(217 days)
No
The document describes a physical medical device (a catheter) and its performance testing, with no mention of software, algorithms, or AI/ML technologies.
Yes
The device is used to treat urine retention and high post-void residual volume, which are medical conditions, thus making it a therapeutic device.
No.
The device description and intended use clearly state that Luja Coude is a catheter used for draining urine from the bladder, not for diagnostic purposes. Its function is to facilitate the outflow of urine for patients with retention or post-void residual volume.
No
The device description clearly outlines a physical, single-use, sterile catheter with a flexible tip, micro holes, an outlet for a urine bag, and a hydrophilic coating. It also mentions sterilization and packaging. This is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Function: The Luja Coude catheter is a device that is inserted into the body (the urethra to the bladder) to drain urine. It is a therapeutic device used to manage urine retention and voiding dysfunction. It does not analyze or test the urine itself.
The description clearly outlines its function as a catheter for draining urine, not for analyzing it.
N/A
Intended Use / Indications for Use
Luja Coude 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 bladder allowing urine to drain. The product is for adult male patients only.
Product codes (comma separated list FDA assigned to the subject device)
EZD
Device Description
Luja Coude is a single-use, sterile catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, and 16 Fr. The reference device supports the inclusion of 8 Fr models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
adult
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)
Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. Testing was performed on final, finished, and sterilized devices as described in the applicable submission sessions. The performance testing demonstrates the subject device is as safe and effective as the predicate device.
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.
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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.
August 25, 2023
Coloplast Corporation Troy Thome Senior Regulatory Affairs Specialist 1601 West River Road North Minneapolis, MN 55411
Re: K230165
Trade/Device Name: Luja Coude Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: July 28, 2023 Received: July 28, 2023
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 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.
1
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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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,
Jessica K. Nguyen -S
Jessica K. Nguyen, 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) K230165
Device Name Luja Coude
Indications for Use (Describe)
Luja Coude 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 bladder allowing urine to drain. The product is for adult 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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TRADITIONAL 510(K) SUMMARY
| Submitted by: | Coloplast A/S
Holtedam1
3050 Humlebaek
Denmark |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Troy Thome
Sr. Regulatory Affairs Specialist
Coloplast
1601 West River Road North
Minneapolis MN 55411
Phone: +1 (612)-356-9917
Email: ustbthome@coloplast.com |
| Date of Summary: | August 24, 2023 |
| Subject Device: | |
| Trade or Proprietary
Name: | Luja Coude |
| Item/Model Numbers: | 20118, 20111, 20112, 20114, 20101, 20102, 20104, 20106 |
| Common Name: | Urological catheter and accessories |
| Regulation/Classification
Name: | Urological catheter and accessories |
| Regulation Number: | 21 CFR 876.5130 |
| Regulatory Class: | II |
| Product Code: | EZD |
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Image /page/4/Picture/1 description: The image contains the logo for Coloplast. The logo consists of a blue globe-like icon on the left and the word "Coloplast" in blue, sans-serif font on the right. The globe icon is made up of several horizontal lines, with the lower half filled in with solid blue.
| Review Panel: | Gastroenterology/Urology |
|---|---|
| Predicate Device: | K190620, SpeediCath Flex Coude Pro |
| The predicate device has not been subject of a design-related | |
| recall. | |
| Reference Device: | K180258, SpeediCath Standard |
| The reference device has not been subject of a design-related | |
| recall. | |
| Device Description: | Luja Coude is a single-use, sterile catheter for intermittent urinary |
| catheterization. The catheter has a flexible tip which contains | |
| several small holes (micro holes) by the tip creating a drainage | |
| zone which allows the urine to flow from the bladder through the | |
| catheter. The drainage end of the device has an outlet to which a | |
| urine bag with a suitable connector can be connected. The catheter | |
| also contains a hydrophilic-coating and is sterilized by irradiation. | |
| The primary packaging provides the sterile barrier and contains a | |
| proof of seal for identification of opened products. | |
| Luja Coude is available in one length (33cm) with a flexible tip | |
| and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, and 16 Fr. The reference | |
| device supports the inclusion of 8 Fr models. | |
| Indications for Use: | Luja Coude 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 adult male patients only. | |
| The subject and predicate devices have the same intended use. |
Technological Characteristics Comparison
The table below summarizes the technological characteristics of Luja Coude as compared to the predicate device.
| Parameter | Subject device | Predicate device | Reference device |
|---|---|---|---|
| Luja Coude | SpeediCath Flex | ||
| Coudé Pro | SpeediCath Standard | ||
| (male models only) | |||
| 510(k) Number | Unassigned | K190620 | K180258 |
| Regulation Name | Urological catheter and | ||
| accessories | Same | Same | |
| Regulation Number | 21 CFR 876.5130 | Same | Same |
| Product Code | EZD | GBM | GBM |
| Classification | II | Same | Same |
| Parameter | Subject device | Predicate device | Reference device |
| Luja Coude | SpeediCath Flex | ||
| Coudé Pro | SpeediCath Standard | ||
| (male models only) | |||
| Prescription Device | Yes | Same | Same |
| Intended Use | Intermittent | ||
| catheterization through the | |||
| urethra. | Same | Same | |
| Condition of Use | Intermittent use and single | ||
| use | Same | Same | |
| Drainage | Micro holes | Eyelets | Eyelets |
| Device Categorization | |||
| per | |||
| ISO 10993 | Surface contacting device | ||
| in contact with mucosal | |||
| membrane for a prolonged | |||
| duration of time (24 h |