ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0

{0}------------------------------------------------ ## 510/k) Summary of safety and effectiveness #### Applicant: SEP 2 9 2003 asap endoscopic products GmbH Tullastr. 87 a 79108 Freiburg / Germany #### Contact: Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, Germany Phone: +49 (451) 388 2864 Fax: +49 (451) 388 2867 Email: crc@crc-online.de #### Device name | Hysteroscope, Types: | 10-0018-00, 10-0019-00, 10-0020-00, 10-0021-00,<br>10-0022-00, 10-0023-00, 10-0024-00, | |-------------------------|----------------------------------------------------------------------------------------| | Gyn. Laparoscope, Types | 10-0015-00, 10-0016-00, 10-0089-00, | #### Common name Hysteroscope, Gyn. Laparoscope #### Predicate device name - Baho Hysteroscope (K # not available) and Galileo hysteroscope (K962256) - Baho Gyn. Laparoscope (K982276) #### Code of Federal Regulations (CFR) number 888.1690 and 884.1720 #### General device description The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system. The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system. {1}------------------------------------------------ 510(k) Sum #### Indications for use Like the predicate device, the asap hysteroscope is used to illuminate and visualize the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The asap gynecologic laparoscope is - like the predicate device - used to permit direct viewing of the organs wihin the peritoneal cavity for the purpose of performing diagnostic and surgical procedures. ### Voluntary standard compliance The asap endoscopse comply with - applicable portions of voluntary standards IEC 60601-2-18 - DIN 58105, part 1 and 2 - DIN 17442 (medical steel), as well as applicable portions of - DIN 980 #### Substantially equivalence - Safety and effectiveness The specifications and intended use of the asap endoscopes are the same to those of the claimed predicate devices. There are no significant differences between the asap endoscopes and the claimed predicates in design or conditions of intended use. The asap endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The asap endoscope conforms to applicable ISO standards. The device will be sold non-sterile, to be sterilized prior to each procedure by the user. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol. #### Conclusion In all respects, the asap endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA. It is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility and it conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the asap endoscopes has been confirmed by validation protocol. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains text around the perimeter. The text reads "Department of Health & Human Services USA". In the center of the seal is an abstract image of an eagle. # SEP 2 9 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Horst Baholzer General Manager asap endoscopic products GmbH Tullastr. 87a 79108 freiburg GERMANY Re: K031974 Trade/Device Name: asap Hysteroscope, Models 10-0018-00, 10-0019-00, 10-0020-00, 10-0021-00, 10-0022-00, 10-0023-00, 10-0024-00; and, asap Gynecologic Laparoscope (Surgery), Models 10-0015-00, 10-0016-00, and 10-0089-00 Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Product Code: 85 HIH Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories Product Code: 85 HET Regulatory Class: II Dated: June 10, 2003 Received: July 1, 2003 Dear Mr. Baholzer: 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 de vices 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. 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); 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. {3}------------------------------------------------ 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 the letter: | 8xx. 1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely vours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # 510(k) Number (if known):_______K031974 # Device Name: Indications For Use: Hysteroscope: Provides illumination and visualization of the cervical canal and the r frorerosevity for the purpose of performing diagnostic and surgical procedures. Gynecologic Laparoscope: Used to permit direct viewing of the organs within the Cyrioosie Laparess a performing diagnostic and surgical procedures. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel h. Inson (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number K031974 **Prescription Use** **(Per 21 CFR 801.109)** (Optional Format 3-10-98)