(136 days)
No
The description focuses on the physical properties and intended use of a conventional intermittent urinary catheter, with no mention of AI or ML capabilities.
No
This device is an intermittent urinary catheter used for bladder drainage, which is a supportive function rather than a therapeutic treatment for disease.
No
The device is described as an intermittent urinary catheter for bladder drainage, not for diagnosing conditions.
No
The device description clearly states it is a physical intermittent urinary catheter made of PVC with a hydrophilic coating, which is a hardware device.
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 diagnose, monitor, or screen for various health issues.
- Device Function: The Cure Catheter is a physical device inserted into the body (urethra) for the purpose of draining the bladder. It is a therapeutic device, not a diagnostic test performed on a sample.
- Intended Use: The intended use clearly states "for the purpose of bladder drainage," which is a physical intervention, not a diagnostic process.
Therefore, the Cure Catheter falls under the category of a medical device used for treatment/management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cure Catheter TM Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females.
The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.
Product codes
EZD
Device Description
The Cure Catheter TM Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra (for bladder drainage)
Indicated Patient Age Range
Adult and pediatric males and females.
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
Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter TM Hydrophilic Coated is biocompatible and safe for its intended use.
Product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Cure Medical Cure Catheter K072539, Cure Pediatric Catheter K110653
Reference Device(s)
Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter K050874, Coloplast SpeediCath K023254
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
Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission
| 510(k) SUMMARY | ||||||
|---|---|---|---|---|---|---|
| Submitted by: | Ann Kenowsky, President | |||||
| Cure Medical, LLC | ||||||
| 3700 Newport Blvd., #301 | ||||||
| Newport Beach, CA 92663 | ||||||
| 949 673 8474 (Phone) | ||||||
| 949 723 0564 (Fax) | ||||||
| email: akenowsky@curemedical.com | ||||||
| Contact person: | John Beasley, MS, RAC (US) | |||||
| MedTech Review, LLC | ||||||
| 257 Garnet Garden Street | ||||||
| Henderson, NV 89015 | ||||||
| 612 889 5168 (Phone) | ||||||
| email: john@medtechreview.com | ||||||
| Date Prepared: | 10 November 2013 | |||||
| Trade Name: | Cure Catheter ™ Hydrophilic Coated | |||||
| Common Name: | Urinary catheter for intermittent use | |||||
| Classification Name: | Urological catheter | |||||
| Device Class: | II | |||||
| Procode: | EZD (catheter, straight) | |||||
| CFR Reference: | 876.5130 | |||||
| Predicate Device(s): | Cure Medical Cure Catheter K072539 | |||||
| Cure Pediatric Catheter K110653 | ||||||
| Reference Devices(s): | Astra Tech AB LoFric® Primo™ Single Use Urinary Catheter | |||||
| K050874 | ||||||
| Coloplast SpeediCath K023254 | ||||||
| Device Description: | The Cure Catheter ™ Hydrophilic Coated is an intermittent | |||||
| urinary catheter intended to be used by adult and pediatric | ||||||
| males and females for the purpose of bladder drainage. The | ||||||
| catheter is manufactured with conventional medical grade | ||||||
| PVC. The surface is coated with a hydrophilic low-friction | ||||||
| coating (polyvinyl pyrrolidone, or PVP) and, when activated |
1
Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission
| Intended Use: | with water it becomes slippery and ready to use. The straight
and Coudè tip configurations have been designed to eliminate
trauma to the urethra and are offered in a variety of sizes.
Each catheter is provided in sterile, single-use packages. |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cure Catheter ™ Hydrophilic Coated is an intermittent
urinary catheter that is inserted through the urethra and
indicated for the purpose of bladder drainage for males and
females. |
The Cure Catheter ™ Hydrophilic Coated and listed predicate devices are all similar in device function, features, Technology Comparison: composition, and intended use as listed in the following table:
| Characteristics | Proposed Device | Predicate Devices | Reference Devices | ||
|---|---|---|---|---|---|
| Cure Catheter ™ | |||||
| Hydrophilic Coated | Cure Medical | ||||
| Cure | |||||
| Catheter™ | Cure Medical | ||||
| Cure | |||||
| Pediatric | |||||
| Catheter™ | Astra Tech AB | ||||
| LoFric® | |||||
| Primo™ Single | |||||
| Use Urinary | |||||
| Catheter | Coloplast | ||||
| SpeediCath | |||||
| 510(k) | / | K072539 | K110653 | K050874 | K023254 |
| Device Features | Hydrophilic coated, | ||||
| with water sachet. | |||||
| Low friction between | |||||
| catheter and urethral | |||||
| mucosa. Ready to | |||||
| use. | No coating | No coating | Hydrophilic | ||
| coated, with | |||||
| water | |||||
| integrated in | |||||
| the package. | |||||
| Low friction | |||||
| between | |||||
| catheter and | |||||
| urethral | |||||
| mucosa. | Hydrophilic | ||||
| coated. Low | |||||
| friction | |||||
| between | |||||
| catheter and | |||||
| urethral | |||||
| mucosa. Ready | |||||
| to use. | |||||
| Sizes¹ | Female 6 inch | ||||
| Straight Tip | |||||
| Ch 6, 8, 10, 12, 14, | |||||
| 16, 18 | Female | ||||
| Straight Tip 6 | |||||
| inch Ch 8, 10, | |||||
| 12, 14, 16, 18 | Pediatric, 10 | ||||
| inch Straight | |||||
| Tip, Ch 8, 10, | |||||
| 12, 14 | Female 150mm | ||||
| Ch 8, 10, 12, 14 | Female | ||||
| Ch 6, 8, 10, 12, | |||||
| 14, 16 | |||||
| Male 16 inch Straight | |||||
| and Coudè Tip | |||||
| Ch 8, 10, 12, 14, 16, | |||||
| 18 | Male Straight | ||||
| Tip 16 inch Ch | |||||
| 8, 10, 12, 14, | |||||
| 16, 18 | Female 200mm | ||||
| Ch 8, 10, 12, 14, | |||||
| 16, 18 | Male | ||||
| Ch 8, 10, 12, 14, | |||||
| 16, 18 | |||||
| Pediatric 10 inch | |||||
| Straight Tip Ch 6, 8, | |||||
| 10, 12, 14 | Male | ||||
| Ch 8, 10, 12, 14, | |||||
| 16, 18, 20, 22, | |||||
| 24 | Tiemann | ||||
| Ch 10, 12, 14 | |||||
| Tiemann | |||||
| Ch 10, 12, 14, | |||||
| 16, 18 | Pediatric | ||||
| Ch 6, 8, 10 | |||||
| Pediatric | |||||
| 200mm | |||||
| Ch 6, 8, 10 | Boy | ||||
| Ch 6, 8, 10, 12 | |||||
| Boy | |||||
| Ch 6, 8, 10 |
1 The name and the symbol "Ch" refer to the Charrière gauge scale, which is often called the French scale.
2
| Characteristics | Proposed Device | Predicate Devices | Reference Devices | ||
|---|---|---|---|---|---|
| Cure Catheter™ | |||||
| Hydrophilic Coated | Cure Medical | ||||
| Cure | |||||
| Catheter™ | Cure Medical | ||||
| Cure | |||||
| Pediatric | |||||
| Catheter™ | Astra Tech AB | ||||
| LoFric® | |||||
| Primo™ Single | |||||
| Use Urinary | |||||
| Catheter | Coloplast | ||||
| SpeediCath | |||||
| 510(k) | / | K072539 | K110653 | K050874 | K023254 |
| Sterility | STERILE | STERILE | STERILE | STERILE | STERILE |
| Packaging | Peel Pack | Peel Pack | Peel Pack | Peel Pack | Peel Pack |
| Device | |||||
| composition | Polyvinyl Chloride | ||||
| (PVC) Catheter with | |||||
| DSM Comfort Coat - | |||||
| polyvinylpyrrolidone |
- Hydrophilic
Material Coating -
and sterile water
sachet | Polyvinyl
Chlorine
Catheter
without
hydrophilic
coating | Polyvinyl
Chlorine
Catheter
without
hydrophilic
coating | Polyvinylchlori
de catheter
coated with
polyvinylpyrrol
idone and salt.
Packaged with
water sachet. | Polyurethane
catheter coated
with
polyvinylpyrrol
idone, placed in
a saline
solution
containing
polyvinylpyrrol
idone. |
| Intended Use | Intermittent
catheterization,
through the urethra,
for the purpose of
bladder drainage for
males and females. | Intermittent
catheterization,
through the
urethra, for the
purpose of
bladder
drainage for
males and
females. | Intermittent
catheterizatio
n through the
urethra for
the purpose of
bladder
drainage for
pediatric
males and
females. | Intermittent
catheterization
of the urethra. | Chronic urine
retention.
Post-void
residual
volume (PVR).
Voiding
dysfunctions. |
Cure Medical - Cure Catheter® Hydrophilic Coated Special 510(k) Submission
Studies conducted per US FDA General Program memorandum #G95-1 indicate that the Cure Catheter ™ Hydrophilic Coated is biocompatible and safe for its intended use.
Performance Testing:
Moreover, product evaluation, through design verification and design validation activities, supports the device's functionality without new questions of safety or effectiveness.
The Cure Catheter ™ Hydrophilic Coated is substantially Conclusion of Comparison: equivalent to the currently marketed predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 23, 2013
Cure Medical LLC c/o John Beasley, MS, RAC Founder and Senior consultant Medtech Review, LLC 257 Garnet Garden Street Henderson, NV 89015
Re: K132500
Trade/Device Name: Cure Catheter® Hydrophilic Coated Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: Class II Product Code: EZD Dated: November 25, 2013 Received: November 26, 2013
Dear Mr. John Beasley:
We have reviewed vour 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 (reporting of medical
4
Page 2 - Mr. John Beasley
device-related 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor YowIndustry/default.htm. 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.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation . Center for Devices and Radiological Health
Enclosure
5
Cure Medical - Cure Catheter ® Hydrophilic Coated Special 510(k) Submission
Indications for Use
510(k) Number (if known): K132500
Device Name: Cure Catheter ® Hydrophilic Coated
Indications for Use:
The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
and/or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(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)
Herbert P. Lerner -S 2013.12.23 09:57:47 -05'00'
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Cure Medical, LLC
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