(200 days)
Self-Cath and Self-Cath Plus are intended for use in male, female and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. The devices are 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.
Self-Cath and Self-Cath Plus devices are single-use, sterile catheters for intermittent urinary catheterization. Self-Cath is an uncoated catheter and Self-Cath Plus has a hydrophilic-coating. The catheters are sterilized by ethylene oxide (EO).
The provided text describes the submission for FDA clearance of the "Self-Cath and Self-Cath Plus" devices (K221401).
Since this document is a 510(k) summary for a medical device and not for an AI/ML algorithm, the requested information pertaining to AI/ML specific criteria (such as number of experts for ground truth, adjudication methods, MRMC studies, standalone performance of an algorithm, training set sample size, etc.) is not applicable and therefore not present in the text.
However, I can extract the acceptance criteria and performance data for the device based on the information provided.
1. Table of Acceptance Criteria and Reported Device Performance
This pertains to the physical and chemical properties of the catheters, not an AI/ML algorithm.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Biocompatibility | Per FDA Guidance: "Use of International Standard ISO 10993-1" (2020) | All tests met pre-determined acceptance criteria. |
| Catheter Performance | ISO 20696:2018 (General Requirements for Intermittent Urethral Catheters)ASTM F623-99:2013 (Standard Practice for Measuring Maximum Loads of Medical Catheters)ASTM D1894:2014 (Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting) | All tests met pre-determined acceptance criteria. |
| Packaging Sterile Barrier Integrity | ISO 11607-1 (Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems) | All tests met pre-determined acceptance criteria. |
| Shelf-Life | ASTM F1980-16 (Standard Guide for Accelerated Aging of Sterile Medical Device Packages) | All tests met pre-determined acceptance criteria. |
Study Information (Based on device testing, not AI/ML algorithm)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for performance testing (e.g., number of catheters tested for each criterion) or the data provenance. It states that "Performance testing for Self-Cath and Self-Cath Plus was conducted per applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable as this is a physical medical device clearance, not an AI/ML diagnostic or prognostic tool requiring expert ground truth for image/data interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable for a physical medical device. Performance testing relies on objective measurements against established standards, not subjective expert adjudication.
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
This question is not applicable as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This question is not applicable as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a physical medical device like a catheter, the "ground truth" for performance testing is defined by compliance with established international and ASTM standards (e.g., specific tensile strength, elongation, biocompatibility limits, flow rates, etc.) and internal methods, verifiable through objective experimental measurements.
8. The sample size for the training set
This question is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable as this is a physical medical device, not an AI/ML algorithm.
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December 2, 2022
Coloplast Preeti Jain Head of Regulatory Affairs - North America 1601 West River Road North Minneapolis, MN 55411
Re: K221401
Trade/Device Name: Self-Cath and Self-Cath Plus Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: November 3, 2022 Received: November 4, 2022
Dear Preeti Jain:
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. You must comply with all the
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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-safetyreporting-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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,
Negeen Haghighi -S
For
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) K221401
Device Name Self-Cath and Self-Cath Plus
Indications for Use (Describe)
Self-Cath and Self-Cath Plus are intended for use in male, female and pediatric patients (neonates, infants, children, adolescents, and transitional adolescents) requiring bladder drainage as determined by their physician. The devices are 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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5. TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/SHoltedam13050 HumlebaekDenmark |
|---|---|
| Contact Person : | Preeti JainHead of Regulatory Affairs, North AmericaColoplast1601 West River Road NorthMinneapolis MN 55411Phone: +1 (612)-413-5614Email: uspj@coloplast.com |
| Date of Summary: | December 2, 2022 |
| Subject Device: | |
| Trade or ProprietaryName: | Self-Cath and Self-Cath Plus |
| Item/Model Numbers: | Self-Cath: 110, 112, 114, 116, 208, 210, 212, 214, 240, 305,306, 308, 310, 408, 410, 412, 414, 416, 418, 450, 460, 608,610, 612, 614, 806, 808, 810, 812, 814, 816, 818, 50201,50202, 50203, 50204 |
| Self-Cath Plus: 4110, 4112, 4114, 4116, 4210, 4212, 4214,4306, 4308, 4310, 4408, 4410, 4412, 4414, 4416, 4418, 4608,4610, 4612, 4614, 4808, 4810, 4812, 4814, 4816 | |
| Common or Usual Name: | Intermittent Catheter, Urethral |
| Regulation/ClassificationName: | Urological Catheter and Accessories |
| Regulation/ClassificationNumber: | 21 CFR 876.5130 |
| Product Code: | EZD |
| Product Code Name: | Catheter, Straight |
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| Review Panel: | Gastroenterology/Urology |
|---|---|
| Predicate Device: | Self-Cath, K100878The predicate device has not been subject of a design-relatedrecall. |
| Reference Device: | Self-Cath Plus, K003784The reference device has not been subject of a design-relatedrecall. |
| Device Description: | Self-Cath and Self-Cath Plus devices are single-use, sterilecatheters for intermittent urinary catheterization. Self-Cath isan uncoated catheter and Self-Cath Plus has a hydrophilic-coating. The catheters are sterilized by ethylene oxide (EO). |
| Indications for Use: | Self-Cath and Self-Cath Plus are intended for use in male,female, and pediatric patients (neonates, infants, children,adolescents, and transitional adolescents) requiring bladderdrainage as determined by their physician. The devices areindicated for those individuals unable to promote a naturalurine flow or for those individuals who have a significantvolume of residual urine following a natural bladder-voidingepisode.The subject and predicate devices have the same intended use. |
| TechnologicalCharacteristics: | The subject devices have the same intended use, indicationsfor use, catheter size, principles of operation, technologicalcharacteristics, and performance specifications as thepredicate device.The difference between the subject devices and predicatedevice is as below:The polyvinyl chloride (PVC) catheter and connector inthe subject devices contain Bis(2-ethylhexyl)terephthalate (DEHT) softener (phthalate) The predicate device contains Bis(2-ethylhexyl) phthalate(DEHP) softener. |
The difference in technological characteristics (softener) do
not raise different questions of safety and effectiveness.
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Performance Data: Performance testing for Self-Cath and Self-Cath Plus was conducted per applicable sections of non-recognized and recognized voluntary consensus standards, as well as established internal methods. The following tests were completed to determine the impact of the proposed material change based on assessment of the device risk documentation:
- Biocompatibility testing according to FDA Guidance . "Use of International Standard ISO 10993-1" (2020).
- . Catheter performance according to ISO 20696:2018, ASTM F623-99:2013, and ASTM D1894:2014.
- Packaging sterile barrier integrity testing per ISO 11607- 1.
- Accelerated and Real Time aged shelf-life testing . according to ASTM F1980-16.
All tests met the pre-determined acceptance criteria.
The performance testing demonstrates the subject devices Conclusion: are 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.