(137 days)
The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
SureCath Set is a sterile, single-use hydrophilic coated intermittent catheter with integrated urine bag. An ampoule of saline solution is provided inside the urine bag. This saline solution from the ampoule is poured over the catheter to activate the coating before use.
Here's an analysis of the provided text regarding acceptance criteria and the study:
The document (K242049) is a Traditional 510(k) Summary for the Coloplast SureCath Set, a sterile, single-use hydrophilic coated intermittent catheter with an integrated urine bag. It demonstrates substantial equivalence to predicate devices. The information provided primarily focuses on non-clinical performance testing rather than human clinical studies involving AI assistance.
Based on the provided text, the device SureCath Set is a medical device, not an AI/ML powered device. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study, effect size of human readers with/without AI, or standalone algorithm performance are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document broadly states that "Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." It also mentions various ISO and ASTM standards to which the device was tested. However, it does not explicitly list specific quantitative acceptance criteria or detailed reported performance values for each test. It only states that the device "met the pre-determined acceptance criteria."
Implicit Acceptance Criteria (based on standards and test descriptions):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met acceptance criteria per ISO 10993 series for cytotoxicity, irritation/intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity. |
| Catheter Performance (ISO 20696, ASTM F623-19, Coloplast Test Methods) | Met acceptance criteria for: - Strength of connection between catheter and urine bag. - Aseptic insertion (non-touch approach) of catheter through urine bag. - Water amount of 20 ml in ampoule must activate coating on catheter. - Friction of the coated catheter after 30 seconds activation time. - Tearing and emptying of the urine bag. - Volume of the urine bag. - Strength of the urine bag. |
| Usability | Met acceptance criteria per EN/IEC 62366-1. |
| Packaging Integrity | Met acceptance criteria per ISO 11607-1, DS EN ISO 20696, ASTM D4169-22 for maintenance of sterile barrier and impact of transportation. |
| Shelf Life/Aging Stability | Met acceptance criteria after accelerated aging per ASTM F1980-21, demonstrating stability for the defined shelf life (24 months at time of submission, planned 36 months). |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical test. It states "Testing was performed on final, finished, and sterilized devices." The provenance of the data is from Coloplast A/S, Denmark. The tests are non-clinical, bench performance tests, so the concepts of "retrospective or prospective" human data don't directly apply here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of non-clinical device testing. There are no "experts" establishing a "ground truth" for a test set in the way it would be for an AI/ML clinical study (e.g., radiologists interpreting images). The "ground truth" for non-clinical tests is based on objective measurements against established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. Non-clinical bench tests rely on objective measurements against defined standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not conducted. The device is a physical medical device (intermittent catheter), not an AI-powered diagnostic or assistive tool. Therefore, there is no "AI assistance" for human readers to improve upon.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm-only performance study was not done. The device is not an algorithm or software requiring human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests is based on:
- Compliance with recognized international standards (ISO, ASTM, EN/IEC).
- Pre-determined acceptance criteria defined by Coloplast for specific performance aspects (e.g., strength, friction, volume, activation).
- Objective measurements of physical and chemical properties.
8. The sample size for the training set
This information is not applicable. "Training set" is a concept for AI/ML models. This document describes testing for a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
November 26, 2024
Coloplast Corp Vallabha Tantry Senior Regulatory Specialist 1601 West River Road North Minneapolis, Minnesota 55441
Re: K242049
Trade/Device Name: SureCath Set Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 12, 2024 Received: October 30, 2024
Dear Vallabha Tantry:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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
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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
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Indications for Use
Submission Number (if known)
K242049
Device Name
SureCath Set
Indications for Use (Describe)
The product is intended for use in male, female, and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
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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Image /page/4/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue text. To the right of the logo, there is the text "K242049" and "Page 1 of 7". The text indicates that this is the first page of a document that is seven pages long.
TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/SHoltedam13050 HumlebaekDenmark |
|---|---|
| Contact Person: | Vallabha Tantry Sr. Regulatory Affairs SpecialistColoplast1601 West River Road NorthMinneapolis MN 55411Phone: +1 (612)-806-1798Email: usvtan@coloplast.com |
| Date of Summary: | July 12, 2024 |
| Subject Device: | |
| Trade or ProprietaryName: | SureCath Set |
| Item/Model Numbers: | 28012, 28013, 28001, 28002, 28003, 28004, 28014, 28005 /28005S, 28006 / 28006S, 28007 / 28007S, 28008 / 28008S,28009 / 28009S, 28010, 28017, 28018, 28019, 28026 /28026S, 28027 / 28027S, 28028 / 28028S, 28029 / 28029S |
| Common Name: | Urological catheter and accessories |
| Regulation/ClassificationName: | Gastroenterology and Urology |
| Regulation Number: | 21 CFR 876.5130 |
| Product Code: | EZD |
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| Review Panel: | Gastroenterology/Urology |
|---|---|
| Predicate Device: | K973090, Conveen EasiCath Set.The predicate device has not been subject of a design-relatedrecall. |
| Reference Device: | K221401, Self-Cath and Self-Cath PlusThe reference devices have not been subject to a design-relatedrecall. |
| Device Description: | SureCath Set is a sterile, single-use hydrophilic coatedintermittent catheter with integrated urine bag. An ampoule ofsaline solution is provided inside the urine bag. This salinesolution from the ampoule is poured over the catheter toactivate the coating before use. |
| Indications for Use: | The product is intended for use in male, female, and pediatricpatients requiring bladder drainage as determined by theirphysician.This device is indicated for those individuals unable to promotea natural urine flow or for those individuals who have asignificant volume of residual urine following a naturalbladder-voiding episode. |
Technological Characteristics Comparison
The table below summarizes the technological characteristics of SureCath Set as compared to the predicate device.
| Parameter | Subject device | Predicate device | Reference Device |
|---|---|---|---|
| SureCath Set | Conveen EasiCath Set | Self-Cath and Self-CathPlus | |
| 510(k) Number | Unassigned | K973070 | K221401 |
| Regulation Name | Gastroenterology and Urology | Gastroenterology and Urology | Gastroenterology and Urology |
| Regulation Number | 21 CFR 876.5130 | 21 CFR 876.5130 | 21 CFR 876.5130 |
| Product Code | EZD | EZDKNX | EZD (Self-Cath)EZL (Self-Cath Plus) |
| Classification | II | II | II |
| Parameter | Subject device | Predicate device | Reference Device |
| SureCath Set | Conveen EasiCath Set | Self-Cath and Self-CathPlus | |
| PrescriptionDevice | Yes | Yes | Yes |
| Intended Use | Intermittentcatheterization throughthe urethra. | Intermittentcatheterizationthrough the urethra. | The product is intendedfor intermittentcatheterization throughthe urethra |
| Indications forUse | The product is intendedfor use in male, female,and pediatric patientsrequiring bladderdrainage as determinedby their physician.This device is indicatedfor those individualsunable to promote anatural urine flow or forthose individuals whohave a significantvolume of residual urinefollowing a naturalbladder-voidingepisode. | The ConveenEasiCath Set isindicated for use bypatients forintermittentCatherization for thepurpose of bladderdrainage. | Self-Cath andSelf-Cath Plus are intendedfor use in male, female,and pediatric patients(neonates, infants,children,adolescents,andtransitionaladolescents) requiringbladder drainage asdetermined by theirphysician. The devicesare indicated for thoseindividuals unable topromote a natural urineflow or for thoseindividuals who have asignificant volume ofresidual urine followinga naturalbladder-voiding episode. |
| Condition ofUse | Intermittent use andsingle use | Same | Same |
| DeviceCategorizationperISO 10993 | Surface contactingdevice in contact withmucosal membrane fora prolonged duration oftime (24 h < t< 30 days) | Same | Same |
| Sterility | SAL 10-6 | Same | Same |
| SterilizationMethod | Ethylene Oxide (EO),Half cycle, Over-kill | Same | Same |
| Shelf Life | 24 months at time ofsubmission (planned 36months) | 36 months | 24 months |
| Parameter | Subject device | Predicate device | Reference Device |
| SureCath Set | Conveen EasiCath Set | Self-Cath and Self-CathPlus | |
| CatheterMaterials | Polyvinyl chloride,DEHT | Polyvinyl chloride,DEHP | Same |
| HydrophilicCoating | Polyvinylpyrrolidone(PVP) with DEHT | Polyvinylpyrrolidone(PVP) with DBP | Polyvinylpyrrolidone(PVP) (Self-Cath Plus) |
| TipConfiguration | Nelaton tip andTiemann tip | Nelaton tip | Straight tipOlive Coudé tipTapered Coudé tip |
| Urine bagmaterial | Polypropylene (PP)(bottom film of theurine bag)Polyethylene (PE) | Same | Not applicable |
| Ampoule | The product is suppliedwith an ampoulecontaining sterile waterfor lubrication of thecatheter. The ampouleis placed inside theurine bag. | Same | None |
| Connector | Polyvinyl chloride(PVC) compoundcontaining differentmasterbatch colours andBis(2-ethylhexyl)terephthalate plasticizer(DEHT) | Polyvinyl chloride(PVC) compoundcontaining differentmasterbatch coloursand DEHP | Polyvinyl chloride(PVC) compoundcontaining differentmasterbatch coloursand Bis(2-ethylhexyl)terephthalate plasticizer(DEHT) |
| PrimaryPackagingDescription | Foil pouch whichprovides identificationof a used product | Same | Same |
| Parameter | Subject device | Predicate device | Reference Device |
| SureCath Set | Conveen EasiCath Set | Self-Cath and Self-CathPlus | |
| PackagingMaterials | Polyethyleneterephthalate (PET) /Polyethylene (PE)Uncoated medical paper | Same | Coated polyolefinUltra-low-densitypolyethylene/Ethylene-vinyl acetate |
| EffectiveCatheterLength | Male (CH 8 - 18)34cm / 13.4inPaediatric(CH 8 – 10)15cm / 5.8 inFemale (CH 8 – 16)15cm / 5.8 in | Same | Male: 14.9 inches (38cm)Female: 4.8 inches (12cm)Pediatric (CH05,CH06): 8.0 inches (20cm)Pediatric (CH08 andCH 10): 8.1 inches (21cm) |
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Image /page/6/Picture/1 description: The image shows the Coloplast logo on the left side. On the right side, the text "K242049 Page 3 of 7" is visible. The logo consists of a blue sphere with horizontal lines on top of it, followed by the word "Coloplast" in blue.
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Image /page/7/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue. To the right of the logo, there is the text "K242049" and "Page 4 of 7". The text appears to be a page number or document identifier.
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Image /page/8/Picture/1 description: The image shows the Coloplast logo, which includes a blue circular graphic to the left of the word "Coloplast" in blue font. To the right of the logo is the text "K242049 Page 5 of 7" in black font. The text indicates that this is page 5 of a 7-page document with the identifier K242049.
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Image /page/9/Picture/1 description: The image shows the Coloplast logo on the left side. On the right side of the image, the text "K242049 Page 6 of 7" is visible. The logo consists of a blue circle with white horizontal lines inside and the word "Coloplast" in blue bold letters.
Summary of Non-Clinical Performance Testing
| Non-clinical test summary: | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. |
|---|---|
| Biocompatibility: | ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation of testing within a risk management processISO 10993-5: 2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicityISO 10993-7: 2008: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residualsISO 10993-10: 2023: Biological evaluation of medical devices - Part 10: Tests for skin sensitizationISO 10993-11: 2017: Biological evaluation of medical devices - Part 11: Tests for systemic toxicityISO 10993-23: 2021: Biological evaluation of medical devices - Part 23: Tests for irritationThe following biological endpoints were addressed: cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity. |
| Catheter performance: | ISO 20696: 2018, Sterile urethral catheters for single useASTM F623-19, Standard performance specification for Foley CatheterColoplast Test Strength of connection between the catheter and the urine bagColoplast Test Method Aseptic insertion (non-touch approach) of catheter through urine bagColoplast Test Method for water amount of 20 ml in ampoule must activate coating on catheterColoplast Test Method Friction of the coated catheter after 30 seconds activation timeColoplast Test Method Tearing and emptying of the urine bagColoplast Test Method Volume of the urine bagColoplast Test Method Strength of the urine bagEN/IEC 62366-1:2015/A1:2020 Medical devices - Part 1: Application of usability engineering to medical devices |
| Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. | |
| Packaging: | ISO 11607-1:2020, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systemsDS EN ISO 20696: 2018, Sterile urethral catheters for single useASTM D4169-22 Standard Practice for Performance Testing of Shipping Containers and SystemsPackaging integrity testing was conducted to verify the maintenance of the sterile barrier through shelf life. Transportation testing was conducted to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment. |
| Aging: | ASTM F1980-21 Standard guide for accelerated aging of sterile barrier systems andmedical devices |
| The stability study investigated whether there were unexpected (significant) changes in product properties overthe shelf-life of the device. The properties meet the acceptance criteria after the aging cycle, the device istherefore deemed to be stable for the defined shelf life. |
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Conclusion
The performance testing demonstrates the subject device is as safe and effective as the predicate device.
§ 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.