(39 days)
SpeediCath Compact 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 catheter is for female patients only.
SpeediCath Compact is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. The packaging of SpeediCath Compact is an integrated part of the product functioning partly as an insertion handle. In use, the inner tube is extended and removed from the handle as the catheter is locked in place with the handle. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.
The provided text describes a 510(k) summary for the SpeediCath Compact device, a urinary catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key takeaway regarding your request: The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner typically associated with clinical trials for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, F1-score, AUC).*
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Coloplast's SpeediCath) through:
- Material and functional similarity: Both are ready-to-use intermittent catheters with hydrophilic coatings, made of the same material, immersed in the same saline solution, sterile, and single-use.
- Minor differences in packaging and intended user group: SpeediCath Compact has a modified packaging for ease of use and is specifically for female use, while the predicate is for both males and females.
- Compliance with relevant standards: The device has been tested against ASTM 623, ASTM D1894, EN 1616, EN 1618, and relevant sections of ISO 10993 (Biological Evaluation of Medical Devices). These standards generally relate to physical properties, biocompatibility, and intended use characteristics of catheters, not diagnostic performance of an AI/ML algorithm.
Therefore, I cannot populate the table or answer most of your specific questions related to AI/ML device performance criteria, sample sizes for test/training sets, expert ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary for this device.
Below is a table reflecting the type of "acceptance criteria" (compliance with standards) and "reported performance" (compliance achieved) as derived from the document, but it's crucial to understand this is not the typical performance evaluation for AI/ML.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Status) |
|---|---|
| ASTM 623 (relevant sections) | Complies |
| ASTM D1894 (relevant sections) | Complies |
| EN 1616 (relevant sections) | Complies |
| EN 1618 (relevant sections) | Complies |
| ISO 10993 (relevant sections - Biological Evaluation of Medical Devices) | Complies |
| Functional Equivalence to Predicate (SpeediCath) | Substantially Equivalent |
Regarding the study that proves the device meets the acceptance criteria:
The study that proves the device meets these "acceptance criteria" is a series of tests demonstrating compliance with the relevant sections of the listed national and international standards (ASTM, EN, ISO). These tests would typically assess physical properties, sterility, biocompatibility, and other performance characteristics specific to urinary catheters. The document states, "SpeediCath Compact has been tested and complies with relevant sections..." which serves as the "proof" within this regulatory submission. The specifics of these tests (e.g., sample sizes, methodology) are not detailed in this summary.
The following information is NOT available in the provided text as it pertains to AI/ML device evaluation, which this document does not cover:
- Sample sizes used for the test set and the data provenance: Not applicable/Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
- Adjudication method for the test set: Not applicable/Not provided.
- 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/Not provided.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided.
- How the ground truth for the training set was established: Not applicable/Not provided.
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pg. 1 of 2
510(k) Summary
SpeediCath Compact
(as required per 21 CFR § 807.92)
| The assigned 510(k) number is: | K072808 |
|---|---|
| Submitter: | Coloplast Corp1601 West River Road NorthMinneapolis, MN 55411 |
| Contact Person: | Rebeka A. StoltmanManager, Regulatory AffairsColoplast Corp1601 West River Road NorthMinneapolis, MN 55411 |
| NOV 0 9 2007 | |
| Telephone: (612) 302-4997Facsimile: (612) 287-4138Email: usrst@coloplast.com | |
| Date Prepared: | September 28, 2007 |
Device Name and Classification
| Trade Name: | SpeediCath Compact |
|---|---|
| Common Name: | Urinary Catheter for Intermittent Use |
| Classification Name: | Gastroenterology-Urology Devices |
| Product Code: | GBM |
Legal Manufacturer / Manufacturing Site
Coloplast A/S Holtedam 1 DK-3050 Humlebaek Denmark
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Device Description
SpeediCath Compact is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. The packaging of SpeediCath Compact is an integrated part of the product functioning partly as an insertion handle. In use, the inner tube is extended and removed from the handle as the catheter is locked in place with the handle. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.
Substantial Equivalence Claim
Coloplast believes the proposed SpeediCath Compact is substantially equivalent in form and function to Coloplast's SpeediCath, which was cleared under 510(k) K023254 on January 27, 2003.
Both SpeediCath Compact and SpeediCath are ready to use intermittent catheters with hydrophilic coatings. The catheter and the hydrophilic coating are made of the same material and are both immersed in the same saline solution. They are both sold sterile and are single use.
The difference between SpeediCath Compact and SpeediCath is the packaging configuration and material, which have been modified for SpeediCath Compact for ease of use improvements. The SpeediCath Compact packaging configuration has the same ready to use features as the predicate, SpeediCath, but is shorter and packaged in pocket-size, single use containers. SpeediCath Compact is for female use only while SpeediCath is available for males and females.
Indications for Use
SpeediCath Compact 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 catheter is for female patients only.
Summary of Testing
SpeediCath Compact has been tested and complies with relevant sections of ASTM 623, ASTM D1894, EN 1616, and EN 1618.
SpeediCath Compact 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/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Ms. Rebeka Stoltman Manager, Regulatory Affairs Coloplast Corporation 1499 West River Road North MINNEAPOLIS MN 55411
Re: K072808
Trade/Device Name: SpeediCath Compact Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: September 28, 2007 Received: October 5, 2007
Dear Ms. Stoltman:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Page 2
Enclosure
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Statement of Indications for Use
510(k) Number (if known): Notknown K072808
Device Name: SpeediCath Compact
Indications for Use:
SpeediCath Compact 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 catheter is for female patients only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ × OR (Per 21 CFR 801.109
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Hels
(Seller Sign Off)
ision Sign-Off) (Urision Sign-Um)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
§ 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.