The PercuCath™ Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. It is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as the nephrostomy tract.

Device Description

The PercuCath™ Urinary Catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids to and from the urinary tract. The PercuCath™ Urinary Catheter is a 100% silicone, latex-free, triple lumen (3-Way) Foley catheter with a lubricious hydrophilic coating and a straight or angled council tip to facilitate insertion. It is composed of a silicone tube that trifurcates into three lumens, a silicone balloon, and a two-way valve. When activated, the valve permits flow in either of two directions, i.e., for inflation or deflation of the balloon. Of the three lumens, one lumen is used for urinary drainage and can be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and, the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. The PercuCath™ Urinary Catheter will be available with a single eyelet or double eyelet, 14 through 24 Fr. Shafts (i.e.,14, 16, 18, 20, 22, and 24), and either a 10 cc or 30 cc balloon.

AI/ML Overview

The PercuCath™ Urinary Catheter is a urological Foley catheter. The provided text indicates the device underwent mechanical testing to demonstrate its performance and substantial equivalence to predicate devices. However, the document does not provide explicit acceptance criteria in a quantitative or qualitative manner other than "met the design specifications" and "substantially equivalent to the predicate devices."

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Design specifications met	Mechanical testing results demonstrated the PercuCath™ Urinary Catheter met the design specifications.
Substantially equivalent to predicate devices	Mechanical testing results demonstrated substantial equivalence to predicate devices (Bardex® Lubri-Sil® 3-Way Foley Catheter and Dover® 100% Silicone Foley Council Tip Catheter).

Note: The document does not define specific numerical or descriptive design specifications or performance metrics for the acceptance criteria.

The study conducted was mechanical testing. The purpose was to show that the PercuCath™ Urinary Catheter met its design specifications and was substantially equivalent to its predicate devices.

Here's the breakdown of the other requested information based on the provided text. Much of this information is not detailed or available in the provided 510(k) summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size: Not specified. The document only mentions "Mechanical testing was performed."
Data provenance: Not specified. It's unclear if this refers to physical device testing in a lab or data collected from a particular region. Given it's mechanical testing, it's likely lab-based and not geographically specific in the sense of patient data.
Retrospective or Prospective: Not applicable for mechanical testing of a device's physical properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable as this was mechanical testing, not a study requiring expert clinical assessment or ground truth establishment in a medical context. The "ground truth" would be the engineering specifications the device was tested against.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically used for clinical studies involving human interpretation or subjective data, not for mechanical testing of device performance against specifications.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical medical device (urinary catheter), not an AI-powered diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For mechanical testing, the "ground truth" would be the predetermined design specifications and performance standards for urological catheters, and potentially the performance characteristics of the predicate devices. These standards are typically based on engineering principles and regulatory requirements, rather than clinical "ground truth" from patients or expert consensus in an imaging context.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Summary

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510(k), [Percuvision]

Page 18 of 50

K090262

MAY 28 2009

5. 510(k) Summary as required by 21 CFR 807.92(c) -

510(k) Owner: Percuvision LLC 765 North Hamilton Road. Suite 260A Gahanna, Ohio 43230 (614) 337-8700 Telephone: Facsimile: (614) 337-2274

Barbara S. Fant, Pharm.D. Contact person: Clinical Research Consultants, Inc. 310 Terrace Avenue Suite 201 Cincinnati, OH 45220 (513) 961-8200 Phone: Facsimile: (513) 961-2858

November 04, 2008 Date:

Trade Name: PercuCath™ Urinary Catheter

Urological Foley catheter Common name:

Classification Name: Class II; 21 CFR 876.5130, Urological Catheter and Accessories

EZL: Catheter, Retention Type, Balloon Product Code:

Identification of a Legally Marketed Predicate Device

The PercuCath™ Urinary Catheter is substantially equivalent to the Bardex® Lubri-Sil® 3-Way Folev Catheter marketed by C.R. Bard. Inc., 510(k) Premarket Notification Number: K002868 FDA Product Code EZL. Secondly, it is substantially equivalent to the Dover® 100% Silicone Foley Council Tip Catheter with manufactured by Tyco Healthcare, 510(k) Premarket Notification Number: K860484, FDA Product Code KOD.

General Description

Percuvision LLC

Proprietary and Confidential Information

11/04/2008

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510(k), [Percuvision]

Page 19 of 50

be connected to a urine collection container (drainage bag or urine meter); one lumen has a two-way valve for inflation/deflation of the Foley balloon; and, the third lumen can be used for irrigation of the bladder. The council tip has an opening (eyelet) in the tip that can be used to pass a guidewire or similar device to facilitate catheter insertion. The PercuCath™ Urinary Catheter will be available with a single eyelet or double eyelet, 14 through 24 Fr. Shafts (i.e.,14, 16, 18, 20, 22, and 24), and either a 10 cc or 30 cc balloon.

Indications for Use and Intended Use

Performance Data

Mechanical testing was performed on the PercuCath™ Urinary Catheter and the results demonstrate that the PercuCath™ Urinary Catheter met the design specifications for the device and were substantially equivalent to the predicate devices.

Basis of Substantial Equivalence

The PercuCath™ Urinary Catheter is substantially equivalent to the Bardex® Lubri-Sil® 3-Way Foley Catheter manufactured by C.R. Bard, Inc. in material, intended use, basic design concept, and biomechanical properties. Secondly, it is substantially equivalent to the Dover® 100% Silicone Foley Council Tip Catheter in its intended use and its council tip with an eyelet.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized eagle with three lines representing its wings.

Public Health Service

MAY 28 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Percuvision LLC % Mr. Jeff D. Rongero Senior Project Engineer UL Health Sciences -Underwriters Laboratories, Inc. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709-3995

Re: K090262

Trade/Device Name: PercuCath Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: May 12, 2009 Received: May 13, 2009

Dear Mr. Rongero: .

We have reviewed your Section 510(k) premarket notification of intent to market the device w o have and have 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 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 (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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

(Gastroenterology/Renal/Urology) (240) 276-0115 21 CFR 876.xxx (240) 276-0115 (Obstetrics/Gynecology) 21 CFR 884.xxx (240) 276-0120 21 CFR 892.xxx (Radiology) Other (240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

KO90262 510(k) Number (if known):

Device Name: PercuCath™ Urinary Catheter

Indications for Use:

Prescription Use X

Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Huld Reuner

(Division Sign Off) Division of Reproductive, Abdominal, and Radiological Devices K090262

510(k) Number_

Percuvision LLC Proprietary and Confidential Information

11/04/2008

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. 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.