(121 days)
No
The summary describes a physical medical device (catheter) and its performance testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
Explanation: The device is used to drain urine from the bladder, which is a therapeutic intervention for patients with urine retention or voiding dysfunction.
No
The device is a catheter used for draining urine, not for diagnosing medical conditions.
No
The device description clearly describes a physical catheter made of polyurethane with a hydrophilic coating, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This testing is done outside the body (in vitro).
- Device Function: The SpeediCath Flex Coude Pro is a catheter used to drain urine directly from the bladder. It is inserted into the body and its function is mechanical (facilitating drainage), not diagnostic testing of a specimen.
- Intended Use: The intended use clearly states it's for draining urine due to retention or residual volume, not for analyzing urine for diagnostic purposes.
Therefore, based on the provided information, the SpeediCath Flex Coude Pro is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SpeediCath Flex Coude Pro is indicated for use by patients with urine retention and patients with 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 product is for male patients only.
Product codes (comma separated list FDA assigned to the subject device)
GBM
Device Description
The SpeediCath Flex Coude' Pro catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a bended flexible tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection form the user's touch during insertion. The SpeediCath Flex Coude' Pro Catheters are offered with a 33cm effective length and range in size from 10Fr to 16Fr. The hydrophilic coating makes this single use catheter ready to use.
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 Flex Coude' Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coude' Pro catheter:
- Accelerated Aged (per ISO F1980-16) shelf life testing for coating and tip bend inspections
- Biocompatibility according to ISO 10993-1 (2009) and FDA Guidance "Use of International Standards ISO 10993-1" (2016)
- Coefficient of friction according to ASTM D1894: 2014
- Transportation testing per ASTM D4169 followed by assessments of coating performance and inspection of damage of packaging
The following tests were completed to determine the impact of the modifications based on assessment of the device risk documentation:
- Catheter kink testing
- Catheter tip integrity
- Coating inspection
- Proof of packing seal
- Peel force test of new material to test for ability to open packaging
The following performance specifications for SpeediCath Flex Coude' Pro were established based on performance testing of the predicate device according to applicable sections of voluntary standards.
- Flow rate according to EN1616/EN1618 and ASTM F623-99: 2013
- Tensile strength according to EN1616/EN1618
- Connector security according to EN1616
All tests passed the pre-determined acceptance criteria. The proposed changes do not impact the performance specifications.
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.
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.
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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 10, 2019
Coloplast Corp Delaney McDougal Sr. Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K190620
Trade/Device Name: SpeediCath Flex Coude Pro Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: GBM Dated: May 29, 2019 Received: May 30, 2019
Dear Delaney McDougal:
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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Glenn B. Bell. Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name SpeediCath Flex Coudé Pro
Indications for Use (Describe)
SpeediCath Flex Coude Pro is indicated for use by patients with urine retention and patients with 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 product is for male patients only.
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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3
TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast Corp
1601 West River Road North
Minneapolis, MN 55411 USA |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person : | Ms. Delaney McDougal
Coloplast Corp
Phone :+1 612-380-8034
Email: usdel@coloplast.com |
| Date of Summary:
Trade or Proprietary Name: | July 10, 2019
SpeediCath Flex Coude' Pro |
| Common or Usual Name: | Catheter urethral |
| Regulation Name: | Urological catheter and accessories |
| Device Class: | Class II |
| Regulation Number:
Product Code: | 21CFR 876.5130
GBM |
| Review Panel: | Gastroenterology/Urology |
| Predicate Device: | SpeediCath Flex Coude' Pro: K180070
Reference device: SpeediCath Standard: K180258 |
| Device Description: | The SpeediCath Flex Coude' Pro catheter is a sterile single use
hydrophilic coated polyurethane catheter for men. The catheter is to
be used for intermittent drainage of the bladder through the urethra by
males with missing or reduced bladder control. The catheter has a
bended flexible tip that facilitates passage through the urethra to the
bladder. The catheter is shielded by a sleeve, which serves as
protection form the user's touch during insertion. The SpeediCath
Flex Coude' Pro Catheters are offered with a 33cm effective length
and range in size from 10Fr to 16Fr. The hydrophilic coating makes
this single use catheter ready to use. |
| Indication for Use: | SpeediCath Flex Coude' Pro is indicated for use by patients with urine
retention and patients with 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 product is for male patients only. |
4
Technological The subject device has the same indications for use, design, catheter Characteristics: French sizes and lengths, and principles of operations as the predicate device. The device includes the same raw catheter coating and sleeve design. The differences between the subject device and predicate device is in the following: . Pouch material and dimensions Sleeve material and dimensions ● ● Wetting agent material and volume . Product variants - line extension
Performance testing for SpeediCath Flex Coude' Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coude' Pro catheter.
- Accelerated Aged (per ISO F1980-16) shelf life testing for ● coating and tip bend inspections
- . Biocompatibility according to ISO 10993-1 (2009) and FDA Guidance "Use of International Standards ISO 10993-1" (2016)
- . Coefficient of friction according to ASTM D1894: 2014
- Transportation testing per ASTM D4169 followed by assessments of coating performance and inspection of damage of packaging
The following tests were completed to determine the impact of the modifications based on assessment of the device risk documentation:
- Catheter kink testing
- Catheter tip integrity
- Coating inspection
- Proof of packing seal
- Peel force test of new material to test for ability to open ● packaging
The following performance specifications for SpeediCath Flex Coude' Pro were established based on performance testing of the predicate device according to applicable sections of voluntary standards.
- Flow rate according to EN1616/EN1618 and ASTM F623-● 99: 2013
- Tensile strength according to EN1616/EN1618
- Connector security according to EN1616 ●
All tests passed the pre-determined acceptance criteria. The proposed changes do not impact the performance specifications.
Summary of Non-Clinical Testing:
5
Substantial Equivalence Table:
| Item | Subject Device | Predicate Device |
|---|---|---|
| Indications for Use | SpeediCath Flex Coude' Pro is | |
| indicated for use by patients with | ||
| urine retention and patients with | ||
| 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 product | ||
| is for male patients only. | SpeediCath Flex Coude' Pro is indicated | |
| for use by patients with urine retention and | ||
| patients with 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 product is for male patients only. | ||
| Sterility | E-beam | E-beam |
| Configuration | Tip: flexible bended tip | Tip: flexible bended tip |
| Materials | Catheter: Polyurethane | |
| Hydrophilic coating: PVP based | ||
| Wetting agent: PEG | ||
| Protective sleeve: color pigment, | ||
| polyethylene styrene isobutylene | ||
| copolymer | ||
| Pouch: Polyethylene & PETP | Catheter: Polyurethane | |
| Hydrophilic coating: PVP based | ||
| Wetting agent: PVP | ||
| Protective sleeve: color pigment and | ||
| polyethylene | ||
| Pouch: Polyethylene & PETP/aluminum | ||
| Pouch | ||
| Configurations | Single & double-loop (pocket-size) | |
| Dimension: | ||
| Single: 249 mm L x 100mm W | ||
| Double: 186 mm L x 87 mm W | Single-loop | |
| Dimension: | ||
| 216 mm L | ||
| 100 mm W | ||
| Biocompatibility | Per ISO 10993 | Per ISO 10993 |
| Friction | Per ASTM D 1894-14 | Per ASTM D 1894-14 |
| Flow rate | Per ASTM F 623-99 | Per ASTM F 623-99 |
| Tensile | Per EN 1616/1618 | Per EN 1616/1618 |
| Shelf life | 2 years | 2 years |
| Available sizes | Fr 10 - 16 single- | |
| loop Fr 10 – 14 | ||
| double-loop | Fr 10 – 16 single-loop |
6
Substantial Equivalence Conclusion:
Based on the intended use, technological characteristics, safety and performance testing included in this submission, Coloplast considers the Product to be substantially equivalent to the currently marketed SpeediCath Flex Coude' Pro.
The SpeediCath Flex Coudé Pro differs from the predicate device in regards to the protective sleeve, primary packaging pouch, wetting agent, and product size variants. The protective sleeve has been updated to a larger overall width to accommodate additional wetting agent. The primary packaging pouch length was increased to allow for additional space inside the pouch for the product, the pull-tab from the predicate product has been removed and replaced with a circular hole in order to provide ease of opening for users with limited dexterity, and the aluminum layer within the pouch has been replaced with a PET layer in order to improve the environmental impact. The wetting agent used within the protective sleeve was updated from PVP water to PEG water which is currently used within the predicate device. The product line has been updated to make available a double-loop (pocket-size) variation which is currently available in the predicate device.