(28 days)
No
The document describes a physical medical device (a catheter) and its intended use and performance testing, with no mention of AI or ML technology.
Yes
The device is used to drain urine from the bladder in patients with urine retention and voiding dysfunction, which is a therapeutic intervention.
No
The device is a catheter used for draining urine, not for diagnosing a condition or disease. Its function is to facilitate the drainage of urine in patients already identified with specific conditions, rather than to identify those conditions.
No
The device description clearly states it is a "sterile, single use urine drainage catheter," which is a physical hardware device, not software. The performance studies also describe testing of physical properties like flow measurements, bond strength, and insertion force.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to drain urine from the bladder through the urethra. This is a direct intervention on the body for therapeutic purposes (draining urine retention), not for examining specimens from the body to provide information about a physiological state, health, or disease.
- Device Description: The description clearly states it's a "urine drainage catheter."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like urine itself for diagnostic markers), using reagents, or providing diagnostic information.
IVD devices are used to perform tests on specimens (like blood, urine, tissue) to diagnose, monitor, or screen for diseases or conditions. This device is a medical device used for a therapeutic procedure.
N/A
Intended Use / Indications for Use
CompactCath is 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
Device Description
The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urethra to reach the 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
Product testing was completed and met the acceptance criteria. Testing included flow measurements, bond strength, deployment, and insertion force using anatomical models to simulate clinical use for both the CompactCath device and the predicate device. Test results show the products are equivalent.
Biocompatibility testing was performed per ISO10993 for the original application. Cytotoxicity was conducted for the special 510(k). All materials were found to be biocompatible and suitable for this use.
Sterilization validation and expiry dating were also completed.
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 26, 2016
CompactCath Inc. Naama Stauber Breckler CEO 887 Federation Way Palo Alto, CA 94303
Re: K160858
Trade/Device Name: CompactCath Intermittent Urinary Catheter Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: EZD Dated: March 25, 2016 Received: March 29, 2016
Dear Naama Stauber Breckler,
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
CompactCath Intermittent Urinary Catheter
Indications for Use (Describe)
CompactCath is 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 PRAStaff@fda.hhs.gov
"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
PSC Publishing Services (10) ; 443-6746 EF
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
Company Information
Submitter CompactCath Inc. 887 Federation Way Palo Alto, CA, 94303 Tel: 408-893-9776 Contact Naama Stauber Breckler CEO Trade Name CompactCath Intermittent Urinary Catheter Common Name CompactCath Intermittent Urinary Catheter Classification Class II
EZD
510 (k) Summary
Device Information
| Indications for Use |
|---|
Regulation
Product Code
CompactCath is 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.
21 CFR 876.5130
Predicate Devices
K140945 CompactCath Intermittent Urinary Catheter
Device Description
The CompactCath Intermittent Urinary Catheter is a sterile, single use urine drainage catheter for use in draining urine from the bladder in subjects with urine drainage problems.
Comparison with the predicate device
The CompactCath Intermittent Urinary Catheter is equivalent to the features of the predicate product. The indications for use, theory of operation, clinical application, methods of manufacturing, and materials used are substantially equivalent. Both devices are intended for insertion into the urethra. advancing to the bladder and to provide a
4
pathway for the drainage of urine in male, female and pediatric patients. Both devices are packaged in a Tyvek pouch, heat-sealed and sterilized. Both devices are intended for single use only.
Performance Testing
Product testing was completed and met the acceptance criteria. Testing included flow measurements, bond strength, deployment, and insertion force using anatomical models to simulate clinical use for both the CompactCath device and the predicate device. Test results show the products are equivalent.
Biocompatibility testing was performed per ISO10993 for the original application. Cytotoxicity was conducted for the special 510(k). All materials were found to be biocompatible and suitable for this use.
Sterilization validation and expiry dating were also completed.
Sterilization
The system is provided sterile and is for single use only.
Packaging
The components are placed in a heat sealed Tyvek pouch.
Materials
All materials used in the manufacture of the CompactCath Intermittent Urinary Catheter are suitable for this use and have been used in previously cleared products. The direct patient contacting material is the same as the predicate devices use silicone as a lubricant for ease of insertion.
Conclusion
The modified CompactCath Intermittent Urinary Catheter is as safe and effective, has the same intended use, technological characteristics and principals of operation as the unmodified predicate device. The minor differences between the modified and the predicate device do not raise any new questions of safety or effectiveness. Therefore, the modified CompactCath Intermittent Urinary Catheter is substantially equivalent.