(262 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and functionality of a mechanical stent and associated insertion tools, with no mention of AI or ML.
Yes.
The device is used for drainage and healing of the ureter, which are therapeutic actions.
No
The device description indicates it is a flexible tubular device used for drainage and healing of the urinary tract, not for identifying or investigating a condition. Its function is interventional/therapeutic.
No
The device description clearly details physical components such as flexible tubular devices, pushers, guidewires, and catheters, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used within the patient's body for drainage and healing of the ureter. This is an in vivo application.
- Device Description: The description details a physical device (stent, pusher, guidewire, catheter) designed for insertion into the urinary tract.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body, while this device is used for a therapeutic and drainage purpose directly within the body.
N/A
Intended Use / Indications for Use
The double loop ureteral stents are used for:
- drainage of the upper urinary tract over fistulas or ureteral obstacles
- healing of the ureter
Product codes
FAD
Device Description
The Biosoft duo Double loop ureteral stents are flexible tubular devices designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization. They have eyes on the straight part. Stent diameters and length vary to accommodate the patient's anatomy. A withdrawal thread is attached on the proximal end to allow removal.
Non-steerable pushers are simple tubes, the clamp can be used to immobilize the pusher onto the guidewire. Steerable pushers are equipped with a blue handle/Luer Lock female connector and made of an inner tube that can move forward and backward inside an external tube, to allow connection/disconnection of the stent.
The ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.
The Biosoft duo Double Loop Ureteral Stents in this submission and the predicate Biosoft Double Loop ureteral stents are supplied in kits which are comprised of any of the following components depending of the reference of the kit:
- A double-loop ureteral stent equipped with a withdrawal thread ●
- A non-steerable pusher provided with a clamp, or a steerable pusher ●
- Available in certain kits: 0
- o A radiopaque 0.035-inch (0.89mm) diameter guidewire: PTFE-coated stainless steel guidewire or fully hydrophilic nitinol guidewire
- A ureteric (also called ureteral) catheter о
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract, ureter
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)
Substantial equivalence is supported by bench testing and biocompatibility testing comparing Biosoft duo Double Loop Ureteral stents to the predicate device.
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
§ 876.4620 Ureteral stent.
(a)
Identification. A ureteral stent is a tube-like implanted device that is inserted into the ureter to provide ureteral rigidity and allow the passage of urine. The device may have finger-like protrusions or hooked ends to keep the tube in place. It is used in the treatment of ureteral injuries and ureteral obstruction.(b)
Classification. Class II (performance standards).
0
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November 2, 2017
Coloplast Corp. Cori L. Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411
Re: K170422
Trade/Device Name: Biosoft® duo Double Loop Ureteral Stents Regulation Number: 21 CFR$ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD Dated: September 20, 2017 Received: September 21, 2017
Dear Cori L. Ragan:
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.
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); 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.
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.
For comprehensive regulatory information about mediation-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,
Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, sans-serif font. The text is black against a white background. The letters are evenly spaced and easy to read.
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
2
Indications for Use
510(k) Number (if known) K170422
Device Name
Biosoft® duo Double Loop Ureteral Stents
Indications for Use (Describe)
The double loop ureteral stents are used for:
-
drainage of the upper urinary tract over fistulas or ureteral obstacles
-
healing of the ureter
| 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
510(k) SUMMARY
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Legal Manufacturer Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Phone: (612) 597-5106 |
| Email: usclr@coloplast.com | |
| Name of Contact Person: | Cori L. Ragan |
| Regulatory Affairs Manager | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | 20 September 2017 |
| Trade or Proprietary Name: | Biosoft® duo Double Loop Ureteral Sten |
| Common or Usual Name: | Biosoft® duo Double Loop Ureteral Sten |
| Classification Name: | Stent, Ureteral |
| (21CFR section 876.4620) | |
| Product Code: FAD | |
| Device Class: 2 |
Legally Marketed Device to Which Your Firm Is Claiming Equivalence:
Biosoft duo Double Loop Ureteral Stents and their accessories are substantially equivalent in performance, indication, design and materials to Biosoft Ureteral Double Loop Stents from Coloplast A/S, cleared under premarket notification numbers K881744 and K981591.
Device Description:
The Biosoft duo Double loop ureteral stents are flexible tubular devices designed with open renal and open vesical ends to be inserted with a guidewire using a pusher. The stents are radiopaque for fluoroscopic visualization. They have eyes on the straight part. Stent diameters and length vary to accommodate the patient's anatomy. A withdrawal thread is attached on the proximal end to allow removal.
Non-steerable pushers are simple tubes, the clamp can be used to immobilize the pusher onto the guidewire. Steerable pushers are equipped with a blue handle/Luer Lock female connector and made of an inner tube that can move forward and backward inside an external tube, to allow connection/disconnection of the stent.
The ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.
4
The Biosoft duo Double Loop Ureteral Stents in this submission and the predicate Biosoft Double Loop ureteral stents are supplied in kits which are comprised of any of the following components depending of the reference of the kit:
- A double-loop ureteral stent equipped with a withdrawal thread ●
- A non-steerable pusher provided with a clamp, or a steerable pusher ●
- Available in certain kits: 0
- o A radiopaque 0.035-inch (0.89mm) diameter guidewire: PTFE-coated stainless steel guidewire or fully hydrophilic nitinol guidewire
- A ureteric (also called ureteral) catheter о
Intended Use of the device:
The Biosoft duo Double Loop Ureteral Stents in this submission and the predicate Biosoft Double Loop ureteral stents have the same intended use:
- Drainage of the upper urinary tract over fistulas or ureteral obstacles ●
- Healing of the ureter
Technological Characteristics Compared to Predicate Device:
The Biosoft duo Double Loop Ureteral stents and their accessories are substantially equivalent in performance, indication, design and materials to Biosoft Ureteral Double Loop Stents from Coloplast A/S, cleared under premarket notification number K981591.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence is supported by bench testing and biocompatibility testing comparing Biosoft duo Double Loop Ureteral stents to the predicate device.