(27 days)
Not Found
No
The description focuses on the mechanical and structural aspects of a positioning catheter and its use with existing ultrasound equipment and templates. There is no mention of any computational analysis, image processing, or algorithms that would suggest AI/ML.
No.
The device is described as a "mechanical positioning device" and a "positioning and imaging-visibility enhancing device" for visualizing the urethral course during diagnostic or therapeutic procedures, not as a device that directly treats a condition.
No
The device is described as a "mechanical positioning device" used for visualizing the urethral course to assist in diagnostic or therapeutic procedures, and it combines the function of a positioning and imaging-visibility enhancing device. It does not perform a diagnostic function itself, but rather aids in procedures that may be diagnostic.
No
The device is described as a "mechanical positioning device" and a "urological catheter" with a "balloon retention mechanism" and a "Catheter Holder." These are all physical components, indicating it is a hardware device, not software-only.
Based on the provided information, the UC-CARE Positioning System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- UC-CARE Positioning System Function: The UC-CARE Positioning System is a mechanical device introduced into the urethra to visualize the urethral course and assist in ultrasound-guided prostate procedures. It is a positioning and imaging-visibility enhancing tool used during a procedure, not a test performed on a sample outside the body.
- Device Description: The description clearly states it's a "mechanical positioning device" and a "positioning and imaging-visibility enhancing device." It functions similarly to a urological catheter with a balloon retention mechanism and is used in conjunction with ultrasound equipment and templates.
- Intended Use: The intended use is for "assistance in diagnostic or therapeutic endorectal ultrasound-guided prostate procedures," focusing on positioning and visualization during the procedure itself.
The device's purpose is to facilitate a medical procedure by providing anatomical guidance and positioning, not to analyze a biological sample for diagnostic information.
N/A
Intended Use / Indications for Use
The UC-CARE Positioning System is a mechanical positioning device, introduced into the urethra as a sterile urological catheter for visualizing the urethral course, aimed for assistance in diagnostic or therapeutic endorectal ultrasound-guided prostate procedures. The device is retained in place by inflating the balloon tip and by attaching it over an ultrasound-stepper and stabilizer with a Brachy-like template.
Product codes
EZL
Device Description
The UCP System is a positioning device used to outline the urethral course during diagnostic or therapeutic transperineal ultrasound-guided prostate procedures. The UCP System combines the function of a positioning and imaging-visibility enhancing device with the configuration of a urological Foley catheter. The configuration and material composition of the patient contact portion of the UCP System part are identical to a commercially available (FDA cleared) urological catheter including a balloon retention mechanism. The device is comprised of two main components: the Urethral Catheter and the Catheter Holder. The device is used together with any commercial endorectal ultrasound stepper and stabilizer as well as brachy-like template grid, available in the market for a transperineal prostate biopsy, brachytherapy, or cryotherapy. The use of the device facilitates simple and safe transperineal needle insertion for diagnostic and therapeutic prostate procedures. The UCP System’s Catheter is introduced into the urethra as a sterile urological catheter and is retained in place by inflating the balloon tip and by the Catheter Holder, which is mounted over the ultrasound stepper and stabilizer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound-guided
Anatomical Site
urethra, prostate
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image shows the logo for UC-CARE Medical Systems. The logo consists of the text "UC-CARE" in a bold, sans-serif font, with the word "Medical Systems" in a smaller font below it. Above the text are five oval shapes, each with a different fill color. From left to right, the ovals are black, black, black, gray, and white.
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510(K) SUMMARY
UC-CARE Positioning System
510(k) Number K 1882919
OCT 2 7 2008
- Applicant's Name: UC-CARE, Ltd. New Ind. Zone, Apollo Bldg. P.O.Box 67 Yokneam 20692 Tel: (972)4-909-7427 Fax: (972)4-993-7323
- Contact Person: Roni Zvuloni, Ph.D. CTO UC-CARE, Ltd. New Ind. Zone, Apollo Bldg., P.O.Box 67, Yokneam 20692 Tel: (972)4-909-7427, Fax: (972)4-993-7323
UC-CARE Positioning System (UCP System) Trade Name:
Classification: Name: Urological Catheter and Accessories Product Code: EZL Regulation No: CFR 21 876.5130 Class: II Panel: Urological Catheter and Accessories
Device Description: The UCP System is a positioning device used to outline the urethral course during diagnostic or therapeutic transperineal ultrasound-guided prostate procedures.
The UCP System combines the function of a positioning and imaging-visibility enhancing device with the configuration of a urological Foley catheter. The configuration and material composition of the patient contact portion of the UCP System part are identical to a commercially available (FDA cleared) urological catheter including a balloon retention mechanism. The device is
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UCP System - 510k Notification
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Image /page/1/Picture/0 description: The image shows the logo for UC-CARE Medical Systems. The logo consists of the text "UC-CARE" in a bold, sans-serif font, with the word "Medical Systems" in a smaller font below it. Above the text are five shaded circles that go from dark to light. The logo is simple and professional, and it is likely used to represent a medical organization or company.
K082919
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comprised of two main components: the Urethral Catheter and the Catheter Holder. The device is used together with any commercial endorectal ultrasound stepper and stabilizer as well as brachy-like template grid, available in the market for a transperineal prostate biopsy, brachytherapy, or cryotherapy. The use of the device facilitates simple and safe transperineal needle insertion for diagnostic and therapeutic prostate procedures.
The UCP System's Catheter is introduced into the urethra as a sterile urological catheter and is retained in place by inflating the balloon tip and by the Catheter Holder, which is mounted over the ultrasound stepper and stabilizer.
Intended Use Statement:
The UC-CARE Positioning System is a mechanical positioning device, introduced into the urethra as a sterile urological catheter for visualizing the urethral course, aimed for assistance in diagnostic or therapeutic endorectal ultrasound-guided prostate procedures.
The device is retained in place by inflating the balloon tip and by attaching it over an ultrasound-stepper and stabilizer with a Brachy-like template.
Predicate Devices: Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Date of approval |
|---|---|---|
| BeamCath | K042110 | 25 Feb, 2005 |
| Disposable Endocavity Ultrasound needle/Biopsy | ||
| Guide | K970514 | 20 Jun, 1997 |
| Simplastic™ Catheter | K963993 | 17 Dec, 1996 |
Conclusion:
UC-CARE Ltd. believes that, based on the information provided in this submission, the UCP System is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness concerns.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 7 2008
UC-CARE Medical Systems Ltd. % Mr. Jonathan S. Kahan Regulatory Counsel Hogan & Hartson, LLP Columbia Square, 555 Thirteenth Street, N.W. WASHINGTON DC 20004
Re: K082919
Trade/Device Name: UC-CARE Positioning System Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: September 30, 2008 Received: September 30, 2008
Dear Mr. Kahan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely vours.
loque M. Whang
Jovce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the logo for UC-CARE Medical Systems. The words "UC-CARE" are in large, bold, black letters. Below that, the words "Medical Systems" are in smaller, black letters. Above the words, there are five circles that fade from black to white.
| 510(k) Number (if known): | K082919 |
|---|---|
| Device Name: | UC-CARE Positioning System |
| Indications for Use: | The UC-CARE Positioning System is a mechanical positioning |
| device, introduced into the urethra as a sterile urological catheter | |
| for visualizing the urethral course, aimed for assistance in | |
| diagnostic or therapeutic endorectal ultrasound-guided prostate | |
| procedures. |
INDICATIONS FOR USE STATEMENT
The device is retained in place by inflating the balloon tip and by attaching it over an ultrasound-stepper and stabilizer with a Brachy-like template.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General & Plastic Surgery Devices 510(k) Number
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 16 LU 510(k) Number
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UCP System - 510k Notification
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