(84 days)
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.
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).
This document is a 510(k) summary for the CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter. It outlines the device's information, predicate devices, indications for use, device description, and comparison.
Here's an analysis of the provided text to extract information about acceptance criteria and study proving device performance, specifically for a medical device, not an AI algorithm:
Acceptance Criteria and Device Performance
The provided document describes the performance testing conducted for the CompactCath™ Lubricated Intermittent Urinary Catheter and OneCath™ Intermittent Urinary Catheter. This is a medical device, not an AI algorithm, and therefore the criteria and study methodology are focused on physical and material properties, sterilization, and biological safety, rather than AI performance metrics like sensitivity, specificity, or AUC.
The document states:
"The following performance tests were completed and the result met the acceptance criteria."
This implicitly indicates that for each test, there was a predefined acceptance criterion (e.g., "must meet the standards outlined in BS EN 1616: 1997 + A1:1999"). The document confirms that these criteria were met by stating "the result met the acceptance criteria."
Since this is a physical medical device, not an AI, many of the typical AI study questions (like sample size for test/training sets, expert adjudication, MRMC studies, effect size of human readers, ground truth for AI, etc.) are not applicable.
Here's the information extracted and framed in the context of a medical device submission:
1. A table of acceptance criteria and the reported device performance
The document lists the standards and regulations the device was tested against. The "reported device performance" is a blanket statement that the device met the acceptance criteria for all listed tests. Specific numerical results or detailed pass/fail thresholds for each individual test within these standards are not provided in this summary.
| Test Category | Applicable Standard/Regulation | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Nonclinical Functional Performance Testing | 1. BS EN 1616: 1997 + A1:1999 "Sterile urethral catheters for single use" | Compliance with all specified requirements and performance characteristics of the standard (e.g., flow rate, dimensional tolerances, integrity, lubrication properties). | "…performed in accordance with… and the result met the acceptance criteria." (Implies compliance with all aspects of the standard.) |
| 2. ASTM F623:99 "Standard Performance Specification for Foley Catheter" (Note: Product is an intermittent catheter, but likely tested for relevant performance aspects like material strength, lubricity if applicable, and other physical properties transferable from a Foley standard). | Compliance with all specified requirements and performance characteristics of the standard. | "…performed in accordance with… and the result met the acceptance criteria." (Implies compliance with all aspects of the standard.) | |
| Biocompatibility Testing | 1. ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process" | Demonstration of biological safety, e.g., non-cytotoxicity, non-sensitization, non-irritation, and other applicable biocompatibility endpoints as guided by the standard and risk assessment. | "…conducted in accordance with… and the result met the acceptance criteria." (Implies the device demonstrated acceptable biological safety as per the standard.) |
| 2. FDA Guidance "Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing." | Adherence to FDA's interpretation and expectations for biocompatibility testing based on ISO 10993-1. | "…conducted in accordance with… and the result met the acceptance criteria." (Implies the device demonstrated acceptable biological safety as per FDA guidance.) | |
| Sterilization Validation | 1. ISO 11137-1:2006 "Sterilization of health care products Radiation Part 1" | Achievement of a defined Sterility Assurance Level (SAL), typically 10^-6, ensuring effective radiation sterilization. | "…conducted according to… and the result met the acceptance criteria." (Implies the sterilization process was validated to achieve the required SAL for radiation sterilization.) |
| 2. ISO 11137-2:2013 "Sterilization of health care products Radiation Part 2" | Compliance with the requirements for establishing the sterilization dose for radiation sterilization. | "…conducted according to… and the result met the acceptance criteria." (Implies the sterilization dose was appropriately established and met the criteria for radiation sterilization.) | |
| 3. 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" | Achievement of a defined Sterility Assurance Level (SAL), typically 10^-6, ensuring effective ethylene oxide (EO) sterilization. | "…conducted according to… and the result met the acceptance criteria." (Implies the sterilization process was validated to achieve the required SAL for ethylene oxide sterilization.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For device performance testing, samples are drawn from production lots, but specific numbers for each test are typically detailed in the full test reports, not the summary. Data provenance is generally not a concept applied in the same way to functional device testing as it is to clinical or imaging data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is a physical medical device. Ground truth, in this context, relates to compliance with engineering standards and biological safety, not expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as this is a physical medical device. Adjudication refers to resolving disagreements in expert interpretations, which is not relevant to validating device specifications against engineering standards.
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
This is not applicable as this is a physical medical device. MRMC studies are used for evaluating diagnostic imaging systems or AI algorithms, not for physical devices like catheters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is a physical medical device. "Standalone" performance refers to an AI algorithm's performance without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance testing is defined by the validated and recognized international and national standards (BS EN, ASTM, ISO) and FDA guidance documents. These standards specify the test methodologies, acceptable ranges, and limits for various physical, chemical, and biological properties of the device.
8. The sample size for the training set
This is not applicable as this is a physical medical device. There is no "training set" in the context of functional and biocompatibility testing for a physical device.
9. How the ground truth for the training set was established
This is not applicable as this is a physical medical device.
{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,
Image /page/1/Picture/6 description: The image shows the name "Glenn B. Bell -S" in a large, bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is easy to read.
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
{2}------------------------------------------------
| 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.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
{3}------------------------------------------------
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 WayPalo Alto, CA 94303Tel: 408-893-9776 |
|---|---|
| Contact | Naama Stauber BrecklerCEO |
Device Information
| Trade/Device Name | CompactCathTM Lubricated Intermittent UrinaryCatheter 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.
§ 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.