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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two medical devices: the Universa® Loop Drainage Catheter Set and the Universa® Malecot Drainage Catheter Set. It does not describe an AI/ML device or a study involving such a device. Therefore, many of the requested categories (such as sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the information related to acceptance criteria and the studies performed for these physical medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Performed	Predetermined Acceptance Criteria	Reported Device Performance
Mechanical Integrity	Tensile Strength Testing	Not explicitly stated but implied to ensure catheter materials/bonds do not fracture during proper clinical use.	The predetermined acceptance criteria were met.
Functional Retention	Loop and Malecot Retention Testing	Not explicitly stated but implied to ensure retention features resist dislodgement/removal.	The predetermined acceptance criterion was met.
Fluid Dynamics	Gravity Flow Rate, Lumen Blockage, and Leakage Testing	Not explicitly stated but implied to ensure consistent water flow without blockage or leakage.	The predetermined acceptance criteria were met.
Biocompatibility	Biocompatibility Testing	Conformance with ISO 10993-1.	The predetermined acceptance criteria were met.
Usability/Performance	Simulated Use Testing	Not explicitly stated but implied to ensure compatibility and performance according to instructions for use.	The results of the study are acceptable for clinical practice.

2. Sample size used for the test set and the data provenance

Sample size: Not specified in the provided document.
Data provenance: Not applicable. These are physical device tests, not data-driven studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. Ground truth for these physical device tests is established through engineering and biological standards, not expert consensus on data interpretation.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable. Performance is measured against physical test standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone study: No. This is not an AI/ML device.

7. The type of ground truth used

The "ground truth" for these physical device tests is based on:
- Engineering specifications and material properties (for tensile strength, flow rates).
- Functional design requirements (for retention).
- International standards (ISO 10993-1 for biocompatibility).
- Instructions for use for simulated clinical performance.

8. The sample size for the training set

Sample size: Not applicable. This is not an AI/ML device, so there is no training set in that context.

9. How the ground truth for the training set was established

Ground truth establishment: Not applicable. No training set for an AI/ML context.

Summary

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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

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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

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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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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 WayP.O. Box 489Bloomington, IN 47402
Phone Number:	(800) 468-1379
Fax Number:	(812) 332-0281
Contact:	Jennifer Richardson
Contact Address:	Cook Incorporated750 Daniels WayP.O. Box 489Bloomington, 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

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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:

Comparison to Predicate Device:

The following table presents the main technological similarities and differences between the predicate and proposed devices.

	Vance PercutaneousMalecot NephrostomyCatheter SetK810368	Percutaneous DrainageLoop Catheter SetsK931195	Universa PercutaneousDrainage Catheter SetsSubject of This Submission
Set components	Drainage catheter (Malecotconfiguration)Two-part trocar needleWire guideDilatorsConnecting tube	Drainage catheter (loopconfiguration)Two-part trocar needleWire guideDilatorsConnecting tube	Includes:Drainage catheter (loop orMalecot tip configuration)Connecting tubeMay also include:Straightening styletsTwo-part trocar needleHollow needleWire guideDilatorsSilicone retention disc withpull tie One-way stopcock
Catheter Size(Fr)	14	6 – 14	6 - 14 (loop), 8 - 24(Malecot)
Catheter Length(cm)	30	12 - 30	15 - 30

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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.

1. 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.
1. 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.
1. 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.
1. Biocompatibility Testing, in conformance with ISO 10993-1, shows the device is biocompatible. The predetermined acceptance criteria were met.
1. 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.

Regulation Number and Section

§ 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.