EZ HSG CATHETER.FOAMSEAL CATHETER

{0}------------------------------------------------ K0835-94/ # JUL 2 1 2009 # 510K Summary (K083594) #### Submitted by: Al Muzzammel, M.D. OBG Products 8292-C Old Courthouse Rd Vienna, VA 22182 Tel: (703) 448-8787 July 17, 2009 Device: Trade Name: Proposed Classification Name: Common/Usual Name: Regulation Number: Product Code: Class: Foam Seal Catheter Cannula, Manipulator/Injector, Uterine HSG Catheter Unclassified LKL Unclassified #### Device Description: Foam Seal Catheter is a single channel catheter intended for use during Foam Seal Cadieter is a single endinsion sonogram. Foam Seal Catheter is a simplified version of double-channel balloon HSG catheter. This device has a single channel version of 1.6mm to 3mm in diameter and has a length of 370mm. Both ends of this catheter are open. The outer end has a luerlock device. A two way lock is attached to this end. The inner end is used to introduce fluid into the cavity of uterus. An introducer this cho. The finiter ens of agent is placed on its mid-segment. Both catherer and of an external caminate of plastic material. A cone-shaped foam component is attached close Calliula are made of placed in the cervical canal during the procedure. The foum to himel end so it can be placed find seal and to keep the catheter in place. Fluid media is injected into the cavity of uterus using this catheter with a syringe. Thich media is injected into ax carry of on the injected fluid. Radiology procedures of ultrasound examination is performed at this time and images of the cavity of the uterus is taken. There are several advantages to this device. This is a single chamel device and is taken. There are several advantages to the cervical canal and keeps the catheter in place without the need of an assistant. {1}------------------------------------------------ ### Predicate Device: This Foam Seal catherer is comparable to existing predicate devices: H/S Elliptosphere Catheter set with 510K number K 013972. 1 #### Intended Use: The Fourn Seal SIS/HSG Catheter is intended for introduction of liquid into the uterine cavity for ultrasonogram and radiology procedure of the uterus and fallopian tubes. #### Summary of Technologies: The Foam Seal Catheter has the same technological characteristics as the predicate The Four Sear Catherer has the bases. The intended use and operating principles are identical. The Foam Seat cather is individually packaged in ETO sterilized blister pack for single use. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle. ## DEPARTMENT OF HEALTH & HUMAN SERVICES #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Al Muzzammel, M.D. President OBG Products 8292-C Old Courthouse Road VIENNA VA 22182 - JUL 2 1 2009 Re: K083594 Trade/Device Name: Foam-Seal Catheter Regulation Number: None Regulatory Class: Unclassified Product Code: LKF Dated: June 22, 2009 Received: June 24, 2009 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 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. 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 (reporting of medical {3}------------------------------------------------ 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Irvine M. Morris Janine M. Morris Acting Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # FDA U.S. Food and Drug Administration CENTER FOR DEVICES AND RADIOLAGICAL HEALTH # Indications for use 10(K) Number (if known): 510K# K083594 Device Name: Foam-Seal Catheter # Indications for Use; Injection of fluid into the uterine cavity during Saline Infusion sonogram (SIS) & hysterosalpinogram (HSG). Following are some Clinical Indications: - 1. Infertility. - 2. Menorrahagia. - 3. Dysmenorrhea. - 4. Suspected Endometrial Polyp. - 5. Uterine Fibroid. - 6. Amenorrhea due to Uterine Synechea (Asherman Syndrome). - 7. Congenital Uterine Anomaly. 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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) tom Whan (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number. Exhibit #3