(90 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical function of a ureteral catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for drainage or irrigation within the urinary tract and for introducing fluids, which are supportive functions for medical procedures but not directly therapeutic in nature.
No
The device is designed for drainage and irrigation, not for diagnosing conditions.
No
The device description clearly details a physical medical device (a ureteral catheter) with specific dimensions, materials, and mechanical features (pigtail coil, luer lock connector, drainage holes). It is not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for drainage or irrigation of the surgical site in the urinary tract and for introducing fluids. This is a direct medical intervention within the body.
- Device Description: The description details a physical catheter designed for insertion into the urinary tract for fluid management.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue, etc., outside of the body.
This device is a medical device used for therapeutic and procedural purposes within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions.
Product codes (comma separated list FDA assigned to the subject device)
78 EYB
Device Description
The Applied Ureteral Catheter has a 5 Fr body, 70 cms long. It incorporates a retentive pigtail coil at one end. The coil aids in retention of the catheter in the renal pelvis during use. Drainage holes are arranged in a spiral pattern extending over the length of the coil to allow for fluid to be irrigated/aspirated through the catheter. The tip of coil has a smooth, atraumatic design for ease of passage through the urinary tract. A luer lock connector is attached at the other end, which may be connected to a drainage or irrigation system as desired. The catheter body is radiopaque and is coated with a hydrophilic coating, which is activated when wet.
The ureteral catheter is designed for placement over a guidewire of up to .038 inches in diameter that is pre-positioned through the urological tract. The catheter coil is temporarily straightened as it is slid over the guidewire. It is pushed up the urological tract until it is placed in a desired position. The luer lock hub is then connected to a source of irrigation or drainage fluid to attain the desired irrigation/aspiration of the urological site.
The ureteral catheter will be supplied in a tyvek/mylar peel pouch (one per pouch) and placed in an outer product carton (one to ten pouches per carton). The ureteral catheter may also be supplied along with a guidewire of up to .038 inches in diameter as a kit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urinary tract / renal pelvis / urological 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)
The Applied Ureteral Catheter was tested for:
- a. Irrigation Flow Rate
- b. Drainage Flow Rate
- c. Coil Retention Strength
Materials used in the manufacture of the Applied Ureteral Catheter were successfully tested to verify biocompatibility of the materials per ISO 10993-1.
Based on the above testing it was concluded that the Applied Ureteral Catheter is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues when used as instructed.
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
MAY 2 2 2002
PAGE 1 OF 2
510(k) SUMMARY
| 510(k) NUMBER: | K020577 |
|---|---|
| SUBMITTED BY: | Applied Medical Resources Corporation |
| 22872 Avenida Empresa | |
| Rancho Santa Margarita, CA-92688 | |
| (949) 713-8000 | |
| CONTACT PERSON: | Anil Bhalani |
| Vice President of Regulatory Affairs and Clinical Programs | |
| DATE OF PREPARATION: | May 10, 2002 |
| NAME OF DEVICE: | Ureteral Catheter |
| CLASSIFICATION NAME: | Catheter, Ureteral, Gastro-Urology |
| (Regulation Number 21CFR 876.5130, Urological catheter | |
| and accessories) | |
| TRADE NAME: | Applied Ureteral Catheter |
| PREDICATE DEVICE: | Pigtail Ureteral Catheter (Ureteral Catheter, K923729), |
| Cook Urological Inc., Spencer, IN. |
INTENDED USE STATEMENT: The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions. The catheter is radiopaque and has a hydrophilic coating to facilitate insertion.
SUMMARY STATEMENT: The Applied Ureteral Catheter has a 5 Fr body, 70 cms long. It incorporates a retentive pigtail coil at one end. The coil aids in retention of the catheter in the renal pelvis during use. Drainage holes are arranged in a spiral pattern extending over the length of the coil to allow for fluid to be irrigated/aspirated through the catheter. The tip of coil has a smooth, atraumatic design for ease of passage through the urinary tract. A luer lock connector is attached at the other end, which may be connected to a drainage or irrigation system as desired. The catheter body is radiopaque and is coated with a hydrophilic coating, which is activated when wet.
The ureteral catheter is designed for placement over a guidewire of up to .038 inches in diameter that is pre-positioned through the urological tract. The catheter coil is temporarily straightened as it is slid over the guidewire. It is pushed up the urological tract until it is placed in a desired position. The luer lock hub is then connected to a source of irrigation or drainage fluid to attain the desired irrigation/aspiration of the urological site.
1
K020577
PAGE 2 OF 2
Page 2 of 2 510(k) Summary Applied Ureteral Catheter
The ureteral catheter will be supplied in a tyvek/mylar peel pouch (one per pouch) and placed in an outer product carton (one to ten pouches per carton). The ureteral catheter may also be supplied along with a guidewire of up to .038 inches in diameter as a kit.
The Applied Ureteral Catheter is similar in function and performance to ureteral catheters currently marketed for the same application. The following tests were performed on the Applied Ureteral Catheter.
- a. Irrigation Flow Rate
- b. Drainage Flow Rate
- c. Coil Retention Strength
Materials used in the manufacture of the Applied Ureteral Catheter were successfully tested to verify biocompatibility of the materials per ISO 10993-1.
Based on the above testing it was concluded that the Applied Ureteral Catheter is substantially equivalent to predicate devices and introduces no new safety and effectiveness issues when used as instructed.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the words "Public Health Service" in bold, black font. The words are stacked on top of each other, with "Public Health" on the top line and "Service" on the bottom line. The text is centered and the background is white.
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an emblem that appears to be an abstract representation of an eagle or other bird-like figure.
MAY 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Anil Bhalani Vice President of Regulatory Affairs and Clinical Programs Applied Medical Resources Corp. 22872 Avenida Empresa RANCHO SANTA MARGARITA CA 92688
Re: K020577
Trade/Device Name: Applied Ureteral Catheter with SL-6 Hydrophilic Coating Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: 78 EYB Dated: February 19, 2002 Received: February 21, 2002
Dear Mr. Bhalani: ·
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 for abo barrent 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.
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 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); 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
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
Applied Medical Resources is providing this separate cover page for the Applied Ureteral Catheter "Indications for Use" as required.
Not assigned 510(k) Number:
Ureteral Stent Device Name:
Indications for Use: The Applied Ureteral Catheter is indicated for use in the urinary tract where drainage or irrigation of the surgical site is desired. It may be used to introduce fluids such as radiopaque contrast media and saline solutions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The -Counter Use OR
(Optional Format -2-96)
David C. Segerson
(Division Sign-Off) Division of Reproductive and Radiological Dev 510(k) Number