terminally sterilized medical devices - Part 2).
- f) Environmental conditioning and simulated shipping distribution were conducted according to
- · ASTM D4332-14, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing and;
- · ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems.
- g) Real time and accelerated aging shelf life testing was completed according to ASTM F1980-16 (Standard guide for accelerated aging of sterile barrier systems for medical devices).
All tests met the pre-determined acceptance criteria.
-
- Clinical Performance Data.
No data from human clinical studies has been included to support the substantial equivalence of the LoFric Elle.
- Clinical Performance Data.
-
- Conclusion Regarding Substantial Equivalence
The subject device and the predicate device have the same intended use for intermittent urinary catheterization. All are single use catheters coated with polyvinyl pyrrolidone and available in one length with different diameters for female users. Performance data are included to address the safety of the subject device. The results of non-clinical bench testing, combined with the design, biocompatibility, and intended use comparison to the predicate device support the substantial equivalence of the subject device.
- Conclusion Regarding Substantial Equivalence
6
| Element | Proposed Device
LoFric® ElleTM | Predicate Device
LoFric® SenseTM (K123751) | Differences between proposed device and
predicate device |
|----------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | LoFric Elle is intended for intermittent
urinary catheterization | LoFric Sense is intended for intermittent
urinary catheterization | None |
| Product Code | EZD | EZD | None |
| Device for
Prescription use | Yes | Yes | None |
| Anatomical site | Bladder through the Urethra | Bladder through the Urethra | None |
| Type/Sizes | Nelaton
CH.10, 12 & 14 | Nelaton
CH. 8, 10, 12 & 14 | The proposed device is not available in CH.8/
FR.8 diameter. |
| Effective length
Acco.to: ISO 20696 | 10 cm (4 inches) | 10 cm (4 inches) | None |
| Tip Configuration | Nelaton (Straight) tip | Nelaton (Straight) tip | None |
| Catheter Material | Polyolefin based elastomer (POBE) | Polyolefin based elastomer (POBE) | The proposed device is composed of
identical base material with slightly different
chemical composition. Biocompatibility and
performance testing has been conducted and
included to address detailed material
formulation differences between the subject
and predicate devices in support of
substantial equivalence. |
| Hydrophilic surface
coating | Polyvinylpyrrolidone (PVP) | Polyvinylpyrrolidone (PVP) | None |
| Features | Single Use, pre-wet and ready to use | Single Use with Integrated water packet | The proposed device is ready to use,
immersed in wetting fluid without separate
water packet. |
| Wetting fluid | Sterile water with glycerol solution | Sterile water with salt solution | The proposed device uses glycerol as wetting
agent. Performance and biocompatibility
testing has been conducted and included to |
| Element | Proposed Device
LoFric® Elle™ | Predicate Device
LoFric® Sense™ (K123751) | Differences between proposed device and
predicate device |
| | | | address the differences between the subject
and predicate devices in support of
substantial equivalence. |
| Connector | Color coded end-funnel | Color coded end-funnel with sleeve for
non-touch technique during insertion | The proposed device has a 12 cm lower
container which can be re-connected as a L-
shape handle for non-touch technique during
insertion. |
| Packaging | A sealed lower and upper container
made by Polypropylene (PP) | Laminate foil of polyester with
aluminum oxide
(PET/Alox), linear low-density
polyethylene (LLDPE)
Water packet: aluminum foil | The proposed device has different packaging
configuration and visual appearance for ease
of use (ready to use) |
| Sterilization method | e-beam | e-beam | None |
| Condition of
Use | Single Use | Single Use | None |
Table 1. Similarities and Differences between the subject and predicate device
7