(224 days)
Self-Cath Closed System is intended for use in male adult patients requiring bladder drainage as determined by their physician. The device is 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.
The Self-Cath Closed System is a disposable single-use, catheter designed for intermittent catheterization integrated with a urine collection bag. The device is sterilized with ethylene oxide (EO) sterilization. The catheter is made with PVC with DEHT as a plasticizer. The Self-Cath catheter used in the system is identical to the catheter recently cleared in K221401.The catheter is provided with a gel lubricant that is placed inside a urine bag, which is closed off with a protection cap (introducer tip cap). During use, the protection cap is removed, and the catheter is pushed out of the urine bag through the introducer tube and tip. The drainage end of the catheter is inside the bag allowing urine to be drained directly into the bag. The urine bag has a tear off section to open the urine bag for emptying. The Self-Cath Closed System includes gloves, swab sticks, a wipe, and a drape in addition to the components above.
The provided text is a 510(k) premarket notification for a medical device called the "Self-Cath Closed System." It primarily focuses on demonstrating substantial equivalence to a predicate device. This type of document is generally for medical device clearances and does not typically involve AI/ML technology or human performance studies in the way you've outlined.
Therefore, many of the specific questions you've asked regarding AI device performance, sample sizes for training sets, expert qualifications for ground truth, MRMC studies, and standalone AI performance are not applicable to this document.
However, I can extract information related to the acceptance criteria and performance testing conducted for this non-AI medical device.
1. A table of acceptance criteria and the reported device performance
The document states: "All tests met the pre-determined acceptance criteria." However, the specific quantitative acceptance criteria and detailed reported performance values are not explicitly listed in the provided text. The document refers to meeting performance per applicable sections of voluntary consensus standards and internal methods.
| Test Category | Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|---|
| Biocompatibility | Based on chemical analysis according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020) | Met the pre-determined acceptance criteria. |
| Catheter Performance | According to ISO 20696:2018 (e.g., Effective Length, Verification of Catheter Surface Finish, Verification of Catheter Effective Shaft Length) | Met the pre-determined acceptance criteria. |
| Urine Collection Bags | According to EN ISO 8669-2:1996 (Rated Volume, Strength of Attachment of the inlet tubing) | Met the pre-determined acceptance criteria. |
| Packaging Sterile Barrier Integrity | Per ISO 11607-1 | Met the pre-determined acceptance criteria. |
| Shelf-life | Accelerated and Real Time aged shelf-life testing according to ASTM F1980-16. Intended shelf life is 3 years. | Met the pre-determined acceptance criteria (demonstrating a 3-year shelf life). |
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 sizes used for the various performance tests (e.g., how many catheters were tested for effective length or surface finish). It also does not mention the data provenance in terms of country of origin or whether the tests were retrospective or prospective, as these are typically laboratory-based engineering and material performance tests.
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)
Not applicable. This is a physical medical device, not an AI/ML diagnostic tool requiring clinical expert ground truth for interpretation. The "ground truth" for these tests comes from adherence to established international standards and laboratory testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As this is not an AI/ML diagnostic or measurement device, there is no need for expert adjudication methods in this context. Performance is determined by standardized test results.
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
Not applicable. This device is an intermittent catheter, not an AI system. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by compliance with recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 20696 for catheter performance, EN ISO 8669-2 for urine bags, ISO 11607-1 for sterile barrier, ASTM F1980-16 for shelf-life). These standards define the test methods and the expected performance criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device.
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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.
August 2, 2023
Coloplast Corporation Preeti Jain Head of Regulatory Affairs 1601 West River Road North Minneapolis, MN 55411
Re: K223821
Trade/Device Name: Self-Cath Closed System Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: FCM Dated: July 7, 2023 Received: July 7, 2023
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.
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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 -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) K223821
Device Name Self-Cath Closed System
Indications for Use (Describe)
Self-Cath Closed System is intended for use in male adult patients requiring bladder drainage as determined by their physician. The device is 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/3/Picture/0 description: The image shows the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue font on the right. The circular graphic has a series of horizontal lines that create a layered effect.
| 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: | July 21, 2023 |
| Trade or ProprietaryName: | Self-Cath Closed System |
| Item Numbers: | 50270/1108, 50271/C1110, 50272/1112, 50273/1114,50274/1116, 50277/2114, 50281/2214, 50285/2614,50286/2814, 50287/2816 |
| Common or Usual Name: | Intermittent Catheter, Urethral |
| Regulation Name: | Urological Catheter and Accessories |
| Regulation Number | 21 CFR 876.5130 |
| Device Class: | Class II |
| Product Code | FCM |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | Self-Cath & Self-Cath Plus K221401The predicate device has not been subject of a design relatedrecall. |
| Reference Device: | Self-Cath Closed System, K070939The reference device has not been subject of a design relatedrecall. |
| Device Description: | The Self-Cath Closed System is a disposable single-use,catheter designed for intermittent catheterization integrated witha urine collection bag. The device is sterilized with ethyleneoxide (EO) sterilization. The catheter is made with PVC withDEHT as a plasticizer. The Self-Cath catheter used in the systemis identical to the catheter recently cleared in K221401.Thecatheter is provided with a gel lubricant that is placed inside aurine bag, which is closed off with a protection cap (introducertip cap). During use, the protection cap is removed, and thecatheter is pushed out of the urine bag through the introducer tubeand tip. The drainage end of the catheter is inside the bagallowing urine to be drained directly into the bag. The urine baghas a tear off section to open the urine bag for emptying.The Self-Cath Closed System includes gloves, swab sticks, awipe, and a drape in addition to the components above. |
| Indications for Use: | Self-Cath Closed System is intended for use in male and femaleadult patients requiring bladder drainage as determined by theirphysician. This device is indicated for those individuals unableto promote a natural urine flow or for those individuals who havea significant volume of residual urine following a naturalbladder-voiding episode. |
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Image /page/4/Picture/0 description: The image contains the logo for Coloplast. The logo consists of a blue, layered sphere on the left and the word "Coloplast" in blue, bold letters on the right. The sphere is made up of several horizontal layers, creating a textured effect.
Technological The subject devices have the same intended use, indications for Characteristics: use, principles of operation, technological characteristics, and performance specifications as the predicate device.
| Product | Subject device | Predicate device | Reference device |
|---|---|---|---|
| Product | Self-Cath ClosedSystem | Self-Cath and Self Cath Plus | Self-Cath ClosedSystem |
| 510(k) Number | K223821 | K221401 | K070939 |
| Regulation Name | Urological catheterand accessories | Urological catheter andaccessories | Same |
| Regulation Number | 21 CFR876.5130 | 21 CFR 876.5130 | Same |
| Product Code | FCM | EZD | Same |
| Classification | II | Same | Same |
| PrescriptionDevice | Yes | Same | Same |
| Intended Use | The product isintended forintermittentcatheterization throughthe urethra | Same | Same |
| Indications forUse | Self-Cath ClosedSystem is intended foruse in male and femaleadult patients requiringbladder drainage asdetermined by theirphysician. This deviceis indicated for thoseindividuals unable topromote a natural urineflow or for thoseindividuals who have asignificant volume ofresidual urinefollowing a naturalbladder-voidingepisode. | Self-Cath is intendedfor use in male,female, and pediatricpatients (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 urinefollowing a naturalbladder-voidingepisode. | Self-Cath CS ClosedSystem is intendedfor use in male orfemale patientsneeding bladderdrainage asdetermined by theirphysician. Morespecifically it isintended for usewhere drainage of thebladder into asuitable receptablesuch as a commodeor bedpan is notfeasible or practical.The device can beused by either thepatient, onceappropriate traininghas taken place, or bya trained health careprofessional. |
| Condition of Use | Intermittent andSingle-Use | Same | Same |
| Sterility | 10-6 | Same | Same |
| SterilizationMethod | Ethylene Oxide (EO),Half cycle, Over-kill | Same | Same |
| Shelf Life | 3 years | Same | Same |
| Variants | Male, Female | Male, Female andPediatrics | Same |
| CatheterMaterials | PVC with DEHT(Shore A 70 and 80) | PVC with DEHT(Shore A 70, 80 and85) | PVC with DEHP(Shore A 70 and 80) |
| Hydrophilic Gel-lubricant | Glycerin based gel | - | Same |
| Tip Configuration | Straight tipOlive Coudé tipTapered Coudé tip | Same | Same |
| Catheter OuterDiameter | CH08 – CH16 | CH05 – CH 18 | Same |
| Urine Bag | PVC with DEHT | - | PVC with DEHP |
| Urine BagComponents:Introducer Tube | PVC with DINCH | - | PVC with DEHP |
| Urine BagComponents:Introducer Tip | PVC with DEHT | - | PVC with DEHP |
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Image /page/5/Picture/0 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in a bold, blue font on the right. The circular graphic has a series of horizontal lines that appear to be a stylized representation of waves or layers.
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Image /page/6/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue circular graphic on the left and the word "Coloplast" in blue on the right. The circular graphic is made up of several horizontal lines that create a layered effect.
Performance Data:
Performance testing for Self-Cath Closed System 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 and toxicological risk assessment based on chemical analysis according to ISO 10993-1:2018 and FDA Guidance "Use of International Standard ISO 10993-1" (2020)
- Catheter performance according to ISO 20696:2018 (e.g. . Effective Length, Verification of Catheter Surface Finish, Verification of Catheter Effective Shaft Length) and EN ISO 8669-2:1996 for Urine collection bags (Rated Volume, Strength of Attachment of the inlet tubing)
- 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 are as Conclusion: safe and effective as the predicate devices.
§ 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.