(384 days)
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for females only.
The SpeediCath Compact Set is a sterile, ready to use intermittent catheter for females. It is a single use catheter with an integrated urine bag. The catheter is a hollow polyurethane tube that facilitates drainage of urine from the bladder through the urethra to the collection bag. It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14. The catheter is hydrophilic coated and placed in a sterile solution (swelling medium) inside a tube, which together with a cover and plug make up the primary packaging and the sterile barrier. The subject device is the same as the predicate device, apart from the swelling medium. The swelling medium resides between the catheter and the tube and lubricates the catheter. The swelling medium in the subject device contains polyethylene glycol (PEG), and the predicate contains polyvinylpyrrolidone (PVP).
The provided text is a 510(k) summary for a medical device (SpeediCath Compact Set), and it describes the performance testing conducted to demonstrate substantial equivalence to a predicate device. However, it does not detail the acceptance criteria and device performance in the context of an AI/ML device or a similar complex medical device that would necessitate the extensive requirements outlined in your prompt (e.g., number of experts, adjudication methods, MRMC studies, training set details).
This document is for a urological catheter, where the primary concern is the material (specifically, the swelling medium) and its physical and biological properties. The "performance testing" here refers to standard engineering and biocompatibility tests, not clinical performance in the sense of diagnostic accuracy or effect on human readers.
Therefore, I cannot directly answer your prompt using the provided text. The information requested (e.g., acceptance criteria for AI, sample sizes for AI test/training sets, expert consensus for ground truth in diagnostic accuracy, MRMC studies) is fundamentally different from the nature of the device and testing described in this 510(k) summary.
In summary, the provided document does not contain the information needed to address your prompt about acceptance criteria and study design for an AI/ML 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 2, 2020
Coloplast Michael Bumgarner Principal Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K192904
Trade/Device Name: SpeediCath Compact Set Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: GBM Dated: September 30, 2020 Received: October 1, 2020
Dear Michael Bumgarner:
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,
Sharon M. Andrews 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) K192904
Device Name SpeediCath Compact Set
Indications for Use (Describe)
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. This device is intended for females only.
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/1 description: The image shows the Coloplast logo, which includes a blue circular graphic with horizontal lines and the word "Coloplast" in blue text. Above the logo, there is the text "K192904" and "Page 1 of 3". The text indicates that this is the first page of a three-page document with the identifier K192904.
TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Coloplast A/SHoltedam13050 HumlebaekDenmark |
|---|---|
| Contact Person: | Michael BumgarnerPrincipal Regulatory Affairs SpecialistColoplast1601 West River Road NorthMinneapolis, MN 55411612-263-0488usmbum@coloplast.com |
| Date of Summary: | 02 November 2020 |
| Trade or ProprietaryName: | SpeediCath Compact Set |
| Common or Usual Name: | Catheter, Urethral |
| Classification Name: | Urological Catheter and Accessories |
| Regulation Number | 21 CFR 876.5130 |
| Classification: | Class II |
| Product Code: | GBM (catheter, urethral) |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Compact Set, K121457The predicate device has not been subject to a design related recall. |
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
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K192904 Traditional 510(k)
| Device Description: | The SpeediCath Compact Set is a sterile, ready to use intermittentcatheter for females. It is a single use catheter with an integratedurine bag.The catheter is a hollow polyurethane tube that facilitates drainageof urine from the bladder through the urethra to the collection bag.It is available in three sizes FR/CH 10, FR/CH 12 and FR/CH 14.The catheter is hydrophilic coated and placed in a sterile solution(swelling medium) inside a tube, which together with a cover andplug make up the primary packaging and the sterile barrier. Thesubject device is the same as the predicate device, apart from theswelling medium. The swelling medium resides between thecatheter and the tube and lubricates the catheter. The swellingmedium in the subject device contains polyethylene glycol (PEG),and the predicate contains polyvinylpyrrolidone (PVP). |
|---|---|
| Indications for Use: | SpeediCath Compact Set is indicated for use by patients withchronic urine retention and patients with a post void residual volume(PVR) due to neurogenic and non-neurogenic voiding dysfunction.The catheter is inserted into the urethra to reach the bladder allowingurine to drain.This device is intended for females only.The subject and predicate device have the same intended use. |
| Performance Testing: | Performance testing for SpeediCath Compact Set was conducted perapplicable sections of voluntary and FDA consensus standards:Sterilization validation was performed by conducting dosesetting per ISO 11137-1:2015 and ISO/TS13004: 2013Accelerated and Real Time aged shelf life testing accordingto ASTM F1980-16Biocompatibility testing (cytotoxicity, irritation, sensitivity,pyrogenicity and chemical characterization) according toISO 10993-1:2018 and FDA Guidance "Use ofInternational Standard ISO 10993-1" (2016)Coefficient of friction according to ASTM D1894:2014Catheter coating friction per internal test methodFinger test: adhesion, cohesiveness, uniformity, andsmoothness per internal test methodCorrosion according to EN ISO 20696:2018 and EN1616:1997pH of the swelling medium per internal test methodOsmolality of the swelling medium per internal test method |
All tests met the pre-determined acceptance criteria.
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Conclusion:
The subject and predicate device have different technological characteristics, specifically a different swelling medium. This difference in technological characteristics does not raise different questions about safety and effectiveness.
The performance testing demonstrates the subject device is as safe and as effective as the predicate device.
This file contains proprietary information and should not be disclosed without the consent of Coloplast.
§ 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.