(3 days)
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.
The Cure Catheter™ 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.
The provided text describes a 510(k) premarket notification for the "Cure Catheter™", an intermittent urinary catheter. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device. Therefore, many of the requested elements for a study proving device acceptance criteria are not applicable or not present in the provided document.
However, I can extract information related to the device's safety and equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible and safe for intended use. | "Standard biocompatibility tests were performed on the Cure Catheter™ to establish device safety... 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." |
| Material Composition | Manufactured with conventional medical grade, latex-free, biocompatible materials. | "Manufactured with conventional medical grade, latex-free, biocompatible materials." This aligns with the biocompatibility testing results. |
| Tip Design | Tip designed to eliminate trauma to the urethra. | "The tip has been designed to eliminate trauma to the urethra." (This is a design claim, not explicitly a performance measurement in the provided text). |
| Sterility | Provided in sterile, single-use packages. | "The catheter comes in a variety of sizes packaged sterile for single-use." (This is a design and packaging claim, not a test result described). |
| Function | Similar function to predicate device (bladder drainage). | "The Cure Catheter™ is substantially equivalent to the predicate device. The two devices are similar in function..." |
| Intended Use | Bladder drainage for males and females. | "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." |
| Substantial Equivalence | Equivalent to the predicate device (Rusch Easy Cath Intermittent Catheters). | "The Cure Catheter™ is substantially equivalent to the currently-marketed predicate device, the Rusch Easy Cath Intermediate Catheter." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical performance data for human users. The non-clinical testing for biocompatibility was performed by NAmSA, but the sample sizes (e.g., number of units tested, number of animal subjects) for these tests are not provided. The data provenance is North America Science Associates, Inc. (NAmSA), and the nature of these tests (e.g., in vitro, in vivo animal studies) would classify them as non-clinical rather than retrospective or prospective human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The document describes non-clinical biocompatibility testing and a comparison to a predicate device, not clinical performance with ground truth established by experts.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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
Not applicable. This is a medical device (catheter), not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used
For biocompatibility, the "ground truth" would be established by the results of standardized tests according to ISO 10993-1 and FDA G95-1 guidelines, demonstrating the absence of harmful biological responses. For substantial equivalence, the "ground truth" is the characteristics and performance of the predicate device (Rusch Easy Cath).
8. The sample size for the training set
Not applicable; there is no mention of a training set for an algorithm or a clinical study.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
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 KenowskyCure Medical, LLC2113 Seville AvenueNewport Beach, CA 92661805-928-0109 (Phone)949 723-4818 (Fax)E-mail: akyant@aol.com |
|---|---|
| Contact Person: | James Smith, Ph.D., RACBentley Biomedical Consulting, LLC28241 Crown Valley Parkway, Suite 510Laguna Niguel, CA 92677949-340-7261 (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 urinarycatheter intended to be used by males and females for thepurpose of bladder drainage. It is manufactured withconventional medical grade, latex-free, biocompatiblematerials. The tip has been designed to eliminate trauma tothe 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 thatis inserted through the urethra and indicated for the purposeof 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.
Image /page/1/Picture/1 description: The image shows a logo with the word "CURE" in a stylized font. The word is contained within a speech bubble-like shape. The logo has a slightly distressed or textured appearance, with a grainy effect throughout.
| Technology Comparison: | The Cure Catheter™ is substantially equivalent to thepredicate device. The two devices are similar in function,composition, and intended use. |
|---|---|
| Nonclinical Testing: | Standard biocompatibility tests were performed on the CureCatheter™ to establish device safety. The tests and assaysperformed are typically performed for these medicaldevices. All tests were performed in accordance with USFDA General Program Memorandum #G95-1 and Part-10993-1 of the International Standard Organization (ISO)Standard (Biological Evaluation of Medical Devices) byNorth America Science Associates, Inc. (NAmSA). Thestudies indicated that the Cure Catheter™ is biocompatibleand safe for its intended use. |
| Conclusion of Comparison: | The Cure Catheter™ is substantially equivalent to thecurrently-marketed predicate device, the Rusch Easy CathIntermediate Catheter. |
.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows a logo with the word "CURE" in bold, stylized letters. The word is set against a circular, textured background that gives the impression of a speech bubble or thought cloud. Below the word, there is a curved, banner-like shape that adds a dynamic element to the design. The overall aesthetic is simple yet impactful, suggesting a message of hope or solution.
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
§ 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.