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

AI/ML Overview

This FDA 510(k) summary describes a submission for a ureteral stent, not an AI/ML powered device. Therefore, much of the requested information about AI model performance, sample sizes for training and testing, ground truth establishment, and expert involvement is not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the study proving it meets those criteria based on the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format as one would expect for an AI model's performance metrics (e.g., sensitivity, specificity, AUC). Instead, the acceptance criteria for a medical device like a ureteral stent are typically based on demonstrating substantial equivalence to an already legally marketed predicate device. This involves showing comparable performance, indications for use, design, and materials.

The study that "proves the device meets the acceptance criteria" is the nonclinical testing (bench testing and biocompatibility testing) performed to demonstrate this substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence:	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 numbers K881744 and K981591. Specifically, the summary states: "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." This equivalence is supported by "bench testing and biocompatibility testing."
- Comparable Performance	Supported by nonclinical testing.
- Comparable Indication for Use	"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"
- Comparable Design	"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....The Biosoft duo Double Loop Ureteral Stents in this submission and the predicate Biosoft Double Loop ureteral stents are supplied in kits..." (Implies similar design principles and components to the predicate)
- Comparable Materials	Supported by nonclinical testing and the assertion of substantial equivalence in materials.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. This document describes nonclinical (bench and biocompatibility) testing, not a clinical study involving human data or an AI model's test set. The "test set" in this context refers to the physical devices and materials undergoing various characterization tests. The document does not specify quantities of devices tested, only that testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a hardware medical device, "ground truth" is typically defined by established material standards, engineering specifications, and biological responses, not expert consensus on images or diagnoses.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for resolving discrepancies in expert labeling of data, which is not pertinent to the evaluation of a ureteral stent through bench and biocompatibility testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. MRMC studies are specific to evaluating diagnostic imaging systems or AI-assisted diagnostic tools. This device is a therapeutic/support device, not an imaging or diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established by:
- Engineering Specifications: Performance characteristics verified through bench testing (e.g., strength, flexibility, radiopacity).
- Biocompatibility Standards: Assessment of material compatibility with living tissue, conducted according to established ISO standards.
- Predicate Device Performance: The legally marketed predicate device itself serves as the benchmark or "ground truth" for demonstrating equivalence.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

510(K) Owner's Name:	Coloplast A/S
Legal Manufacturer Address:	Holtedam 13050 Humlebaek, Denmark
Phone/Fax/Email:	Phone: (612) 597-5106Email: usclr@coloplast.com
Name of Contact Person:	Cori L. RaganRegulatory Affairs Manager
Address/Contact:	1601 West River RoadMinneapolis, 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: FADDevice 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 ureteric catheter supplied with a connector fitted with a Luer tip can be used for inserting the guidewire or injecting contrast medium.

{4}------------------------------------------------

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.

Regulation Number and Section

§ 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).