NEO-VAGINA SURGERY SET AND ACCESSORIES

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the date "JAN - 7 2009" on the left side. To the right of the date is the logo for STORZ, with the words "KARL STORZ ENDOSCOPY" written underneath. The logo is in black and white and has a bold, sans-serif font. The image appears to be a scan or photocopy of a document. | 510(K) SUMMARY | | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor/Submitter: | Karl Storz Endoscopy-America, Inc. | | Contact Person: | Crystal Dizol<br>Regulatory Affairs Specialist<br>Email: cdizol@ksea.com | | Date of Submission: | June 26, 2007 | | Device Trade Name: | Karl Storz Neo-vagina Surgery Set and Accessories | | Common Name: | Vaginal Dilator | | Classification Name: | Vaginal Stent | | Regulation Number: | 21 CFR § 4.3900 | | Product Code: | HDX | | Predicate Device(s): | Bioteque America, Inc. (K003380)<br>Specialities REMEEX International, S.L. (K033310) | | Device Description: | The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by<br>qualified surgeons to be placed in the vagina to enlarge the vaginal cavity and<br>maintain the vaginal canal after laparoscopic-assisted creation of a neo-vagina. | | Indications for Use: | The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by<br>qualified surgeons in women with congenital absence of the vagina who have<br>failed first-line non-surgical treatment with conventional vaginal dilators. The set<br>is used in conjunction with a laparoscopic surgical procedure to create and<br>enlarge the vaginal cavity via continuous traction between the abdomen and<br>vulva, and to maintain the vaginal canal after surgery. | | Technological<br>Characteristics: | The KSEA Neo-vagina Surgery Set and Accessories and its predicate devices<br>are removable reusable devices, intended to enlarge the vagina by stretching<br>and maintain vaginal patency. They are composed of biocompatible and<br>autoclavable materials and are available in a range of sizes to meet the clinical<br>and aesthetic needs of each case. | | Summary of<br>Substantial<br>Equivalence: | The KSEA Neo-vagina Surgery Set and Accessories is substantially equivalent<br>to the predicate device since the basic features, design, and intended uses are<br>similar. The minor differences between the KSEA Neo-vagina Surgery Set and<br>Accessories and the predicate devices raise no new issues of safety and<br>effectiveness, as these design differences have no effect on the performance,<br>function, or intended use of the devices. | . r ् : . : {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three horizontal bars representing its wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is in all capital letters. ## Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 7 2009 Ms. Crystal Dizol. Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe CULVER CITY CA 90230-7600 Re: K071754 > Trade/Device Name: KSEA Neo-vagina Surgery Set and Accessories Regulation Number: 21 CFR §884.3900 Regulation Name: Vaginal stent Regulatory Class: II Product Code: HDX Dated: December 29, 2008 Received: December 30, 2008 Dear Ms. Dizol: 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 indictions 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 The general controls provisions of the Act include requirements for annual registration, including of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. {2}------------------------------------------------ ## Page 2 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); 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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Jozue M. Whang Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE K071754 510(k) Number: Device Name: KSEA Neo-vagina Surgery Set and Accessories - Indications for Use: The KSEA Neo-vagina Surgery Set and Accessories is indicated for use by qualified surgeons in women with congenital absence of the vagina who have failed first-line non-surgical treatment with conventional vaginal dilators. The set is used in conjunction with a laparoscopic surgical procedure to create and enlarge the vaginal cavity via continuous traction between the abdomen and vulva, and to maintain the vaginal canal after surgery. Prescription Use: (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) Halus Remen (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number Page 1 of ____________________________________________________________________________________________________________________________________________________________________