(238 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of drainage catheters and their accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is used for drainage, which is a therapeutic intervention aimed at treating medical conditions such as fluid accumulation in the renal pelvis or bladder.
No
Explanation: The device is described as being used for "placement of a loop catheter...for drainage" and to "provide bladder drainage," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly details physical components such as catheters, sutures, locking mechanisms, and accessories like needles and dilators. The performance studies also focus on physical characteristics like dimensional testing, tensile strength, and flow rate, indicating a hardware-based device.
Based on the provided information, these devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is for percutaneous placement of a loop catheter for drainage in the renal pelvis (kidney) or bladder. This is a therapeutic and procedural use, not a diagnostic one.
- Device Description: The description details the physical components and how the catheter is placed and secured within the patient's body for drainage. It does not mention any components or processes related to analyzing samples from the body to provide diagnostic information.
- Performance Studies: The performance studies listed focus on the physical and functional characteristics of the device itself (dimensional testing, flow rate, tensile strength, retention, biocompatibility, etc.), not on the accuracy or reliability of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. These devices are used for drainage, which is a treatment or management procedure.
N/A
Intended Use / Indications for Use
Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.
Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.
Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.
Product codes (comma separated list FDA assigned to the subject device)
LJE, KOB
Device Description
The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc®
- Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc.
- Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc.
- Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device.
The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture.
Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
renal pelvis, bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 subject devices underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility testing were conducted in accordance with applicable performance standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.
- Dimensional Testing
- Compatibility and post-urine compatibility
- Flow Rate and Liquid Leakage
- Tensile Strength Hub-to-Shaft, Shaft, Catheter to Connecting Tube
- Retention
- Radiopacity
- MRI Testing
- Biocompatibility Testing shows that the subject devices conform to the biocompatibility requirements based on its intended use. All evaluation criteria were met.
- Sterilization
- Package integrity and stability
- Shelf-life
All predetermined acceptance criteria were met.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2020
Cook Incorporated Carly Powell Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K191498
Trade/Device Name: Cook-Cope Loop Nephrostomy Set Ultrathane Nephrostomy Set with Mac-Loc Ultrathane Suprapubic Set with Mac-Loc Regulatory Class: Unclassified Product Code: LJE, KOB
Dated: December 3, 2019 Received: December 4, 2019
Dear Carly Powell:
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.
1
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. 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.
Jessica K. Nguven, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K191498
Device Name Cook-Cope Loop Nephrostomy Set Ultrathane Nephrostomy Set with Mac-Loc Ultrathane Suprapubic Set with Mac-Loc
Indications for Use (Describe)
Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.
Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.
Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.
| 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)
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510(k) Summary
Cook-Cope Loop Nephrostomy Set Ultrathane® Nephrostomy Set with Mac-Loc® Ultrathane® Suprapubic Set with Mac-Loc® As required by 21 CFR §807.92 Date Prepared: December 3, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification | |
|---|---|---|
| Applicant: | Cook Incorporated | |
| Contact: | Carly Powell | |
| Paul Meyer | ||
| Applicant Address: | Cook Incorporated | |
| 750 Daniels Way | ||
| Bloomington, IN 47404 | ||
| Contact Phone: | (812) 335-3575 x104913 | |
| Contact Fax: | (812) 332-0281 | |
| Device Information: | ||
| Trade Name: | Cook-Cope Loop Nephrostomy Set | |
| Ultrathane® Nephrostomy Set with Mac-Loc® | ||
| Ultrathane® Suprapubic Set with Mac-Loc® | ||
| Common Name: | Catheter, Nephrostomy (Product Code: LJE) | |
| Catheter, Suprapubic (and Accessories) | ||
| (Product Code: KOB) | ||
| Classification Name: | None (Product Code: LJE), | |
| Suprapubic urological catheter and accessories | ||
| (Product Code: KOB) | ||
| Regulation: | None (Product Code: LJE) | |
| 21 CFR §876.5090 (Product Code: KOB) | ||
| Device Classification: | Unclassified, Class II | |
| Product Code. Panel: | LJE. KOB. Gastroenterology/Urology |
4
Predicate Device:
- Primary predicate: The Universa® Percutaneous Drainage Catheter Sets cleared . on November 18, 2014 (K140085).
- . Secondary predicate: Dawson-Mueller Drainage Catheter and Set within the Multipurpose Drainage Catheter and Set cleared on May 1, 2018 (K173035).
Device Description:
The bundled submission includes the Cook-Cope Loop Nephrostomy Set, Ultrathane® Nephrostomy Set with Mac-Loc®, and the Ultrathane® Suprapubic Set with Mac-Loc®
- . Cook-Cope Loop Nephrostomy Set and Catheter: The catheter is placed using standard percutaneous nephrostomy techniques into the kidney. The catheter is then secured in place by pulling the suture taut to create the distal retention loop, wrapping around the catheter shaft and knotting the suture. The latex is then folded over the suture and the excess suture is cut off. The catheter is kept in place within the patient using a retention disc.
- . Ultrathane Nephrostomy Set with Mac-Loc: The catheter is placed using standard percutaneous nephrostomy techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the monofilament, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using a retention disc.
- Ultrathane Suprapubic Set with Mac-Loc: The catheter is placed using standard . suprapubic techniques. The catheter is then secured in place by pulling the suture taut to create the distal retention loop. While maintaining traction on the tether, the locking cam lever is pushed down until a distinct "snap" is felt. The catheter's distal loop is now locked into position. The excess suture is trimmed off. The catheter is then kept in place within the patient using the enclosed StatLock device.
The subject percutaneous drainage catheter sets consist of a flexible tube with an open distal tip and drainage holes. The distal end of the subject devices has either a Mac-Loc locking loop or a cope loop. A Mac-Loc locking loop mechanism secures the distal
5
catheter loop configuration by means of a nylon monofilament. After the catheter is placed in the desired location, the nylon thread is pulled tight to form the distal loop configuration. Then the locking cam lever can be pushed down to snap into position, thereby locking the distal loop in position. The cope loop configuration is formed by pulling back the suture, and then the loop can be locked in place by sliding a latex sleeve over the suture.
Some catheter sets have a radiopaque marker to aid the user in placement. The proximal hub assembly of the devices provides a Luer lock hub to allow the user to connect to a fluid collection device (not subject of this submission). Accessories include introducing catheters, catheter securing devices, needles, cannulas, stylets, dilators, and wire guides.
Indications for Use:
- . The Cook-Cope Loop Nephrostomy Set: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.
- . The Ultrathane Nephrostomy Set with Mac-Loc: This device is used for percutaneous placement of a loop catheter in the renal pelvis for nephrostomy drainage.
- The Ultrathane Suprapubic Set with Mac-Loc: The Ultrathane Suprapubic Set . with Mac-Loc is used to provide bladder drainage by percutaneous placement of a loop catheter.
Comparison to Predicates:
The subject devices have similar indications for use, methods of operation, and fundamental technological characteristics as the predicate devices. Differences between the subject devices and the predicate devices include slight dimensional variations and variations in materials. Characteristics of the subject devices that differ from the predicate device are supported by testing. These differences do not raise any new questions of safety and/or effectiveness.
Performance Data:
The subject devices underwent the applicable testing listed below to ensure reliable design and performance under the testing parameters. Performance and biocompatibility
6
testing were conducted in accordance with applicable performance standards and FDA guidance documents to confirm the reliable performance of critical device characteristics.
- Dimensional Testing
- Compatibility and post-urine compatibility
- Flow Rate and Liquid Leakage ●
- Tensile Strength Hub-to-Shaft, Shaft, Catheter to Connecting Tube ●
- Retention ●
- Radiopacity
- MRI Testing ●
- Biocompatibility Testing shows that the subject devices conform to the . biocompatibility requirements based on its intended use. All evaluation criteria were met.
- . Sterilization
- Package integrity and stability ●
- Shelf-life
All predetermined acceptance criteria were met.
Conclusion:
The data included in this submission indicate that the subject devices do not raise new questions of safety and/or effectiveness compared to the predicate devices (K140085) and (K173035), which supports a determination of substantial equivalence.