SIALO DRAIN

{0}------------------------------------------------ Sialo Drain 510(k) pg 1 of 2 ### 510(K) SUMMARY # SIALOTECH DILATION BALLOON KIT AND ACCESSORIES ### 510(k) Number K072334 JUL 1 8 2008 | Applicant's Name: | Sialo Technologies Ltd.<br>Suite 220<br>11 Ben Gurion Boulevard<br>Ashkelon 78281<br>Israel<br>Tel: +972-8-6710795<br>Fax: +972-9-6782524<br>e-mail: reuven@sialotechnology.com | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Ahava Stein/ Ofer Hornick<br>A. Stein - Regulatory Affairs Consulting<br>20 Hata'as St.<br>Kfar Saba 44425<br>Israel<br>Tel. + 972-9-7670002<br>Fax. +972-9-7668534<br>e-mail: asteinra@netvision.net.il or oh_asra@netvision.net.il | | Date Prepared: | August 2007 | | Trade Name: | Sialo Drain | | Classification Name: | CFR Classification section 878.4200 (Product code OAJ) | | Classification: | Class II medical Device | | Predicate Device: | The Sialo Drain device is comparable to the following predicate devices: | | | - The Tal MicroDrainage Set manufactured by Boston Scientific Corp. (510k exempt). | | | - The Drainage Catheters manufactured by Cook Inc. (510k exempt) | | | - The Jacobs Frontal Sinus Cannula manufactured by Hood Laboratories (510k exempt). | | | - The Jackson Lachrymal Intubation Set manufactured by Accutome (510k exempt). | Delia {1}------------------------------------------------ - The Lachrymal Jones Tube manufactured by Gunther Weiss -Scientific Glassblowing co. (510k exempt). - Device Description: The Sialo drain is a flexible, single lumen, sterile, single use, disposable cannula made of biocompatible radio-opaque polyurethane material. ## Intended Use / Indication for Use: The Sialo Drain is a medical device for use by qualificd surgeons in the treatment of salivary gland diseases for the purpose of drainage. The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek. Performance Standards: None. The Sialo Drain device has been subjected to extensive safety, Test Data: performance, and validation testing before release. Final testing of the SialoTech device included various performance tests designed to ensure that the device met all its functional specifications. Tests have been performed to ensure the device complies with industry and safety standards. - Substantial The Sialo Drain device is similar to other drains which are put in Equivalence: many body orifices and wounds after surgical procedures, similar to the Sialo Drain. - The conclusions drawn from the above Performance Testing and Conclusions: comparison to predicate devices, is that the Sialo Drain device is substantially equivalent in safety and efficacy to the predicate devices listed above. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is an abstract symbol resembling an eagle or bird in flight, composed of several curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Sialo Technologies, Ltd. % Stein Regulatory Affairs Consulting Ms. Ahava Stein Beit Hapa'amon (Box 124) 20 Hata'as St. 44425 Kfar Saba ISRAEL JUL 1 8 2008 Re: K072334 Trade/Device Name: Sialo Drain Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: I Product Code: OAJ Dated: June 30, 2008 Received: July 2, 2008 Dear Ms. Stein: 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 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 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}------------------------------------------------ Page 2 - Ms. Ahava Stein 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 Biometric's (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 yours. Mark M. Mulkison Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Sialo Drain 510(k) pg 1 of 1 #### INDICATIONS FOR USE 510(k) Number (if known): K072334 Device Name: Sialo Drain Intended Use Statement: The Sialo Drain is a medical device for use by qualified surgeons in the treatment of salivary gland diseases for the purpose of drainage. The Sialo Drain is an intraoral/extraoral drainage catheter, intended to allow continuous drainage of saliva and/or fluid irrigation of the salivary duct by temporary insertion into the salivary gland, whether orally or through the cheek. Prescription Use (Per 21 C.F.R. 801 Subpart D) C) OR Over-The-Counter Use (Optional Format Subpart (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) —————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————— Concurrence of CDRH, Office of Device Evaluation (ODE) _ (Division Star Off (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** /<072234 Page 4-2