(86 days)
Not Found
No
The 510(k) summary describes a physical catheter and its intended use, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as allowing urine to drain for patients with chronic urine retention and voiding dysfunction, which constitutes a therapeutic intervention.
No
The device description indicates it is a catheter used to drain urine, which is a therapeutic function, not a diagnostic one. Its purpose is to manage chronic urine retention and voiding dysfunction, not to identify or assess a medical condition.
No
The device description clearly states it is a physical catheter made of polyurethane, pre-lubricated, and intended for insertion into the urethra. This is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The SpeediCath Compact Eve is a physical device (a catheter) that is inserted into the body to drain urine. It is a therapeutic device used to manage a physical condition (urine retention and voiding dysfunction).
- Intended Use: The intended use clearly describes a physical intervention (inserting a catheter) to facilitate urine drainage, not a test performed on a sample.
Therefore, the SpeediCath Compact Eve is a medical device, but it falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SpeediCath Compact Eve 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.
Product codes
GBM
Device Description
The SpeediCath Compact Eve is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the handle is turned to break the packaging, connect a urine bag to the end of the handle, if required, and the catheter is pulled out of the packaging. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SpeediCath Compact Eve has been tested and complies with relevant sections of ASTM 623-99, ASTM D1894-11, EN 1616 and EN 1618.
SpeediCath Compact Eve has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and appear to be connected by flowing lines at the bottom. The seal 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 Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2015
Coloplast Corp. Meg Daniel Regulatory Affairs Specialist 1601 West River Road North Minneapolis. MN 55411
Re: K150935 Trade/Device Name: Speedicath Compact Eve Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: GBM Dated: June 19, 2015 Received: June 22, 2015
Dear Meg Daniel,
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. 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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely yours,
Herbert P. Lerner -S
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 K150935
Device Name: SpeediCath Compact Eve
Indications for Use:
SpeediCath Compact Eve 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)
OR Prescription Use X (Per 21 CFR 801.109
Over-The-Counter Use
(Optional Format 1-2-96)
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510(k) Summary
SpeediCath Compact Set
(as required per 21 CFR § 807.92)
The assigned 510(k) number is: K150935 Submitter: Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 Contact Person: Megan Daniel Regulatory Affairs Specialist Coloplast Corp 1601 West River Road Minneapolis, MN 55411 USA Office: (612) 302-4930 Mobile: (612) 615-5088 (612) 287-4138 Fax: e-mail: usmeco@coloplast.com
Device Name and Classification
| Trade Name: | SpeediCath Compact Eve |
|---|---|
| Common Name: | Urinary Catheter for Intermittent Use |
| Classification Name: | Urological catheters and accessories |
| Product Code: | GBM |
April 2, 2015
Legal Manufacturer
Date Prepared:
Coloplast A/S Holtedam 1 DK-3050 Humlebaek Denmark
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Device Description
The SpeediCath Compact Eve is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. In use, the handle is turned to break the packaging, connect a urine bag to the end of the handle, if required, and the catheter is pulled out of the packaging. 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 Eve is substantially equivalent in form and function to Coloplast's SpeediCath Compact, which was cleared under 510(k) K072808 on November 9, 2007.
SpeediCath Compact Eve and the predicate device are sterile, single use catheters for intermittent use with hydrophilic coatings.
Both SpeediCath Compact Eve and SpeediCath Compact 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 Eve and the predicate device is the packaging configuration and visual appearance, a 2 cm longer catheter and the outlet, which can be connected to a urine bag. These modifications are made for ease of use and discretion improvements. The SpeediCath Compact Eve packaging configuration has the same ready to use features as the predicate. SpeediCath Compact, and is packaged in discrete containers.
SpeediCath Compact Eve and the predicate, SpeediCath Compact, are for females only.
Indications for Use
SpeediCath Compact Eve 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 Eve has been tested and complies with relevant sections of ASTM 623-99, ASTM D1894-11, EN 1616 and EN 1618.
SpeediCath Compact Eve has been tested and complies with relevant sections of ISO 10993, Biological Evaluation of Medical Devices.