GLASS LOSS OF RESISTANCE SYRINGE

{0}------------------------------------------------ K063018 ## SUMMARY B # 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Regulatory Affairs Contact: | Muhamad Ansari<br>Busse Hospital Disposables<br>PO Box: 11067<br>75 Arkay Dr.<br>Hauppauge NY 11788 | JAN 2 2 2007 | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Telephone: | 631-435-4711 Ext: 254 | | | Fax: | 631-435-2849 | | | Date Summary Revised: | January 17, 2007 | | | Product Trade Name: | Glass Loss of Resistance Syringe | | | Common Name: | Conduction Anesthetic | | | Classification: | Class II, 21 CFR 868.5140 | | | Product Code: | CAZ | | | Predicate Device: | BD Glass Loss of Resistance Syringe -<br>(Pre-Amendment Device) | | | Device Description: | The Glass Loss of Resistance Syringe is a single use<br>device, which is sold as sterile individually<br>packaged and sterile packaged inside a<br>kit/procedure tray. The syringe will be available in<br>luer lock and luer slip tip. | | | Intended Use: | The Glass Loss of Resistance Syringe is intended<br>for use in conjunction with an epidural needle, to<br>verify the needle tip placement in the epidural space<br>by the loss of Resistance technique, it will be filled<br>with air and/or saline during use. The loss of<br>Resistance Syringe is not intended for injection or<br>aspiration. The syringe will be sold sterile<br>individually packaged, and as part of a sterile kit. | | 44 - 11 - 11, {1}------------------------------------------------ ## 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE Summary of Testing: All materials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were L929 Men Elution Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, Hemolysis - Rabbit Blood Test, and Kligman Maximization Test. These materials have met the testing requirements and were found to be acceptable for the intended use. Technological Characteristics: [21 CFR 807.92(a)(6)] The subject device has the same Technological Characteristics as a legally marketed predicate device. Conclusion: [21 CFR 807.92(b)(3)] The above statements are accurate representations of the device Busse intents to market. All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted. {2}------------------------------------------------ Public Health Service Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services, USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles a stylized caduceus or a symbol representing health and well-being. ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 2 2007 Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated P.O. Box 11067 75 Arkay Drive Hauppauge, New York 11788 Re: K063018 Trade/Device Name: Glass Loss of Resistance Syringe Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: December 12, 2006 Received: December 15, 2006 Dear Mr. Ansari: 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 Eederal Register. {3}------------------------------------------------ ### Page 2 - Mr. Ansari 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. 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 (240) 276-0120. 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 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, Chris Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ### INDICATIONS FOR USE 510(k) Number (if known): Device Name: Glass Loss of Resistance Syringe. Indication for Use: The Glass Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique; it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit. Prescription Use × (Per 21 CFR 801Subpart D) AND/OR Over-The-Counter Use_ (Per 21 CFR 801Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Pearson 11 10 2017 K068018