(72 days)
The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag and 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 sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cure Catheter™ Closed System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | US FDA General Program Memorandum #G95-1 | Met acceptance criteria for all tests conducted | Met the acceptance criteria for all tests conducted |
| Biocompatibility | ISO 10993-1 (Biological Evaluation of Medical Devices) | Considered biocompatible under the conditions tested | Considered biocompatible under the conditions tested |
| Substantial Equivalence | Comparison toPredicate Device (Rusch MMG/O'Neil Catheter) | Similar in function, composition, and intended use | Similar in function, composition, and intended use |
| Functionality | Bladder Drainage (as per Intended Use) | Effective for bladder drainage in males and females | Indicated for the purpose of bladder drainage for males and females |
| Material Safety | Conventional medical grade, latex-free, biocompatible | Composed of these materials | Manufactured with conventional medical grade, latex-free, biocompatible materials |
| Design Safety | Tip designed to eliminate trauma to the urethra | Tip طراحی for atraumatic insertion | The tip has been designed to eliminate trauma to the urethra |
| Sterility | Packaged sterile for single-use | Packaged sterile for single-use | Comes in a variety of sizes packaged sterile for single-use |
Notes on Acceptance Criteria and Performance:
- The document primarily focuses on biocompatibility and substantial equivalence to a predicate device as the key acceptance criteria.
- The "Reported Device Performance" column largely reiterates that the device met the stated criteria or aligns with the design specifications, indicating compliance.
- The document doesn't provide specific numerical thresholds or detailed pass/fail rates for these criteria beyond stating that they were "met."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for the test set used in the nonclinical testing for biocompatibility. It only states that "Standard biocompatibility tests were performed."
- Data Provenance: The biocompatibility tests were performed by North America Science Associates, Inc. (NAmSA). The country of origin of the data is not explicitly stated but can be inferred to be within North America given the name of the testing organization. The tests were nonclinical, meaning they were not performed on human subjects but rather in a laboratory setting (e.g., in-vitro or in-vivo animal studies as per ISO 10993). Therefore, the data is retrospective in the sense that it's a report on tests already completed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For nonclinical biocompatibility testing, ground truth is established by adherence to recognized standards (like ISO 10993-1) and the successful outcome of the tests as interpreted by relevant scientific personnel, but not typically by "experts" in the sense of clinical reviewers establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set
- This is not applicable and not provided as the evaluation involved nonclinical biocompatibility testing and substantial equivalence, not a diagnostic or clinical performance study requiring adjudication of expert opinions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or data, often comparing AI assistance to unassisted human performance. The Cure Catheter™ is a urological catheter, and its evaluation focuses on material safety, functional design, and substantial equivalence, not diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable. The Cure Catheter™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is inherent in its physical properties and design.
7. The Type of Ground Truth Used
- The "ground truth" for the biocompatibility testing was established by adherence to internationally recognized standards (US FDA General Program Memorandum #G95-1 and ISO 10993-1) and the measured outcomes of the performed tests (e.g., absence of cytotoxicity, irritation, sensitization).
- For the substantial equivalence claim, the ground truth was the characteristics of the predicate device (Rusch MMG/O'Neil Catheter) and the comparison of the Cure Catheter's features, function, and intended use against those characteristics.
8. The Sample Size for the Training Set
- This is not applicable as the Cure Catheter™ is a physical medical device and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as the device does not involve a training set.
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510(k) SUMMARY
JUN 1 1 2008
Submitted by:
Ann Kenowsky Cure Medical, LLC 2113 Seville Avenue Newport Beach, CA 92661 949 673-8474 (Phone) 949 723-4818 (Fax) E-mail: akyant@aol.com
Contact Person:
James Smith, Ph.D., RAC DeFerris, Inc. 29442 Pointe Royale Laguna Niguel, CA 92677 949-340-7261 (phone) 949-340-7141 (fax) E-mail: jrsmith@deferris.com
Date Prepared: February 7, 2008 Trade Name: Cure Catheter™ Closed System Common Name: Urological Catheter Classification Name: Catheter, Urological Device Class: II Procode: KOD/FCM CFR Reference: 876.5130 Predicate Device: Rusch MMG/O'Neil Catheter (K010420) Predicate 510(k) #: K010420 (Rusch) Device Description: The Cure Catheter™ Closed System is an intermittent
urinary catheter attached to a collection bag and 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 sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.
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| Intended Use: | The Cure CatheterTM Closed System is an intermittenturinary catheter attached to a collection bag that is insertedthrough the urethra and indicated for the purpose of bladderdrainage for males and females. The urinary cathetercomes in a variety of sizes packaged sterile for single-use. |
|---|---|
| Technology Comparison: | The Cure CatheterTM Closed System is substantiallyequivalent to the predicate device. The devices are similarin function, composition, and intended use. |
| Nonclinical Testing: | Standard biocompatibility tests were performed on the CureCatheterTM Closed System to establish device safety. Thetests and assays performed are typically performed forthese medical devices. All tests were performed inaccordance with US FDA General Program Memorandum#G95-1 and Part-10993-1 of the International StandardOrganization (ISO) Standard (Biological Evaluation ofMedical Devices) by North America Science Associates,Inc. (NAmSA). The Cure CatheterTM Closed System metthe acceptance criteria for all tests conducted and isconsidered biocompatible under the conditions tested. |
| Conclusion of Comparison: | The Cure CatheterTM Closed System is substantiallyequivalent to the currently-marketed predicate device, theRusch MMG/O'Neil Catheter. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2008
Cure Medical, LLC c/o James Smith, Ph.D., RAC Consultant, Regulatory Affairs DeFerris, Inc. 29442 Pointe Rovale LAGUNA NIGUEL CA 92677
K080881 Re:
Trade/Device Name: Cure Catheter" Closed System Regulation Number: 21 CFR §876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Codes: KOD and FCM Dated: May 22, 2008 Received: May 27, 2008
Dear Dr. Smith:
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 (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 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 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.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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/cdrh/industry/support/index.html.
Sincerely vours.
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
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INDICATIONS FOR USE
9080881 510(k) Number (if known):_
Device Name: Cure Catheter Closed System
Indications for Use:
The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
Prescription Use × (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)
Herbert Hoover
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
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Cure Medical, LLC 2113 Seville Avenue, Newport Beach, CA 92661 Page 4 of 21
§ 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.