(3 days)
Not Found
No
The 510(k) summary describes a standard intermittent urinary catheter made of conventional materials, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on biocompatibility, which is standard for this type of device.
No
The device is described as an intermittent urinary catheter for bladder drainage, which is a supportive or assistive function, not a therapeutic treatment for a disease or condition.
No
The device is an intermittent urinary catheter used for bladder drainage, not for diagnosing medical conditions.
No
The device description clearly states it is a physical catheter made of conventional medical grade materials, not software.
Based on the provided information, the Cure Catheter™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Cure Catheter™ Function: The Cure Catheter™ is a device inserted into the body (through the urethra) for the purpose of physically draining the bladder. It does not analyze or test any biological samples in vitro (outside the body).
- Intended Use: The intended use clearly states "bladder drainage," which is a physical intervention, not a diagnostic test.
Therefore, the Cure Catheter™ falls under the category of a medical device used for a therapeutic or procedural purpose, not an in vitro diagnostic purpose.
N/A
Intended Use / Indications for Use
The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The unders catheter comes in a variety of sizes packaged sterile for single-use.
Product codes (comma separated list FDA assigned to the subject device)
KOD, EZD, GBM
Device Description
The Cure Catheter TM device is an intermittent urinary catheter intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to-open, sterile, single-use packages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra, bladder
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)
Nonclinical Testing: Standard biocompatibility tests were performed on the Cure Catheter™ to establish device safety. The tests and assays performed are typically performed for these medical devices. All tests were performed in accordance with US FDA General Program Memorandum #G95-1 and Part-10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North America Science Associates, Inc. (NAmSA). The studies indicated that the Cure Catheter™ is biocompatible and safe for its intended use.
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.
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Image /page/0/Picture/0 description: The image shows a logo with the word "CURE" in a stylized font. The word is placed inside a speech bubble-like shape with a curved tail extending from the bottom right. The background of the logo has a textured, slightly blurred appearance, giving it a vintage or distressed look. The overall design is simple yet eye-catching, with the word "CURE" being the central focus.
SEP 1 3 2007
Image /page/0/Picture/2 description: The image shows handwritten text on a white background. The text at the top reads "K072539", and below that, it says "Page 1 of 2". The handwriting appears to be in black ink, and the overall image has a simple, document-like quality.
510(k) SUMMARY
| Submitted by: | Ann Kenowsky
Cure Medical, LLC
2113 Seville Avenue
Newport Beach, CA 92661
805-928-0109 (Phone)
949 723-4818 (Fax)
E-mail: akyant@aol.com |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | James Smith, Ph.D., RAC
Bentley Biomedical Consulting, LLC
28241 Crown Valley Parkway, Suite 510
Laguna Niguel, CA 92677
949-340-7261 (phone)
949-340-7141 (fax)
E-mail: jrsmith@bentleybiomed.com |
| Date Prepared: | August 11, 2007 |
| Device Name: | Cure Catheter TM |
| Trade Name: | Cure Catheter TM |
| Common Name: | Intermittent Urinary Catheter |
| Classification Name: | Catheter, Urological |
| Device Class: | II |
| Procode: | KOD |
| CFR Reference: | 876.5130 |
| Predicate Device: | Rusch Easy Cath Intermittent Catheters |
| Predicate 510(k) #: | K033023 (Rusch) |
| Device Description: | The Cure Catheter TM device is an intermittent urinary
catheter intended to be used by males and females for the
purpose of bladder drainage. It is manufactured with
conventional medical grade, latex-free, biocompatible
materials. The tip has been designed to eliminate trauma to
the urethra and is provided in a variety of sizes in easy-to-
open, sterile, single-use packages. |
| Intended Use: | The Cure Catheter TM is an intermittent urinary catheter that
is inserted through the urethra and indicated for the purpose
of bladder drainage for males and females. |
CURE MEDICAL • 2113 Seville Ave. • Newport Beach, CA 92661 • 800 570-1778 • www.curemedical.com
1
K072534
Page 2 of 2.
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| Technology Comparison: | The Cure Catheter™ is substantially equivalent to the
predicate device. The two devices are similar in function,
composition, and intended use. |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical Testing: | Standard biocompatibility tests were performed on the Cure
Catheter™ to establish device safety. The tests and assays
performed are typically performed for these medical
devices. All tests were performed in accordance with US
FDA General Program Memorandum #G95-1 and Part-
10993-1 of the International Standard Organization (ISO)
Standard (Biological Evaluation of Medical Devices) by
North America Science Associates, Inc. (NAmSA). The
studies indicated that the Cure Catheter™ is biocompatible
and safe for its intended use. |
| Conclusion of Comparison: | The Cure Catheter™ is substantially equivalent to the
currently-marketed predicate device, the Rusch Easy Cath
Intermediate Catheter. |
.
2
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SEP 1 3 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Cure Medical, LLC c/o Mr. Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747
Re: K072539
Trade/Device Name: Cure Catheter™ Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD and GBM Dated: September 7, 2007 Received: September 10, 2007
Dear Mr. Conry:
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 individe for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commence 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 ano rice. The general 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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA".
Protecting and Promoting Public Health.
3
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 not 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.
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 10gal/y marketed predicate device results in a classification for your device and thus, persons 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). 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.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:_ Cure Catheter
Indications for Use:
The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The unders catheter comes in a variety of sizes packaged sterile for single-use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulen Lemen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
Page
نيت
CURE MEDICAL • 2113 Seville Ave. • Newport Beach, CA 92661 • 800 570-1778 • www.curemedical.com