(176 days)
No
The device description and performance studies focus on the physical properties and function of the dilators, with no mention of AI or ML.
No.
The device is intended for "dilatation" during procedures, which is a mechanical action to facilitate access or manipulate tissue, not to treat a disease or condition itself.
No
The device, Ureteral Dilators and Percutaneous Nephrostomy Dilators, is intended for dilatation of the ureter and tract preparation, respectively, which are interventional/therapeutic uses, not diagnostic.
No
The device description clearly states the device is made of physical materials (PEBA, HDPE, PTFE) and is a hollow rigid tube, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical dilatation of the ureter and for tract preparation or protection during percutaneous nephrostomy procedures. This is a physical intervention on the body.
- Device Description: The device is described as hollow rigid tubes made of PEBA and HDPE/PTFE. These are physical instruments used for manipulation within the body.
- 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, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a procedural purpose.
N/A
Intended Use / Indications for Use
Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures.
Percutaneous Nephrostomy Dilators:
Dilator for tract preparation or splittable working sheath to protect the parenchyma.
Product codes
EZN
Device Description
Ureteral dilators:
The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA) with tapered tips at the distal and proximal end. Total length is approximately 48 cm.
The dilators are compatible with a 0.038 inch (0.97 mm) guidewire. Outer diameters are either:
- CH FR 08 at one end and CH FR 10 at the other end
- CH FR 12 at one end and CH FR 14 at the other end
Percutaneous Nephrostomy (PCN) dilators:
The simple dilators are hollow tubes made in Polyether Block Amide (PEBA), with a tapered distal tip and straight cut proximal end. Total length is approximately 21cm.
The dilators are compatible with a 0.038 inch (0.97mm) guide-wire.
The dilator with splittable sheath consists of a high-density polyethylene (HDPE) dilator fitted with a Polytetrafluoroethylene (PTFE) sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter, parenchyma
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 comparing Ureteral and Percutaneous Nephrostomy Dilators to the predicate device and biocompatibility testing performed on the Ureteral and Percutaneous Nephrostomy Dilators.
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
§ 876.5470 Ureteral dilator.
(a)
Identification. A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2017
Coloplast Corporation Cori L. Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411
Re: K170531
Trade/Device Name: Ureteral Dilators and Percutaneous Nephrostomy Dilators Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: EZN Dated: August 10, 2017 Received: August 14, 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.
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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 801); medical device reporting (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Benjamin R. Fisher -S
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)
Device Name
Ureteral Dilators and Percutaneous Nephrostomy Dilators
Indications for Use (Describe) Ureteral Dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures.
Percutaneous Nephrostomy Dilators:
Dilator for tract preparation or splittable working sheath to protect the parenchyma.
| 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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7. 510(k) SUMMARY
| 510(K) Owner's Name: | Coloplast A/S |
|---|---|
| Address: | Holtedam 1 |
| 3050 Humlebaek, Denmark | |
| Phone/Fax/Email: | Office: 612.597.5106 |
| Email: usclr@coloplast.com | |
| Name of Contact Person: | Cori Ragan |
| Regulatory Affairs Manager | |
| Address/Contact: | 1601 West River Road |
| Minneapolis, MN 55411 | |
| Date Prepared: | 21 February 2017 |
| Trade or Proprietary Name: | Ureteral Dilator |
| Percutaneous Nephrostomy Dilators | |
| Common or Usual Name: | Ureteral Dilator |
| Percutaneous Nephrostomy Dilators | |
| Classification Name: | Ureteral dilator |
| (21CFR section 876.5470) | |
| (Product Code: EZN) | |
| Device Class: 2 |
Legally Marketed Device to Which Your Firm is Claiming Equivalence:
The Ureteral and Percutaneous Nephrostomy Dilators are substantially equivalent in performance, indication, design and materials to Cook Medical AQ® Hydrophilic Dilator, cleared under premarket notification number K961904.
Device Description:
Ureteral dilators:
The Ureteral Dilators are hollow rigid tubes made of Polyether Block Amide (PEBA) with tapered tips at the distal and proximal end. Total length is approximately 48 cm.
The dilators are compatible with a 0.038 inch (0.97 mm) guidewire. Outer diameters are either:
- CH FR 08 at one end and CH FR 10 at the other end
- CH FR 12 at one end and CH FR 14 at the other end ●
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Percutaneous Nephrostomy (PCN) dilators:
The simple dilators are hollow tubes made in Polyether Block Amide (PEBA), with a tapered distal tip and straight cut proximal end. Total length is approximately 21cm.
The dilators are compatible with a 0.038 inch (0.97mm) guide-wire.
The dilator with splittable sheath consists of a high-density polyethylene (HDPE) dilator fitted with a Polytetrafluoroethylene (PTFE) sheath.
Intended Use of the device:
Ureteral dilators: Intended to be used for dilatation of the ureter during ureteroscopic procedures.
Percutaneous Nephrostomy Dilators: Dilator for tract preparation or splittable working sheath to protect the parenchyma.
Technological Characteristics Compared to Predicate Device:
The Ureteral and Percutaneous Nephrostomy Dilators are substantially equivalent in performance, design and materials to Cook Medical AQ® Hydrophilic Dilator, cleared under premarket notification number K961904.
Summary and Conclusions from the Nonclinical Tests Submitted:
Substantial equivalence is supported by bench testing comparing Ureteral and Percutaneous Nephrostomy Dilators to the predicate device and biocompatibility testing performed on the Ureteral and Percutaneous Nephrostomy Dilators.