(268 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a urinary catheter, with no mention of AI or ML technologies.
Yes
The device is a urinary catheter used to drain urine from the bladder, which is a therapeutic intervention for patients with urine retention or voiding dysfunction.
No
The device, a urinary catheter, is used to drain urine from the bladder, which is a therapeutic function, not a diagnostic one. It is indicated for managing urine retention and post-void residual volume, not for diagnosing these conditions.
No
The device description clearly states it is a physical catheter made of polyurethane, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain urine from the bladder via the urethra. This is a direct intervention on the body for therapeutic purposes (relieving urine retention).
- Device Description: The device is a physical catheter designed for insertion into the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis of a specimen.
The device is a medical device, specifically a urinary catheter, but it falls under the category of devices used for direct patient care and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Urinary catheter for intermittent use. The catheter 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 the urine to drain.
Product codes (comma separated list FDA assigned to the subject device)
GBM
Device Description
The SpeediCath Standard is a sterile single use hydrophilic coated polyurethane catheter. The catheter is placed in a swelling media, packed and sealed in a foil pouch and sterilized.
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)
Performance testing for SpeediCath Standard was conducted according to applicable sections of voluntary standards:
- Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016) was completed.
- Bench testing was completed per ASTM D1894:2014 and internal test methods.
- Accelerated Aged (in compliance with ASTM F1980-16) shelf life testing was completed.
- Sterilization dose confirmation was completed according to ISO 11137-2: 2013.
All tests met the pre-determined acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SpeediCath, K023254
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 25, 2018
Coloplast Troy Thome Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, Minnesota 55411
Re: K180258
Trade/Device Name: SpeediCath Standard Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: GBM Dated: September 21, 2018 Received: September 24, 2018
Dear Troy Thome:
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 mav, 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 avare 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. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Glenn B. Bell -S
for
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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Indications for Use
510(k) Number (if known) K180258
Device Name SpeediCath Standard
Indications for Use (Describe)
Urinary catheter for intermittent use.
The catheter is indicated for use by patients with chronic urine retents with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the ureach the bladder allowing the urine to drain.
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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SpeediCath Standard 510(k) Summary
| Submitted by: | Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411 USA |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Troy Thome
Coloplast Corp
Phone : 612-704-9909
Fax : 612-287-4138
Email : ustthome@coloplast.com |
| Date of Summary: | October 24, 2018 |
| Trade or Proprietary Name: | SpeediCath® Standard |
| Common or Usual Name: | Catheter, urethral |
| Classification Name: | Urological catheter and accessories
21CFR 876.5130 |
| Classification: | Class II |
| Product Code: | GBM |
| Predicate Device: | SpeediCath, K023254 (Manufacturer: Coloplast) |
| Device Description: | The SpeediCath Standard is a sterile single use hydrophilic coated
polyurethane catheter. The catheter is placed in a swelling media,
packed and sealed in a foil pouch and sterilized. |
| Indication for Use: | Urinary catheter for intermittent use.
The catheter 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 the urine to drain. |
| Technological Characteristics: | The subject device has the same indications for use, design, materials
(with exception of the swelling media that lubricates the catheter) and
principles of operations as the predicate device. The subject device
includes the same coating and packaging configuration. |
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Summary of Non-Clinical Testing:
Performance testing for SpeediCath Standard was conducted according to applicable sections of voluntary standards:
- . Biocompatibility testing according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1" (2016) was completed.
- Bench testing was completed per ASTM D1894:2014 and . internal test methods.
- . Accelerated Aged (in compliance with ASTM F1980-16) shelf life testing was completed.
- . Sterilization dose confirmation was completed according to ISO 11137-2: 2013.
All tests met the pre-determined acceptance criteria.
The SpeediCath Standard is as safe and effective and is substantially equivalent to the legally marketed predicate device as demonstrated by the same intended use, same principles of operation, similar technological characteristics and performance data, and does not raise different questions of safety and effectiveness.
Substantial Equivalence Conclusion: