GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

{0}------------------------------------------------ SUMMARY OF SAFETY & EFFECTIV Image /page/0/Picture/1 description: The image shows the logo for Glenveigh. The logo consists of a stylized, abstract swirl above the word "Glenveigh". The word "Glenveigh" is written in a serif font, and there is a trademark symbol after the word. 8. This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. APR 1 4 2010 | APPLICANT | Glenveigh Surgical, LLC<br>401 Chestnut Street, Suite 230<br>Chattanooga, TN 37402<br>Rick Proctor<br>Tel: 423-243-3460<br>Fax: 423-634-8080<br>Email: rick.proctor@glenveigh.com | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | OFFICIAL<br>Correspondent | Penny Northcutt, RAC, CQA<br>Regulatory Consultant for Glenveigh Surgical<br>REGSolutions, LLC<br>Tel: 678-428-6978<br>Fax: 678-513-0937<br>Email: pennynorthcutt@theregsolutions.com | | TRADE NAME: | Glenveigh Vaginal Repair Balloon Catheter | | CLASSIFICATION<br>NAME: | Obstetric-Gynecologic Specialized Manual Instrument | | DEVICE<br>CLASSIFICATION | Class II per 21 CFR §884.4530 | | AND PRODUCT<br>CODE | Product Code: KNA | | PREDICATE<br>DEVICE NAME | EpiStat/V-Stat Vaginal Tamponade Balloon (K060289)<br>Cleared July 7, 2006<br>Gauze Packing | ## SUBSTANTIAL EQUIVALENCE: The Glenveigh Vaginal Repair Balloon Catheter is substantially equivalent to the EpiStat/V-Stat Vaginal Tamponade Balloon cleared under K060289. Both the Glenveigh Vaginal Repair Balloon Catheter and the predicate devices have the same method of operation, to temporarily block the flow of fluids to assist in episiotomy/laceration repair. મ {1}------------------------------------------------ Bench testing has demonstrated that the Glenveigh Vaginal Repair Balloon Catheter is functionally equivalent to predicate EpiStat/V-Stat Vaginal Tamponade Balloon, and that any minor differences do not affect safety or effectiveness. ## DESCRIPTION OF THE DEVICE: The Glenveigh Vaginal Repair Balloon Catheter is a single lumen balloon-type catheter which temporarily blocks the flow of fluids to assist in episiotomy/laceration repair. The device consists of the following main components: a vaginal balloon, a tubing/catheter shaft, and an inflation assembly. ### INDICATIONS FOR USE: 8. The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure. ### PERFORMANCE DATA: The Glenveigh Vaginal Repair Balloon Catheter materials that come in direct contact with the patient have a long history of use in medical use and are biocompatible according to ISO 10993. Design verification performance test results demonstrate that the Glenveigh Vaginal Repair Balloon Catheter performs its intended use and is equivalent to the predicate device. #### CONCLUSION: Based on the performance testing, it can be concluded that the Glenveigh Vaginal Repair Balloon Catheter is equivalent to the predicate EpiStat/V-Stat Vaqinal Tamponade Balloon with respect to intended use and technological characteristics. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Glenveigh Surgical, LLC c/o Ms. Penny Northcutt, RAC, COA Regulatory Consultant for Glenveigh Surgical REGSolutions, LLC 717 Lakeglen Drive SUWANEE GA 30034 APR 1 4 2010 K093904 Trade Name: Glenveigh Vaginal Repair Balloon Catheter Regulation Number: 21-CFR & 884,4530 Regulation Name: Obstetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: KNA Dated: March 30, 2010 Received: March 31, 2010 Dear Ms. Northcutt: Re: 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 of medical device-related {3}------------------------------------------------ Page 2 - 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Janine M. Morris Acting Director. Division of Reproductive. Abdominal, and Radiological Devices office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use K093904 510(k) Number (if known): Device Name: GLENVEIGH VAGINAL REPAIR BALLOON CATHETER Indications For Use: The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal laceration repair to temporarily prevent the post partum discharge of fluids from the vagina in order to assist with the episiotomy/laceration repair procedure. Prescription Use × (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hulen Rumen (Division Sidn-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number