(309 days)
Not Found
No
The summary describes a mechanical drainage catheter set and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for percutaneous urine drainage from the genitourinary system, which is a medical intervention to treat a health condition, thus classifying it as a therapeutic device.
No
Explanation: The device is intended for percutaneous urine drainage, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components such as catheters, connecting tubes, needles, wire guides, and dilators, indicating it is a hardware medical device. The performance studies also focus on physical properties like tensile strength, retention, and flow rate.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide percutaneous urine drainage from the genitourinary system." This is a therapeutic and drainage function performed directly on the patient's body.
- Device Description: The description details a physical catheter and associated components used for drainage.
- 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, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples outside the body to gain diagnostic information. This device is used inside the body for drainage.
N/A
Intended Use / Indications for Use
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
Product codes (comma separated list FDA assigned to the subject device)
FEW, KOB, LJE
Device Description
The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
genitourinary system
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 device was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
-
- Tensile Strength Testing shows the tensile force during proper clinical use should not fracture the catheter set materials and/or bonds. The predetermined acceptance criteria were met.
-
- Loop and Malecot Retention Testing shows that the loop and Malecot retention features of the catheters resist dislodgement or removal of the catheter. The predetermined acceptance criterion was met.
-
- Gravity Flow Rate, Lumen Blockage, and Leakage Testing Testing shows that water will consistently flow through the catheters without any blockage or leakage. The predetermined acceptance criteria were met.
-
- Biocompatibility Testing, in conformance with ISO 10993-1, shows the device is biocompatible. The predetermined acceptance criteria were met.
-
- Simulated Use Testing shows that the devices are compatible and perform according to the instructions for use. The results of the study are acceptable for clinical practice.
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
§ 876.5090 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2014
Cook Incorporated Jennifer Richardson Regulatory Affairs Team Lead 750 Daniels Way P.O. Box 489 Bloomington, IN 47402-0489
Re: K140085 Trade/Device Name: Universa® Loop Drainage Catheter Set Universa® Malecot Drainage Catheter Set Regulation Number: 21 CFR 876.5090 Regulation Name: Suprapubic urological catheter and accessories Regulatory Class: Class II Product Codes: FEW, KOB, LJE Dated: October 24, 2014 Received: October 27, 2014
Dear Jennifer Richardson,
This letter corrects our substantially equivalent letter of November 18, 2014.
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. 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
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -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
510(k) Number (if known) K140085
Device Name
Universa® Loop Drainage Catheter Set Universa® Malecot Drainage Catheter Set
Indications for Use (Describe)
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
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
5. 510(k) Summary
Cook Incorporated Universa® Loop Drainage Catheter Set and Universa® Malecot Drainage Catheter Set 510(k) Summary 21 CFR 807.92
Submitted By:
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone Number: | (800) 468-1379 |
| Fax Number: | (812) 332-0281 |
| Contact: | Jennifer Richardson |
| Contact Address: | Cook Incorporated |
| 750 Daniels Way | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Contact Phone Number: | 800-346-2686 or 812-335-3575 ext 2370 |
| Contact Fax Number: | 812-332-0281 |
| Date Prepared: | 24 October 2014 |
Device Information:
Trade name:
Common name: Classification: Regulation: Product Code:
Universa® Loop Drainage Catheter Set Universa® Malecot Drainage Catheter Set Percutaneous Drainage Catheter Class II, Unclassified 21 CFR §876.5090 FEW, KOB, LJE
Predicate Devices:
Percutaneous Drainage Loop Catheter Sets
K931195, December 22, 1993
Vance Percutaneous Malecot Nephrostomy Catheter Set
K810368, March 20, 1981
4
Cook Incorporated Universa® Percutaneous Drainage Catheter Sets Traditional 510(k) January 10, 2014
Indications for Use:
The Universa® Loop Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
The Universa® Malecot Drainage Catheter Set is intended to provide percutaneous urine drainage from the genitourinary system.
Device Description:
The Universa® Percutaneous Drainage Catheter Sets include introductory and exchange sets available with either a loop (6-14 Fr) or a Malecot catheter (8-24 Fr). Suprapubic sets are available with a Malecot catheter (8-16 Fr). Each set includes a drainage catheter and connecting tube, and may also include straightening stylets, trocar needle with obturator, hollow needle, wire guide, dilators, silicone retention disc with pull tie, or one-way stopcock. The devices will be supplied sterile and intended for one-time use.
Comparison to Predicate Device:
The following table presents the main technological similarities and differences between the predicate and proposed devices.
| | Vance Percutaneous
Malecot Nephrostomy
Catheter Set
K810368 | Percutaneous Drainage
Loop Catheter Sets
K931195 | Universa Percutaneous
Drainage Catheter Sets
Subject of This Submission |
|-------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Set components | Drainage catheter (Malecot
configuration)
Two-part trocar needle
Wire guide
Dilators
Connecting tube | Drainage catheter (loop
configuration)
Two-part trocar needle
Wire guide
Dilators
Connecting tube | Includes:
Drainage catheter (loop or
Malecot tip configuration)
Connecting tube
May also include:
Straightening stylets
Two-part trocar needle
Hollow needle
Wire guide
Dilators
Silicone retention disc with
pull tie One-way stopcock |
| Catheter Size
(Fr) | 14 | 6 – 14 | 6 - 14 (loop), 8 - 24
(Malecot) |
| Catheter Length
(cm) | 30 | 12 - 30 | 15 - 30 |
5
Cook Incorporated Universa® Percutaneous Drainage Catheter Sets Traditional 510(k) January 10, 2014
The proposed devices are substantially equivalent to the predicate in terms of intended use, duration of use, principles of operation, and technological characteristics.
Discussion of Tests and Test Results:
The device was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
-
- Tensile Strength Testing shows the tensile force during proper clinical use should not fracture the catheter set materials and/or bonds. The predetermined acceptance criteria were met.
-
- Loop and Malecot Retention Testing shows that the loop and Malecot retention features of the catheters resist dislodgement or removal of the catheter. The predetermined acceptance criterion was met.
-
- Gravity Flow Rate, Lumen Blockage, and Leakage Testing Testing shows that water will consistently flow through the catheters without any blockage or leakage. The predetermined acceptance criteria were met.
-
- Biocompatibility Testing, in conformance with ISO 10993-1, shows the device is biocompatible. The predetermined acceptance criteria were met.
-
- Simulated Use Testing shows that the devices are compatible and perform according to the instructions for use. The results of the study are acceptable for clinical practice.
Conclusions Drawn from the Tests:
The results of these tests provide reasonable assurance that the device is as safe and effective as the predicate device and support a determination of substantial equivalence.