(147 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a standard intermittent urinary catheter, with no mention of AI or ML.
No
This device is an intermittent urinary catheter for bladder drainage, which is a diagnostic/management tool rather than a therapeutic device that treats or cures a disease.
No
The device is described as an intermittent urinary catheter for bladder drainage, which is a therapeutic purpose, not diagnostic.
No
The device description clearly states it is a physical intermittent urinary catheter made of conventional medical grade materials, not software.
Based on the provided information, this device 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is an "intermittent urinary catheter" used for "bladder drainage." This is a physical device inserted into the body to perform a mechanical function (draining fluid).
- Lack of Diagnostic Testing: There is no mention of the device being used to analyze samples or provide diagnostic information based on biological markers. Its purpose is purely functional.
Therefore, the Cure Pediatric Catheter is a medical device, but it falls under the category of a therapeutic or functional device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
Product codes
EZD
Device Description
The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric 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
pediatric
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
Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO 10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices). The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use.
Key Metrics
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.
0
K1106.53
page 1 of 2
AUG - 1 2011
5. 510(k) Summary
SUMMARY
Cure Medical, LLC
Submitter's name:
Address:
2113 Seville Avenue Newport Beach, CA 92661
Phone: Fax number: 949-673-5117 949 723-4818
Name of contact person:
Robyn Scopis Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606 Phone: 949-262-0411 Fax: 949-552-2821
Date the summary was prepared: July 28, 2011
Name of the device: Trade or proprietary name: Common or usual name: Classification name: Classification Product Code
Cure Pediatric Catheter Cure Pediatric Catheter Intermittent Urinary Catheter Catheter, Straight 2 EZD
The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
| 510(k)
| Number | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K072539 | Cure Catheter | Cure Medical |
| K080881 | Cure Catheter Closed System | Cure Medical |
Description of the device:
The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric 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.
1
K110 653
page 2 of 2
Indications:
An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
Summary of the technological characteristics of our device compared to the predicate device:
The Cure Pediatric Catheter is substantially equivalent to the predicate devices. The catheter design is identical to both predicates K072539 and K080881 (except in length) and materials are identical to the predicate K080881.
Summary of Nonclinical Testing:
Standard biocompatibility tests were performed on the Cure Catheter to establish device safety. All tests were performed in accordance with ISO10993-1 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices). The studies indicated that the Cure Pediatric Catheter is biocompatible and safe for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Cure Medical. LLC % Ms. Robyn Scopis Regulatory Specialist Regulatory Specialist, Inc. 3722 Ave. Sausalito IRVINE CA 92606
AUG - 1 2011
Re: K110653
Trade/Device Name: Cure Pediatric Catheter by Cure Medical, LLC Regulation Number: 21 CFR$ 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZD Dated: July 25, 2011 Received: July26, 2011
Dear Ms. Scopis:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related
3
Page 2
adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
v.tua.gov/medicaldevices/recallssection.cfm/industry/declaration.htm
Sincerely yours,
Hubert Lemmer MD
Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
4. Indications for Use Statement
Indications for Use
510(k) Number (if known): K110653
Device Name: Cure Pediatric Catheter by Cure Medical, LLC
Indications for Use:
An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for singleuse.
× AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
해양도출장샵ロューヨン
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
icion Sion-Of of Reproductive, Gastro-Renal, and
.....
Page 1 of