(266 days)
No
The device description and performance studies focus on the physical characteristics, materials, and mechanical function of a urinary catheter and collection system. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is intended for bladder drainage, which is a supportive and palliative function rather than directly treating a medical condition or disease.
No
The device is described as an intermittent urinary catheter for bladder drainage, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states it is a physical intermittent urinary catheter attached to a collection bag, made of conventional medical grade materials. The performance studies also focus on physical characteristics and sterilization, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "bladder drainage for males and females" via insertion through the urethra. This is a physical intervention for drainage, not a test performed on a sample taken from the body to provide diagnostic information.
- Device Description: The description details a physical catheter and collection bag system for draining urine. It does not mention any components or processes related to analyzing a sample for diagnostic purposes.
- Performance Studies: The performance studies listed focus on physical and material properties of the catheter and packaging (sterilization, biocompatibility, shelf-life, flow rate, tensile strength, etc.). These are typical performance tests for a medical device used for drainage, not for an IVD.
- Lack of IVD Indicators: There is no mention of analyzing a sample, detecting biomarkers, providing diagnostic information, or any other characteristic typically associated with an IVD.
In summary, the device is a medical device used for a therapeutic/management purpose (bladder drainage), not for providing diagnostic information from a sample.
N/A
Intended Use / Indications for Use
The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag 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 Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag 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 Dextra® and Cure Catheter® Closed System catheters 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 minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra
Indicated Patient Age Range
Adults
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)
Performance testing for the Cure Dextra® and Cure Closed System® were 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 10993-7:2008
- . Biocompatibility testing (cytotoxicity, irritation, sensitization, and subacute systemic toxicity) 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 11607-2:2019
- Real Time aged shelf-life testing according to ISO 11607-1:2019
- 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
The data and information provided in this submission support the conclusion that the Cure Dextra® and Cure Closed System (subject devices) are substantially equivalent to the predicate device (K080881).
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.
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
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November 7, 2023
ConvaTec, Inc. % Dawn Norman Partner MRC Global, LLC 9085 East Mineral Circle, Suite 110 Centennial, CO 80112
Re: K230400
Trade/Device Name: Cure Dextra® and Cure Catheter® Closed System Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: October 11, 2023 Received: October 11, 2023
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
1
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); 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-regulatory-information/postmarketing-safety-reportingcombination-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 -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
2
Indications for Use
510(k) Number (if known) K230400
Device Name
Cure Dextra® and Cure Catheter® Closed System
Indications for Use (Describe)
The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag 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 Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag 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.
| 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
510(k) Summary Cure Dextra® and Cure Catheter® Closed System November 7, 2023
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 Dextra® and Cure Catheter® Closed System |
| Common Name: | Catheter, Urological |
| Classification: | Class II |
| Regulation Number: | 21 CFR 876.5130 |
| Regulation Name: | Urological Catheter and Accessories |
| Product Code: | EZD |
| Primary Predicate: | Cure Catheter® Closed System. K080881 |
Device Description:
The Cure Dextra® and Cure Catheter® Closed System catheters 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 minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.
4
The target population for the Closed System and Dextra is both males and females. The selection of the French size (Ch) of the catheter is based on the size of the patient and is prescribed by a health care professional. The effective shaft length of the catheter (i.e., Dextra 286 mm and Closed System 290 mm) meets the requirements of ISO 20696:2018 for the minimum effective shaft length (275mm) for males and minimum effective shaft length (60 mm) for females.
Indications for Use:
The Cure Dextra® Closed System is an intermittent urinary catheter attached to a collection bag 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 Cure Catheter® Closed System is an intermittent urinary catheter attached to a collection bag 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.
Comparison of Technological Characteristics:
The subject catheters are a modified version of the predicate Cure Catheter® Closed System (K080881). The subject device modifications do not raise different questions about safety and effectiveness. A detailed comparison between the subject devices and the predicate and reference devices is provided in the table below.
5
Comparison of Technological Characteristics Table:
| Information | Subject Device | Primary Predicate Device | Reference Device | Substantial Equivalence |
|---|---|---|---|---|
| Device | Cure Catheter® Closed System® and | |||
| Cure Dextra® Closed System® | Cure Catheter® Closed System | |||
| K080881 | Cure Ultra® | |||
| K221593 | N/A | |||
| Indications for Use | The Cure Catheter® Closed System is an | |||
| intermittent urinary catheter attached | ||||
| to a collection bag 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 Cure Dextra® Closed System is an | ||||
| intermittent urinary catheter attached | ||||
| to a collection bag 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 Cure Catheter™ Closed System is | |||
| an intermittent urinary catheter | ||||
| attached to a collection bag 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 packaged sterile for single-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. | Identical to the primary predicate | |||
| Patient Population | For male and female adults | For male and female adults | For male and female adults | Identical to the primary predicate |
| Regulation | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 | Identical to the primary predicate |
| Product Code | EZD | KOD/FCM | EZD | Similar to the predicate, identical |
| to reference device | ||||
| Tube Size Range | ||||
| (Effective Length/OD | ||||
| French) | Closed System: 310mm (+/- 5) effective | |||
| length 8-16 Fr | ||||
| Dextra: 310 mm (+/- 5) effective length | ||||
| 12-16 Fr | Male: 310 mm effective length 8-16Fr | |||
| Female: 165mm (6.5 inch) length 8- | ||||
| 16Fr | Male Ultra: 375 mm (14.76 inch) | |||
| length, 8-18 Fr | ||||
| Female Ultra: 97 mm (3.82 inch) | ||||
| length, 8-16 Fr | ||||
| Female Ultra Plus: 175 mm (6.88) inch | ||||
| length, 8-18 Fr | The effective length of both the | |||
| subject devices and the predicate | ||||
| devices is identical | ||||
| Information | Subject Device | Primary Predicate Device | Reference Device | Substantial Equivalence |
| Device | Cure Catheter® Closed System® and | |||
| Cure Dextra® Closed System® | Cure Catheter® Closed System | |||
| K080881 | Cure Ultra® | |||
| K221593 | N/A | |||
| Technological Features | Straight or Coude Tip Catheter | |||
| PVC | ||||
| Smooth Tip | ||||
| Polished Eyelets | ||||
| Multiple sizes for both male and female | ||||
| use | ||||
| Sterile Packaged for single | ||||
| Pre-lubricated: Water Based Hydrophilic | ||||
| Coating | ||||
| Drainage Bag for collecting urine | ||||
| Gripper for ease of indexing tube | ||||
| Modified the interface tube to increase | ||||
| surface area of the bag weld | Straight Tip Catheter | |||
| PVC | ||||
| Smooth Tip | ||||
| Polished Eyelets | ||||
| Multiple sizes for both male and | ||||
| female use | ||||
| Sterile Packaged for single use | ||||
| Pre-lubricated: Water Based | ||||
| Hydrophilic Coating | ||||
| Drainage Bag for collecting urine | Straight or Coude Tip Catheter | |||
| PVC | ||||
| Smooth Tip | ||||
| Polished Eyelets | ||||
| Multiple sizes for both male and | ||||
| female use | ||||
| Sterile Packaged for single use | ||||
| Handling gripper for male catheters | ||||
| Pre-lubricated: Water Based | ||||
| Hydrophilic Coating | ||||
| Open end for convenient use without | ||||
| collection bag | The Closed System modified the | |||
| interface tube to increase surface | ||||
| area of the bag weld and the | ||||
| Dextra has a gripper for ease of | ||||
| indexing the tubing. These | ||||
| additions do not create different | ||||
| questions of safety or | ||||
| effectiveness. | ||||
| Sterilization | Ethylene Oxide | |||
| SAL: 10-6 | Ethylene Oxide | |||
| SAL: 10-6 | Ethylene Oxide | |||
| SAL: 10-6 | Identical to primary predicate | |||
| Biocompatibility | Evaluation and testing as applicable | |||
| within the risk management process, the | ||||
| FDA Biocompatibility Guidance | ||||
| Document (September 2023) and ISO |
| All tests were performed in
accordance with US FDA General
Program Memorandum #G95-1 and
Part- 10993-1 of the International
Standard Organization (ISO) Standard
(Biological Evaluation of Medical
Devices). The test articles were
considered biocompatible under the
conditions tested. | All tests were performed in accordance
with US FDA General Program
Memorandum #G95-1 and Part-
10993-1 of the International Standard
Organization (ISO) Standard (Biological
Evaluation of Medical Devices). The
test articles were considered
biocompatible under the conditions
tested. | Biological equivalency between
the subject device and the
predicate was established by
biological testing or justification. |
| Catheter Tube Material | PVC
Coudé tipped tubing contains a blue
stripe comprised of