(138 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.
The device is intended for males only.
The SpeediCath Compact Set (Male) is a sterile, single use, disposable polyurethane catheter for males with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.
This document is a 510(k) summary for a medical device (SpeediCath Compact Set) and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with specific acceptance criteria and performance metrics typically found in clinical trial reports for novel devices.
Therefore, much of the requested information regarding acceptance criteria, specific device performance against those criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be found in the provided text. The document describes a regulatory filing for marketing clearance, not a primary research study.
However, I can extract the information that is present and explain why other information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices. |
| Physical/Mechanical Properties (e.g., lubricity, material strength, dimensional integrity) | Complies with relevant sections of ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, and ISO 8669-2. |
| Sterility | "sterile" (mentioned in device description) |
| Functionality (e.g., ease of use, drainage, collection) | "allows easy drainage and collection of urine" (implied functional performance, not quantified) |
| Substantial Equivalence | Believed to be substantially equivalent in form and function to Coloplast's SpeediCath (K023254 and K973070 are referenced as similar). |
Explanation: The document states that the device "complies with relevant sections" of several standards. These standards themselves contain specific acceptance criteria for various aspects (e.g., biocompatibility testing, material properties, catheter dimensions, lubricity). However, the specific numerical or qualitative acceptance criteria from these standards and the exact numerical performance results of the SpeediCath Compact Set against those criteria are not detailed here. This is typical for a 510(k) summary, which generally affirms compliance rather than presenting raw data.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "testing" against various standards, which would involve samples, but the specific number of units tested is not provided.
- Data Provenance: This information is not provided. The testing refers to compliance with international standards, but where the testing was conducted or whether it involved human subjects (beyond usability aspects) is not detailed. The primary purpose of this filing is to demonstrate substantial equivalence based on material and design characteristics and adherence to recognized standards.
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 device is a urinary catheter, not an AI or diagnostic imaging device that typically requires expert consensus for ground truth establishment on a "test set" from a clinical perspective. The "ground truth" for this device's performance would be its adherence to engineering and biocompatibility standards, and its functional design for urine drainage, which is verified by laboratory testing and design review, not clinical expert consensus in the way an AI algorithm for diagnosis would be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As above, the nature of this device and its testing doesn't involve expert adjudication for ground truth in a clinical sense. Compliance with standards is typically verified through laboratory testing and quality assurance processes.
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 is not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness study was conducted or mentioned.
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 this device's regulatory clearance is its compliance with established international and national engineering, safety, and biocompatibility standards (ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618, ISO 8669-2, ISO 10993) and its substantial equivalence to a predicate device. This is determined through laboratory testing, design documentation, and comparison of specifications.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable. As above, no training set in the AI sense was used. The "ground truth" for the predicate device (SpeediCath, K023254) would have been established through its own regulatory pathway, which would also involve compliance with standards and demonstration of safety and effectiveness for its intended use.
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page 1 of 3
510(k) Summary
SpeediCath Compact Set
(as required per 21 CFR § 807.92)
The assigned 510(k) number is:
K121458
Submitter:
Coloplast Corp 1601 West River Road North Minneapolis, MN 55411
Contact Person:
Brian E. Schmidt Regulatory Affairs Manager Coloplast Corp 1601 West River Road Minneapolis, MN 55411 USA Office: (612) 302-4987 Mobile: (612) 968-9567 (612) 287-4138 Fax: e-mail: usbes@coloplast.com
Date Prepared:
September 25, 2012
Device Name and Classification
| Trade Name: | SpeediCath Compact Set |
|---|---|
| Common Name: | Urinary Catheter for Intermittent Use |
| Classification Name: | Gastroenterology-Urology Devices |
| Product Code: | GBM |
Legal Manufacturer / Manufacturing Site
Coloplast AJS Holtedam 1 DK-3050 Humlebaek Denmark
1
2012
ОСТ
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Device Description
The SpeediCath Compact Set (Male) is a sterile, single use, disposable polyurethane catheter for males with a pre-attached urine collection bag. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the cover is removed, the bag is unfolded and the catheter is pulled out of the packaging thereby extending and locking it to its full length. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.
Substantial Equivalence Claim
Coloplast believes the proposed SpeediCath Compact Set is substantially equivalent in form and function to Coloplast's SpeediCath, which was cleared under 510(k) K023254 on January 27, 2003.
SpeediCath Compact Set and the predicate device are sterile, single use catheters for intermittent use with hydrophilic coatings.
Both SpeediCath Compact Set and SpeediCath are ready to use catheters with hydrophilic coatings made of the same material and are both immersed in the same saline solution.
The difference between SpeediCath Compact Set and SpeediCath is the packaging configuration and material, the telescopic extension of the catheter as well as the addition of an attached urine collection bag. These modifications are made for discretion and ease of use improvements. The SpeediCath Compact Set packaging configuration has the same ready to use features as the predicate, SpeediCath, and is packaged in discrete containers. SpeediCath Compact Set is short in storage and is extended to its full length in use.
SpeediCath Compact Set is similar to other catheters, e.g. Conveen EasiCath Set (K973070), in that they both have a pre-attached bag for urine collection.
SpeediCath Compact Set is for males only while SpeediCath is available for males and females.
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Indications for Use
SpeedlCath 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 nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The device is intended for males only.
Summary of Testing
SpeediCath Compact Set has been tested and complies with relevant sections of ASTM 623, ASTM D1894, EN 1616, EN 1617, EN 1618 and ISO 8669-2.
SpeediCath Compact Set has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609. Silver Spring, MD 20993-0002
2012
OCT
Mr. Brian Schmidt Regulatory Affairs Manager Coloplast A/S 1601 West River Road North MINNEAPOLIS MN 55411
Re: K121458
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: August 31, 2012 Received: September 5, 2012
Dear Mr. Schmidt:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Securi >10(x) promatic is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivaled in in referenced above and nave determined the devices marketed in interstate for use stated in the enclosure) to legally manage the Medical Device Amendments, or to commerce prior to May 28, 1970, the chacinent with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance was are as penarket application (PMA).
and Cosmetic Act (Act) that do not require approval approval provisions of the Act. T and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The You may, therefore, market the device, subject to the gening mishranding and general controls provisions of the rict merides required in the states misted to contract lightling devices, good manufacturing practice, rabornig, und information related to contract liability. adulteration. Please note: CDAT does not ovaraate information of misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) mo citing major regulations affecting your device can be
it may be subject to additional controls. Exist. Box In addition FDA ma it may be subject to additional contubis. LATSCHE : Arts 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In additio found in the Code of Federal Regulations, Frid 2017
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 Please be advised that FDA s issualic of a subscribes with other requirements of the Act
that FDA has made a determination that your device of the Fig. Edgers iss. You must that FDA has made a decemination that your as real by other Federal agencies. You must or any Federal statutes and regulations annunsion of other the morting the morting of medi comply with all the Act s requirements, including, Suchooning (1000)
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set device-lefated adverse events) (21 CFR Part 820); and if applicable, the electronic forul in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please II you desire specific advice for your do free en oa coolor
go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/cases of Also, places go to mip.naw.ida.gowritound Dri Collection is (CDRH's) Office of Compliance. Also, please the Center for Devices and Radioners of Reading by reference to premarket notification (21CFR Patters) (21 note the regulation chance, "misoraname of colorerse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin K. - tucker
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number (if known): Not known K121458
Device Name: SpeediCath Compact Set
Indications for Use:
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and Speedicatif Compact Occ in indication of Dos to neurogenic and non-neurogenic patients with a post vold rochaus. Voloserted into the urethra to reach the bladder allowing urine to drain.
The device is intended for males only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR Prescription Use_ × (Per 21 CFR 801.109
Over-The-Counter Use_
(Optional Format 1-2-96)
Vorz
(Division Sign-Off) ision of Reproductive, Gastro-Renal, and
§ 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.