(139 days)
No
The description focuses on the mechanical and material properties of a catheter and collection bag, with no mention of AI or ML technologies.
Yes.
The device is used to drain urine from the bladder, which alleviates chronic urine retention and manages post void residual volume, thus providing a therapeutic benefit for a medical condition.
No
The device description indicates that the SpeediCath Compact Set is a catheter used for draining and collecting urine, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical catheter with an attached urine collection bag, made of polyurethane and pre-lubricated. This is a hardware 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 medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Device Function: The SpeediCath Compact Set is a catheter used to drain urine directly from the bladder. It is inserted into the body.
- Intended Use: The intended use describes a physical intervention (draining urine) rather than a diagnostic test on a sample.
Therefore, the SpeediCath Compact Set is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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 females only.
Product codes
GBM
Device Description
The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females 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. The catheter with attached bag is then ready to use allowing easy drainage and collection of urine.
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 Set has been tested and complies with relevance 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only
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.
0
510(k) Summary
ーシー
SpeediCath Compact Set
(as required per 21 CFR § 807.92)
The assigned 510(k) number is: K121457
| 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
Fax: (612) 287-4138
e-mail: usbes@coloplast.com |
Date Prepared:
September 28, 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 A/S Holtedam 1 DK-3050 Humlebaek Denmark
2 2012
OCT
1
Device Description
The SpeediCath Compact Set (Female) is a sterile, single use, disposable polyurethane catheter for females 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. 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 Compact, which was cleared under 510(k) K072808 on November 9, 2007.
SpeediCath Compact Set and the predicate device are sterile, single use catheters for intermittent use with hydrophilic coatings.
Both SpeediCath Compact Set and SpeediCath Compact are ready to use catheters with hydrophilic coatings made of the same materials and are both immersed in the same saline solution.
The difference between SpeediCath Compact Set and SpeediCath Compact is the packaging configuration and packaging material, a 2 cm longer catheter as well as the addition of an attached urine collection bag. These modifications are made for ease of use improvements. The SpeediCath Compact Set packaging configuration has the same ready to use features as the predicate, SpeediCath Compact, and is packaged in discrete containers.
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 and the predicate, SpeediCath Compact, are for females only.
Indications for Use
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 nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The device is intended for females only.
2
Summary of Testing
SpeediCath Compact Set has been tested and complies with relevance 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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT
2012
Mr. Brian Schmidt Regulatory Affairs Manager Coloplast A/S 1601 West River Road North MINNEAPOLIS MN 55411
Re: K121457
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 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
4
Page 2-
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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,
Sincerely yours,
Benjamin K. Evanko
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
5
Statement of Indications for Use
510(k) Number (if known): K121457
Device Name: SpeediCath Compact Set
Indications for Use:
SpeediCath Compact Set is indicated for use by patients with chronic urine retention and opeculoutir Oompact Ooks includione (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 females 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)
Division'Sign-Off) vision of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number