(55 days)
None
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI or ML.
Yes.
The device is used for the treatment of ureteral stenosis, which is a medical condition, making it a therapeutic device.
No
Explanation: The device is a balloon catheter used for dilation and treatment of ureteral conditions, not for diagnosing them.
No
The device description clearly describes a physical catheter with a balloon, lumens, and associated hardware for inflation, indicating it is a hardware medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the In-Ka® ureteral balloon dilatation catheter is used directly on the patient to dilate the ureteral meatus and/or ureteral canal. It is an invasive device used for a therapeutic procedure.
- The device description and performance studies focus on the physical and mechanical properties of the catheter. This is typical for a medical device used in a surgical or interventional procedure, not for a device that analyzes biological samples.
Therefore, the In-Ka® ureteral balloon dilatation catheter is a medical device used in vivo (within the body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
In-Ka® ureteral balloon dilatation catheters are intended for:
- Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
- Treatment of ureteral stenosis
Product codes
EZN
Device Description
The In-Ka Ureteral Balloon Dilatation Catheter is a urinary balloon catheter intended for dilation of the ureteral meatus or the ureteral canal or for treatment of ureteral stenosis. The catheter is a double lumen catheter with a balloon at the distal end and supplied in three balloon diameters ranging from 4 - 6 mm. Each 75 cm long In-Ka catheter is supplied sterile for a single use. Either a manometer or a 10cc syringe is included for balloon inflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ureteral meatus and/or ureteral canal
Indicated Patient Age Range
Patients requiring endourologic procedures and/or presenting with ureteral stenosis.
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing: The biocompatibility evaluation for the In-Ka Ureteral Balloon Dilatation Catheters device was conducted in accordance with ISO 10993-1 and FDA guidance document for Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process". The In-Ka Ureteral Balloon Dilatation Catheters are categorized as surface devices (natural route) or as externally communicating devices (percutaneous route) coming in contact with mucous membrane (natural route) or tissues (suprapubic route) for limited (
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. 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 features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 11, 2020
Coloplast Corp. Cori L. Ragan Regulatory Affairs Manager 1601 West River Road North Minneapolis, MN 55411
Re: K201007
Trade/Device Name: In-Ka® Ureteral Balloon Dilatation Catheters Regulation Number: 21 CFR§ 876.5470 Regulation Name: Ureteral Dilator Regulatory Class: II Product Code: EZN Dated: April 15, 2020 Received: April 17, 2020
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. 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,
Purva Pandya Acting 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) K201007
Device Name
In-Ka® Ureteral Balloon Dilatation Catheters
Indications for Use (Describe)
In-Ka® ureteral balloon dilatation catheters are intended for:
- . Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
- . Treatment of ureteral stenosis
Target population
Patients requiring endourologic procedures and/or presenting with ureteral stenosis.
Duration of Use
In-Ka® ureteral balloon dilatation catheters are intended for transient use (less than 1 hour).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
5. 510(k) SUMMARY
| I.
SUBMITTER
| 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 North |
| Minneapolis, MN 55411 | |
| Date Prepared: | 15-Apr-2020 |
| II. | |
| DEVICE | |
| Trade or Proprietary Name: | In-Ka® Ureteral Balloon Dilatation Catheter |
| Common or Usual Name: | Ureteral Balloon Dilatation Catheter |
| Classification Name: | Dilator, Catheter, Ureteral |
| (21 CFR section 876.5470) | |
| Product Code: EZN | |
| Device Class: 2 |
III. PREDICATE DEVICE
The In-Ka Ureteral Balloon Dilatation Catheters are substantially equivalent in performance, indication, design and materials to Bard® Uroforce™ Balloon Dilation Catheters, cleared under premarket notification number K993840.
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The In-Ka Ureteral Balloon Dilatation Catheter is a urinary balloon catheter intended for dilation of the ureteral meatus or the ureteral canal or for treatment of ureteral stenosis. The catheter is a double lumen catheter with a balloon at the distal end and supplied in three balloon diameters ranging from 4 - 6 mm. Each 75 cm long In-Ka catheter is supplied sterile for a single use. Either a manometer or a 10cc syringe is included for balloon inflation.
4
V. INDICATIONS FOR USE
In-Ka ureteral balloon dilatation catheters are intended for:
- · Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
- · Treatment of ureteral stenosis
Target population
Patients requiring endourologic procedures and/or presenting with ureteral stenosis.
Duration of Use
In-Ka ureteral balloon dilatation catheters are intended for transient use (less than 1 hour).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE
The In-Ka Ureteral Balloon Dilatation Catheters are substantially equivalent in performance, indication, design and materials to Bard Uroforce Balloon Dilation Catheters, cleared under premarket notification number K993840. There are no significant technological differences between the subject devices and the predicate. Bard Uroforce Balloon Dilation Catheters (predicate) and the In-Ka Ureteral Balloon Dilatation Catheter (subject device) are each supplied with inflation devices which can either be a manometer or a syringe. Both the subject and predicate devices have dual lumens to allow for similar size guidewires (0.035 inch for In-Ka and 0.038 inch for Uroforce) and for balloon inflation. The recommended balloon inflation pressures are a maximum of 17 atm for the In-Ka balloon and 23 atm for the Uroforce balloon. The In-Ka balloon diameters and lengths (4 - 6 mm diameter and 40 mm long) fall within the range covered in the Bard Uroforce Balloon Dilation Catheter (4-8 mm diameter and 4 - 10 cm long). Both devices are 75 cm long, supplied sterile, and intended for a single use.
PERFORMANCE DATA VII.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the In-Ka Ureteral Balloon Dilatation Catheters device was conducted in accordance with ISO 10993-1 and FDA guidance document for Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process". The In-Ka Ureteral Balloon Dilatation Catheters are categorized as surface devices (natural route) or as externally communicating devices (percutaneous route) coming in contact with mucous membrane (natural route) or tissues (suprapubic route) for limited (