(114 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a physical catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No. Drainage or collection of urine, even though it may alleviate symptoms, is not considered a therapeutic effect as per the definition of therapy in the context of medical devices.
No
The device is a catheter used for drainage, collection, and measurement of urine, and irrigation of the bladder. These are therapeutic and monitoring functions, not diagnostic.
No
The device description clearly describes a physical, tubular catheter made of silicone with multiple lumens, a balloon, and a valve. This is a hardware device, not software.
Based on the provided information, the PercuCath™ Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the drainage, collection, and measurement of urine from the urinary tract. This is a direct interaction with the patient's body for therapeutic and collection purposes.
- Device Description: The device is a catheter designed for insertion into the body to facilitate fluid movement.
- Lack of IVD Characteristics: IVD devices are used to examine specimens outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening. The PercuCath™ Catheter does not perform any analysis or testing of the collected urine; it simply collects and facilitates drainage.
Therefore, the PercuCath™ Catheter is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract, urethra, bladder, nephrostomy tract
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)
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.
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
§ 876.5130 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.
0
510(k), [Percuvision]
Page 18 of 50
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
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
Percuvision LLC
Proprietary and Confidential Information
11/04/2008
1
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
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.
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.
2
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.
3
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
4
4. Indications for Use Statement
KO90262 510(k) Number (if known):
Device Name: PercuCath™ Urinary Catheter
Indications for Use:
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.
Prescription Use X
OR
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