(168 days)
No
The device description and performance studies focus on the physical characteristics, materials, and standard performance metrics of a urinary catheter, with no mention of AI or ML capabilities.
No.
A therapeutic device is typically aimed at treating a disease or condition to achieve a cure or significant improvement. While bladder drainage is a medical intervention, this device primarily provides temporary relief for a symptom (bladder distention) rather than treating an underlying disease or restoring normal function in a therapeutic sense. It's a support/management device for bladder dysfunction.
No
Explanation: The device is an intermittent urinary catheter used for bladder drainage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is an intermittent urinary catheter made of conventional medical grade, biocompatible materials, indicating it is a physical hardware device.
Based on the provided information, the Cure Ultra® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "bladder drainage for males and females" by inserting the catheter through the urethra. This is a direct intervention on the body for a physiological purpose (draining urine), not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics and materials of the catheter, designed for insertion and drainage.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself for diagnostic markers), reagents, or any process that would involve testing specimens in vitro.
- Performance Studies: The performance studies listed are related to the physical and biological safety of the device for insertion and use within the body (sterilization, biocompatibility, packaging integrity, flow rate, etc.). These are typical performance tests for medical devices that interact with the body, not for IVDs.
In summary, the Cure Ultra® is a medical device used for a therapeutic/management purpose (bladder drainage), not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males. The urinary catheter comes in a variety of sizes and is packaged sterile for singleuse.
The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
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
Adults
Intended User / Care Setting
Adults who need assistance with bladder drainage due to conditions causing dysfunction of the urinary system.
The target population for Cure Ultra® is male and female adults.
Additional users are healthcare professionals including nurses, and/or caregivers, and family members who help patients with catheterization.
Cure Ultra® target users will be those who are able self-catheterize and have no or minimal dexterity impairment. However, users with dexterity impairments are not excluded from the intended users should they wish to use the device with assistance from others.
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)
Performance testing for the Cure Ultra® device system was conducted per applicable sections of voluntary and FDA consensus standards:
- Sterilization validation was adopted into an existing terminal cycle validation per AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:1995
- Biocompatibility testing (cytoxicity, irritation, sensitization, and chemical characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
- Sterile packaging in accordance with ISO 11607-1:2006 and ISO 11607-2:2006
- Real time aged shelf-life testing according to ISO 11607-1:2006
- Packaging integrity testing according to ASTM F2096-11 (2019)
- Diameter and effective shaft length testing performed according to ISO 20696:2018
- Flow rate, tensile, strength, and kink stability testing performed in accordance with ISO 20696:2018
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.
Cure Catheter® Closed System, K080881
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.
Cure Catheter® (K072539)
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.
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November 17, 2022
ConvaTec, Inc. % Dawn Norman Partner MRC Global, LLC 9085 E Mineral Circle, Suite 110 Centennial, CO 80112
Re: K221593
Trade/Device Name: Cure Ultra® Female, Cure Ultra® Male, Cure Ultra® Plus Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: October 6, 2022 Received: October 18, 2022
Dear Dawn Norman:
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 (OS) 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,
for
Angel A. Soler-garcia -S
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
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Indications for Use
510(k) Number (if known) K221593
Device Name
Cure Ultra® Female, Cure Ultra® Male, Cure Ultra® Plus
Indications for Use (Describe)
The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males. The urinary catheter comes in a variety of sizes and is packaged sterile for singleuse.
| 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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510(k) Summary
Cure Ultra® November 17, 2022
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92 (c).
| Company: | ConvaTec, Inc.
7815 National Service Road, Suite 600
Greensboro, NC 27409 |
|-------------------------------|------------------------------------------------------------------------------------------------------|
| Primary Contact: | Dawn Norman
Partner, MRC Global
Phone: 618-604-3064
Dawn.Norman@askmrcglobal.com |
| Company/Secondary
Contact: | Courtney Smith
Director, Regulatory Affairs
Phone: 239-776-2947
Courtney.Smith@ConvaTec.com |
| Trade Name: | Cure Ultra® Female, Cure Ultra® Male, Cure Ultra® Plus |
| Common Name: | Catheter, Urological |
| Regulation Name: | Urological Catheter and Accessories |
| Classification: | Class II |
| Regulation Number: | 21 CFR 876.5130 |
| Panel: | Gastroenterology/Urology |
| Product Code: | EZD |
| Predicate Device | Cure Catheter® Closed System, K080881 |
Description:
The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical
4
grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
Indications for Use:
The Cure Ultra® is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.
The Intended Use Population
Adults who need assistance with bladder drainage due to conditions causing dysfunction of the urinary system.
The target population for Cure Ultra® is male and female adults. The selection of the CH size of the catheter is based on the size of the patient and is prescribed by a health care professional. The length of the catheter meets the requirements of ISO 20696:2018 for the minimum effective shaft length (275 mm) for males and minimum effective shaft length (60 mm) for females.
Additional users are healthcare professionals including nurses, and/or caregivers, and family members who help patients with catheterization.
Cure Ultra® target users will be those who are able self-catheterize and have no or minimal dexterity impairment. However, users with dexterity impairments are not excluded from the intended users should they wish to use the device with assistance from others.
Basis of Substantial Equivalence:
The subject Cure Ultra® is substantially equivalent to the predicate Cure Catheter® Closed System (K080881).
The subject catheter is a modified version of the predicate Cure Catheter® Closed System (K080881). The subject device is a pre-lubricated, open catheter system that allows for patient convenience when catheterization is required while away from home. It does not include a collection bag and instead should be used to allow urine to flow directly into a toilet or other collection system (similar to the previously cleared Cure Catheter® (K072539)). Modifications to French size and length have been validated, the addition of male coude tip type, addition of the male gripper sleeve improved handling, and the lack of the collection bag does not present new safety or effectiveness questions or new risk to patients. The catheter tube and funnel are manufactured from Polyvinyl chloride (PVC) and pre-lubricated with Lubrajel MG, identical to the predicate device.
Thus, it can be concluded that the subject device modifications do not raise new questions about safety and effectiveness.
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Performance Testing:
Performance testing for the Cure Ultra® device system was conducted per applicable sections of voluntary and FDA consensus standards:
- Sterilization validation was adopted into an existing terminal cycle validation per AAMI/ISO 11135-1:2014/AMD 1:2018 and ISO 10993-7:1995
- Biocompatibility testing (cytoxicity, irritation, sensitization, and chemical characterization) according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
- Sterile packaging in accordance with ISO 11607-1:2006 and ISO 11607-2:2006
- Real time aged shelf-life testing according to ISO 11607-1:2006
- Packaging integrity testing according to ASTM F2096-11 (2019)
- Diameter and effective shaft length testing performed according to ISO 20696:2018
- Flow rate, tensile, strength, and kink stability testing performed in accordance with ISO 20696:2018
Conclusion:
The data and information provided in this submission support the conclusion that the Cure Ultra® device system (subject device) is substantially equivalent to its predicate device (K080881) and the proposed modification does not significantly affect the safety or effectiveness of the device.