(267 days)
No
The device description and performance studies focus on the physical properties and functionality of a catheter set, with no mention of AI or ML.
Yes
The device is used for temporary suprapubic urinary diversion and drainage, which is a therapeutic intervention.
No
The device is described as a catheter set used for temporary suprapubic urinary diversion and drainage, not for diagnosing a condition. Its performance studies focus on physical properties like tensile strength and leakage, rather than the accuracy of diagnosing a disease.
No
The device description clearly outlines physical components like a catheter, trocar stylet, access sheath, drainage adapter, and catheter support, indicating it is a hardware-based medical device.
Based on the provided information, the Cook® Cystostomy Catheter Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "temporary suprapubic urinary diversion and drainage." This is a therapeutic and drainage procedure performed directly on the patient's body.
- Device Description: The device components (catheter, trocar stylet, drainage adapter, catheter support) are all designed for physical insertion and drainage within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for a therapeutic and drainage purpose.
N/A
Intended Use / Indications for Use
The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.
Product codes
KOB
Device Description
The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 French with a working length of 54 centimeters, a trocar stylet with access sheath having an outer diameter of 10 to 14 French with a length of either 11 or 11.2 centimeters, a drainage adapter with stopcock available in 12 to 16 gauge and a soft low-profile silicone catheter support with pull tie. The set is supplied sterile, intended for one-time use only, and 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
Not Found
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 to demonstrate that the Cook® Cystostomy Catheter Set met applicable design requirements.
- Biocompatibility
- Tensile Strength
- Leakage and Flow
- Dimensional and Compatibility
Results of the testing support a conclusion that the subject device Cook® Cystostomy Catheter Set met the design input requirements based on the intended use and raises no new questions of safety and effectiveness as compared to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a blue square and the agency's name in a sans-serif font.
January 18, 2019
Cook Incorporated Danlu Chen Regulatory Affairs Specialist 750 Daniels Way, P.0. Box 489 Bloomington, IN 47402
K181097 Re:
Trade/Device Name: Cook® Cystostomy Catheter Set Regulation Number: 21 CFR§ 876.5090 Regulation Name: Suprapubic Urological Catheter and Accessories Regulatory Class: II Product Code: KOB Dated: December 19, 2018 Received: December 20, 2018
Dear Danlu Chen:
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. 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/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
Indications for Use
B-4
See PRA Statement below.
510(k) Number (if known) K181097
Device Name Cook® Cystostomy Catheter Set
Indications for Use (Describe)
The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.
| 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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3
Traditional 510(k) Premarket Notification Cook® Cystostomy Catheter Set Cook Incorporated January 16, 2019
2.0 510(k) Summary
Cook® Cystostomy Catheter Set 21 CFR §876.5090 Date Prepared: January 16, 2019
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Contact: | Jiayin Furnish |
| Andrew Breidenbach | |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact Phone: | (812) 335-3575 |
| Contact Fax: | (812) 332-0281 |
| Device Information: |
Trade Name: Cook® Cystostomy Catheter Set Device Common Name: Suprapubic Urological Catheter and Accessories Classification Name: Suprapubic Urological Catheter and Accessories 21 CFR §876.5090 Regulation Number: Product Code: KOB Device Classification: Class II Review Panel: Gastroenterology/Urology
Predicate Devices:
All Silicone Supra-Pubia Catheter, Models 4880/4890 (K014002)
Universa® Percutaneous Drainage Catheter Set (Malecot Suprapubic Set) (K140085)
Device Description:
The Cook® Cystostomy Catheter Set is composed of a single-lumen silicone catheter available in 8 to 12 French with a working length of 54 centimeters, a trocar stylet with access sheath having an outer diameter of 10 to 14 French with a length of either 11 or 11.2 centimeters, a drainage
4
Traditional 510(k) Premarket Notification Cook® Cystostomy Catheter Set Cook Incorporated January 16, 2019
adapter with stopcock available in 12 to 16 gauge and a soft low-profile silicone catheter support with pull tie. The set is supplied sterile, intended for one-time use only, and packaged in a peelopen pouch with a three-year shelf life.
Indications for Use:
The Cook® Cystostomy Catheter Set is used for temporary suprapubic urinary diversion and drainage for less than or equal to four weeks.
Comparison to Primary Predicate Device:
The subject device, Cook® Cystostomy Catheter Set, and the predicate device, All Silicone Supra-Pubia Catheter, Models 4880/4890 (K014002), are similar in intended uses, fundamental technological characteristics, and methods of operation. Differences between the characteristics of the subject device and the predicate device include:
- Indications for Use .
- . Design Features
- Dimensions ●
Differences between the characteristics of the subject device and the predicate device are supported by testing. The subject device raises no new questions of safety and effectiveness as compared to the predicate device.
Comparison to Secondary Predicate Device:
The subject device, Cook® Cystostomy Catheter Set, and the secondary predicate device, Universa® Percutaneous Drainage Catheter Set (Malecot Suprapubic Set) (K140085), are similar in intended uses, fundamental technological characteristics, and methods of operation. Differences between the characteristics of the subject device and the predicate device include:
- Indications for Use
- Design Features
- . Dimensions
Differences between the characteristics of the subject device and the secondary predicate device are supported by testing. The subject device raises no new questions of safety and effectiveness as compared to the predicate device.
5
Traditional 510(k) Premarket Notification Cook® Cystostomy Catheter Set Cook Incorporated January 16, 2019
Performance Data:
The following testing was performed to demonstrate that the Cook® Cystostomy Catheter Set met applicable design requirements.
- . Biocompatibility
- . Tensile Strength
- . Leakage and Flow
- Dimensional and Compatibility .
Results of the testing support a conclusion that the subject device Cook® Cystostomy Catheter Set met the design input requirements based on the intended use and raises no new questions of safety and effectiveness as compared to the predicate device