MACY CATHETER

{0}------------------------------------------------ ## 510(k) Summary Prepared July 15, 2013 | Sponsor: | Hospi Corporation<br>2384 Gehringer Drive<br>Concord, CA 94520 | |-----------------------|-----------------------------------------------------------------------| | Contact Person: | Igal Ladabaum | | Telephone: | 650-483-1035 | | Fax: | 925-676-0151 | | Submission Date: | July 15, 2013 | | Device Name: | Macy Catheter | | Common Name: | Rectal Catheter | | Classification: | | | Regulatory Class: | II | | Review Category: | 21 CFR Gastrointestinal Tube and Accessories<br>(ref. 21 CFR 876.5980 | | Classification Panel: | Gastroenterology/Urology | ## A. Legally Marketed Predicate Devices The Macy Catheter is substantially equivalent to the Indwelling Fecal Management System- Non-Sterile, (IFMS) manufactured by Bowel Management Systems (K023344). ### B. Device Description The Macy Catheter has been designed for comfort and safety by utilizing a flexible silicone body that enables administration of liquids/medications to the rectum. The device has two lumens, one for administering the liquids/medications and the other for inflation of the retention balloon. The catheter is inserted into the rectum and a small, soft retention balloon is inflated with water via the inflation valve. Liquids/medications are delivered via the medication valve, through the catheter, and into the rectum. The retention balloon can be easily deflated for removal of the catheter. The Macy Catheter remains in the recturn until expelled upon defecation (or removed for defecation if the patient prefers). ## C. Intended Use The Macy Catheter is intended to provide rectal access to administer liquids/medications. # JAN 2 4 2014 {1}------------------------------------------------ # D. Substantial Equivalence , The submission device is substantially equivalent to the Indwelling Fecal Management System- Non-Sterile (IFMS) manufactured by Bowel Management Systems (K023344). | Feature | Predicate Device | Subject Device | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for use | Indwelling Fecal Management System-<br>Non-Sterile<br>(IFMS by Bowel Management<br>Systems) K023344 | Macy Catheter | | | Diversion of fecal matter to minimize<br>external contact with the patient, to<br>facilitate the collection of fecal matter<br>for patients requiring stool<br>management, and to provide access for<br>colonic irrigation to trigger a<br>defecatory response, and administration<br>of enemas/medication. | The Macy Catheter is intended<br>to provide rectal access to<br>administer<br>liquids/medications. | | Intended Users | Healthcare Professionals | Healthcare Professionals | | Class | II | II | | Regulation number | 21CFR 876.5980 | 21CFR 876.5980 | | Code | KNT | KNT | | Catheter and lumen material | Silicone | Silicone,<br>Compliant with ISO 10993 | | Retention Balloon | 35-40ml water inflated silicone<br>balloon, 2.08 inch outer diameter when<br>inflated. Positioned adjacent to<br>sphincter in distal rectum. | 15 ml water inflated silicone<br>balloon, 1.1 inch outer<br>diameter when inflated.<br>Positioned adjacent to<br>sphincter in distal rectum. | | Administration of<br>Liquids/<br>Medications | Silicone lumen with flared tapered port<br>termination. | Silicone lumen with valved<br>port for enteral/oral syringe. | | Insertion Diameter | 1.2 inches nominal | 0.29 inches maximum | | Fecal drainage<br>lumen and stop-<br>flow balloon | Yes | No | | Safety features | Not specified in device labeling | Compliant with ISO 80369-1<br>minimizing risks of<br>misconnection. Retention<br>balloon, smaller than most<br>formed stool, can be expelled<br>with defecation; meets<br>applicable test criteria of<br>Standard Test Methods for<br>Enteral Feeding devices with<br>Retention Balloon. | | Single use | Yes | Yes | | Sterile | No | No | | Length | 64.5 Inches | 20 Inches | # E. Performance Data Bench testing was conducted on the device to verify that it met design specification established under the Design Control Process with successful results. The performance {2}------------------------------------------------ verification test results are provided in the submission under the section on Performance Data, Section 18. Biocompatibility testing was conducted in compliance with applicable parts of ISO 10993 as determined by ISO 10993 Part 1. Biocompatibility test reports are provided in the submission under the section on Biocompatibility Testing, Section 15. The nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence include: - Mechanical verification testing including ASTM F 2528-06 test methods (for . example balloon and shaft size, balloon integrity and reliability via balloon volume maintenance and balloon burst volume tests, device tensile strength, lumen patency and flow rate, balloon and shaft mechanical properties). - . Packaging and shipping stress simulations - Verification of design features intended to mitigate mistaken connections per ISO . 80369-1. - GLP test results for applicable biocompatibility testing. Test reports included are: . - Cytotoxicity-medication valve as fabricated, leveraged catheter test o article of identical fabrication but slightly different geometry and sterile. - Sensitization-medication valve as fabricated, leveraged catheter test o article of identical fabrication but slightly different geometry and sterile. - Irritation-medication valve as fabricated, leveraged catheter test article O of identical fabrication but slightly different geometry and sterile. - Systemic toxicity (acute)-catheter portion as fabricated. o - Sub-chronic toxicity (sub-acute)-leveraged catheter test article of ം identical fabrication but slightly different geometry and sterile. - Genotoxicity—leveraged catheter test article of identical fabrication but o slightly different geometry and sterile. - Muscle Implantation (test for local effects after implantation, 4 week)-O test coupons cut from catheter as fabricated. The results of the tests performed demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device identified in Part A of this summary. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure, composed of three curved lines. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 24, 2014 Hospi Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313 Re: K133881 > Trade/Device Name: Macy Catheter Regulation Number: 21 CFR§ 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: January 8, 2014 Received: January 10, 2014 Dear Mark Job, 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 general condinaturing 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. {4}------------------------------------------------ Page 2 - Mark Job ﻭﺍﻟﺘﺮﻛﻴﺐ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ 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/ReportalProblem/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 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}------------------------------------------------ Indications For Use 510(k) Number (if known): K133881 Device Name: Macy Catheter 1. 2 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Indications for Use: The Macy Catheter is intended to provide rectal access to administer liquids/medications. Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Herbert P. Lerner -S 2014.01.24 13:12:20 -05'00' Page 4-2