(230 days)
No reference devices were used in this submission.
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML capabilities.
Yes
The device is described as assisting in "creating a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action," indicating its use in a medical procedure to achieve a therapeutic outcome.
No
Explanation: The device is described as a "Percutaneous Balloon Dilatation Catheter" indicated for "dilation of the tract to create a percutaneous renal access." Its purpose is to facilitate a procedure (dilation), not to diagnose a condition. While it mentions "radiographic visualization and positioning," this is for guiding the therapeutic action, not for diagnostic imaging itself.
No
The device description clearly outlines physical components such as a balloon catheter, Amplatz sheath, and potentially an inflation device (manometer), indicating it is a hardware medical device. The performance studies also focus on the physical and mechanical properties of these components.
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 dilation of a percutaneous renal tract and maintaining that tract. This is a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The device is a balloon catheter and sheath designed for physical manipulation within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a patient's health status. IVDs are used for testing samples in vitro.
The device is a medical device used for a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the percutaneous tract dilation).
The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).
Product codes (comma separated list FDA assigned to the subject device)
LJE
Device Description
The In-Ka® Percutaneous Balloon Dilatation Catheters are balloon catheters intended for dilation of the nephrostomy tract to create a percutaneous renal access. The catheter is a 7 Fr double lumen catheter supplied with a radiopaque Amplatz sheath. The catheter is supplied with or without an inflation device (manometer) depending on the model. Amplatz sheaths are also sold separately from the catheter. The 30 Fr balloon is equipped with a radiopaque stainless-steel ring on its distal extremity corresponding to the balloon's working length to allow radiographic visualization and positioning. Each In-Ka catheter is supplied sterile for a single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal
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)
Biocompatibility Testing:
Testing was conducted based upon ISO 10993-1 (2009) and FDA Guidance for Use of International Standard ISO 10993-1. Tests completed: Cytotoxicity, Sensitization, Irritation, Acute Systemic toxicity.
Results: The protocol and results of biocompatibility testing were acceptable.
Mechanical Testing:
Performance testing was conducted with samples aged at T=0 and 3 years accelerated aging.
In-Ka Percutaneous Balloon Dilatation Catheter Testing included: Visual evaluation, Dimensional Testing (Balloon deflated profile, Catheter tip length, Balloon diameter, Balloon length, Radiopaque marker band to balloon alignment, Shaft diameter and length), Balloon testing (Balloon sheath removal force, Simulated Use Catheter Preparation, deployment, and retraction, Balloon Inflation / Deflation Time, Balloon compliance, Balloon Cycle Testing / Multiple inflation testing, Balloon Burst), Marker Band Removal Force, Radiopacity, Guidewire compatibility with distal Channel, Compatibility with Amplatz Sheath, High Pressure Test (Nominal burst pressure, Maximum burst pressure), Injection Luer Compatibility, Tensile strength testing (Catheter shaft, Catheter / Connector junction, Luer connector).
Amplatz Sheath Testing included: Visual Evaluation, Radiopacity, Compression Resistance, Dimensional Evaluations (Length, Inner Diameter, External Diameter, Bevel Angle).
Manometer Testing included: Pressure Accuracy Testing.
Results: The results of mechanical performance tests were acceptable.
Sterilization:
The devices are sterilized using ethylene oxide in a validated cycle demonstrating a sterility assurance level (SAL) of 10-6.
Shelf Life:
The In-Ka Percutaneous Balloon Dilatation Catheter was subjected to package integrity testing and verification testing to support the proposed shelf life.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
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.
No reference devices were used in this submission.
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
N/A
0
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December 17, 2020
Coloplast Corp. Sihem Darraji Corporate Director, Global Regulatory Affairs 1601 West River Road North Minneapolis. MN 55411
Re: K201165
Trade/Device Name: In-Ka® Percutaneous Balloon Dilatation Catheter and Amplatz Sheath Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LJE Dated: November 13, 2020 Received: November 16, 2020
Dear Sihem Darraji:
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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.
1
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 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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 medical devices and radiation-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.
Sharon M. Andrews 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) K201165
Device Name
In-Ka® Percutaneous Balloon Dilatation Catheter and Amplatz Sheath
Indications for Use (Describe)
The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the percutaneous tract dilation).
The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).
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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510(k) SUMMARY - K201165
| I.
SUBMITTER
| 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: | Sihem Darraji |
| Corporate Director, Global Regulatory Affairs | |
| Address/Contact: | 1601 West River Road North |
| Minneapolis, MN 55411 | |
| Date Prepared: | December 17, 2020 |
| II. | |
| DEVICE | |
| Trade or Proprietary Name: | In-Ka® Percutaneous Balloon Dilatation Catheter and |
| Amplatz Sheath | |
| Common or Usual Name: | Nephrostomy Catheter |
| Classification Name: | Catheter, Nephrostomy |
| Product Code: LJE | |
| Device Class: Unclassified |
III. PREDICATE DEVICE
Bard X-Force™ N30 Nephrostomy Balloon Dilation Catheters, cleared under premarket notification number K080944
The predicate device has the following indication for use:
- Dilation of the nephrostomy tract and placement of the working sheath .
This predicate has not been subject to a design-related recall.
No reference devices were used in this submission.
DEVICE DESCRIPTION IV.
The In-Ka® Percutaneous Balloon Dilatation Catheters are balloon catheters intended for dilation of the nephrostomy tract to create a percutaneous renal access.
4
The catheter is a 7 Fr double lumen catheter supplied with a radiopaque Amplatz sheath. The catheter is supplied with or without an inflation device (manometer) depending on the model. Amplatz sheaths are also sold separately from the catheter.
The 30 Fr balloon is equipped with a radiopaque stainless-steel ring on its distal extremity corresponding to the balloon's working length to allow radiographic visualization and positioning. Each In-Ka catheter is supplied sterile for a single use.
V. INDICATIONS FOR USE
The In-Ka® Percutaneous Balloon Dilatation Catheters are indicated for dilation of the tract to create a percutaneous renal access in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. The balloon catheter is designed for transient use (for the duration of the percutaneous tract dilation).
The Amplatz sheath is used during renal dilation to provide and maintain a nephrostomy tract in patients requiring a percutaneous renal procedure for urine drainage or therapeutic action. It is designed for short-term use (up to 3 hours).
The subject and predicate device have the same intended use.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The subject and predicate device have different technological characteristics, including lumen length and material, balloon length and material, and balloon max pressure. These differences in technological characteristics do not raise different questions of safety and effectiveness.
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VII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing
Biocompatibility testing was conducted based upon ISO 10993-1 (2009): Biological evaluation of medical devices – Part 1: "Evaluation and testing within a risk management process" and FDA Guidance for Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" - Guidance for Industry and Food and Drug Administration Staff - June 16, 2016. The following biocompatibility testing was completed:
- Cytotoxicity ●
- Sensitization
- Irritation ●
- Acute Systemic toxicity ●
The protocol and results of biocompatibility testing were acceptable.
Mechanical Testing
Performance testing was conducted with samples aged at T=0 and 3 years accelerated aging. The performance testing included the following tests:
In-Ka Percutaneous Balloon Dilatation Catheter Testing
- Visual evaluation ●
- Dimensional Testing .
- Balloon deflated profile O
- Catheter tip length O
- Balloon diameter O
- Balloon length O
- Radiopaque marker band to balloon alignment O
- Shaft diameter and length O
- Balloon testing
- Balloon sheath removal force O
- Simulated Use Catheter Preparation, deployment, and retraction O
- Balloon Inflation / Deflation Time O
- Balloon compliance O
- Balloon Cycle Testing / Multiple inflation testing O
- Balloon Burst o
- Marker Band Removal Force
- Radiopacity ●
- Guidewire compatibility with distal Channel ●
- Compatibility with Amplatz Sheath ●
- High Pressure Test ●
- 0 Nominal burst pressure
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K201165 Page 4 of 4
- o Maximum burst pressure
- Injection Luer Compatibility
- Tensile strength testing ●
- Catheter shaft O
- Catheter / Connector junction O
- Luer connector O
Amplatz Sheath
- Visual Evaluation
- . Radiopacity
- Compression Resistance ●
- Dimensional Evaluations ●
- o Length
- Inner Diameter O
- External Diameter o
- o Bevel Angle
Manometer
- Pressure Accuracy Testing ●
The results of mechanical performance tests were acceptable.
Sterilization
The In-Ka Percutaneous Balloon Dilatation Catheters and Amplatz Sheaths are sterilized using ethylene oxide in a validated cycle demonstrating a sterility assurance level (SAL) of 10 °.
Shelf Life
The In-Ka Percutaneous Balloon Dilatation Catheter was subjected to package integrity testing and verification testing to support the proposed shelf life.
No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices.
VIII. CONCLUSIONS
The In-Ka Percutaneous Balloon Dilatation Catheter and the Amplatz Sheath have been demonstrated to be substantially equivalent to the predicate, Bard X-Force N30 Nephrostomy Balloon Dilation Catheters.