SIB CATHETER, MODEL 61-7005

{0}------------------------------------------------ MAY 2 1 2002 Oa1a7a Page 1 of 2 、「Andrew State」の「Andrew Station」の一般的には、「Marin Marin - Barner - Barner - # Attachment 4 # 510(k) Summary and the security of the minister and the considered to | Device<br>Description | Trade Name: | SIB Catheter | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | | Common Name: | Hysterosonography Catheter | | | Classification Name: | Cannula, manipulator/injector, Uterine, Product<br>Code LKF | | Predicate<br>Device | K013972, H/S Elliptosphere Catheter Set, 12/17/01 | | | Date | April 17, 2002 | | | Contact | Richard Hettenbach<br>Vice President, Regulatory Affairs and Quality Assurance<br>Ackrad Laboratories, Inc.<br>70 Jackson Drive<br>Cranford, NJ 07016<br>Tel: (908) 276-6390<br>Fax: (908) 276-1895 | | | Device | The SIB Catheter consists of a 5 F balloon catheter with a single lumen<br>polyurethane shaft with an end hole. The balloon inflates upon infusion of<br>contrast media into the uterus. Increasing the infusion rate will cause the<br>balloon to grow thereby occluding the cervical canal. Cessation of saline<br>injection will cause the balloon to collapse. | | | Intended Use | The SIB Catheter is intended for the delivery of diagnostic contrast media<br>agents into the female reproductive tract for examination of the uterus | | | Technological<br>Characteristics | The SIB Catheter has the same technological characteristics<br>as the predicate device. The intended use, operating principle are<br>identical. The SIB Catheter is packaged and sterilized using the same<br>materials and processes. | | {1}------------------------------------------------ Pre-clinical testing has been conducted to verify that the product meets the Performance performance requirements described. It was determined that the SIB Data Catheter performs safely and effectively. Conclusion The SIB Catheter is substantially equivalent to the predicate H/S Elliptosphere Catheter Set. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Richard Hettenbach Vice President, Regluatory Affairs/Quality Assurance ACKRAD Laboratories, Inc. 70 Jackson Drive CRANFORD NJ 07016 Re: K021272 Trade/Device Name: SIB Catheter Model 61-7005 Regulation Number: None Regulatory Class: Unclassified Product Code: 85 LKF Dated: April 17, 2002 Received: April 22, 2002 Dear Mr. Hettenbach: 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); 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 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: | 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" (21 CFR Part 807.97). 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 yours, Nancy Crozdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Attachment 2 ## Indications for Use Statement 210(k) Number KO21272 SIB Catheter Device Name Indications for Use The SIB Catheter is used for the delivery of diagnostic contrast media into the female reproductive tract for examination of the uterus. ### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED ### Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use V (Per 21 CFR 801.109) OR Over-The Counter Use_ David A. Aycock (Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 02/272 510(k) Number