(84 days)
Not Found
No
The summary describes a standard intermittent urinary catheter and does not mention any AI or ML capabilities. The performance studies are based on physical and biological testing standards, not data-driven algorithms.
Yes
The device is indicated for use in patients with chronic urine retention and post-void residual volume due to neurogenic and non-neurogenic voiding dysfunction, which are medical conditions that the device aims to manage or treat.
No
Explanation: The device is a urinary catheter, indicated for draining urine. Its function is to facilitate drainage, not to diagnose a condition.
No
The device description clearly states it is a "sterile, single use urine drainage catheter," which is a physical medical device, not software. The performance studies also focus on physical characteristics like functional performance, biocompatibility, and sterilization.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "urine drainage catheter." Its purpose is to be inserted into the body to drain urine. It does not analyze or test the urine itself.
- Intended Use: The intended use is for "draining urine from the bladder" in patients with urine drainage problems. This is a therapeutic or management function, not a diagnostic one.
The device is an interventional medical device used for managing a physical condition (urine retention/voiding dysfunction), not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
CompactCath TM Lubricated Intermittent Urinary Catheter and OneCath TM Intermittent Urinary Catheter are indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
Product codes
EZD, EZC
Device Description
The CompactCath™ and OneCath™ Intermittent Urinary Catheter are sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Both catheters will be offered in multiple French sizes (8 – 18 Fr.), lengths (10" and 16"), two tip designs (straight and coudé).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Urethra to bladder
Indicated Patient Age Range
male, female, and pediatric patients (adolescents and transitional adolescents)
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
Nonclinical functional performance testing was performed in accordance with:
- BS EN 1616: 1997 + A1:1999 "Sterile urethral catheters for single use" ; and
- ASTM F623:99 "Standard Performance Specification for Foley Catheter"
Biocompatibility testing was conducted in accordance with:
- ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"; and
- FDA Guidance "Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing."
Sterilization validation were conducted according to:
- ISO 11137-1:2006 Sterilization of health care products Radiation Part 1; and
- ISO 11137-2:2013 Sterilization of health care products Radiation Part 2.
- ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2018
Compactcath, Inc. % Tehyen Chu Regulatory Affairs Specialist ATOM Health Corporation 12FL, No.122 Songjiang Rd. Taipei City, 104 Taiwan
Re: K180738
Trade/Device Name: CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD. EZC Dated: May 18, 2018 Received: May 25, 2018
Dear Tehyen Chu:
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.
1
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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
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| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | K180738 |
|---|---|
| Device Name | CompactCath TM Lubricated Intermittent Urinary Catheter and OneCath TM Intermittent Urinary Catheter |
| Indications for Use (Describe) | CompactCath TM Lubricated Intermittent Urinary Catheter and OneCath TM Intermittent Urinary Catheter are indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain. |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
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Image /page/3/Picture/0 description: The image shows the logo for CompactCath. The logo features a stylized blue hand with a circle in the palm, followed by the text "COMPACT" stacked above "CATH". The text is also in blue and has a clean, modern font.
510(k) Summary
In accordance with 21CFR 807.92, the following information is provided for the CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter 510(k) Premarket Notification.
Company Information
| Submitter | CompactCath, Inc.
887 Federation Way
Palo Alto, CA 94303
Tel: 408-893-9776 |
|-----------|-------------------------------------------------------------------------------------|
| Contact | Naama Stauber Breckler
CEO |
Device Information
| Trade/Device Name | CompactCathTM Lubricated Intermittent Urinary
Catheter and OneCathTM Intermittent Urinary Catheter |
|------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name | Intermittent Urinary Catheter |
| Classification | Class II |
| Regulation Number | 21 CFR 876.5130 |
| Regulation Name | Urological Catheter and Accessories |
| Primary Product Code | EZD |
| Secondary Product Code | EZC |
Predicate Devices
- . K160858 CompactCath™ Intermittent Urinary Catheter
- . K140945 CompactCath™ Intermittent Urinary Catheter
Indications for Use
CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter are indicated for use in male, female, and pediatric patients (adolescents and transitional adolescents) with chronic urine retention and patients with post void residual volume (PVR) due to neurogenic and nonneurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
4
Image /page/4/Picture/0 description: The image shows the logo for CompactCath. The logo consists of a stylized hand on the left and the word "COMPACT" stacked on top of the word "CATH" on the right. The hand and the text are in a light blue color.
Device Description
The CompactCath™ and OneCath™ Intermittent Urinary Catheter are sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Both catheters will be offered in multiple French sizes (8 – 18 Fr.), lengths (10" and 16"), two tip designs (straight and coudé).
Comparison with the predicate device
The CompactCath™ and OneCath™ Intermittent Urinary Catheter have the same technological characteristics as the predicate devices. In addition, the indications for use, clinical application, user operation, method of manufacturing, materials and packaging are all substantially equivalent.
Performance Testing
The following performance tests were completed and the result met the acceptance criteria.
- Nonclinical functional performance testing was performed in accordance with: .
-
- BS EN 1616: 1997 + A1:1999 "Sterile urethral catheters for single use" ; and
-
- ASTM F623:99 "Standard Performance Specification for Foley Catheter"
-
- . Biocompatibility testing was conducted in accordance with:
-
- ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"; and
-
- FDA Guidance "Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing."
-
- Sterilization validation were conducted according to:
-
- ISO 11137-1:2006 Sterilization of health care products Radiation Part 1; and
-
- ISO 11137-2:2013 Sterilization of health care products Radiation Part 2.
-
- ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --
- Requirements for the development, validation and routine control of a sterilization process for medical devices
- ●
-
Conclusion
Based on the testing results provided in this premarket notification, the proposed device is as safe and effective, has the same intended use, technological characteristics and principals of operation as the predicate device. The minor differences between the two devices do not raise any new questions of safety or effectiveness. Therefore, the proposed device is substantially equivalent to the predicate device.