COMPACTCATH INTERMITTENT URINARY CATHETER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of three faces in profile, stacked on top of each other. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the image. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 21, 2014 CompactCath % Gregory Mathison President Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, MN 55612 Re: K140945 > Trade/Device Name: CompactCath Intermittent Urinary Catheter Regulation Number: 21 CFR§ 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: II Product Code: EZD Dated: June 30, 2014 Received: August 14, 2014 Dear Gregory Mathison, 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 (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. 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/ucm115809.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/ResourcesforYou/Industry/default.htm. Sincerely vours. # 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 {2}------------------------------------------------ # Indications For Use # Indication CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) 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. Indications of Use Red-line version: # Indication CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) 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. {3}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. 510(k) Number (if known) K140945 Device Name CompactCath Intermittent Urinary Catheter Indications for Use (Describe) CompactCath Intermittent Urinary Catheted for use in male, female, and pediatric patients (adolescent and transitonal adolescent) with chronic urine retention and patients with post void residual volume (PVR) due to newogenic 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 807 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {4}------------------------------------------------ # Modified 510(K) Summary # 510(k) Summary | Date of Submission: | March 31, 2014 | |---------------------|---------------------------------------------------------------| | Classification | Class II | | Trade Name | CompactCath Intermittent Urinary Catheter | | Submitter | CompactCath Inc.<br>2945A Bush St<br>San Francisco, CA, 94115 | | | Contact:<br>Gregory Mathison | Regulatory Affairs #### Indications for Use The CompactCath Intermittent Urinary Catheter is indicated for use in male, female, and pediatric patients (adolescent and transitional adolescent) 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. #### Predicate Devices K100878 Self Cath Catheter Coloplast A/S #### 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. ## Sterilization The system is provided sterile and is for single use only. #### Packaging The components are placed in a heat sealed Tyvek pouch. {5}------------------------------------------------ ## 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 device. Both devices use silicone as a lubricant for ease of insertion. # 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. All materials were found to be biocompatible and suitable for this use. Sterilization validation and expiry dating were also completed. ## Summary of Substantial Equivalence 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 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. | Feature/ Information | CompactCath | Coloplast | Substantial Equivalence | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | CompactCath Inc. | Coloplast A/S | | | 510(k) Number | K140945 | K100878 | | | FDA Classification | Class II | Class II | Same | | Regulation number | 876.5130 | 876.5130 | Same | | Product Code | EZD | EZD | Same | | Indications for Use | The CompactCath Intermittent<br>Urinary Catheter is indicated for<br>use in male, female and pediatric<br>patients (adolescents and<br>transitional adolescents) with<br>chronic urine retention and patients<br>with post void residual volume<br>(PVR) due to neuorgenic and non-<br>neurogenic voiding dysfunction.<br>The catheter is inserted into the<br>urethra to reach the bladder<br>allowing urine to drain. | The Self Cath Catheter is intended<br>for use in male, female, and<br>pediatric patients (neonates,<br>infants, children, adolescents, and<br>transitional adolescents) requiring<br>bladder drainage as determined by<br>their physician. This device is<br>indicated for those individuals<br>unable to promote a natural urine<br>flow or for those individuals who<br>have a significant volume of<br>residual urine following a natural<br>bladder-voiding episode. | Equivalent - both devices are indicated<br>for bladder drainage in males, females<br>and adolescents, and transitional<br>adolescents patients. Intermittent<br>catheterization is indicated for patients<br>who have residual urine remaining in<br>their bladder. | | Technology & Design /<br>Description | Tubular catheter which is inserted<br>into the urethra and advanced into<br>the bladder to facilitate urine<br>drainage | Tubular catheter which is inserted<br>into the urethra and advanced into<br>the bladder to facilitate urine<br>drainage | Equivalent - both devices are tubular<br>catheters that allow urine drainage when<br>inserted into the urethra to the bladder | | Materials | Catheter - PVC | Catheter - PVC | Equivalent - same base materials - exact<br>vendor and classification of predicate | Refer to the table below for comparison data and substantial equivalence rationale {6}------------------------------------------------ | | | | | material unknown. | |--------------------------------------------------------|----------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Physical<br>Dimensions | Length | 16" (for adults), 10" (for pediatric) | 16" (for adults), 10" (for pediatric) | Same | | | Diameter | 8-12FR | 8-18FR | Same | | | Number of<br>eyelets | 2 | 2 | Same | | Clinical Procedure | | Inserted into the urethra and<br>advanced into the bladder to<br>facilitate urine drainage | Inserted into the urethra and<br>advanced into the bladder to<br>facilitate urine drainage | Equivalent - same clinical application -<br>device is introduced into the urethra and<br>advanced to the bladder to facilitate<br>urine drainage | | Theory of Operation | | Provides a pathway for urine<br>drainage | Provides a pathway for urine<br>drainage | Same | | Lubricated | | Yes - silicone | Yes - silicone | Equivalent - both catheters are pre-<br>lubricated for ease of use and patient<br>comfort | | Method of Sterilization | | Radiation | ETO | Equivalent - both devices are provided<br>sterile. CompactCath is sterilized with<br>Radiation in a validated cycle. Predicate<br>device is sterilized using ETO gas. | | SAL | | 10-6 | Unknown | Equivalent - assumed to be 10-6 as this is<br>a FDA cleared product | | Single Use | | Yes | Yes | Same | | Shelf Life | | 6 months | 2 Years | Equivalent | | Packaging | | Tyvek pouch | Tyvek pouch | Equivalent | | Performance specifications &<br>testing summary (avg.) | | Insertion force | Female 0.08 lbf<br>Male 1.08 lbf | Female 0.06 lbf<br>Male 1.38 lbf | | | | Flow test | 504 ml/min | 520 ml/min | | | | Hub pull | 17.97 (lbf, {N}) | 14.96 (lbf, {N}) |