SOFTSEAL HSG CATHETER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JUN 2 2 2004 Al Muzzammel, MD Official Correspondent Modern Medical Equipment Mfg., Ltd. E & M Engineering 1705 Dabney Road RICHMOND VA 23230 ## Re: K040238 Trade/Device Name: Softseal HSG Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: June 2, 2004 Received: June 4, 2004 Dear Dr. Muzzammel: 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 for are carsion 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. 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. 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 that a Printeral 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 qadiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my you to ough finding of substantial equivalence of your device to a legally premaired 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 If you desire spoolite 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 Addisonaliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Comphanes at (2017-2211) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small miormation on your responsional 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 yours, Nancy C. Brydon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 1. Indications for Use 510(k) Number (if known): K040238 Device Name: Softseal HSG Catheter ## Indications For Use: Indications I VI OSC. Softseal Catheter (a uterine manipulator/injector) is used to access the uterine cavity for Softseal Catheter (a atention of contrast fluid (or gas) into the uterus to enable the the injection and retemator of contrast not for intrafallopian procedure. The perforing clinical indications are some of the applications - 1. Infertility - 2. Menorrhagia - 3. Dysmenorrhca Due to Uterine Synechia - 4. Suspected Endometrial Polyp - 5. Submucous Fibroid - 5. Submutorus I lorean Uterine Synechia (Asherman Syndrome) - 7. Congenital Uterine Abnormality Prescription Use > AND/OR Over-The Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 . Daniel G. Ingram (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number.