(261 days)
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.
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.
The provided text describes the "Malecot Nephrostomy Catheter/Stent Set" and its 510(k) submission (K180029). However, it does not contain the specific details required to complete your request for acceptance criteria and a study proving device performance in the context of AI/ML or a diagnostic device.
The document discusses performance testing for a medical device (a catheter/stent), but this testing relates to physical properties, biocompatibility, and imaging safety, not diagnostic performance or AI model evaluation.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (in the context of a diagnostic AI/ML device)
- Sample size used for the test set and data provenance
- Number of experts and their qualifications for ground truth establishment
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study details
- Standalone performance details
- Type of ground truth used (e.g., pathology, outcomes data)
- Sample size for the training set
- How ground truth for the training set was established
The provided text pertains to a traditional medical device (catheter/stent) and its physical and material performance testing, not a diagnostic device involving AI or machine learning algorithms that would typically have the kind of acceptance criteria and studies you are asking about.
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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.
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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
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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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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)
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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.
§ 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).