(261 days)
Not Found
No
The description focuses on the physical characteristics, materials, and performance testing of a drainage catheter and stent, with no mention of AI or ML capabilities.
Yes
The device is a nephrostomy drainage catheter and ureteral stent, which are used to drain fluids and maintain patency, directly addressing a medical condition (urinary obstruction/drainage) and providing a therapeutic benefit to the patient.
No
The device is described as a "drainage catheter and ureteral stent," intended for therapeutic purposes (draining and stenting) rather than for diagnosing conditions. Its function is to facilitate fluid flow, not to detect or identify diseases.
No
The device description clearly outlines physical components made of radiopaque polyurethane, including a catheter/stent, stylets, connecting tube, and retention disc. Performance studies also focus on physical properties like tensile strength, flow rate, and biocompatibility, indicating 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 drainage and stenting within the body (nephrostomy tract and ureteral). This is a therapeutic and drainage function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a physical catheter/stent designed for insertion into the body. It does not involve reagents, analyzers, or any components typically associated with in vitro diagnostic testing.
- Performance Studies: The performance studies focus on physical properties, biocompatibility, and safety for use within the body (tensile strength, flow rate, MR safety, etc.). There are no studies related to analyzing biological samples or providing diagnostic information.
In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device is used within the body for drainage and support.
N/A
Intended Use / Indications for Use
The Malecot Nephrostomy Catheter/Stent Set is intended for use as a nephrostomy drainage catheter and ureteral stent. The catheter is placed percutaneously through an existing nephrostomy tract.
Product codes (comma separated list FDA assigned to the subject device)
FAD, LJE
Device Description
The Malecot Nephrostomy Catheter/Stent Set consists of a catheter/stent, two flexible stylets, a connecting tube, and a retention disc with pull tie. The Malecot catheter/stent is a single device consisting of an externally draining catheter in line with an internally draining ureteral stent. It is constructed from radiopaque polyurethane and has a malecot wing design located on the distal end of the catheter and proximal end of the stent. The stent (distal) portion of the device is available in an outer diameter of 7 Fr with a length of 20 cm. The catheter (proximal) portion of the device is available in an outer diameter between 12 Fr to 24 Fr with lengths of 25.5, 27.0, or 27.4 cm.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nephrostomy tract
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)
The following testing was performed in order to demonstrate that the subject device, Malecot Nephrostomy Catheter/Stent Set, met applicable design requirements.
- Biocompatibility
- Tensile Strength ●
- Catheter and Stent Shaft O
- Hub to Shaft Bond of Catheter and Flexible Stylet O
- Malecot o
- Connection of Catheter to Connecting Tube O
- Retention Strength
- Catheter to Connecting Tube and Retention Disc O
- Flow Rate and Liquid Leakage
- 0 Curved and Straight Flow Rate
- Radiopacity
- Component Compatibility ●
- Magnetic Resonance (MR) Imaging Safety
- Shelf Life following Accelerated Aging to Three-year Real-time Equivalency ●
All predetermined acceptance criteria for the testing were met. Therefore, the results of these tests support a conclusion that the Malecot Nephrostomy Catheter/Stent will perform as intended and support a determination of substantial equivalence to the 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.
Not Found
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
§ 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).
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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2018
Cook Incorporated Minjin Choi Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K180029
Trade/Device Name: Malecot Nephrostomy Catheter/Stent Set Regulation Number: 21 CFR§ 876.4620 Regulation Name: Ureteral Stent Regulatory Class: II Product Code: FAD, LJE Dated: August 24, 2018 Received: August 27, 2018
Dear Minjin Choi:
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 mav, 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 avare 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
Glenn B. Bell -S
for
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K180029
Device Name Malecot Nephrostomy Catheter/Stent Set
Indications for Use (Describe)
The Malecot Nephrostomy Catheter/Stent Set is intended for use as a nephrostomy drainage catheter and ureteral stent. The catheter is placed percutaneously through an existing nephrostomy tract.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) V Over-The-Counter Use (21 CFR 801 Subpart C)
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See PRA Statement below.
3
Image /page/3/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is in white, sans-serif font, and is placed at the top of the logo. Below "COOK" is the word "MEDICAL" in white, sans-serif font, set against a dark red background.
510(k) Summary
COOK INCORPORATED
750 DANIELS WAY
BLOOMINGTON, IN 47404 USA
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM
Malecot Nephrostomy Catheter/Stent Set 21 CFR §807.92 Date Prepared: December 29, 2017
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Minjin Choi |
| Andrew Breidenbach | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 339-2235 x104901 |
| Contact Fax: | (812) 332-0281 |
Device Information:
| Trade Name: | Malecot Nephrostomy Catheter/Stent Set |
|---|---|
| Common Name: | Stent, Ureteral |
| Classification Regulation: | 21 CFR§876.4620, Ureteral Stent |
| Product Code: | FAD, LJE |
| Device Class/Classification Panel: | Class II, Gastroenterology/Urology |
Predicate Devices:
-
Primary predicate device: 트
Expel Nephroureteral Drainage Stent with Twist-Loc Hub System (K141344) -
י Secondary predicate device: Universa Malecot Drainage Catheter Exchange Set (K140085)
4
Image /page/4/Picture/15 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The word "MEDICAL" is smaller than the word "COOK".
Device Description:
The Malecot Nephrostomy Catheter/Stent Set consists of a catheter/stent, two flexible stylets, a connecting tube, and a retention disc with pull tie. The Malecot catheter/stent is a single device consisting of an externally draining catheter in line with an internally draining ureteral stent. It is constructed from radiopaque polyurethane and has a malecot wing design located on the distal end of the catheter and proximal end of the stent. The stent (distal) portion of the device is available in an outer diameter of 7 Fr with a length of 20 cm. The catheter (proximal) portion of the device is available in an outer diameter between 12 Fr to 24 Fr with lengths of 25.5, 27.0, or 27.4 cm.
The set will be supplied sterile and is intended for one-time use. The set is packaged in a peel-open pouch with a three-year shelf life.
Indications for Use:
The Malecot Nephrostomy Catheter/Stent Catheter Set is intended for use as a nephrostomy drainage catheter and ureteral stent. The catheter is placed percutaneously through an existing nephrostomy tract.
Comparison to Predicate Devices:
The Malecot Nephrostomy Catheter/Stent Set and the primary predicate device, Expel Nephroureteral Drainage Stent with Twist-Loc Hub System (K141344), are substantially equivalent in that these devices have similar intended uses, methods of operation, and designs. The subject device and secondary predicate device, Universa Percutaneous Drainage Catheter Set (K140085) are also similar in intended uses, methods of operation, and dimensions. The modifications from the predicate devices include:
- . Indications for Use
- Catheter/Stent Size
- 트 Catheter/Stent Retention Configuration
- 트 Catheter/Stent Materials
- . Stylet
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Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, uppercase letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, uppercase letters on a red background. The word "MEDICAL" is smaller than the word "COOK".
Differences between the characteristics of the subject device and the predicate devices are supported by testing.
Performance Data:
The following testing was performed in order to demonstrate that the subject device, Malecot Nephrostomy Catheter/Stent Set, met applicable design requirements.
- Biocompatibility
- Tensile Strength ●
- Catheter and Stent Shaft O
- Hub to Shaft Bond of Catheter and Flexible Stylet O
- Malecot o
- Connection of Catheter to Connecting Tube O
- Retention Strength
- Catheter to Connecting Tube and Retention Disc O
- Flow Rate and Liquid Leakage
- 0 Curved and Straight Flow Rate
- Radiopacity
- Component Compatibility ●
- Magnetic Resonance (MR) Imaging Safety
- Shelf Life following Accelerated Aging to Three-year Real-time Equivalency ●
Conclusion:
All predetermined acceptance criteria for the testing were met. Therefore, the results of these tests support a conclusion that the Malecot Nephrostomy Catheter/Stent will perform as intended and support a determination of substantial equivalence to the predicate devices.